CN102716394A - Medicine composition for treating skin diseases - Google Patents

Abstract

The present invention relates to pharmaceutical compositions for skin diseases. Specifically, the present invention relates to a composition, which is prepared from the following Chinese medicinal materials: Sophora flavescens, Smilax cocos, Capillary wormwood, Cortex Phellodendron, Gentiana, Cortex dictamni, Purslane, Kochia scoparia, Herbs, raw licorice, and optional menthol and ice flakes. The composition of the present invention has a significant increase in itching domain, can effectively inhibit mouse ear swelling, and is expected to have good safety. In addition, the composition of the present invention can effectively inhibit xylene-induced ear swelling in mice, and can effectively inhibit paw swelling caused by egg white in rats.

Description

Pharmaceutical composition for skin diseases

technical field

The invention belongs to the technical field of traditional Chinese medicine, and relates to a composition prepared from a variety of traditional Chinese medicines, which can be used to treat or prevent skin diseases such as eczema, pruritus and other diseases. Chinese medicinal composition such as Smilax smilax.

Background technique

Skin diseases with eczema and itching as the main symptoms have greatly troubled people's daily work and life. The pathogenesis of eczema is more complicated, and in terms of internal factors, it has an important relationship with the allergic constitution of the body. In addition, excessive fatigue, mental stress, insomnia, gastrointestinal dysfunction, emotional changes, as well as infection lesions, metabolic disorders and endocrine dysfunction, etc., all cause or aggravate the condition of eczema. Eczema can be induced by external stimuli such as heat, sweating, scratching, friction, sunlight, ultraviolet rays, cold, various animal fur, plants, and chemical substances.

When the external triggering factors cannot be removed, the control of eczema mainly depends on drug treatment. At present, Western medicine has no specific treatment for eczema, and symptomatic treatment is often used. Oral antihistamines are the most common treatment, such as diphenhydramine, phenergan, chlorpheniramine, cyproheptadine, etc., and can also be used in combination with sedatives and vitamin C. Commonly used external medicines include 3% boric acid solution, 5% lead acetate solution, Daribo's (copper sulfate, zinc sulfate) solution, corticosteroid cream, paste, etc. If infection occurs, antibiotic ointment should be used together. Antihistamines are centrally depressant and cause drowsiness and fatigue after taking them. The course of hormone therapy is generally 2 to 3 weeks, but it is easy to rebound after stopping the drug. Hormonal drugs have many adverse reactions, which can cause skin atrophy, telangiectasia, acne, rosacea, purpura, perioral dermatitis, etc. Long-term use of hormone ointment may also cause systemic side effects, such as decreased bone density, thalamus-pituitary - Adrenal (HPA) axis inhibition, growth inhibition, cataracts, etc. Local immunomodulators are a series of new drugs that have appeared recently. They can be used locally without side effects of systemic immunosuppression. They are a class of drugs with broad application prospects in the field of dermatology. Topical application of immunomodulator tacrolimus or pimecrolimus can have a good effect on dermatitis and eczema, and there is no adverse reaction of topical corticosteroids. However, it can cause systemic adverse reactions such as flu-like symptoms, fever, and headache. A placebo-controlled multicenter study showed that about 30% of patients had flu-like symptoms, 19% had headaches, and very few patients had joint pain, back pain, skin tingling, light sensitivity, allergies, etc., obviously Not suitable for battlefield or disaster relief frontline use.

Traditional Chinese medicine believes that eczema belongs to the syndrome of dampness and heat. Reason, soak the skin. The body is weak, the spleen is the cause of dampness, and the skin loses nourishment. Or because damp heat accumulates for a long time, consumes Yin and blood, transforms dryness and generates wind, and causes blood deficiency and wind-dryness, and skin onychomycosis all can cause eczema. Dampness is the main factor in the pathogenesis. Because the dampness is heavy and viscous, it is easy to stay and hard to go. Therefore, the skin diseases caused by dampness are pleomorphic, lingering, and difficult to heal quickly. In the treatment, dispelling dampness is always the priority, or clearing away heat and dispelling wind and promoting dampness, or drying dampness and invigorating the spleen, or invigorating the spleen to remove dampness, or promoting blood circulation and dehumidification, or nourishing yin and dehumidification, etc., which can often receive the expected curative effect.

Non-hormonal drug treatment is the direction of eczema treatment. Traditional Chinese medicine treatment has less systemic side effects, and topical treatment with external preparations is more direct and can reduce systemic side effects of drugs. Therefore, finding effective external preparations of traditional Chinese medicine is an important direction for the treatment of eczema.

Pruritus is a sensation (itch sensation) on the surface of the skin and the mucous membranes adjacent to the skin. Itch is a sensation of sensing parasites and irritants in the superficial layers of the skin in order to remove the intruders, irritants through an itching action. Pruritus is a sensation that is readily understood as eliciting an urge to scratch, but its mechanisms are not fully understood.

Diseases with pruritus, which can be broadly categorized into pruritic dermatoses (eg, dermatitis, urticaria, psoriasis, xeroderma, tinea) with skin disorders, and renal dialysis and visceral disorders without skin disorders Pruritus caused by disease [eg, diabetes, blood disease, cholestatic liver disease (primary biliary cirrhosis) and kidney disease], hyperthyroidism, multiple sclerosis, etc. is pruritus cutaneous. Other diseases accompanied by strong itching include corneal and conjunctival diseases such as allergic conjunctivitis. These diseases have increased rapidly in recent years and are becoming a big problem from the viewpoint of quality of life (QOL). The common point of many pruritus diseases is that it can cause a vicious circle due to scratching. A representative of substances known to cause itching is histamine, which can cause itching when introduced from the outside or released from mast cells in the body.

Antihistamines, antiallergics, topical steroids, etc. can be used in the treatment of itchy skin diseases. However, they all have side effects, and there is no drug that can satisfy the treatment of pruritus caused by pruritic skin diseases. Moreover, it has recently been reported that factors other than histamine are involved in the pruritus of atopic dermatitis. In fact, there are many clinical cases showing that antihistamines and antiallergic drugs have no significant effect on pruritus of atopic dermatitis. Antihistamines and topical steroids are sometimes prescribed for the treatment of skin pruritus, but they are almost ineffective. At present, there is no effective treatment method, and there is no medicine that can satisfy the treatment of the above-mentioned diseases accompanied by pruritus. Drugs that are effective in suppressing itching due to the cause of the disease.

When people look for traditional Chinese medicines that can be used to treat or prevent skin diseases such as eczema, itching, etc., they usually consider their therapeutic effects, and the safety and tolerability of traditional Chinese medicines are usually better than chemical medicines. At present, there is still a need for a new method for relieving itching clinically, especially a method for treating or preventing skin diseases such as eczema and pruritus with traditional Chinese medicine.

Contents of the invention

The purpose of the present invention is to provide a new method for clinical treatment or prevention of skin diseases such as eczema, pruritus and other diseases. It has satisfactory effects of treating or preventing skin diseases such as eczema, pruritus and other conditions. The present invention has been accomplished based on this finding.

To this end, the first aspect of the present invention provides a composition, which is prepared from the following Chinese medicinal materials: Sophora flavescens, Smilax cocos, capillary wormwood, Cortex Phellodendri, Gentiana, fresh bark, purslane, Kochia chinensis, Baibu, raw licorice.

According to the composition of the first aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and the amount of Smilax cocos is 3-24 parts by weight, such as 5-20 parts by weight, such as 8-18 parts by weight, such as 10-15 parts by weight parts, such as about 12 parts by weight.

According to the composition of the first aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and the amount of capillary is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight parts, such as about 8 parts by weight.

According to the composition of the first aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and the amount of Cortex Phellodendri is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight , such as about 8 parts by weight.

According to the composition of the first aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of gentian is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight. parts by weight, such as about 6 parts by weight.

According to the composition of the first aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and the amount of white fresh bark is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight. parts by weight, for example about 8 parts by weight.

According to the composition of the first aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of purslane is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight. parts by weight, such as about 6 parts by weight.

According to the composition of the first aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and Kochia scoparia is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight. parts by weight, for example about 8 parts by weight.

According to the composition of the first aspect of the present invention, the flavescens in the medicinal material is 8 parts by weight, and the part amount is 2.5-20 parts by weight, such as 3-18 parts by weight, such as 5-15 parts by weight, such as 8-12 parts by weight parts, such as about 10 parts by weight.

According to the composition of the first aspect of the present invention, the amount of flavescens in the medicinal materials is 8 parts by weight, and the amount of raw licorice is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight parts, such as about 6 parts by weight.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 3-24 parts by weight of Smilax cocos, 2-16 parts by weight of capillary wormwood, and 2-16 parts by weight of Cortex Phellodendri , 1.5-12 parts by weight of gentian, 2-16 parts by weight of white fresh skin, 1.5-12 parts by weight of purslane, 2-16 parts by weight of Kochia chinensis, 2.5-20 parts by weight of Baibu, 1.5-12 parts by weight of raw licorice parts by weight.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 8-18 parts by weight of Smilax cocos, 4-12 parts by weight of capillary wormwood, and 4-12 parts by weight of Cortex Phellodendri , 3-9 parts by weight of gentian, 4-12 parts by weight of white fresh cortex, 3-9 parts by weight of purslane, 4-12 parts by weight of Kochia scoparia, 5-15 parts by weight of Baibu, 3-9 parts by weight of raw licorice parts by weight.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 12 parts by weight of Smilax cocos, 8 parts by weight of capillary wormwood, 8 parts by weight of Cortex Phellodendri, 6 parts by weight of Gentiana 8 parts by weight, 8 parts by weight of white fresh skin, 6 parts by weight of purslane, 8 parts by weight of Kochia chinensis, 10 parts by weight of Radix radix, 6 parts by weight of raw licorice.

The composition according to the first aspect of the present invention, wherein the medicinal material further includes menthol and/or borneol. In one embodiment, the medicinal material further includes menthol. In one embodiment, the medicinal material further includes borneol. In one embodiment, the medicinal materials also include menthol and borneol.

According to the composition of the first aspect of the present invention, the flavescens in the medicinal material is 8 parts by weight, and the amount of menthol is 0.1-3 parts by weight, such as 0.3-2 parts by weight, such as 0.5-1 parts by weight, such as 0.7-0.9 parts by weight parts, such as about 0.8 parts by weight.

According to the composition of the first aspect of the present invention, the flavescens in the medicinal material is 8 parts by weight, and the amount of borneol is 0.1-2 parts by weight, such as 0.2-1.5 parts by weight, such as 0.3-1.0 parts by weight, such as 0.4-0.6 parts by weight , such as about 0.53 parts by weight.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 3-24 parts by weight of Smilax cocos, 2-16 parts by weight of capillary wormwood, and 2-16 parts by weight of Cortex Phellodendri , 1.5-12 parts by weight of gentian, 2-16 parts by weight of white fresh skin, 1.5-12 parts by weight of purslane, 2-16 parts by weight of Kochia chinensis, 2.5-20 parts by weight of Baibu, 1.5-12 parts by weight of raw licorice parts by weight, 0.1-3 parts by weight of menthol, and 0.1-2 parts by weight of borneol.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 8-18 parts by weight of Smilax cocos, 4-12 parts by weight of capillary wormwood, and 4-12 parts by weight of Cortex Phellodendri , 3-9 parts by weight of gentian, 4-12 parts by weight of white fresh cortex, 3-9 parts by weight of purslane, 4-12 parts by weight of Kochia scoparia, 5-15 parts by weight of Baibu, 3-9 parts by weight of raw licorice parts by weight, 0.8-2 parts by weight of menthol, and 0.2-1.5 parts by weight of borneol.

The composition according to the first aspect of the present invention is prepared from the following Chinese medicinal materials: 8 parts by weight of Sophora flavescens, 12 parts by weight of Smilax cocos, 8 parts by weight of capillary wormwood, 8 parts by weight of Cortex Phellodendri, 6 parts by weight of Gentiana 8 parts by weight, 8 parts by weight of white fresh skin, 6 parts by weight of purslane, 8 parts by weight of Kochia scoparia, 10 parts by weight of Baibu, 6 parts by weight of raw licorice, 0.8 parts by weight of menthol, and 0.53 parts by weight of borneol.

The composition according to the first aspect of the present invention further includes pharmaceutically acceptable excipients.

The composition according to the first aspect of the present invention includes pharmaceutically acceptable excipients. In one embodiment, the pharmaceutically acceptable excipient includes a carrier vehicle. In one embodiment, the carrier vehicle is selected from water and ethanol at a concentration below 50%. In one embodiment, the carrier vehicle is 0-40% ethanol. In one embodiment, the carrier vehicle is 10-30% ethanol. In one embodiment, the carrier vehicle is about 20% ethanol.

According to the composition of the first aspect of the present invention, wherein the Sophora flavescens, Smilax smilax, capillary wormwood, Cortex Phellodendri, Gentiana, Radix Cortex, Purslane, Kochia officinalis, Radix Licorice, Raw Glycyrrhiza are extracted and added to in the composition.

The composition according to the first aspect of the present invention is in the form of oral medicament or external medicament.

The composition according to the first aspect of the present invention is in the form of a medicament for external use.

The composition according to the first aspect of the present invention is in a pharmaceutical form selected from the group consisting of ointment, cream, gel, liniment, spray.

According to the composition according to the first aspect of the present invention, the total amount of crude drug per 100g or per 100ml is 10-500g, such as 20-250g, such as 20-100g, such as 10-50g, such as 20-40g, such as 25-35g , for example about 30g.

According to the composition of the first aspect of the present invention, wherein also comprise the adjuvant selected from following: acid-base regulator (for example hydrochloric acid, sodium hydroxide), preservative (for example mud parkin methyl ester, ethyl ester, propyl ester), pH value Antimicrobial agents (such as chlorobutanol), consistency regulators (such as povidone, cellulose and its derivatives), etc.

The second aspect of the present invention provides the use of a combination of the following Chinese medicinal materials in the preparation of products for the treatment or prevention of mammalian (such as human) skin diseases such as eczema, pruritus, etc. Gentian grass, white fresh skin, purslane, Kochia chinensis, hundred tubers, raw licorice.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of Smilax cocos is 3-24 parts by weight, such as 5-20 parts by weight, such as 8-18 parts by weight, such as 10-15 parts by weight , such as about 12 parts by weight.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of capillary is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight , such as about 8 parts by weight.

According to the use of the second aspect of the present invention, the flavescens in the medicinal material is 8 parts by weight, and the amount of Cortex Phellodendri is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight, For example about 8 parts by weight.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal materials is 8 parts by weight, and the amount of gentian is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight parts, such as about 6 parts by weight.

According to the use of the second aspect of the present invention, the amount of Sophora flavescens in the medicinal materials is 8 parts by weight, and the amount of white fresh skin is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight parts, such as about 8 parts by weight.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of purslane is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight parts, such as about 6 parts by weight.

According to the use of the second aspect of the present invention, the flavescens in the medicinal material is 8 parts by weight, and the Kochia scoparia is 2-16 parts by weight, such as 3-15 parts by weight, such as 4-12 parts by weight, such as 5-10 parts by weight parts, such as about 8 parts by weight.

According to the use of the second aspect of the present invention, the medicinal material of Sophora flavescens is 8 parts by weight, and the amount is 2.5-20 parts by weight, such as 3-18 parts by weight, such as 5-15 parts by weight, such as 8-12 parts by weight , such as about 10 parts by weight.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of raw licorice is 1.5-12 parts by weight, such as 2-10 parts by weight, such as 3-9 parts by weight, such as 4-8 parts by weight , such as about 6 parts by weight.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 3-24 parts by weight of Smilax cocos, 2-16 parts by weight of capillary, 2-16 parts by weight of Cortex Phellodendri, 1.5-12 parts by weight of Gentiana 2-16 parts by weight of white fresh skin, 1.5-12 parts by weight of purslane, 2-16 parts by weight of Kochia chinensis, 2.5-20 parts by weight of Baibu, 1.5-12 parts by weight of raw licorice.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 8-18 parts by weight of Smilax cocos, 4-12 parts by weight of capillary, 4-12 parts by weight of Cortex Phellodendri, 3-9 parts by weight of Gentiana parts, 4-12 parts by weight of white fresh skin, 3-9 parts by weight of purslane, 4-12 parts by weight of Kochia scoparia, 5-15 parts by weight of Baibu, 3-9 parts by weight of raw licorice.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 12 parts by weight of Smilax cocos, 8 parts by weight of capillary wormwood, 8 parts by weight of Phellodendron cortex, 6 parts by weight of gentian, and 8 parts by weight of white fresh bark , 6 parts by weight of purslane, 8 parts by weight of Kochia scopariae, 10 parts by weight of 100 parts by weight, and 6 parts by weight of raw licorice.

According to the use of the second aspect of the present invention, the medicinal materials further include menthol and/or borneol. In one embodiment, the medicinal material further includes menthol. In one embodiment, the medicinal material further includes borneol. In one embodiment, the medicinal materials also include menthol and borneol.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of menthol is 0.1-3 parts by weight, such as 0.3-2.0 parts by weight, such as 0.5-1 parts by weight, such as 0.7-0.9 parts by weight , such as about 0.8 parts by weight.

According to the use of the second aspect of the present invention, the amount of flavescens in the medicinal material is 8 parts by weight, and the amount of borneol is 0.1-2 parts by weight, such as 0.2-1.5 parts by weight, such as 0.3-1.0 parts by weight, such as 0.4-0.6 parts by weight, For example about 0.53 parts by weight.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 3-24 parts by weight of Smilax cocos, 2-16 parts by weight of capillary, 2-16 parts by weight of Cortex Phellodendri, 1.5-12 parts by weight of Gentiana 2-16 parts by weight of white fresh skin, 1.5-12 parts by weight of purslane, 2-16 parts by weight of Kochia scoparia, 2.5-20 parts by weight of Baibu, 1.5-12 parts by weight of raw licorice, 0.1-3 parts by weight of menthol parts by weight, borneol 0.1-2 parts by weight.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 8-18 parts by weight of Smilax cocos, 4-12 parts by weight of capillary, 4-12 parts by weight of Cortex Phellodendri, 3-9 parts by weight of Gentiana 4-12 parts by weight of white fresh skin, 3-9 parts by weight of purslane, 4-12 parts by weight of Kochia chinensis, 5-15 parts by weight of Baibu, 3-9 parts by weight of raw licorice, 0.3-2 parts by weight of menthol parts by weight, borneol 0.2-1.5 parts by weight.

According to the use of the second aspect of the present invention, the medicinal materials include: 8 parts by weight of Sophora flavescens, 12 parts by weight of Smilax cocos, 8 parts by weight of capillary wormwood, 8 parts by weight of Phellodendron cortex, 6 parts by weight of gentian, and 8 parts by weight of white fresh bark , 6 parts by weight of purslane, 8 parts by weight of Kochia chinensis, 10 parts by weight of Baibu, 6 parts by weight of raw licorice, 0.8 parts by weight of menthol, and 0.53 parts by weight of borneol.

According to the use of the second aspect of the present invention, the product includes pharmaceutically acceptable excipients. In one embodiment, the pharmaceutically acceptable excipient includes a carrier vehicle. In one embodiment, the carrier vehicle is selected from water and ethanol at a concentration below 50%. In one embodiment, the carrier vehicle is 0-40% ethanol. In one embodiment, the carrier vehicle is 10-30% ethanol. In one embodiment, the carrier vehicle is about 20% ethanol.

According to the use of the second aspect of the present invention, wherein the Sophora flavescens, Smilax smilax, Capsicum chinensis, Cortex Phellodendri, Gentiana, Radix Cortex, Purslane, Kochia scoparia, Radix baculata, Raw licorice are extracted and added to the of the products described above.

The use according to the second aspect of the present invention, wherein the product is in the form of an oral medicament or an external medicament.

Use according to the second aspect of the present invention, wherein said product is in the form of a medicament for external use.

The use according to the second aspect of the present invention, wherein the product is in a pharmaceutical form selected from the group consisting of ointment, cream, gel, liniment, spray.

The use according to the second aspect of the present invention, wherein the total amount of crude drug per 100g or per 100ml of the product is 10-50g, such as 20-40g, such as 25-35g, such as about 30g.

According to the purposes of the second aspect of the present invention, wherein said product also includes auxiliary materials selected from the following: acid-base regulators (such as hydrochloric acid, sodium hydroxide), preservatives (such as paraffin methyl ester, ethyl ester, propyl ester ), bacteriostats (such as chlorobutanol), consistency regulators (such as povidone, cellulose and its derivatives), etc.

The third aspect of the present invention provides a method for preparing any one of the compositions described in the first aspect of the present invention, which includes the following steps: making Sophora flavescens, Smilax cocos, capillary wormwood, Phellodendron cortex, Gentian grass, white fresh bark, and purslane Amaranthus, Kochia chinensis, Radix Potabilis and Raw Glycyrrhiza are extracted with a solvent, the obtained extract is concentrated, optional menthol and borneol are added, and optional pharmaceutically acceptable auxiliary materials are added to obtain the product.

According to the method of the third aspect of the present invention, wherein the solvent used for extraction is selected from water, aqueous ethanol, or ethanol. In one embodiment, the extraction solvent is aqueous ethanol. In one embodiment, the aqueous ethanol is ethanol at a concentration of 10-95%. In one embodiment, the aqueous ethanol is ethanol at a concentration of 20-90%. In one embodiment, the aqueous ethanol is ethanol at a concentration of 30-85%. In one embodiment, the aqueous ethanol is ethanol at a concentration of 40-80%. In one embodiment, the aqueous ethanol is ethanol at a concentration of 50-80%. Although the present invention uses ethanol with a concentration of 50-80% as a solvent for extraction in some examples, the obtained extract shows excellent antipruritic effect, but those skilled in the art understand that other concentrations of ethanol and water or ethanol can It is expected to obtain an extract with good antipruritic effect, because in some examples of the present invention, subjects directly orally took 8 parts by weight of Sophora flavescens, 12 parts by weight of Smilax cocos, 8 parts by weight of capillary wormwood, 8 parts by weight of Cortex Phellodendri, 6 parts by weight of gall grass, 8 parts by weight of white fresh cortex, 6 parts by weight of purslane, 8 parts by weight of Kochia chinensis, 10 parts by weight of Baibu, and 6 parts by weight of raw licorice. At the dose of 10g medicinal material/50kg body weight/day, a good antipruritic effect with a total effective rate of 88% is achieved.

In one embodiment of the method of the third aspect of the present invention, the method comprises using 65-85% ethanol to reflux to extract Sophora flavescens, Smilax cocos, capillary wormwood, Phellodendron cortex, Gentiana radix, white fresh bark, purslane, Kochia chinensis , 100 root, raw licorice, concentrate the extract, add optional menthol, borneol, and add optional pharmaceutically acceptable auxiliary materials to obtain the product.

In one embodiment of the method of the third aspect of the present invention, the method comprises using 70-80% ethanol to reflux extract Sophora flavescens, Smilax cocos, capillary wormwood, Phellodendron cortex, Gentiana radix, white fresh bark, purslane, Kochia chinensis 1-5 times (such as 1-4 times, such as 1-3 times; such as 1-5 hours each time, such as 1-4 hours each time, such as 1-3 hours each time, such as every 1-3 hours 2 hours), concentrate the extract to a relative density of 1.01 to 1.30, filter to remove impurities, add menthol, borneol, and add optional pharmaceutically acceptable adjuvants (for example, solvents such as 0-50% ethanol, and preservatives Such as ethyl hydroxybenzoate, etc.), that is, too.

In one embodiment of the present invention, the active ingredient contained in the composition is 1-100g crude drug/100g composition based on the total crude drug material, such as 5-75g/100g, such as 10-50g/100g, such as 20 - 40g/100g, such as 25-35g/100g, such as about 30g/100g. In one embodiment of the present invention, wherein said composition contains ethanol at a concentration of 1-50%, such as 5-40%, such as 10-30%, such as 15-25%, such as about 20%.

Any aspect of the present invention or any technical feature of any implementation of this any aspect is also applicable to any other implementation or any implementation of any other aspect, as long as they do not contradict each other, of course When applicable, the corresponding features can be appropriately modified if necessary. Various aspects and features of the present invention are further described below.

All the documents cited in the present invention are incorporated herein by reference in their entirety, and if the meaning expressed in these documents is inconsistent with the present invention, the expression of the present invention shall prevail. In addition, various terms and phrases used in the present invention have common meanings known to those skilled in the art. Even so, the present invention still hopes to make a more detailed description and explanation of these terms and phrases here. The terms and phrases mentioned are as follows: If there is any inconsistency with the known meaning, the meaning expressed in the present invention shall prevail.

In the present invention, an effective amount of the composition of the present invention may be administered to a subject in need thereof. As used herein, the term "effective amount" refers to an amount that can achieve the purpose of preventing and/or treating the condition, disorder, condition or disease of the present invention in a subject. Dosages for use of the compositions of the present invention can be readily determined by those skilled in the art from the context of the present invention. In particular, according to the present invention, the term "effective amount" is to be understood as the amount of the composition of the invention for the treatment and/or prevention of said condition, disorder, condition or disease with a reasonable effect/risk ratio applicable to any medical treatment and/or prevention. Enough amount. It should be recognized, however, that the total daily amount of the compositions of the present invention may be determined by those skilled in the art within the scope of sound medical judgment. For any particular subject, the specific prophylactically effective dosage level will depend on a number of factors, including the subject's age, weight, general health, sex, and diet; the particular composition employed; and other therapeutically active substances used in combination or concomitantly with the compositions of the present invention; and similar factors well known in the medical field. As far as the present invention is concerned, the general daily dosage range is converted into medicinal materials, which can be 0.1-100g/kg body weight, such as 0.2-50g/kg body weight, such as 0.2-25g/kg body weight, such as 0.5-50g/kg body weight, For example, 0.5-25 g/kg body weight, such as 1-20 g/kg body weight, such as 2-10 g/kg body weight.

As used herein, the term "composition", which may be a drug or any other product that contributes to health. Therefore, in the present invention, the term "composition" may be used interchangeably with "pharmaceutical composition". In addition, the composition of the present invention can be used as a composition for preventing skin discomfort, and such compositions are often referred to as health products, such as disinfection products, etc. Therefore, in the present invention, the terms "composition" and " "Pharmaceutical composition" has the broadest meaning, that is, it can refer to medicines, health care products, or disinfection products.

As described herein, the term "extract" will include extracts of any purity that can be used to achieve the purpose of the present invention, and those skilled in the art can understand that the extraction purity of the extracts of the present invention can be within a larger range according to the spirit of the present invention Variety. For example, the extract obtained by extracting various medicinal materials of the present invention, according to the difference of different process conditions, 1kg of total medicinal materials can be extracted to obtain any amount between 10g and 500g (such as 50g to 200g, such as 50g to 150g), that is, different purity According to different needs, those skilled in the art can use extracts of different purity to formulate a composition suitable for the needs.

In the present invention, when referring to "crude medicinal materials" or "crude drugs", it includes Sophora flavescens, Smilax cocos, Capsicum chinensis, Phellodendron phellodendri, Gentian grass, Fresh bark, Purslane, Kochia scoparia, Radix baculata, Raw licorice , and (if present, it can be understood as raw medicinal material or crude drug) menthol, borneol.

The present invention provides compositions comprising one or more nontoxic physiologically acceptable carriers formulated together. The compositions may be particularly specially formulated for oral or rectal administration in solid or liquid form, or for injectable administration, or for topical, eg dermal, application. The compositions provided herein are particularly suitable for topical application, such as for dermal application.

The composition of the present invention has the effects of clearing away heat and dampness, relieving itching, and detoxification. According to "Methods and Ideas of Research on the Efficacy of Traditional Chinese Medicine" edited by Chen Qi, we have carried out anti-inflammatory, anti-itching, and anti-allergic effects on it. academic research. These anti-inflammatory, antipruritic and antiallergic pharmacodynamic models are well known in the art and can be used to evaluate drugs for the prevention or treatment of skin diseases, especially typical models for symptoms such as eczema and itching.

The present inventor establishes the itching model of guinea pig histamine phosphate, so that the itching threshold is used as an index, observes the influence of guinea pigs on the itching threshold of histamine phosphate after administration of each test group, and evaluates the different compositions of the present invention.

Antipruritic effect of dose groups. It can be seen from the results of the composition of the present invention on the itching induced by histamine phosphate in guinea pigs that the composition of the present invention significantly increases the itching domain.

The present inventor established a delayed type hypersensitivity reaction model, took the ear swelling inhibition rate as an index, observed the effect of each test group on the mouse ear swelling inhibition rate after administration, and evaluated the anti-allergic effect of different dosage groups of the composition of the present invention ; And measure thymus and spleen index, observe the impact on immune function of mice after administration. The results show that the composition of the present invention can effectively inhibit mouse ear swelling. As can be seen from the impact of the sample on the weight of the immune organs of the mice, all the drug groups have no significant difference compared with the model group or the blank group, that is, the three doses of the composition of the present invention have no effect on the spleen and thymus of the mice. effect, while the positive drug had a significant effect on the spleen and thymus of mice. It shows that the composition of the present invention is expected to have a good safety profile.

The present inventor established the experimental model of mouse auricle swelling caused by xylene, and took the degree of swelling as an index to observe the effect of mice on xylene-induced mouse auricle swelling after administration in each test group, and evaluate different doses of the composition of the present invention. Antipruritic effect of the group. The results show that the composition of the present invention can effectively inhibit xylene-induced ear swelling in mice.

The present inventor establishes a model of rat egg white paw swelling, takes the degree of paw swelling as an index, observes the degree of paw swelling in each test group after administration, evaluates the influence of different dosage groups of the composition of the present invention on paw swelling, and measures Effects of drugs on paw swelling of rats 1h, 2h, 4h, 6h after the test. From the test results of the composition of the present invention on rat egg white paw swelling, it can be seen that the composition of the present invention can effectively inhibit rat egg white paw swelling.

Detailed ways

The present invention is further illustrated below through specific embodiments/experimental examples, but it should be understood that these embodiments and experimental examples are only used for more detailed description, and should not be interpreted as being used to limit the present invention in any form. invention.

The present invention provides general and/or specific descriptions of the materials and test methods used in the tests. While many of the materials and methods of manipulation which are employed for the purposes of the invention are well known in the art, the invention has been described here in as much detail as possible. It will be clear to those skilled in the art that in the following, unless otherwise specified, the materials and operation methods used in the present invention are well known in the art.

A, preparation example part

Embodiment 1: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 12g, Yin Chen 8g, Cork 8g, Gentiana 6g, white fresh skin 8g, Purslane 6g, Kochia 8g, Baibu 10g, raw licorice 6g, Menthol 0.8g, borneol 0.53g.

Preparation method: take 10 herbs except menthol and borneol, reflux extraction with 7.5 times the volume of 75% ethanol twice, each time for 2 hours, concentrate the combined extracts and recover ethanol until the density of the concentrated solution is 1.04g /ml. Add an appropriate amount of ethanol solution of appropriate concentration to the concentrated solution, so that the content of raw medicinal materials and the concentration of ethanol are about 30g/100ml and about 20% respectively, stir well, let stand overnight, and remove impurities by centrifugal filtration. Dissolve menthol, borneol and ethylparaben (to make the final concentration 0.05%) in an appropriate amount of ethanol, add to the filtrate, stir well, so that the content of raw medicinal materials and the concentration of ethanol are 30g/100ml and 20% respectively, and this is obtained. Invention composition. The pharmaceutical composition can be used as external solution, liniment, spray and other dosage forms.

Embodiment 2: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 3g, Yin Chen 16g, Cork 2g, Gentiana 12g, white fresh skin 2g, Purslane 12g, Kochia 2g, Baibu 20g, raw licorice 1.5g, Menthol 0.1g, borneol 2g.

Preparation method: take 10 herbs except menthol and borneol, reflux extraction with 6 times the amount of 75% ethanol twice, each time for 2 hours, filter; add menthol and borneol to the combined extract, dissolve; The liquid medicine was concentrated into a thick paste, and dried into powder 8.6g. This dry powder is dissolved with 20% ethanol, prepares the pharmaceutical composition of the present invention, the amount equivalent to raw medicinal material in every 100 grams of this pharmaceutical composition is 30 grams, and this pharmaceutical composition can be used as external solution, liniment, spray and other dosage forms.

Embodiment 3: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 24g, Yin Chen 2g, Cork 16g, Gentiana 1.5g, white fresh skin 16g, Purslane 1.5g, Kochia 16g, Baibu 2.5g, raw licorice 12g, Menthol 3g, borneol 0.1g.

Preparation method: take 10 herbs except menthol and borneol, extract with 10 times the amount of 50% ethanol under reflux for 1 hour, and filter; then use 5 times the amount of 80% ethanol to reflux extract for 2 hours, filter; Add menthol and borneol to the extract, dissolve; the liquid is concentrated into a thick paste, dried into powder 12.1g. This dry powder is dissolved in water, and add carbomer to make its amount 5%, and add paraben ethyl ester to make its amount 0.05%, be prepared into the pharmaceutical composition of the present invention that is gel, every 100 grams of this The amount equivalent to raw medicinal materials in the pharmaceutical composition is 30 grams.

Embodiment 4: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 8g, Yin Chen 12g, Cork 12g, Gentiana 3g, white fresh skin 4g, Purslane 9g, Kochia 4g, Baibu 15g, raw licorice 3g, Menthol 2g, borneol 0.2g.

Preparation method: take 10 herbs except menthol and borneol, extract with 6 times the amount of 95% ethanol under reflux for 1 hour, and filter; then use 5 times the amount of 70% ethanol to reflux extract for 1 hour, filter; then The filter residue was reflux extracted with 5 times the amount of water for 1 hour, filtered; menthol and borneol were added to the combined extract, and dissolved; the liquid was concentrated into a thick paste and dried into 8.6 g of powder. This dry powder is dissolved with 20% ethanol, prepares the pharmaceutical composition of the present invention, the amount equivalent to raw medicinal material in every 100 grams of this pharmaceutical composition is 50 grams, and this pharmaceutical composition can be used as external solution, liniment, spray and other dosage forms.

Embodiment 5: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 18g, Yin Chen 4g, Cork 4g, Gentiana 9g, white fresh skin 12g, Purslane 3g, Kochia 12g, Baibu 5g, raw licorice 9g, Menthol 0.3g, borneol 1.5g.

Preparation method: take 10 herbs except menthol and borneol, decoct with 10 times the amount of water for 1.5 hours, filter; then reflux the filter residue with 8 times the amount of 90% ethanol for 1 hour, filter; then filter the residue with 5 times the amount of 70% ethanol was extracted under reflux for 1 hour, filtered; menthol and borneol were added to the combined extract and dissolved; the liquid was concentrated into a thick paste and dried into a powder of 9.3g. This dry powder is dissolved with 20% ethanol, prepares the pharmaceutical composition of the present invention, the amount equivalent to raw medicinal material in every 100 grams of this pharmaceutical composition is 10 grams, and this pharmaceutical composition can be used as external solution, liniment, spray and other dosage forms.

In addition, the inventor also added the dry powder obtained in this embodiment to the classic cream base or ointment base of pharmacy to prepare cream and ointment respectively, and every 100 grams of the cream or ointment was equivalent to the raw medicinal material The amount is 10 grams.

In addition, the dry powder obtained in this example was dissolved in water to prepare the traditional Chinese medicine spray of the present invention, and the amount of raw medicinal materials in every 100 grams of the traditional Chinese medicine spray was 50 grams. In addition, the dry powder is dissolved in 50% ethanol to prepare the traditional Chinese medicine spray of the present invention, and the amount of raw medicinal materials in every 100 grams of the traditional Chinese medicine spray is 10 grams. In addition, the dry powder is dissolved with 30% ethanol to prepare the traditional Chinese medicine spray of the present invention, and the amount of raw medicinal materials in every 100 grams of the traditional Chinese medicine spray is 20 grams.

Embodiment 6: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 12g, Yin Chen 8g, Cork 8g, Gentiana 6g, white fresh skin 8g, Purslane 6g, Kochia 8g, Baibu 10g, raw licorice 6g

Preparation method: take 10 herbs, extract twice with 6 times the amount of 70% ethanol under reflux, each time for 1.5 hours, filter; concentrate the combined extracts into a thick paste, and dry them into a powder of 8.5g. Add the dry powder to microcrystalline cellulose at a ratio of 1:1, mix well, pack into capsules, 250 mg per capsule, and obtain the composition of the present invention. The composition can be used orally, or can be dissolved/suspended in water and applied to the skin.

Embodiment 7: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 8g, Yin Chen 12g, Cork 12g, Gentiana 3g, white fresh skin 4g, Purslane 9g, Kochia 4g, Baibu 15g, raw licorice 3g,

Preparation method: get 10 herbs, pulverize into fine powder crossing 80 mesh sieves; add 1/3 fine powder amount of refined honey as binder to make honeyed pills (3 grams in weight) to obtain the composition of the present invention.

Embodiment 8: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 18g, Yin Chen 4g, Cork 4g,

Gentiana 9g, white fresh skin 12g, Purslane 3g, Kochia 12g, Baibu 5g, raw licorice 9g,

Preparation method: get 10 herbs, pulverize into fine powder through 80-mesh sieve; add 1/3 fine powder amount of refined honey as binder to make honeyed pills (1 gram in weight) to obtain the composition of the present invention.

Embodiment 9: Preparation of the composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 12g, Yin Chen 8g, Cork 8g, Gentiana 6g, white fresh skin 8g, Purslane 6g, Kochia 8g, Baibu 10g, raw licorice 6g, Menthol 1.5g, borneol 1g.

Preparation method: take 10 herbs except menthol and borneol, reflux extraction with 6 times the amount of 95% ethanol twice, each time for 2 hours, filter; add menthol and borneol to the combined extract, dissolve; The medicinal solution is concentrated into a thick paste and dried into a powder. This dry powder is dissolved with 20% ethanol, prepares the pharmaceutical composition of the present invention, the amount equivalent to raw medicinal material in every 100 grams of this pharmaceutical composition is 30 grams, and this pharmaceutical composition can be used as external solution, liniment, spray and other dosage forms.

Embodiment 10: preparation composition of the present invention

formula:

Sophora flavescens 8g, Tuckahoe 12g, Yin Chen 8g, Cork 8g, Gentiana 6g, white fresh skin 8g, Purslane 6g, Kochia 8g, Baibu 10g, raw licorice 6g, Menthol 0.8g, borneol 0.53g.

Preparation method: take 10 herbs except menthol and borneol, decoct and extract twice with 7 times the amount of water, each time for 2 hours, filter; add menthol and borneol to the combined extract, dissolve; The liquid was concentrated into a thick paste, and dried into powder 9.2g. Add the dry powder to microcrystalline cellulose at a ratio of 1:1, mix well, pack into capsules, 250 mg per capsule, and obtain the composition of the present invention. The composition can be used orally, or can be dissolved/suspended in water and applied to the skin.

B: Test case part

Test example 1: the stability investigation of composition of the present invention

The stability of the composition of the present invention was investigated according to the technology of quality stability research in the "Measures for the Administration of Drug Registration".

Inspection items: traits, identification, inspection and content.

Test sample: the medicinal solution of embodiment 1 (packed in a plastic bottle, which can be used for external spray administration, in the following test examples, when referring to "spray", it refers to the medicinal solution of embodiment 1 in the form of spray medication).

Test method (accelerated test): Put the test sample into a desiccator (RH75%) with a saturated NaCl solution, and place it in a constant temperature and humidity chamber at a temperature of 40±2°C at 0, 1, 2, 3. Sampling and determination at 6 months. The test results are shown in Table 1.

Table 1: Accelerated test results

Conclusion: As can be seen from the results, the composition of the present invention meets the general stability requirements of medicines. Although the form of the composition and the formula ratio are different, the applicant finds that the compositions of the present invention prepared by other embodiments all meet the general stability requirements of medicines in the above-mentioned accelerated test method, for example, the ratio of data in June in each assay item The difference between the data in 0 month does not exceed 10%.

Test Example 2: Effect of the composition of the present invention on the itching response of guinea pig histamine phosphate

Establish guinea pig histamine phosphate-induced itching model, take itching threshold as an index, observe the effect of guinea pigs on the itching threshold of histamine phosphate-induced itching after administration of each test group, and evaluate the antipruritic effect of different dosage groups of the composition of the present invention.

1. Test material:

Reagent: the composition of Example 1 (spray type, crude drug content and ethanol concentration are respectively 30g/100ml, 20%);

Positive control drug: Sanjiu Piyanping (compound dexamethasone acetate cream, produced by China Resources Sanjiu Pharmaceutical Co., Ltd.);

Excipient: 20% alcohol;

Pruritus: Histamine Phosphate.

2. Experimental animals: healthy qualified guinea pigs, Beijing Keyu Animal Breeding Center, license number: SCXK-(Beijing) 2007-0003. Body weight 250-300g, average 270g, male and female, 60 animals, randomly divided into 6 groups, 10 animals in each group; 6 animal groups were model control group, excipient control group, Piyanping group, spray low, Middle and high dose groups.

3. Administration dose, route, test grouping

Model group: no administration.

Positive group: 0.1 g of Piyanping was given, and the dosage was equivalent to 370 mg/Kg.

Excipient group: administer 0.1ml of excipient 20% ethanol, the dosage is equivalent to 0.37ml/Kg.

Low-dose group: 0.1ml of reagent spray was given. The body weight of guinea pigs is calculated as 270g/only on average, and the dosage converted into biomedicine is 113mg/Kg.

Middle-dose group: 0.15ml of reagent spray was given. The body weight of guinea pigs is calculated as 270g/only on average, and the dosage converted into biomedicine is 169mg/Kg.

High-dose group: 0.2ml of reagent spray was given. The body weight of guinea pigs is calculated as 270g/only on average, and the dosage converted into biomedicine is 226mg/Kg.

4. Data and statistical processing: The measurement data is based on "mean ± standard deviation (x ± s)"; the comparison of sample means between multiple groups is performed by analysis of variance, and those with uneven variance are transformed accordingly.

5. Test method [Refer to the following literature: The Ministry of Health of the People's Republic of China Drug Administration Bureau edited. Guidelines for New Drug Research of Traditional Chinese Medicine (Pharmacy, Pharmacology, Toxicology)[s]: 179]

Select guinea pig skin itching model induced by histamine phosphate, and divide guinea pigs into 6 groups randomly, model control group, vehicle control group, Piyanping group, sample low, medium and high dose groups, 10 in each group. One day before the test, the dorsum of the right hind foot of the guinea pigs in each group was shaved, and the drug was applied once. Among them, the excipient control group was coated with 20% alcohol, and the model control group was not coated with medicine. On the day of the test, the shaved area was scratched with No. 0 sandpaper, with an area of 1 cm ² . Topically reapply the medicine 1 time. After 10 minutes, drip 0.01% histamine phosphate 0.05ml/piece on the wound, and then every 3 minutes according to 0.01%, 0.02%, 0.03%, 0.04%...The concentration increases, each time is 0.05mL/piece, Until the guinea pig appears to lick the right hind foot. The total amount of histamine phosphate administered when guinea pigs licked their right hind paw was taken as the itching threshold, and the itching thresholds of each group were recorded and compared.

6. The test results are shown in the following table 2:

Table 2: Effects of the composition of the present invention on the itching response induced by histamine phosphate in guinea pigs (x ± s)

group n Dose (mg/kg) Itching threshold (total amount of histamine phosphate/μg) Model control group 10 - 35±34 Excipient Control 10 - 63±59 Piyanping group 10 370mg/Kg 84±54 ^＊ Agent group in the sample 10 169mg/Kg 139±132 ^* Sample high dose group 10 226mg/Kg 147±115 ^＊＊

Note: Comparing each group with the model control group, ^* P<0.05, ^** P<0.01; n=10.

From the results of the composition of the present invention to the itching reaction of guinea pig histamine phosphate, it can be seen that there are significant differences between the positive control group, the sample medium dose group, and the sample high dose group compared with the model control group, that is, there is a significant difference in the itching domain. In addition, the low-dose group also had a significant difference compared with the model group. There was no significant difference between the vehicle group and the model group.

Test example 3: the antiallergic reaction test of the composition of the present invention

In this test, by establishing a delayed-type hypersensitivity model, using the ear swelling inhibition rate as an index, observe the effect on the mouse ear swelling inhibition rate after administration of the composition test group of the present invention, and evaluate the anti-allergic effect of different dosage groups of the composition of the present invention. Reaction; measure thymus and spleen index, observe the effect on immune function of mice after administration, and provide data support for clinical efficacy.

1. Test material:

Reagent: the composition of Example 1 (spray type, crude drug content and ethanol concentration are respectively 30g/100ml, 20%);

Positive control drug: Sanjiu Piyanping (compound dexamethasone acetate cream, produced by China Resources Sanjiu Pharmaceutical Co., Ltd.);

Inflammatory agent: 2.4-dinitrochlorobenzene (DNCB); preparation: 2% DNCB, weighing 100mg, dissolved in 5ml acetone salad oil (acetone: salad oil = 2.5: 2.5ml)

Excipient: 20% alcohol;

2. Experimental animals: Kunming mice, SPF grade, Experimental Animal Center, Academy of Military Medical Sciences, license number: SCXK-(Army) 2007-004. Weight 18-20g, half male and half male, 70 rats were randomly divided into 7 groups, 10 rats in each group. The 7 animal groups are:

Blank group: 75% ethanol 0.1ml, skin administration, 24h later 75% ethanol 0.1ml repeated.

Model group: 2% DNCB 0.1ml, administered to the skin, 24h later repeated 2% DNCB 0.1ml.

Positive group: 2% DNCB 0.1ml, administered to the skin, 24h later, repeated administration of 2% DNCB 0.1ml, and the positive drug Piyanping 0.1g, continuous administration for 5 days. The dosage of the positive drug group was equivalent to 370mg/Kg.

Excipient group: 2% DNCB 0.1ml, skin administration, 24h later repeated 2%DNCB 0.1ml, and excipient 20% ethanol 0.1ml, continuous administration for 5 days. The dosage of the vehicle group was equivalent to 0.37ml/Kg.

Low-dose group: 2% DNCB 0.1ml, administered to the skin, 24h later, 2% DNCB 0.1ml was repeated, and the experimental drug reagent spray 0.1ml was given, and the administration was continued for 5 days.

Medium-dose group: 2% DNCB 0.1ml, administered to the skin, 24h later, 2% DNCB 0.1ml was repeated, and test drug reagent spray 0.15ml was administered for 5 consecutive days.

High-dose group: 2% DNCB 0.1ml, administered to the skin, 24h later, repeated 2% DNCB 0.1ml, and 0.2ml test drug reagent spray, administered continuously for 5 days.

The doses of the above low, middle and high dose groups converted into crude drug doses were 113mg/Kg, 169mg/Kg and 226mg/Kg respectively.

3. Data and statistical processing: The measurement data is based on "mean ± standard deviation (x ± s)"; the comparison of sample means among multiple groups is performed by analysis of variance, and those with uneven variance are transformed accordingly.

4. Test method: Mice were randomly divided into 7 groups and shaved. Except for the blank control group coated with 0.1mL ethanol, the mice in each group were evenly coated with 0.1mL of 2% DNCB on the depilated area for sensitization; the next day, each Corresponding drugs were applied to the depilated area of the mice in the treatment group, and the same amount of excipients were applied to the blank and model control groups, once a day for 5 consecutive days. On the 5th day, the mice in each group were evenly coated with 1% DNCB on the inner and outer sides of the right ear for stimulation. After 24 hours, the mice were sacrificed by cervical dislocation, and the ears of the same parts of the two ears of the mice were punched out with a hole punch with a diameter of 7 mm, weighed, and the swelling inhibition rate (%) was calculated according to the following formula. The mouse spleen and thymus were removed at the same time, and the spleen index and thymus index were calculated. The results are shown in Table 3 and Table 4.

Table 3: Effects of compositions of the present invention on delayed-type hypersensitivity in mice (x ± s)

group n Dose (g/kg) Degree of swelling (/mg) Inhibition rate(/%) Blank control group 10 - 1.0±1.45 - Model control group 10 - 4.4±1.04 - Excipient group 10 - 3.9±2.85 10.8 Piyanping group 10 370mg/kg 1.6±1.20 ^＊＊ 64.1 Sample low dose group 10 113mg/kg 2.4±1.79 ^＊＊ 44.4 Agent group in the sample 10 169mg/kg 2.0±2.29 ^＊＊ 53.6 Sample high dose group 10 226mg/kg 2.0±1.40 ^＊＊ 54.7

Note: Compared with the model control group, ^** P<0.01; n=10.

Table 4: Effect of the composition of the present invention on the weight of immune organs in mice (x ± s)

group n Dose (g/kg) Thymus index (g/kg) Spleen index (g/kg) Blank control group 10 - 4.8±0.98 4.3±1.29

Model control group 10 - 4.7±0.66 3.9±0.98 Excipient group 10 - 4.4±0.92 3.4±0.72 Piyanping group 10 370mg/kg 1.8±0.29 ^＊＊ 1.0±0.32 ^＊＊ Sample low dose group 10 113mg/kg 4.6±1.16 3.9±0.82 Agent group in the sample 10 169mg/kg 4.7±1.19 3.9±0.72 Sample high dose group 10 226mg/kg 5.0±0.73 4.0±0.96

Note: Compared with the model control group, ^** P<0.01; n=10.

From the measurement results of the degree of swelling, it can be seen that there is a significant difference between the model control group and the blank group, indicating that the modeling is successful; there is no significant difference between the excipient group and the model group, indicating that the excipient has no drug effect; There are significant differences between the middle and high dose groups and the positive group compared with the model group, that is, the swelling degree of the three groups of samples and the swelling degree of the positive group are significantly lower than that of the model group.

It can be seen from the influence of the sample on the weight of the immune organs of the mice that all the drug groups had no significant difference compared with the model group or the blank group, that is, the three doses of the drug did not affect the spleen and thymus of the mice, while Positive drugs had significant effects on the spleen and thymus of mice.

Therefore, the low, middle and high dose groups of the composition of the present invention all have obvious anti-allergic effects, but will not affect the spleen and thymus.

Test Example 4: Anti-inflammatory test

In this test, by establishing the experimental model of xylene-induced mouse auricle swelling, taking the degree of swelling as an index, observing the effect of mice on xylene-induced mouse auricle swelling after administration of each test group, and evaluating different dosage groups of the composition of the present invention anti-inflammatory effect.

1. Test material:

Reagent: the composition of Example 1 (spray type, crude drug content and ethanol concentration are respectively 30g/100ml, 20%);

Positive control drug: Sanjiu Piyanping (compound dexamethasone acetate cream, produced by China Resources Sanjiu Pharmaceutical Co., Ltd.);

Pruritus: Histamine Phosphate

Excipient: 20% alcohol;

2. Experimental animals: Kunming mice, SPF grade, Experimental Animal Center, Academy of Military Medical Sciences, license number: SCXK-(Army) 2007-004. Weight 18-20g, half male and half male, 60 rats were randomly divided into 6 groups, 10 rats in each group. The 6 animal groups are:

Model group: Mice were evenly smeared with 0.05mL of xylene on the right ear. After 1.5h, they were sacrificed by cervical dislocation, and the left and right ears were punched and weighed.

Positive group: 0.05 mL of xylene was evenly applied to the right ear of the mouse, and 0.1 g of dermatitis was applied to the right ear after 30 minutes. After 1 hour, the mouse was killed by cervical dislocation, and the left and right ears were punched and weighed. The dosage of the positive drug Piyanping group is equivalent to 370mg/Kg.

Vehicle group: 0.05 mL of xylene was evenly applied to the right ear of the mice. After 30 minutes, 0.1 ml of vehicle was applied to the right ear. After 1 hour, the mice were sacrificed by cervical dislocation, and the left and right ears were punched and weighed. The dosage of the vehicle group was equivalent to 0.37ml/Kg.

Low-dose group: 0.05 mL of xylene was evenly applied to the right ear of the mouse, and after 30 minutes, 0.1 ml of the composition of the present invention was applied to the right ear, and the positive drug was given continuously for 5 days. One hour later, they were killed by cervical dislocation, and the left and right ears were perforated and weighed.

Medium-dose group: 0.05 mL of xylene was evenly applied to the right ear of the mouse, and after 30 minutes, 0.15 mL of the composition of the present invention was applied to the right ear, and the positive drug was given continuously for 5 days. One hour later, they were killed by cervical dislocation, and the left and right ears were perforated and weighed.

High-dose group: 0.05 mL of xylene was evenly applied to the right ear of mice, and after 30 minutes, 0.2 ml of the composition of the present invention was applied to the right ear, and the positive drug was given continuously for 5 days. One hour later, they were killed by cervical dislocation, and the left and right ears were perforated and weighed.

The above three drug groups: the dosages of the low, middle and high dose groups of the composition of the present invention are converted into biomedicine doses of 1.525g/Kg, 2.288g/Kg, and 3.050g/Kg.

3. Data and statistical processing: The measurement data is based on "mean ± standard deviation (x ± s)"; the comparison of sample means among multiple groups is performed by analysis of variance, and those with uneven variance are transformed accordingly.

4. Test method: xylene-induced ear swelling in mice [see, Xu Shuyun, Bian Rulian, Chen Xiu. Pharmacological Experimental Methodology 【M】． 3rd edition. Beijing: People's Health Publishing House, 2002: 906, 1407, 1429]: the mice were randomly divided into 6 groups, i.e. model control group, excipient control group, Piyanping group, low, middle and high levels of the composition spray of the present invention Dosage group, 10 rats in each group. The right ears of the mice in each group were evenly smeared with 0.05 mL of xylene, and 30 minutes later, the right ears of the mice in the treatment group were smeared with the corresponding drug, and the control group was smeared with excipients, 0.1 g each. After 60 minutes of administration, the mice were sacrificed by cervical dislocation, and the same parts of the ears of the mice were punched with a 7mm punch, and weighed. The difference between the weights of the two ear pieces was used as the swelling degree, and the average swelling degree of each group was calculated, and calculated according to the following formula Swelling inhibition rate (%). The results are shown in Table 5.

Table 5: Effect of the composition of the present invention on xylene-induced ear swelling in mice (x ± s)

group n Dose (g/kg) Degree of swelling (/mg) Inhibition rate(/%) model group 10 - 10.6±3.40 - Excipient group 10 - 11.0±3.87 -4.1 Piyanping group 10 370mg/kg 6.5±3.67 ^＊＊ 38.3 Sample low dose group 10 1.525g/kg 5.8±5.06 ^＊＊ 45.0 Agent group in the sample 10 2.288g/kg 7.0±3.41 ^＊＊ 34.0 Sample high dose group 10 3.050g/kg 6.8±3.95 ^＊＊ 35.9

Note: Compared with the model control group, ^** P<0.01; n=10.

From the results of the influence of the composition of the present invention on xylene-induced auricle swelling in mice, there are significant differences between the sample low, medium and high-dose groups and the positive group compared with the model group, that is, the swelling degree and positive Compared with the model group, the swelling degree of the excipient group was significantly lower than that of the model group; there was no significant difference between the excipient group and the model group, indicating that the excipient had no drug effect; the swelling inhibition rates of the sample low, medium, high dose groups and the positive group were 45.0 %, 34.0%, 35.9%, 38.3%, there was no significant difference between the sample dosage groups; there was also no significant difference between the sample dosage groups and the positive group, indicating that the anti-inflammatory effects of the sample group and the positive group were equivalent.

Test Example 4: Effect of the composition of the present invention on rat egg white paw swelling

In this experiment, by establishing a rat model of egg white paw swelling, taking the degree of paw swelling as an index, observing the degree of paw swelling in each test group after administration, and evaluating the influence of different dosage groups of the composition of the present invention on paw swelling.

Reagent: the composition of Example 1 (spray type, crude drug content and ethanol concentration are respectively 30g/100ml, 20%);

Positive control drug: Sanjiu Piyanping (compound dexamethasone acetate cream, produced by China Resources Sanjiu Pharmaceutical Co., Ltd.);

Egg protein: 10% fresh egg white.

Excipient: 20% alcohol;

2. Experimental animals: Wister rats, both male and female, China National Institutes for Food and Drug Control, license number: SCXK-(Beijing) 2009-0017. Weight 180-200g, half male and half male, 70 rats were randomly divided into 7 groups, 10 rats in each group. The 7 animal groups are:

Blank group: 0.1ml of distilled water was applied to the sole of the right hind foot, and the volume of the right hind foot was measured at 2h, 3h, 5h, and 7h.

Model group: 0.1ml of distilled water was applied to the sole of the right hind foot, and 1 hour later, 0.05ml of 10% fresh egg white was subcutaneously injected into the right hind foot of each group. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection.

Positive group: 0.1 g of dermatitis was applied on the sole of the right hind foot, and 1 hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection. The dosage of the positive drug Piyanping group is equivalent to 370mg/Kg.

Vehicle group: 0.1ml of vehicle was applied to the sole of the right hind foot, and 1 hour later, 0.05ml of 10% fresh egg white was subcutaneously injected into the right hind foot. One hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection. The administration amount of the vehicle (20% ethanol) group corresponded to 0.37 ml/Kg.

Low-dose group: 0.1 ml of the composition of the present invention was applied to the sole of the right hind foot, and 1 hour later, the right hind foot was subcutaneously injected with 0.05 ml of 10% fresh egg white. One hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection.

Medium-dose group: 0.15ml of the composition of the present invention was applied to the sole of the right hind foot, and 1 hour later, the right hind foot was subcutaneously injected with 0.05ml of 10% fresh egg white. One hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection.

High-dose group: 0.2 ml of the composition of the present invention was applied to the sole of the right hind foot, and 1 hour later, the right hind foot was subcutaneously injected with 0.05 ml of 10% fresh egg white. One hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection.

The above three drug groups: the dosages of the low, middle and high dose groups of the composition of the present invention are converted into biomedicine doses of 153 mg/Kg, 229 mg/Kg, and 305 mg/Kg.

3. Data and statistical processing: The measurement data is based on "mean ± standard deviation (x ± s)"; the comparison of sample means among multiple groups is performed by analysis of variance, and those with uneven variance are transformed accordingly.

4. Test method: according to literature [Chen Qi. Research methods and ideas of efficacy of traditional Chinese medicine [M] Beijing: People's Health Publishing House. 2005: 1083] method, 70 rats were randomly divided into 7 groups, 10 in each group. On the day of the experiment, the normal volume of the right hind paw of the rats in each group was measured with a self-made volume measuring device, and then the drug was applied to each group, and the same amount of distilled water was applied to the control group. One hour later, 0.05 ml of 10% fresh egg white was subcutaneously injected into the right hind foot of each group. The right hind paw volume was measured 1h, 2h, 4h, 6h after egg white injection. The ratio of the volume change of the right hind foot before and after inflammation to the initial volume was the swelling rate, and the differences in the swelling rates of each group were compared. The results are shown in Tables 6, 7, 8, and 9, respectively.

Table 6: Effect of the composition on egg white paw swelling in rats (1h after injection) (x±s)

group n Degree of swelling (/mg) Inhibition rate(/%) Blank control group 10 -80±53.7 - model group 10 380±122.9 - Excipient group 10 290±84.3 23.7 Piyanping group 10 138±108.0 63.7 Agent group in the sample 10 202±100.2 46.8 Sample high dose group 10 199±105.8 47.6

Table 7: Effect of the composition on egg white paw swelling in rats (2h after injection) (x±s)

group n Degree of swelling (/mg) Inhibition rate(/%) Blank control group 10 -60±73.8 - model group 10 320±75.3 - Excipient group 10 355±89.6 -10.9 Piyanping group 10 194±104.2 39.4 Agent group in the sample 10 138±117.8 56.9 Sample high dose group 10 149±132.5 53.4

Table 8: Effect of the composition on egg white paw swelling in rats (4h after injection) (x±s)

group n Degree of swelling (/mg) Inhibition rate(/%) Blank control group 10 70±63.2 - model group 10 295±89.6 -

Excipient group 10 280±82.3 5.1 Piyanping group 10 58±60.3 80.3 Agent group in the sample 10 80±103.3 72.9 Sample high dose group 10 92±105.5 68.6

Table 9: Effect of the composition on egg white paw swelling in rats (6h after injection) (x±s)

group n Degree of swelling (/mg) Inhibition rate(/%) Blank control group 10 -91±86.0 - model group 10 285±88.3 - Excipient group 10 350±110.6 -22.8 Piyanping group 10 20±147.1 93.0 Agent group in the sample 10 145±106.6 49.1 Sample high dose group 10 157±116.9 44.9

As can be seen from the assay results of the composition of the present invention to rat egg white paw swelling, the model group has a significant difference compared with the blank group, indicating that the modeling is successful; There is a significant difference, indicating that the middle and high dose groups and the positive group of the sample can reduce the egg white paw swelling effect of rats; the effect of the middle and high dose group of the sample and the positive group has no significant difference, that is, the effect is equivalent; the test results of the low dose group Not obtained. It can be seen that the composition of the present invention has the effect of reducing egg white paw swelling in rats.

In the supplementary test, the sprays obtained in Example 2 and Example 3 are respectively used as reagents, and tested in the same way as above Test 2, 3, and 4, and the results show that the combination of the present invention of Example 2 and Example 3 The above test results of the composition of the present invention and the composition of the present invention in Example 1 are substantially consistent in statistics.

Claims (10)

1. compositions, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae.

2. according to the compositions of claim 1, Radix Sophorae Flavescentis is in 8 weight portions in its medical material:

Rhizoma Smilacis Glabrae 3-24 weight portion, 5-20 weight portion for example, 8-18 weight portion for example, 10-15 weight portion for example, for example about 12 weight portions;

Herba Artemisiae Scopariae 2-16 weight portion, 3-15 weight portion for example, 4-12 weight portion for example, 5-10 weight portion for example, for example about 8 weight portions;

Cortex Phellodendri 2-16 weight portion, 3-15 weight portion for example, 4-12 weight portion for example, 5-10 weight portion for example, for example about 8 weight portions;

Radix Gentianae 1.5-12 weight portion, 2-10 weight portion for example, 3-9 weight portion for example, 4-8 weight portion for example, for example about 6 weight portions;

Cortex Dictamni 2-16 weight portion, 3-15 weight portion for example, 4-12 weight portion for example, 5-10 weight portion for example, for example about 8 weight portions;

Herba Portulacae 1.5-12 weight portion, 2-10 weight portion for example, 3-9 weight portion for example, 4-8 weight portion for example, for example about 6 weight portions;

Fructus Kochiae 2-16 weight portion, 3-15 weight portion for example, 4-12 weight portion for example, 5-10 weight portion for example, for example about 8 weight portions;

Radix Stemonae 2.5-20 weight portion, 3-18 weight portion for example, 5-15 weight portion for example, 8-12 weight portion for example, for example about 10 weight portions; And/or

Radix Glycyrrhizae 1.5-12 weight portion, 2-10 weight portion for example, 3-9 weight portion for example, 4-8 weight portion for example, for example about 6 weight portions.

3. according to the compositions of claim 1, it is characterized in that:

It is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion; Perhaps

It is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 8-18 weight portion, Herba Artemisiae Scopariae 4-12 weight portion, Cortex Phellodendri 4-12 weight portion, Radix Gentianae 3-9 weight portion, Cortex Dictamni 4-12 weight portion, Herba Portulacae 3-9 weight portion, Fructus Kochiae 4-12 weight portion, Radix Stemonae 5-15 weight portion, Radix Glycyrrhizae 3-9 weight portion; Perhaps

It is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 12 weight portions, Herba Artemisiae Scopariae 8 weight portions, Cortex Phellodendri 8 weight portions, Radix Gentianae 6 weight portions, Cortex Dictamni 8 weight portions, Herba Portulacae 6 weight portions, the Fructus Kochiae 8 weight portions, the Radix Stemonae 10 weight portions, Radix Glycyrrhizae 6 weight portions.

4. according to the compositions of claim 1, also comprise Mentholum and/or Borneolum Syntheticum in the wherein said medical material.

5. according to the compositions of claim 4, Radix Sophorae Flavescentis is in 8 weight portions in its medical material:

Mentholum 0.1-3 weight portion, 0.3-2.0 weight portion for example, 0.5-1 weight portion for example, 0.7-0.9 weight portion for example, for example about 0.8 weight portion; And/or

Borneolum Syntheticum 0.1-2 weight portion, 0.2-1.5 weight portion for example, 0.3-1.0 weight portion for example, 0.4-1.6 weight portion for example, for example about 0.53 weight portion.

6. according to the compositions of claim 1, it is by comprising that following Chinese crude drug is prepared into: Radix Sophorae Flavescentis 8 weight portions, Rhizoma Smilacis Glabrae 3-24 weight portion, Herba Artemisiae Scopariae 2-16 weight portion, Cortex Phellodendri 2-16 weight portion, Radix Gentianae 1.5-12 weight portion, Cortex Dictamni 2-16 weight portion, Herba Portulacae 1.5-12 weight portion, Fructus Kochiae 2-16 weight portion, Radix Stemonae 2.5-20 weight portion, Radix Glycyrrhizae 1.5-12 weight portion, Mentholum 0.1-3 weight portion, Borneolum Syntheticum 0.1-2 weight portion.

7. according to the compositions of claim 1, wherein said Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae join in the said compositions through extraction.

8. according to the compositions of claim 1, it is the form that is medicinal preparation for oral administration or topical agent.Preferably it is to be to be selected from following medicine type: ointment, ointment, gel, liniment, spray.

9. the preparation that is combined in of following traditional Chinese medicines material is used for treatment or prevents the for example purposes of the product of disease such as eczema, pruritus of mammal (for example people) dermatosis: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae.Further, this purposes has like the described characteristic of the arbitrary embodiment of description second aspect.

10. prepare each said method for compositions of claim 1-8; It may further comprise the steps: Radix Sophorae Flavescentis, Rhizoma Smilacis Glabrae, Herba Artemisiae Scopariae, Cortex Phellodendri, Radix Gentianae, Cortex Dictamni, Herba Portulacae, the Fructus Kochiae, the Radix Stemonae, Radix Glycyrrhizae are used solvent extraction; The extracting solution that obtains is concentrated; Add optional Mentholum, Borneolum Syntheticum, and add optional pharmacy acceptable auxiliary, promptly get.