CN105232606B - A kind of external pharmaceutical composition for acne treatment and preparation method thereof - Google Patents

Abstract

The invention provides an external pharmaceutical composition for treating acne and a preparation method thereof, belonging to the technical field of pharmaceutical compositions. The invention solves the problem that in the existing medicinal composition for treating acne, the treatment cycle of traditional Chinese medicine is long and the curative effect is slow, while the treatment of western medicine has large side effects. The pharmaceutical composition comprises: 20-55 parts of natural plant essential oil, 45-75 parts of B vitamins, 10-20 parts of vitamin E and 10-30 parts of antibiotics in parts by weight. In the present invention, through the combined application of Chinese and Western medicines, the medicines produce synergistic effects to achieve the purpose of enhancing the efficacy of medicines without any side effects. The composition has antibacterial and anti-inflammatory properties, promotes wound healing, inhibits scar formation, and reduces pigmentation. The effect is remarkable for the treatment of acne.

Description

A kind of external pharmaceutical composition for acne treatment and preparation method thereof

technical field

The invention belongs to the technical field of pharmaceutical compositions, and in particular relates to an external pharmaceutical composition for treating acne and a preparation method thereof.

Background technique

The occurrence of acne is the result of the interaction of many factors, and its pathogenesis is mainly related to factors such as the level of sex hormones, the massive secretion of sebaceous glands, the proliferation of Propionibacterium acnes, abnormal keratinization of the pilosebaceous ducts, and inflammation. Environmental factors and genetic factors interact and promote each other to induce and aggravate acne.

In the process of acne treatment, in addition to paying attention to drug treatment, patients with family history of acne and severe acne should avoid the following risk factors (such as eating spicy food, high-fat food, animal oil, egg products, fish products, contact reflex line, sunlight exposure, etc.). Eat more vegetable oil, fruits and vegetables to reduce the occurrence and aggravation of acne.

At present, there are many kinds of preparations for treating acne, among which "a pharmaceutical composition for treating acne (patent application number: CN 104524463A)" is treated by taking traditional Chinese medicine orally, which has long cycle, slow curative effect, many contraindications, and easy recurrence. In addition, "metronidazole ester for the treatment of rosacea (patent application number: CN 102958920AG)" is treated by external application of western medicine, which has large side effects and is prone to drug resistance.

Contents of the invention

The purpose of the present invention is to solve the problems of long period of use of traditional Chinese medicine, slow curative effect, and large side effects of Western medicine in the existing external pharmaceutical composition for treating acne, and to provide an external pharmaceutical composition for acne treatment and its preparation method.

The present invention firstly provides an external pharmaceutical composition for treating acne, which comprises:

Preferably, the natural plant essential oil includes a mixture of comfrey oil and evening primrose oil.

Preferably, in the mixture, the mass ratio of comfrey oil and evening primrose oil is (10-30):(10-25).

Preferably, the B vitamins include a mixture of vitamin B ₁₂ , vitamin B ₆ , vitamin B ₁ and vitamin B ₂ .

Preferably, the mass ratio of vitamin B ₁₂ , vitamin B ₆ , vitamin B ₁ and vitamin B ₂ in the mixture is (20-25):(5-15):(10-20):(10-15 ).

Preferably, the antibiotic is erythromycin, streptomycin or oxytetracycline.

Preferably, the described pharmaceutical composition for external use for the treatment of acne, in parts by weight, includes:

Comfrey oil 10-30 parts, evening primrose oil 10-25 parts, vitamin E 10-20 parts, vitamin B ₁₂ 20-25 parts, vitamin B ₆ 5-15 parts, B ₂ 10-15 parts, B ₁ 10- 20 parts, 10-30 parts of antibiotics.

The present invention also provides a preparation method of an external pharmaceutical composition for acne treatment, comprising:

Step 1: extract natural plant essential oil;

Step 2: Put B vitamins and antibiotics into the tissue masher in turn, run for 1-3 minutes, let it stand for 5-10 minutes, add vitamin E and natural plant essential oils, and run for 1-3 minutes to get acne treatment Pharmaceutical composition for external use.

Preferably, the natural plant essential oil includes a mixture of comfrey oil and evening primrose oil.

Preferably, the method for extracting evening primrose oil is supercritical _CO2 fluid extraction, the extraction pressure is 33-35MPa, the extraction temperature is 30-45°C, and the extraction time is 1.5-3 hours, Flow rate 2L/min.

Beneficial effects of the present invention

The present invention provides an external pharmaceutical composition for treating acne and its preparation method. The composition of the present invention includes natural plant essential oils, vitamins and antibiotics. Through the combined application of Chinese and Western medicines, the medicines have a synergistic effect, achieving For the purpose of enhancing the drug effect without any side effects, the composition has the functions of antibacterial, anti-inflammation, promoting wound healing, inhibiting scar formation and reducing pigment deposition, and has remarkable effect on treating acne.

The pharmaceutical composition of the present invention was used in 500 cases of acne patients clinically observed from 2011 to 2015, and the clinical reports are as follows:

1) Clinical data

Among the 500 cases in this group, there were 171 males and 329 females. The youngest was 19 years old and the oldest was 48 years old. The course of disease ranged from 3 months to 5 years.

2) Acne Pillsbury grading method:

1. Mild

Mild is grade I, mainly acne, a small amount of papules and pustules, and the total number of lesions is less than 30.

2. Moderate

Moderately divided into II, III two levels. Grade II is characterized by acne, a moderate amount of papules and pustules, and the total number of lesions is between 31 and 50; Grade III is manifested by a large number of papules and pustules, occasionally large inflammatory lesions, widely distributed, and the total number of lesions is 51 Between -100, there are less than 3 nodules.

3. Severe

Severe is grade IV, manifested as nodular/cystic acne or acne conglomerate, most of which have pain and form cysts and sinus tracts, with a total of more than 100 lesions and more than 3 nodules/cysts.

3) Curative effect evaluation criteria

Cure: skin damage subsided, subjective symptoms disappeared.

Significantly effective: more than 70% of the skin damage has subsided. No new lesions appeared.

Ineffective: less than 30% of the skin lesions disappeared, and new skin lesions continued to appear during the treatment.

4) Treatment method

Usage and dosage: after washing the face, apply the pharmaceutical composition for external use of the present invention to the affected area. The smeared area is larger than the area of the affected area, and the thickness is preferably 1 cm. In order not to affect work and study, it can be applied before going to bed and washed with warm water after getting up in the morning. .

Course of treatment: not less than 1 course of treatment (2-3 weeks), no rebound after curing.

5) Therapeutic effect:

The medicinal composition of the present invention is applied to 500 cases of acne patients aged 18-45, 484 cases (96.8%) are cured, 14 cases (2.8%) are markedly effective, and 2 cases (0.4%) are ineffective. Total effective rate (99.6%)

(Note: some of these 500 routine patients have used other types of products to be ineffective or relapsed, and some are patients who have failed after treatment in a beauty parlor. With the external pharmaceutical composition of the present invention, the lighter ones are treated after a course of treatment (2-3 week) after the acne disappears, acne marks, and pigmentation are significantly reduced. After a course of continuous medication, the pigmentation disappears and the skin is fine and smooth. Severe cases need three courses of medication before they can be cured. All patients have no adverse reactions during the treatment , the cured patients were followed up regularly, the curative effect was stable, and no recurrence occurred. Among them, two patients with acne failed to follow the course of treatment and stopped taking medicine halfway, but the wound surface improved significantly.)

6) Typical cases Cases of voluntary disclosure by patients:

① A 19-year-old female had been ill for half a year, and had less than 30 acnes and pustules of various sizes on her forehead and triangular area. She was diagnosed with mild acne. Readme marketed drugs have been used but repeated attacks. After 2 courses of treatment, the medicament of the present invention is used externally on the affected area, and the acne and pustules subside, the acne marks disappear, and the ruddy healthy complexion is restored. Follow up a case by regular visits to and do not see recurrence in one year.

②A 28-year-old woman who has been ill for 5 years and has more than 30 acne and pustules on her face. She said that her skin was fair before the illness, but after the illness she was full of pustules. She was unwilling to communicate with others. She was treated in a beauty salon for three months , spending thousands of dollars, repeated attacks, no improvement. When the medicine of the present invention is used externally on the affected part, the redness and swelling of the face disappears in the first course of treatment, and scabs are formed in the second course of treatment of acne and pustules. In the third course of treatment, acne scars fade away and basically disappear, and the skin basically returns to normal skin color. Follow up a case by regular visits to and do not see recurrence in one year.

③A 23-year-old man with large areas of acne on the face, neck and shoulders, red and swollen face, manifested as cystic acne, cysts connected into pieces, no normal healthy skin tissue on the face, reported pain, diagnosis For severe acne. Use the composition of the present invention for external use on the affected part, the first course of treatment for acne on the face and neck and shoulders, the redness and swelling subsided, and the pain disappeared. In the second course of treatment, the pus was absorbed and the cyst shrank. In the third course of treatment, the facial acne disappeared, the acne marks faded, and the skin on the face, neck and shoulders returned to normal skin luster. After the complete cure, no recurrence was found in the one-year follow-up.

④ A 35-year-old male with acne for three years. The whole nose is red and swollen, and a large number of papules and pustules are superimposed on the mandibular and neck throat. The number is more than 50. The diagnosis is moderate grade III acne. The self-reported use of multiple drugs Not only did it not improve, but there was a tendency to aggravate it. Using the composition of the present invention for external use on the affected area, the redness and swelling of the nose is relieved in the first course of treatment, papules and pustules of different sizes on the jaw and neck throat are reduced, and the nasal pustule shrinks in the second course of treatment, and the size of the jaw and neck throat is reduced. The various pimples and pustules disappeared. In the third course of treatment, the skin on the nose, jaw and throat of the neck returned to normal skin color, the acne marks faded, and the acne marks on some affected areas disappeared. Follow up a case by regular visits to and do not see recurrence in one year.

Detailed ways

The present invention firstly provides an external pharmaceutical composition for treating acne, which comprises:

According to the present invention, described natural plant essential oil comprises the mixture of comfrey oil and evening primrose oil; In the described mixture, the mass ratio of comfrey oil and evening primrose oil is preferably (10-30): (10- 25).

According to the present invention, the B vitamins include a mixture of vitamin B ₁₂ , vitamin B ₆ , vitamin B ₁ and vitamin B ₂ . The mass ratio of vitamin B ₁₂ , vitamin B ₆ , vitamin B ₁ and vitamin B ₂ in the mixture is preferably (20-25):(5-15):(10-20):(10-15).

According to the present invention, the vitamin E has an important protective effect on the cell membrane of the body, maintains the integrity of the cell membrane, protects the skin from ultraviolet rays and pollution, reduces scars and pigmentation; at the same time, it can be used as a stabilizer to prevent vitamin _B12 from being damaged. oxidation.

According to the present invention, the antibiotic is preferably erythromycin, streptomycin or oxytetracycline. External use of antibiotics has anti-inflammatory, detumescence, astringent effects, and prevents wounds from continuing to be infected.

According to the present invention, the described external pharmaceutical composition for acne treatment preferably includes in parts by weight:

Comfrey oil 10-30 parts, evening primrose oil 10-25 parts, vitamin E 10-20 parts, vitamin B ₁₂ 20-25 parts, vitamin B ₆ 5-15 parts, B ₂ 10-15 parts, B ₁ 10- 20 parts, 10-30 parts of antibiotics.

The pharmacological action of medicine of the present invention is as follows:

①Evening primrose (Oenthera biennis L.), also known as evening primrose, mountain sesame, etc., is a perennial herb of the willow leaf family. It is native to North America. It is introduced into Northeast my country as a flower and becomes wild. It is mainly produced in the eastern mountainous area of Northeast China. . Evening primrose oil is the oil extracted from the seeds of evening primrose. It has a remarkable moisturizing effect in cosmetics and prevents keratinization of epidermal cells. Evening primrose oil has strong biological activity, antibacterial, anti-inflammatory, and antioxidant activities. , to accelerate wound healing.

② Comfrey is the dry root of Arnebia euchroma (Royle) johnst. Historically recorded in "Shen Nong's Materia Medica", it tastes bitter, cold in nature, and has the effect of cooling blood, detoxifying, penetrating rashes, and transforming it. Comfrey oil is extracted from Comfrey, which can promote wound healing, inhibit scar formation, moisturize skin, anti-inflammation and anti-oxidation.

③B vitamins

Vitamin B ₁₂ (Vitamin B ₁₂ ), also known as cobalamin for external use, can significantly relieve pain and itching, relieve local microvascular spasm, promote wound healing, and reduce scar formation;

Vitamin B ₁ (Vitamin B ₁ ), thiamine is the basic substance to maintain carbohydrate and nerve function. External application can regulate skin cell function, help the recovery of skin and mucous membrane cell damage, and accelerate wound healing;

Vitamin B ₂ (Vitamin B ₂ ), riboflavin is necessary for the metabolism of carbohydrates, lipids and amino acids in the body, and is also a cellular antioxidant, which can help the skin resist sun damage, and the skin becomes rough when the body is deficient ;

Vitamin B ₆ (Vitamin B ₆ ), there are three naturally occurring forms of pyridoxal, pyridoxine, and pyridoxamine. It participates in various metabolic processes and has a good anti-androgen hormone effect. By inhibiting the hair follicle sebaceous duct The role of abnormal keratinization, reduce epithelial cell keratinization and keratin embolism of pilosebaceous gland mouth, prevent acne formation, improve local microcirculation, and promote skin lesion repair.

④ Vitamin E (Vitamin E) is a fat-soluble vitamin, and its hydrolyzed product is tocopherol, which is one of the main antioxidants. It has an important protective effect on the cell membrane of the body and maintains the integrity of the cell membrane. Protects skin from UV rays and pollution, reducing blemishes and pigmentation. At the same time, it can act as a stabilizer to prevent the oxidation _of vitamin B12.

⑤ Antibiotics: Antibiotics for external use have anti-inflammatory, detumescence, astringent effects, and prevent wounds from continuing to be infected.

The external pharmaceutical composition for acne treatment according to the present invention can be made into emulsifiable cream, lotion, facial cream, facial cleanser, and described emulsifiable cream, emulsion, facial cream, facial cleanser all can adopt the conventional preparation method of corresponding type preparation to make.

The present invention also provides a preparation method of an external pharmaceutical composition for acne treatment, comprising:

Step 1: extract natural plant essential oil, described natural plant essential oil preferably comprises the mixture of comfrey oil and evening primrose oil, and the method for described extraction evening primrose oil is preferably supercritical CO _The method of fluid extraction, described The extraction pressure is preferably 33-35MPa, the extraction temperature is 30-45°C, the extraction time is 1.5-3 hours, and the flow rate is 2L/min; the extraction method of the comfrey oil is preferably heated by a constant temperature electric heating mantle, preferably olive oil Oil is used as a solvent, the ratio of solid to liquid is preferably 1:6, the extraction temperature is 60°C, and the extraction time is 3h;

Step 2: Put B vitamins and antibiotics into the tissue masher in turn, first turn on the slow gear and gradually turn on the fast gear, run for 1-3 minutes, turn off the instrument and let it stand for 5-10 minutes, then add vitamin E and natural plant essential oils , running for 1-3min, the external pharmaceutical composition for acne treatment is obtained.

Below in conjunction with embodiment the present invention is described in further detail

Example 1

Evening primrose oil extraction method: take dried primrose seeds and pulverize, pass through a 50-mesh sieve, and use supercritical _CO2 fluid extraction to extract volatile components. Extraction conditions: extraction pressure is 35Pa, extraction temperature is 45°C, extraction time is 1.5 hours, flow rate 2L/min;

The extraction method of comfrey oil is heated by a constant temperature electric heating mantle, olive oil is used as a solvent, the ratio of solid to liquid is preferably 1:6, the extraction temperature is 60°C, and the extraction time is 3 hours;

Put 20 parts of vitamin B ₁₂ , 5 parts of B ₆ , 10 parts of B ₂ , 10 parts of B ₁ and 10 parts of erythromycin into the tissue masher in turn, first turn on the slow gear and gradually turn to the fast gear, and run for 3 minutes. After closing the instrument and standing it for 5 minutes, add 10 parts of vitamin E, 10 parts of comfrey oil, and 10 parts of evening primrose oil, and run for 3 minutes to obtain an external pharmaceutical composition for acne treatment.

Example 2

Evening primrose oil extraction method: take dried primrose seeds and pulverize them, pass through a 60-mesh sieve, and use supercritical _CO2 fluid extraction to extract volatile components. Extraction conditions: extraction pressure is 30MPa, extraction temperature is 30°C, extraction time is 2 hours, flow rate 2L/min;

The extraction method of comfrey oil is heated by a constant temperature electric heating mantle, olive oil is used as a solvent, the ratio of solid to liquid is preferably 1:6, the extraction temperature is 60°C, and the extraction time is 3 hours;

Put 25 parts of vitamin B ₁₂ , 5 parts of B ₆ , 15 parts of B ₂ , 20 parts of B ₁ and 30 parts of streptomycin into the tissue masher in turn, first turn on the slow gear and gradually turn to the fast gear, and run for 3 minutes. After the instrument was turned off and left standing for 5 minutes, 20 parts of vitamin E, 30 parts of comfrey oil, and 25 parts of evening primrose oil were added and operated for 3 minutes to obtain an external pharmaceutical composition for acne treatment.

Example 3

Evening primrose oil extraction method: take dried primrose seeds and pulverize them, pass through a 40-mesh sieve, and use supercritical _CO2 fluid extraction to extract volatile components. Extraction conditions: extraction pressure is 33MPa, extraction temperature is 35°C, extraction time is 3 hours, flow rate 2L/min;

The extraction method of comfrey oil is heated by a constant temperature electric heating mantle, olive oil is used as a solvent, the ratio of solid to liquid is preferably 1:6, the extraction temperature is 60°C, and the extraction time is 3 hours;

Put 22 parts of vitamin B ₁₂ , 10 parts of B ₆ , 12 parts of B ₂ , 15 parts of B ₁ and 20 parts of oxytetracycline into the tissue masher in turn, first turn on the slow gear and gradually turn to the fast gear, and run for 3 minutes. After the instrument was turned off and left standing for 5 minutes, 15 parts of vitamin E, 20 parts of comfrey oil, and 15 parts of evening primrose oil were added and operated for 3 minutes to obtain an external pharmaceutical composition for acne treatment.

Claims (5)

1. an external pharmaceutical composition for acne treatment, characterized in that, in parts by weight, the raw materials are: Described natural plant essential oil is the mixture of comfrey oil and evening primrose oil; In the mixture, the mass ratio of comfrey oil and evening primrose oil is (10-30): (10-25); _The B vitamins are _a mixture _of vitamin B12, vitamin B6, vitamin B1 and vitamin B2 _; Described antibiotic is erythromycin, streptomycin or oxytetracycline. 2. a kind of external pharmaceutical composition for acne treatment according to claim 1, is characterized in that, in the described mixture, the mass ratio of vitamin B ₁₂ , vitamin B ₆ , vitamin B ₁ and vitamin B ₂ is ( 20-25): (5-15): (10-20): (10-15). 3. a kind of external pharmaceutical composition for acne treatment according to claim 1, is characterized in that, by weight, raw material is: Comfrey oil 10-30 parts, evening primrose oil 10-25 parts, vitamin E 10-20 parts, vitamin B ₁₂ 20-25 parts, vitamin B ₆ 5-15 parts, vitamin B ₂ 10-15 parts, vitamin B ₁ 10-20 copies, 10-30 copies of antibiotics. 4. a kind of preparation method for the external pharmaceutical composition of acne treatment according to claim 1, is characterized in that, comprises: Step 1: extract natural plant essential oil; Step 2: Put B vitamins and antibiotics into the tissue masher in turn, run for 1-3 minutes, let it stand for 5-10 minutes, add vitamin E and natural plant essential oils, and run for 1-3 minutes to get acne treatment Pharmaceutical composition for external use. 5. a kind of preparation method for the external pharmaceutical composition of acne treatment according to claim 4, is characterized in that, the method for extracting evening primrose oil is supercritical CO _The method for fluid extraction, extraction pressure is 33- 35MPa, the extraction temperature is 30-45°C, the extraction time is 1.5-3 hours, and the flow rate is 2L/min.