CN118662550A - A Chinese medicine composition and a pharmaceutical preparation for treating or preventing rhinitis - Google Patents

Abstract

The invention provides a traditional Chinese medicine composition and a pharmaceutical preparation for treating or preventing rhinitis. The traditional Chinese medicine composition comprises the following components: flos Magnoliae, herba Schizonepetae, radix Saposhnikoviae, periostracum Cicadae, folium Perillae and herba Menthae. The pharmaceutical preparation for treating or preventing rhinitis comprises the active ingredients of the traditional Chinese medicine composition. The traditional Chinese medicine composition and the pharmaceutical preparation provided by the invention have the effects of dispelling wind and promoting resuscitation, and can be used for treating or preventing the allergic rhinitis of children, which belongs to the pathogenic wind attacking the lung and the nasal obstruction disorder, and the nasal diseases mainly represented by sudden or repeated nasal itching, frequent sneeze, clear nasal discharge such as water, nasal obstruction and the like, which are caused by the feeling of pathogenic wind or pollen, dust and unclean qi; or allergic rhinitis with the symptoms.

Description

A Chinese medicine composition and a pharmaceutical preparation for treating or preventing rhinitis

Technical Field

The invention belongs to the field of medical technology, and specifically relates to a traditional Chinese medicine composition and a pharmaceutical preparation for treating or preventing rhinitis.

Background Art

Rhinitis is an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors and systemic diseases. Chronic rhinitis is generally considered difficult to treat, and some people even regard it as a lifelong recurring disease. Although rhinitis does not directly endanger human life, the symptoms of recurrent rhinitis and its long course of illness often seriously affect people's lives, work and communication, causing many inconveniences to rhinitis patients.

Allergic rhinitis (AR) refers to a non-infectious inflammatory disease of the nasal mucosa, which is caused by the release of IgE-mediated mediators (mainly histamine) after atopic individuals come into contact with allergens, and involves the participation of a variety of immune-active cells and cytokines. There are three necessary conditions for its occurrence: specific antigens, that is, substances that cause the body's immune response; atopic individuals, that is, the so-called individual differences and allergic constitutions; and the encounter between specific antigens and atopic individuals. Allergic rhinitis is a global health problem that can lead to many diseases and loss of labor. The main clinical symptoms are sudden and recurrent nasal itching, sneezing, clear runny nose, and nasal congestion, which belongs to the category of "nasal allergy" in traditional Chinese medicine. Western medicine's treatment principles include avoiding contact with allergens, using antihistamines and corticosteroids, and allergen desensitization therapy. Although these treatments have certain therapeutic effects, they also have certain adverse reactions, and the long-term efficacy is not ideal. For example, although Western medicine drug therapy can control allergic reactions clinically, it cannot achieve the self-stabilizing regulation and conditioning effects on the endocrine and immune systems. This may be an important reason why Western medicine is difficult to achieve a consolidated effect in the treatment of allergic rhinitis.

In traditional Chinese medicine, this disease is called allergic rhinitis. The occurrence of this disease is mainly related to the deficiency of lung, spleen and kidney yang, the peculiar constitution, and the weak defense against external diseases. Therefore, the person cannot tolerate the invasion of wind, cold, pollen and other unclean air, or is triggered by certain foods, resulting in paroxysmal nasal itching, sneezing, and long, clear runny nose, which recurs repeatedly. Traditional Chinese medicine has also conducted a lot of research on the treatment of allergic rhinitis, and has achieved remarkable results.

Pediatric diseases are different from those of adults, and have their own particularities in both physiology and pathology. Only by mastering these particularities can we better prevent and treat pediatric diseases. In childhood, the internal organs are delicate, the physical form and qi are not sufficient, and the material basis of the body's essence, blood, body fluids and various physiological functions are not mature and perfect. Another characteristic is that children are in the process of growth and development, with vigorous vitality and rapid development. The physique, wisdom and internal organs functions are constantly changing and developing towards maturity. In general, although children have weak bodies and delicate internal organs, they are very energetic. Based on the characteristics of children's delicate bodies, fragile internal organs and incomplete physiological functions, they have poor resistance to diseases. Children's "lungs are often insufficient" and have the pathological characteristics of easy onset and rapid transmission. They are not only easily injured by the six external pathogens, but also the pathogenic factors change and transmit rapidly.

Allergic rhinitis in children is a common allergic disease in childhood. The disease has an acute onset. If it is not treated thoroughly, it may develop into bronchial asthma, and it may also be accompanied by allergic conjunctivitis, chronic sinusitis, sleep disorders and other diseases, which seriously affect the physical and mental health and quality of life of children. At present, in the treatment of allergic rhinitis with Western medicine, antihistamines and nasal glucocorticoids are the first-line drugs in clinical practice, which can control symptoms in a short period of time, but some children are prone to recurrence after stopping the medication; avoiding allergens can effectively improve the symptoms of children, but some allergens such as dust and mites are ubiquitous in the daily life of children, and it is difficult to block contact from the root; immunotherapy has short-term and long-term effects on allergic rhinitis, and has a certain effect on the course of the disease. It has a good control effect on preventing allergic rhinitis from developing into asthma, but its treatment cycle is long, which affects its promotion and application in clinical practice. Therefore, traditional Chinese medicine has great potential in the treatment of allergic rhinitis in children. Traditional Chinese medicine treatment adopts syndrome differentiation and treatment, and achieves the effects of alleviating clinical symptoms and controlling the recurrence of the disease by regulating the special constitution of children.

Currently, the drugs for treating allergic rhinitis have their own advantages and disadvantages. In order to cope with various application scenarios, more different types of drugs for treating allergic rhinitis still need to be developed.

Summary of the invention

In view of the shortcomings of the prior art, the present invention aims to provide a Chinese medicine composition and a pharmaceutical preparation for treating or preventing rhinitis. The Chinese medicine composition and the pharmaceutical preparation have the effects of dispelling wind and opening the orifices, and have good preventive and therapeutic effects on rhinitis, especially allergic rhinitis in children.

To achieve this object, the present invention adopts the following technical solutions:

In a first aspect, the present invention provides a traditional Chinese medicine composition, comprising: magnolia, schizonepeta spicate, siler, cicada shell, perilla leaf and mint.

In some embodiments of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

Among them, the weight proportion of the magnolia can be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts or 20 parts, etc.

The weight proportions of the Nepeta spicate can be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts or 20 parts, etc.

The weight proportions of the windproof material may be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts or 20 parts, etc.

The weight proportions of the cicada shell can be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts or 15 parts, etc.

The weight proportions of the perilla leaves can be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts, 15 parts, 16 parts, 18 parts or 20 parts, etc.

The weight proportions of the mint can be 1 part, 2 parts, 3 parts, 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 13 parts or 15 parts.

In some embodiments of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

In some embodiments of the present invention, the Chinese medicine composition comprises the following components in parts by weight:

The compatibility mechanism of the Chinese medicine composition provided by the present invention is as follows:

Magnolia and Schizonepeta spicate are the main drugs. Magnolia is the first choice for dispelling wind and evil, and clearing the nasal passages. Schizonepeta spicate is located at the top of the Schizonepeta plant, floating upward. Although its functions and indications are the same as those of Schizonepeta, its ascending and dispersing power is stronger than that of Schizonepeta. It has a pungent and dispersing aroma, is good at dispersing wind, and is slightly warm but not strong. It has a mild nature and is the most peaceful product for dispersing wind and cold. It can be used regardless of wind-cold, wind-heat or those with no obvious cold or heat. The two flavors are used together to dispel wind and evil, dispel wind and stop itching, so that wind evil can pass through the skin and clear the nasal passages, so they are both the main drugs.

Fangfeng and Chantui are assistant drugs. Fangfeng tastes pungent and sweet, is slightly warm in nature, and can dispel wind and relieve exterior symptoms. It has a strong wind-dispelling power and is a moisturizer for wind-clearing drugs; Chantui tastes sweet and salty, is cool in nature, and is good at dispersing wind-heat in the lung meridian to promote lung function and relieve throat pain. It can also stop wind and stop spasms. The ventilation and olfactory functions of the nose must rely on the movement of lung qi. Therefore, the two drugs are used together to help the main drug dispel wind and open the orifices, and are assistant drugs.

Perilla leaf is an adjuvant. It is pungent and warm in nature, and has the power to dispel cold and relieve exterior symptoms, and help the main and auxiliary medicines dispel wind, so as to relieve nasal congestion, runny nose, sneezing, and nasal itching.

Mint is a guiding drug. Mint is light and floating, has a fragrant aroma that can open the orifices, and has a strong ability to dispel external evils and directly reach the site of disease.

The Chinese medicine composition provided by the present invention has the effects of dispelling wind and clearing the orifices. It can be used for children with allergic rhinitis, which is caused by wind evil invading the lungs, nasal obstruction, and nasal diseases mainly manifested by sudden or repeated nasal itching, frequent sneezing, clear watery nasal discharge, nasal congestion, etc. due to exposure to wind evil, or exposure to pollen, dust and unclean air; or allergic rhinitis with the above symptoms.

In a second aspect, the present invention provides a use of the traditional Chinese medicine composition as described in the first aspect in preparing a method for treating or preventing rhinitis.

Among them, the rhinitis is preferably allergic rhinitis, more preferably children's allergic rhinitis.

In a third aspect, the present invention provides a pharmaceutical preparation for treating or preventing rhinitis, wherein the pharmaceutical preparation comprises the effective ingredients of the traditional Chinese medicine composition as described in the first aspect.

In some embodiments of the present invention, the pharmaceutical preparation further comprises an excipient.

The excipients may be selected from binders, fillers, disintegrants, lubricants, emulsifiers, flavoring agents, cosolvents, solubilizers, colorants, etc. The present invention does not impose any particular restrictions on the specific types of the excipients, and those skilled in the art may select them according to actual needs.

In some embodiments of the present invention, the dosage form of the pharmaceutical preparation is a mixture, syrup, tablet, capsule, oral liquid, granule or granule.

In a fourth aspect, the present invention provides a method for preparing the pharmaceutical preparation according to the third aspect, the preparation method comprising the following steps:

(1) soaking magnolia, schizonepeta spicate, perilla leaf and mint in water to extract volatile oil, thereby obtaining volatile oil, a first water extract and medicinal residues;

(2) mixing the medicinal residue with fangfeng and cicada shells with water, and performing water extraction to obtain a second water extract;

(3) preparing the volatile oil, the first water extract and the second water extract into the dosage form of the pharmaceutical preparation.

In some embodiments of the present invention, the soaking time in step (1) is 0.5-1 h; for example, it can be 0.5 h, 0.6 h, 0.7 h, 0.8 h, 0.9 h or 1 h.

In some embodiments of the present invention, the time for extracting the volatile oil in step (1) is 6-10 hours; for example, it can be 6 hours, 6.5 hours, 7 hours, 7.5 hours, 8 hours, 8.5 hours, 9 hours, 9.5 hours or 10 hours, etc.

In some embodiments of the present invention, the water extraction method in step (2) is: decoction at least 3 times (for example, 3 times, 4 times, 5 times or 6 times, etc.), each decoction is 1-1.5 hours (for example, 1 hour, 1.1 hours, 1.2 hours, 1.3 hours, 1.4 hours or 1.5 hours, etc.). It should be understood by those skilled in the art that after each decoction, it is necessary to filter, add water to the filter residue for the next decoction, and the filtrate is combined to obtain the second water extract.

In some embodiments of the present invention, preparing the volatile oil, the first water extract and the second water extract into the dosage form of the pharmaceutical preparation comprises the following steps:

The volatile oil is included with β-cyclodextrin, dried at a temperature below 40° C., and crushed into fine powder to obtain a volatile oil inclusion compound;

The first water extract and the second water extract are mixed, and then concentrated to a clear paste with a relative density of 1.05-1.15 at 50°C, ethanol is added to make the ethanol content 60-75%, and the mixture is allowed to stand for 12-24 hours, filtered, and the filtrate is used to recover ethanol, and concentrated to a clear paste with a relative density of 1.15-1.30 at 50°C;

The clear paste with a relative density of 1.15-1.30 at 50° C., volatile oil inclusion compound, sucrose and dextrin are mixed to prepare granules.

Compared with the prior art, the present invention has the following beneficial effects:

The Chinese medicine composition provided by the invention is scientifically matched with magnolia, schizonepeta spicate, siler, cicada shell, perilla leaf and mint, and can play the role of dispelling wind and opening the orifices. The Chinese medicine composition can be used for children with allergic rhinitis syndrome, which is caused by wind evil invading the lungs, nasal obstruction syndrome, nasal diseases mainly manifested by sudden or repeated nasal itching, frequent sneezing, clear nasal discharge, nasal congestion, etc., or allergic rhinitis with the above symptoms, to achieve good prevention and treatment effects.

The pharmaceutical preparation provided by the present invention has a simple prescription, a simple production process, little toxicity and side effects, is convenient to administer, is easy to manufacture, has a low cost, and is more suitable for children.

DETAILED DESCRIPTION

The technical solution of the present invention is further described below by means of specific implementation methods. It should be understood by those skilled in the art that the specific implementation methods are only used to help understand the present invention and should not be regarded as specific limitations of the present invention.

Example 1

This embodiment provides a Chinese medicine composition, comprising the following components in parts by weight:

This embodiment also provides a granule for treating or preventing rhinitis, and the preparation method thereof is as follows:

(1) adding magnolia, schizonepeta spicate, perilla leaf, and mint in the traditional Chinese medicine composition provided in this embodiment to water and soaking for 0.5 hours, extracting volatile oil for 10 hours, and obtaining volatile oil, a first water extract, and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Fangfeng and Chantuo in the Chinese medicine composition and a corresponding amount of water, continue to decoct for 1 hour, filter, continue to add water to the residue and decoct twice, each time for 1 hour, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.15 (50° C.), add ethanol to make the ethanol content 60%, stir well, let stand for 12 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.30 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Example 2

This embodiment provides a Chinese medicine composition, comprising the following components in parts by weight:

This embodiment also provides a granule for treating or preventing rhinitis, and the preparation method thereof is as follows:

(1) adding magnolia, schizonepeta spicate, perilla leaf, and mint in the traditional Chinese medicine composition provided in this embodiment to water and soaking for 1 hour, extracting volatile oil for 6 hours, and obtaining volatile oil, a first water extract, and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Fangfeng and Chantuo in the raw material Chinese medicine composition and a corresponding amount of water, continue to decoct for 1.5 hours, filter, continue to add water to the residue and decoct twice, each time for 1.5 hours, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.05 (50° C.), add ethanol to make the ethanol content 75%, stir well, let stand for 24 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.15 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Example 3

This embodiment provides a Chinese medicine composition, comprising the following components in parts by weight:

This embodiment also provides a granule for treating or preventing rhinitis, and the preparation method thereof is as follows:

(1) adding magnolia, schizonepeta spicate, perilla leaf, and mint in the traditional Chinese medicine composition provided in this embodiment to water and soaking for 0.8 hours, extracting volatile oil for 8 hours, and obtaining volatile oil, a first water extract, and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Fangfeng and Chantuo in the Chinese medicine composition and a corresponding amount of water, continue to decoct for 1.2 hours, filter, continue to add water to the residue and decoct twice, each time for 1.2 hours, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.10 (50° C.), add ethanol to make the ethanol content 65%, stir well, let stand for 18 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.20 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Example 4

This embodiment provides a Chinese medicine composition, comprising the following components in parts by weight:

This embodiment also provides a granule for treating or preventing rhinitis, and the preparation method thereof is as follows:

(1) adding magnolia, schizonepeta spicate, perilla leaf, and mint in the traditional Chinese medicine composition provided in this embodiment to water and soaking for 0.8 hours, extracting volatile oil for 8 hours, and obtaining volatile oil, a first water extract, and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Fangfeng and Chantuo in the Chinese medicine composition and a corresponding amount of water, continue to decoct for 1.2 hours, filter, continue to add water to the residue and decoct twice, each time for 1.2 hours, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.10 (50° C.), add ethanol to make the ethanol content 65%, stir well, let stand for 18 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.20 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Example 5

This embodiment provides a Chinese medicine composition, comprising the following components in parts by weight:

This embodiment also provides a granule for treating or preventing rhinitis, and the preparation method thereof is as follows:

(1) adding magnolia, schizonepeta spicate, perilla leaf, and mint in the traditional Chinese medicine composition provided in this embodiment to water and soaking for 0.8 hours, extracting volatile oil for 8 hours, and obtaining volatile oil, a first water extract, and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Fangfeng and Chantuo in the Chinese medicine composition and a corresponding amount of water, continue to decoct for 1.2 hours, filter, continue to add water to the residue and decoct twice, each time for 1.2 hours, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.10 (50° C.), add ethanol to make the ethanol content 65%, stir well, let stand for 18 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.20 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Comparative Example 1

This comparative example provides a commercially available drug, which is Biyankang.

Comparative Example 2

This comparative example provides a decoction for clearing wind and clearing the meridians, comprising the following components in parts by weight:

This comparative example also provides a preparation method of Shufeng Tongqiao Decoction as follows:

(1) Adding the five herbs of magnolia, perilla leaf, schizonepeta, angelica dahurica and Xanthium sibiricum in the Chinese medicine composition provided in this comparative example into water and soaking them for 0.8 hours, extracting volatile oil for 8 hours, and obtaining volatile oil, a first water extract and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at a temperature below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, the six herbs of the Chinese medicine composition, namely, burdock fruit, schisandra chinensis, pseudoginseng, raw liquorice, cicada shell, and saposhnikovia divaricata, and a corresponding amount of water are added, and the mixture is decocted for 1.2 hours, filtered, and the residue is decocted twice, each time for 1.2 hours, filtered, and the filtrates are combined to obtain a second water extract; the first water extract and the second water extract are mixed, and then concentrated to a clear paste with a relative density of 1.10 (50° C.), ethanol is added to make the ethanol content 65%, stirred evenly, allowed to stand for 18 hours, filtered, and the filtrate is used to recover ethanol, and concentrated to a clear paste with a relative density of 1.20 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Comparative Example 3

This comparative example provides a Chinese medicine composition, comprising the following components in parts by weight:

The preparation method is as follows:

(1) adding magnolia, perilla leaf, schizonepeta spicate and angelica dahurica to the Chinese medicine composition provided in this comparative example and soaking them in water for 0.8 hours, extracting volatile oil for 8 hours, and obtaining volatile oil, a first water extract and medicinal residues; encapsulating the volatile oil with β-cyclodextrin, drying at below 40° C., and crushing into fine powder to obtain a volatile oil inclusion compound;

(2) After the residue is properly cooled, add the two herbs of Saposhnikovia divaricata and Schisandra chinensis and a corresponding amount of water in the raw Chinese medicine composition, continue to decoct for 1.2 hours, filter, continue to add water to the residue and decoct twice, each time for 1.2 hours, filter, and combine the filtrates to obtain a second water extract; mix the first water extract and the second water extract, and then concentrate to a clear paste with a relative density of 1.10 (50° C.), add ethanol to make the ethanol content 65%, stir well, let stand for 18 hours, filter, recover ethanol from the filtrate, and concentrate to a clear paste with a relative density of 1.20 (50° C.);

(3) Take the clear paste obtained in step (2), add the above-mentioned volatile oil inclusion compound, an appropriate amount of sucrose and an appropriate amount of dextrin, make granules, spray an appropriate amount of essence, mix well, and obtain granules for treating or preventing rhinitis.

Comparative Example 4

This comparative example provides a commercially available drug, which is diclofenac sodium.

Performance Testing

Experiment 1: Effects on the rat allergic rhinitis model induced by 2,4-diisocyanate toluene (juvenile animals)

Modeling:

Healthy SD rats, SPF grade, weighing 60-80g, were selected. Ten rats were selected as the normal control group, half male and half female, and the rest of the rats were used for modeling. Basic sensitization was first performed, with 10% 2,4-diisocyanatotoluene (TDI) olive oil solution as the allergen. During the sensitization period, the modeling group injected 20μL of 10% TDI olive oil solution into the bilateral nasal cavities of the rats, 10μL on each side, and dropped the nose once a day for 7 consecutive days. The normal control group injected olive oil with the same dose; the stimulation period: starting from the 9th day, the modeling group injected 20μL of 10% TDI olive oil solution into the bilateral nasal cavities of the rats, 10μL on each side, and dropped the nose once every other day until the end of the observation of the drug. The normal control group injected olive oil with the same dose. After 4 stimulations, the modeling effect was evaluated by scoring. After 30 minutes of observation after stimulation, the number of sneezes, the degree of nasal itching and the amount of nasal secretions were recorded. The scoring criteria were the same as in Table 1. The modeling was successful when the total score reached 5 points.

Grouping and drug administration:

The animals with successful modeling were randomly divided into model control group, high, medium and low dose groups of Example 5, comparative example 1 (Bi Yan Kang group), comparative example 2 (Shu Feng Tong Qiao Tang group), comparative example 3, 10 rats in each group, half of them were male and half of them were female. Each group was gavaged and administered, and the specific administration was as follows: rats: 1.98g crude drug/kg in low dose group, 3.96g crude drug/kg in medium dose group, 7.92g crude drug/kg in high dose group; comparative example 1 (Bi Yan Kang group): 0.8g/kg, comparative example 2 (Shu Feng Tong Qiao Tang group): 10.22g crude drug/kg, comparative example 3: 7.92g crude drug/kg, normal control group and model control group were gavaged and given equal volumes of distilled water, and the administration was continued for 14 days. Control group drug Bi Yan Kang tablets, Sinopharm Group Dezhong (Foshan) Pharmaceutical Co., Ltd., batch number: C23055, each tablet weighs 0.37g (containing 1mg of chlorpheniramine maleate).

Observation indicators:

Behavioral observations were performed every 7 days. 20 μL of 10% TDI olive oil solution was injected into the bilateral nasal cavities of the rats, 10 μL on each side, for stimulation. The rats were observed for 30 minutes after stimulation, and the number of sneezes, degree of nasal itching, and amount of nasal secretions were recorded and scored according to the standards in Table 1.

Table 1. Symptom scoring standard table for rats

Experimental results:

(1) The behavioral scoring results are shown in Table 2.

Table 2. Results of rat behavioral scoring

Note: In Table 2, “*” indicates P < 0.05 compared with the model group, and “**” indicates P < 0.01 compared with the model group.

After modeling, the symptom scores of the young rats in the model group, the high, medium and low dose groups of Example 5, and the comparative example 1, 2 and 3 groups were all greater than 5 points, indicating that the modeling was successful.

On the 7th day after administration, compared with the model group, the symptom scores of the high-dose, medium-dose and comparative example 1 groups of Example 5 were significantly reduced (P < 0.01); after 14 days of observation, the high-dose group was able to maintain a significant difference (P < 0.01); the symptom scores of comparative examples 1 and 2 were also reduced to varying degrees (P < 0.05). The Chinese medicine composition of Example 5 provided in the present disclosure can more effectively reduce the symptom scores.

Experiment 2: Anti-inflammatory experiment: Effects on acetic acid-induced increase in peritoneal capillary permeability in mice (young animals)

Grouping:

Healthy ICR mice, SPF grade, weighing 13-15 g, were selected and randomly divided into 5 groups according to their weight, namely, a model control group, high, medium and low dose groups of Example 5, and a comparative example 4 (diclofenac sodium group), with 10 mice in each group, half of which were male and half were female.

Dosage:

Each group was gavaged with the following specific dosage: 2.86 g crude drug/kg for the low-dose group, 5.72 g crude drug/kg for the medium-dose group, and 11.44 g crude drug/kg for the high-dose group; 6.5 mg/kg of diclofenac sodium, and the model control group was gavaged with the same volume of distilled water (0.2 mL/10 g body weight), once a day for 5 consecutive days.

Reference substance: diclofenac sodium sustained-release tablets, Hunan Warner Pharmaceutical Co., Ltd., batch number: 230902, each tablet weighs 0.1 g (calculated as C ₁₄ H ₁₀ Cl ₂ NaNO ₂ ).

Indicator observation:

One hour after the last dose, 0.5% Evans blue solution 0.1 mL/10 g was injected into the tail vein, 0.7% acetic acid 0.1 mL/10 g was injected intraperitoneally 10 minutes later, and 5 mL of normal saline injection was injected intraperitoneally 10 minutes later. The mice were killed, the abdomen was gently rubbed 50 times, the skin was cut open, the peritoneal fluid was aspirated with a pipette, centrifuged, the supernatant was taken to measure the absorbance at a wavelength of 590 nm, and the inhibition rate was calculated. The test results are listed in Table 3.

Table 3. Analysis of the results of anti-inflammatory experiments in mice

Group Absorbance Inhibition rate Control group 0.209±0.023 — Example 5 High dose group 0.137±0.010 34.4% Example 5 Dosage Group 0.146±0.009 30.1% Example 5 Low dose group 0.154±0.008 26.3% Comparative Example 4 (Diclofenac Sodium Group) 0.141±0.010 32.5%

Through the analysis of the data in Table 3, the following conclusion can be drawn: the diclofenac sodium group and each dosage group of Example 5 can significantly alleviate the increase in peritoneal capillary permeability caused by acetic acid, among which the high-dose group of Example 5 has the best effect.

It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

The above description is only a specific embodiment of the present invention, so that those skilled in the art can understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present disclosure. Therefore, the present invention will not be limited to the embodiments described herein, but should conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims (10)

1. A Chinese medicine composition, characterized in that the Chinese medicine composition comprises: magnolia, schizonepeta spicate, siler, cicada shell, perilla leaf and mint. 2. The Chinese medicine composition according to claim 1, characterized in that the Chinese medicine composition comprises the following components in parts by weight: 3. The Chinese medicine composition according to claim 1 or 2, characterized in that the Chinese medicine composition comprises the following components in parts by weight: 4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that the Chinese medicine composition comprises the following components in parts by weight: 5. Use of the Chinese medicine composition according to any one of claims 1 to 4 in preparing a treatment or prevention of rhinitis. 6. The use according to claim 5, characterized in that the rhinitis is allergic rhinitis, preferably children's allergic rhinitis. 7. A pharmaceutical preparation for treating or preventing rhinitis, characterized in that the pharmaceutical preparation comprises the effective ingredients of the traditional Chinese medicine composition according to any one of claims 1 to 4. 8. The pharmaceutical preparation according to claim 7, characterized in that the pharmaceutical preparation further comprises an excipient; Preferably, the dosage form of the pharmaceutical preparation is a mixture, syrup, tablet, capsule, oral liquid, granule or granule. 9. A method for preparing the pharmaceutical preparation according to claim 7 or 8, characterized in that the preparation method comprises the following steps: (1) soaking magnolia, schizonepeta spicate, perilla leaf and mint in water to extract volatile oil, thereby obtaining volatile oil, a first water extract and medicinal residues; (2) mixing the medicinal residue with fangfeng and cicada shells with water, and performing water extraction to obtain a second water extract; (3) preparing the volatile oil, the first water extract and the second water extract into the dosage form of the pharmaceutical preparation. 10. The preparation method according to claim 9, characterized in that the soaking time in step (1) is 0.5-1h; Preferably, the time for extracting the volatile oil in step (1) is 6-10 hours; Preferably, the water extraction method in step (2) is: decocting at least 3 times, each decocting for 1-1.5 hours; Preferably, preparing the volatile oil, the first water extract and the second water extract into the dosage form of the pharmaceutical preparation comprises the following steps: The volatile oil is included with β-cyclodextrin, dried at a temperature below 40° C., and crushed into fine powder to obtain a volatile oil inclusion compound; The first water extract and the second water extract are mixed, and then concentrated to a clear paste with a relative density of 1.05-1.15 at 50°C, ethanol is added to make the ethanol content 60-75%, and the mixture is allowed to stand for 12-24 hours, filtered, and the filtrate is used to recover ethanol, and concentrated to a clear paste with a relative density of 1.15-1.30 at 50°C; The clear paste with a relative density of 1.15-1.30 at 50° C., volatile oil inclusion compound, sucrose and dextrin are mixed to prepare granules.