CN114470060B - Traditional Chinese medicine composition for treating allergic rhinitis and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating allergic rhinitis and preparation method thereof Download PDF

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CN114470060B
CN114470060B CN202210272182.2A CN202210272182A CN114470060B CN 114470060 B CN114470060 B CN 114470060B CN 202210272182 A CN202210272182 A CN 202210272182A CN 114470060 B CN114470060 B CN 114470060B
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isatis root
refining
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water
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宋风
谢洋
田燕歌
任嘉铭
张彭
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First Affiliated Hospital of Henan University of TCM
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Abstract

The invention provides a traditional Chinese medicine composition for treating allergic rhinitis and a preparation method thereof, wherein the traditional Chinese medicine composition comprises honeysuckle, isatis root, houttuynia cordata, borneol and pharmaceutic adjuvant, and the pharmaceutic adjuvant is selected from butyrolactone modified sulfobutyl-beta-cyclodextrin sodium, water and a penetrating agent laurocapram. The butyrolactone modified sulfobutyl-beta-cyclodextrin is adopted to include the insoluble honeysuckle extract, the isatis root extract and the houttuynia cordata extract, so that the solubility of the extracts is greatly increased, the extracts are easy to release and absorb, the absorption of the medicine is promoted, and the bioavailability is improved; the borneol in the formula can promote the absorption of the three extracts, can increase the comfort of the nasal spray preparation and effectively treat allergic rhinitis. The Chinese medicinal composition has stable quality.

Description

Traditional Chinese medicine composition for treating allergic rhinitis and preparation method thereof
Technical Field
The invention relates to the field of medicinal preparations, relates to a traditional Chinese medicine composition for treating allergic rhinitis and a preparation method thereof, and particularly relates to a traditional Chinese medicine composition for treating allergic rhinitis, which comprises honeysuckle, isatis root, houttuynia cordata and borneol, and a preparation method thereof.
Background
Allergic rhinitis, i.e., allergic rhinitis, refers to a non-infectious inflammatory disease of the nasal mucosa in which IgE-mediated mediators (mainly histamine) are mainly released after an atopic individual is exposed to an allergen, and various immune-active cells, cytokines, and the like are involved. The requirements for this to occur are 3: specific antigen is the substance which causes the immune response of the organism; atopic individuals, so-called individual differences, allergic constitutions; the specific antigen meets both idiotypic individuals. Allergic rhinitis is a global health problem that can lead to many illnesses and loss of labor.
With the increasingly prominent problem of atmospheric pollution, the threat to human health, especially the respiratory system, is more and more obvious. The relevant data show that: the main pollutants in the air such as PM2.5, ozone, nitrogen dioxide, sulfur dioxide and automobile exhaust are all likely to induce the occurrence and aggravation of allergic rhinitis, asthma and upper respiratory tract disease symptoms.
Allergic rhinitis is a chronic inflammatory reaction disease of nasal mucosa, which is mainly characterized by nasal itching, sneezing, nasal hypersecretion, nasal mucosa swelling and the like, wherein after an atopic individual contacts an allergen, a mediator mediated by IgE is mainly released by histamine, and a plurality of immune active cells, cytokines and the like participate. Although allergic rhinitis is not a serious disease, 70 percent of severe allergic rhinitis can affect sleep, 94 percent of severe allergic rhinitis can affect life and work, the influence on the quality of life even exceeds the serious diseases such as hypertension, diabetes and the like, and the allergic rhinitis is possibly combined with various diseases such as otitis media, nasosinusitis, nasal polyp, asthma and the like, and the harm to health is larger.
At present, the treatment of allergic rhinitis is mainly carried out by desensitization, hormone, immunity and other methods, the short-term curative effect is obvious generally, but the effect is difficult to maintain after drug withdrawal, and the desensitization drug and the hormone drug cannot be used for a long time and cannot maintain the effect, and side effects such as mucosal dryness, epistaxis, mouthfeel, headache and the like are easy to occur.
At present, no ideal medicine and method for treating allergic rhinitis exists clinically. In the process of absorption and distribution of systemic medicines such as oral medicines or injections, part of the medicines are destroyed by stomach and intestine and liver or are shunted by blood circulation, the effective concentration of the medicines really reaching the pathological change part is very low, the treatment effect is difficult to achieve, and pathogenic bacteria can be induced to resist medicines to cause the pathological change to be chronic, so the treatment effect is poor and the cure rate is low; the commonly used topical medicine, such as nasal drop, only has the effects of contracting blood vessels and improving nasal obstruction symptoms caused by rhinitis, has single pharmacological action, undesirable drug effect and large toxic and side effects, and can cause drug-induced rhinitis. The laser therapy burns the lesion part by using high temperature generated by laser beam to eliminate inflammatory tissues and pathogenic bacteria, and although the laser therapy has curative effect, the laser therapy has traumatism, complex operation and high cost. Therefore, the existing medicines and methods for treating allergic rhinitis have the defects of slow effect, poor curative effect, long treatment course, low cure rate, large toxic and side effects, high cost of patients and the like.
Traditional Chinese medicine has been used for thousands of years to treat allergic rhinitis. Tang Dynasty Sun Simiao treats the principal disease by differentiating syndromes from lung and kidney deficiency, while in the golden period Liu Heng from fire-heat theory and Ming Qing Yi Jia from lung and spleen qi deficiency. Modern Chinese medicine also provides various schemes for treating allergic rhinitis from various angles, and some ancient and new prescriptions are added and subtracted. Feng Rong Chang applied Yu Ping san has good curative effect on allergic rhinitis; the xanthium fruit powder for treating nasosinusitis and rhinorrhea with turbid nasal discharge recorded in volume five of Jisheng Fang (prescription of Jisheng) is prepared from magnolia flower, xanthium fruit, dahurian angelica root, szechuan lovage rhizome, mint, fritillaria, fermented soybean, chrysanthemum and liquorice and has good effect on treating allergic rhinitis. The Liming adopts a random contrast research method to provide a decoction prepared from bulk drugs such as madder, lithospermum, divaricate saposhnikovia root, cicada slough, earthworm, paniculate swallowwort root, dark plum fruit and the like to treat allergic rhinitis, and also obtains a conclusion that the curative effect is obvious compared with that of western medicines.
The inventor of the application provides the traditional Chinese medicine composition for effectively treating the allergic rhinitis in long-term practice, and the composition has the advantages of simple formula, simple and convenient preparation process, convenient administration and small toxic and side effects, can well improve the rhinitis symptoms of patients, and is not easy to relapse.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating allergic rhinitis, which comprises honeysuckle, isatis root, houttuynia cordata and borneol, and a preparation method thereof. The Chinese medicinal composition has stable quality, and can effectively treat allergic rhinitis.
In order to realize the purpose of the invention, the following technical scheme is adopted:
a Chinese medicinal composition for treating allergic rhinitis comprises flos Lonicerae extract, radix Isatidis extract, herba Houttuyniae extract, borneolum, and medicinal adjuvants.
The honeysuckle extract is chlorogenic acid, and the purity of the chlorogenic acid is not lower than 75%; the further purity is not lower than 78%; further, the purity is not less than 85%.
The preparation method of the honeysuckle extract comprises the following steps:
(1) Extraction: soaking flos Lonicerae in 10-12 times of water for 60 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain flos Lonicerae extract 1.
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding a mixed solvent of ethanol and acetone in a weight ratio of 2.5; collecting supernatant, and concentrating to relative density of 1.30 to obtain flos Lonicerae extract 2.
(3) Re-refining: and (3) refining the honeysuckle extract 2 prepared in the step (2) for 1-2 times by using the method in the step (2) as a starting material to obtain the honeysuckle extract.
The isatis root is mainly produced from south isatis root in southwest of China, the plant body of the isatis root is named isatis root, also called as malan, is a tubular Isatis of Acanthaceae of the order of flores in dicotyledons, and is a perennial herbaceous plant.
The preparation method for extracting the isatis root comprises the following steps:
(1) Extraction: taking radix Isatidis, adding 10-12 times of water for the first time, soaking for 30 minutes, decocting for 1-1.5 hours, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain radix Isatidis extract 1.
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 75-80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain radix Isatidis extract 2.
(3) Re-refining: and (3) taking the isatis root extract 2 prepared in the step (2) as a starting raw material, and refining for 1-2 times according to the method in the step (2) to obtain the isatis root extract.
The preparation method of the houttuynia cordata extract comprises the following steps:
(1) Extraction: taking herba Houttuyniae, adding 8-10 times of water for the first time, soaking for 30 minutes, decocting for 1-2 hours, and filtering; adding 7-8 times of water for the second time, decocting for 1-1.5 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.15 to obtain herba Houttuyniae extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding acetone until the acetone content is 10% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain herba Houttuyniae extract 2;
(3) Re-refining: and (3) refining the houttuynia cordata extract 2 prepared in the step (2) for 1-2 times by using the method in the step (2) as a starting material to obtain the houttuynia cordata extract.
Furthermore, the weight ratio of the honeysuckle extract to the isatis root extract to the houttuynia cordata extract to the borneol is (22-25): 11-13): 6-7): 1; preferably (22-24) (11-12) (6-7) and 1; more preferably (22.5-23.6): 11.2-11.7): 6.3-6.6): 1; more preferably 23.2.
Further, the pharmaceutic adjuvant is selected from butyrolactone modified sulfobutyl-beta-cyclodextrin sodium, water and a penetrating agent laurocapram.
The water is preferably water for injection.
The structural formula of the butyrolactone modified sulfobutyl-beta-cyclodextrin sodium is shown in figure 1, wherein n is 8-12.
Further, the preparation method of the butyrolactone modified sulfobutyl-beta-cyclodextrin sodium comprises the following steps:
under the protection of N2, adding sulfobutyl-beta-cyclodextrin, butyrolactone and stannous octoate into an N, N-dimethylformamide solvent, mixing, heating to 100 ℃ for reaction for 10 hours, then cooling to room temperature, adding the reaction mixture into diethyl ether, precipitating, and recrystallizing with absolute ethyl alcohol to obtain butyrolactone-modified sulfobutyl-beta-cyclodextrin sodium.
Further, the molar ratio of the butyrolactone to the sulfobutyl-beta-cyclodextrin is 15-25.
Further, the butyrolactone modified sodium sulfobutyl-beta-cyclodextrin has an average molecular weight of 7000 to 8500, and PDI of not more than 1.5, preferably not more than 1.4, and more preferably not more than 1.35.
The invention further provides application of the traditional Chinese medicine composition for treating rhinitis in preparing a product for treating allergic rhinitis.
Further, the traditional Chinese medicine composition can be a nasal spray, a nasal drop and the like.
Further, the invention provides a preparation method of the traditional Chinese medicine composition for treating rhinitis
(1) Adding butyrolactone modified sulfobutyl-beta-cyclodextrin sodium into flos Lonicerae extract, radix Isatidis extract and herba Houttuyniae extract, heating to 40-50 deg.C, stirring for 1-2 hr until it is clear brown solution, and adding Borneolum; filtering (0.45 μm) to obtain Chinese medicinal composition liquid 1;
(2) Adding a penetrant into the liquid medicine 1, and stirring for 25-30 minutes; adding the rest of water for injection; obtaining a Chinese medicinal composition liquid 2;
(3) The Chinese medicinal composition is filled into bottles to prepare nasal spray and nasal drops.
Compared with the prior art, the invention has the following beneficial effects:
the butyrolactone modified sulfobutyl-beta-cyclodextrin is adopted to include the insoluble honeysuckle extract, the isatis root extract and the houttuynia cordata extract, so that the solubility of the extracts is greatly increased, the extracts are easy to release and absorb, the absorption of the medicine is promoted, and the bioavailability is improved; in addition, borneol is a common aromatic resuscitation inducing medicine and assistant and guide medicine, has the characteristics of inducing resuscitation and refreshing mind, having fragrant migration, guiding medicine upward, having weak vigor by exclusive movement and having active effect by assistant and guide medicine, and is suitable for being used together with other medicines. The borneol in the formula of the invention can promote the absorption of the three extracts, can increase the comfort of the nasal spray preparation, and can effectively treat allergic rhinitis.
Drawings
FIG. 1: the structural formula of butyrolactone modified sulfobutyl-beta-cyclodextrin sodium is shown in the specification.
Detailed Description
The invention discloses a traditional Chinese medicine composition for treating allergic rhinitis, which comprises honeysuckle, isatis root, houttuynia cordata and borneol and a preparation method thereof. It is expressly intended that all such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the scope of the invention. While the invention has been described in terms of preferred embodiments, it will be apparent to those skilled in the art that variations and modifications in the methods and applications described herein, or appropriate variations and combinations thereof, may be made to implement and use the inventive technique without departing from the spirit and scope of the invention.
For a better understanding of the invention, and not as a limitation on the scope thereof, all numbers expressing quantities, percentages, and other numerical values used in this application are to be understood as being modified in all instances by the term "about". At the very least, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
The present invention is further illustrated by the following examples, which are not intended to limit the invention in any way.
Preparation example 1: honeysuckle extract
(1) Extraction: soaking flos Lonicerae in 10-12 times of water for 60 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain flos Lonicerae extract 1.
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding a mixed solvent of ethanol and acetone in a weight ratio of 2.5; collecting supernatant, and concentrating to relative density of 1.30 to obtain flos Lonicerae extract 2.
(3) Re-refining: and (3) refining the honeysuckle extract 2 prepared in the step (2) for 2 times by using the honeysuckle extract 2 as a starting material according to the method in the step (2) to obtain the honeysuckle extract.
The chlorogenic acid content in the tea is 82% by detection.
Preparation example 2: honeysuckle extract
(1) Extraction: soaking flos Lonicerae in 10-12 times of water for 60 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain flos Lonicerae extract 1.
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 50% -60%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain flos Lonicerae extract 2.
(3) Re-refining: and (3) refining the honeysuckle extract 2 prepared in the step (2) for 2 times by using the honeysuckle extract 2 as a starting material according to the method in the step (2) to obtain the honeysuckle extract.
The chlorogenic acid content in the extract is 74% by detection.
Preparation example 3: isatis root extract
(1) Extraction: soaking radix Isatidis (herba Kalimeridis) in 10-12 times of water for 30 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain radix Isatidis extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 75% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain radix Isatidis extract 2;
(3) Re-refining: and (3) refining 2 times by taking the isatis root extract 2 prepared in the step (2) as a starting raw material according to the method in the step (2) to obtain an isatis root extract 3.
Preparation example 4: isatis root extract
(1) Extraction: soaking radix Isatidis (herba Kalimeridis) in 10-12 times of water for 30 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain radix Isatidis extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 75% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain radix Isatidis extract.
Preparation example 5: isatis root extract
(1) Extraction: soaking radix Isatidis (Isatis tinctoria L.) in 10-12 times of water for 30 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain radix Isatidis extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 75% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain radix Isatidis extract 2;
(3) Re-refining: and (3) refining 2 times by taking the isatis root extract 2 prepared in the step (2) as a starting raw material according to the method in the step (2) to obtain an isatis root extract 3.
Preparation example 6: houttuynia cordata extract
(1) Extraction: adding 8-10 times of water into herba Houttuyniae, soaking for 30 min, decocting for 1-2 hr, and filtering; adding 7-8 times of water for the second time, decocting for 1-1.5 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.15 to obtain herba Houttuyniae extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding acetone until the acetone content is 10% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain herba Houttuyniae extract 2;
(3) Re-refining: and (3) refining the houttuynia cordata extract 2 prepared in the step (2) for 2 times by using the houttuynia cordata extract 2 as a starting material according to the method in the step (2) to obtain the houttuynia cordata extract 3.
Preparation example 7: houttuynia cordata extract
(1) Extraction: adding 8-10 times of water into herba Houttuyniae, soaking for 30 min, decocting for 1-2 hr, and filtering; adding 7-8 times of water for the second time, decocting for 1-1.5 hours, and filtering; mixing filtrates, and concentrating to relative density of 1.15 to obtain herba Houttuyniae extract 1;
(2) Refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding acetone until the acetone content is 10% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain herba Houttuyniae extract 2.
Preparation example 8: butyrolactone modified sulfobutyl-beta-cyclodextrin sodium
Under the protection of N2, adding sulfobutyl-beta-cyclodextrin (21.63 g, 10 mmol), butyrolactone (13.76 g, 160 mmol) and stannous octoate (0.4 mg, 1.0 mu mol) into an N, N-dimethylformamide solvent, mixing, heating to 100 ℃ for reaction for 10 hours, then cooling to room temperature, adding the reaction mixture into diethyl ether, precipitating, and recrystallizing with absolute ethyl alcohol to obtain butyrolactone modified sulfobutyl-beta-cyclodextrin sodium.
The average molecular weight by GPC was 8251, PDI was 1.31.
Preparation examples 9 to 12: butyrolactone modified sulfobutyl-beta-cyclodextrin sodium.
The addition of butyrolactone was as in the following table, and the other preparation methods were as in preparation example 8.
Figure BDA0003553996070000071
Examples 1 to 5: traditional Chinese medicine composition for treating allergic rhinitis
Figure BDA0003553996070000072
The preparation method comprises the following steps:
(1) Adding butyrolactone modified sulfobutyl-beta-cyclodextrin sodium into flos Lonicerae extract, radix Isatidis extract and herba Houttuyniae extract, heating to 40-50 deg.C, stirring for 1-2 hr until it is clear brown solution, and adding Borneolum; filtering (0.45 μm) to obtain Chinese medicinal composition liquid 1;
(2) Adding penetrating agent laurocapram into the liquid medicine 1, and stirring for 25-30 minutes; adding the rest of water for injection; obtaining a Chinese medicinal composition liquid 2;
(3) The traditional Chinese medicine composition is filled into a bottle to prepare the nasal spray.
Examples 6 to 10: traditional Chinese medicine composition for treating allergic rhinitis
Figure BDA0003553996070000081
The preparation method comprises the following steps: the same as in examples 1 to 5.
Examples 11 to 13: traditional Chinese medicine composition for treating allergic rhinitis
Figure BDA0003553996070000091
The preparation method comprises the following steps: the same as in examples 1 to 5.
Example 14: pharmacodynamic test of the traditional Chinese medicine composition for treating allergic rhinitis
1. Model preparation and group therapy
Triamcinolone acetonide nasal spray (corticoids, produced by Jiangxi Zhenshiming pharmaceutical Co., ltd.), ovalbumin (OVA), rat IgE enzyme linked immunosorbent assay kit (Nanjing Biotech), and Mucin5AC antibody (Abcam, UK). A
150 rats with half male and female weight of 200g +/-30 g; after one week of adaptive feeding of rats, 100 male and female rats are selected in a half random way and are subjected to molding treatment by adopting an ovalbumin OVA sensitization method: intraperitoneal injection of 1mL of OVA suspension (containing 0.9% sodium chloride, 20mgOVA and 30mg aluminum hydroxide) is carried out once every other day for 8 times (15 d) to carry out basic sensitization; rats were instilled with 10% OVA saline solution into both anterior nares, 50 μ L each side, 1 time a day, starting on day 16 for 10 consecutive days to stimulate allergic rhinitis.
After successful molding, the model group, the positive control group and the groups of examples 1 to 13 (nasal sprays prepared in examples 1 to 13) were randomized; 10 of the above groups were administered by intraperitoneal injection and nasal drip, and the administration of the drugs was physiological saline.
The normal group and the model group were each nasally dropped with physiological saline, the positive control group was nasally dropped with triamcinolone acetonide nasal spray, and the nasal sprays prepared in examples 1 to 10 were each nasally dropped at 50. Mu.L for 1 time/day for 2 weeks, and each administration group was applied to the nostrils on both sides of the rat by a pipette.
2. Detection indexes are as follows: serum IgE content detection
After rat anesthesia, abdominal artery blood was taken, serum was separated, and enzyme-linked immunoassay was performed according to the kit instructions.
3. Statistical analysis method
Data were processed by SPSS software and analyzed by One-Way ANOVA (One-Way ANOVA) and expressed as (mean. + -. Standard deviation). P < 0.05 indicates that the difference is statistically significant.
4. Results
Detection result of IgE content in blood of rats in each group
Group of After 2 weeks of treatment
Normal group 0.341±0.148
Model set 1.117±0.247**
Positive control group 0.724±0.153#
EXAMPLE 1 group 0.404±0.123##&&
EXAMPLE 2 group 0.417±0.127##&&
EXAMPLE 3 group 0.421±0.126##&&
EXAMPLE 4 group 0.431±0.112##&
EXAMPLE 5 group 0.439±0.116##&
EXAMPLE 6 group 0.453±0.180##&
EXAMPLE 7 group 0.464±0.156##&
EXAMPLE 8 group 0.761±0.121#
EXAMPLE 9 group 0.807±0.118
EXAMPLE 10 group 0.826±0.112
EXAMPLE 11 group 0.872±0.115
EXAMPLE 12 group 0.853±0.116
EXAMPLE 13 group 0,877±0.129
Note: p < 0.05, P < 0.01, compared to normal group
Compared with the model group, the # P is less than 0.05, and the # P is less than 0.01;
, & P & lt 0.01, & P & lt 0.05 & gt, as compared with the positive control group
(1) Compared with the normal group, the content of the allergic medium IgE in the model group is obviously increased, and the two groups have very obvious difference (P is less than 0.01), which indicates that the model is successfully made.
(2) Compared with a model group, the nasal sprays prepared in examples 1 to 7 can obviously reduce the content of an allergic medium IgE, and all the nasal sprays have very obvious difference (P < 0.01), which indicates that the nasal sprays prepared in examples 1 to 7 can treat allergic rhinitis.
Compared with the positive control group, the nasal spray prepared in examples 1-7 can obviously reduce the content of the allergic medium IgE, and has very different values (P < 0.05) or very obvious differences (P < 0.01), which indicates that the spray prepared in examples 1-7 is superior to the corticosteroid drug triamcinolone acetonide in reducing the content of the allergic main medium IgE (the positive control group).
(3) Compared with a model group, the nasal spray prepared in example 8 can obviously reduce the content of an allergic medium IgE, and all the nasal sprays have obvious difference (P < 0.05), which indicates that the nasal spray prepared in example 8 can treat allergic rhinitis.
Compared with the positive control group, the nasal spray prepared in example 8 can not reduce the content of the IgE of the allergic medium, and has no significant difference (P is more than 0.05), which indicates that the spray prepared in example 8 is not superior to the corticosteroid medicament triamcinolone acetonide in reducing the IgE of the allergic main medium (the positive control group).
(4) The nasal sprays prepared in examples 9-10 were able to reduce the content of the allergic mediator IgE, but did not differ significantly (P > 0.05) as compared to the model group, indicating that the nasal sprays prepared in examples 9-10 were not able to treat allergic rhinitis,
compared with the positive control group, the nasal spray prepared in examples 9-10 can not reduce the content of the IgE serving as an allergic medium, and has no significant difference (P is more than 0.05), which indicates that the spray prepared in examples 9-10 is not superior to the corticosteroid medicament triamcinolone acetonide in reducing the IgE serving as an allergic main medium (the positive control group).
(4) The nasal sprays prepared in examples 11-13 were able to reduce the content of the allergic mediator IgE, but did not differ significantly (P > 0.05) compared to the model group, indicating that the nasal sprays prepared in examples 11-13 were not able to treat allergic rhinitis,
compared with the positive control group, the nasal spray prepared in examples 11-13 can not reduce the content of the IgE serving as an allergic medium, and has no significant difference (P is more than 0.05), which indicates that the spray prepared in examples 11-13 is not superior to the triamcinolone acetonide serving as a corticosteroid medicament in reducing the IgE serving as an allergic main medium (the positive control group).
Analyzing the data of example 1 and example 8, the specific south isatis root extract can be synergistically acted with honeysuckle extract, houttuynia cordata extract, borneol and the like, the allergic rhinitis treatment effect is good, and the treatment effect of the extract prepared by using the north isatis root instead of the south isatis root extract is remarkably different. Therefore, the south isatis root extract is preferred in the prescription.
Analysis of examples 1-5 and examples 11-13 revealed that: the honeysuckle extract, the isatis root extract, the houttuynia cordata extract and the borneol in a specific ratio play a synergistic effect, and the prepared traditional Chinese medicine composition can effectively treat allergic rhinitis; when any one of the components is absent, the prepared chinese medicinal composition has a poor effect of treating allergic rhinitis without a significant difference (P > 0.05) compared to the model group as in examples 11-13, and thus the chinese medicinal composition prepared in examples 11-13 cannot be used for treating allergic rhinitis.
Example 15: the traditional Chinese medicine composition for treating allergic rhinitis is subjected to a pharmacodynamic test after being placed for 6 months under accelerated conditions.
1. Test samples: the nasal sprays prepared in examples 1-7 were allowed to stand under accelerated conditions for 6 months (temperature 40 c 2 c, humidity 75% +/-5%), and detecting the drug effect.
2. Model preparation as in example 11, rats of 100 were divided into 10 groups, randomized into model group, positive control group, and examples 1-7 (nasal spray prepared in examples 1-7 was accelerated for 6 months); 10 of the above groups were administered by intraperitoneal injection and nasal drip, and the administration of the drugs was physiological saline.
The normal group and the model group were each nasally dropped with physiological saline, the positive control group was nasally dropped with triamcinolone acetonide nasal spray, and the nasal sprays prepared in examples 1 to 10 were each nasally dropped at 50. Mu.L for 1 time/day for 2 weeks, and each administration group was applied to the nostrils on both sides of the rat by a pipette.
3. The detection index and the statistical analysis method were the same as those in example 11.
4. As a result:
group of After 2 weeks of treatment
Normal group 0.347±0.161
Model set 1.113±0.235**
Positive control group 0.727±0.136#
EXAMPLE 1 group 0.398±0.103##&&
EXAMPLE 2 group 0.425±0.125##&&
EXAMPLE 3 group 0.413±0.134##&&
EXAMPLE 4 group 0.432±0.116##&
EXAMPLE 5 group 0.445±0.111##&
EXAMPLE 6 group 0.823±0.113
EXAMPLE 7 group 0.791±0.121
Note: p < 0.05, P < 0.01, compared to normal group
Compared with the model group, the # P is less than 0.05, and the # P is less than 0.01;
, & P & lt 0.01, & P & lt 0.05 & gt, as compared with the positive control group
(1) Compared with the normal group, the content of the allergic medium IgE in the model group is obviously increased, and the content of the allergic medium IgE in the model group is very obviously different (P is less than 0.01), which indicates that the model building is successful.
(2) Compared with the model group, the nasal spray prepared in the examples 1-5 can still remarkably reduce the content of IgE in an allergic medium after being placed for 6 months, and all the nasal sprays have very remarkable difference (P is less than 0.01), which indicates that the quality of the examples 1-5 is stable.
Compared with the positive control group, the nasal spray prepared in examples 1-5 can still significantly reduce the content of the allergic medium IgE after being placed for 6 months, and all the differences are very different (P is less than 0.05) or very significant (P is less than 0.01), which indicates that the quality of the spray prepared in examples 1-5 is stable.
(3) Compared with the model group, the nasal spray prepared in examples 6-7 can reduce the content of the allergic medium IgE after being placed for 6 months at an accelerated speed, but has no significant difference (P is more than 0.05), which indicates that the nasal spray prepared in examples 6-7 has poor stability and the drug effect is significantly reduced after being placed for 6 months at an accelerated speed.
Compared with a positive control group, the nasal spray prepared in examples 6-7 can not reduce the content of an allergic medium IgE, and has no significant difference (P is more than 0.05), which indicates that the spray prepared in examples 6-7 has poor stability and the drug effect is significantly reduced after the spray is placed for 6 months.
Analysis of the data shows that only the honeysuckle extract, the radix isatidis extract, the houttuynia cordata extract and the borneol prepared by a specific process and the specific modified cyclodextrin can exert the synergistic effect with each other to effectively treat the allergic rhinitis.

Claims (3)

1. A Chinese medicinal composition for treating allergic rhinitis comprises flos Lonicerae extract, radix Isatidis extract, herba Houttuyniae extract, borneolum, and medicinal adjuvants;
the honeysuckle extract is chlorogenic acid, and the purity of the chlorogenic acid is not lower than 75%;
the pharmaceutic adjuvant is butyrolactone modified sulfobutyl-beta-cyclodextrin sodium, water and a penetrating agent laurocapram;
the weight ratio of the honeysuckle extract to the isatis root extract to the houttuynia cordata extract to the borneol is (22-24);
the preparation method of the honeysuckle extract comprises the following steps:
extraction: soaking flos Lonicerae in 10-12 times of water for 60 min, decocting for 1-1.5 hr, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain flos Lonicerae extract 1;
refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding a mixed solvent of ethanol and acetone in a weight ratio of 2.5; collecting supernatant, and concentrating to relative density of 1.30 to obtain flos Lonicerae extract 2;
re-refining: refining the honeysuckle extract 2 prepared in the step (2) as a starting material for 1-2 times according to the method in the step (2) to obtain a honeysuckle extract;
the isatis root is a south isatis root produced in the southwest region of China, and the plant body of the isatis root is named as isatis root and is also named as horse blue;
the preparation method for extracting the isatis root comprises the following steps:
extraction: taking radix Isatidis, adding 10-12 times of water for the first time, soaking for 30 minutes, decocting for 1-1.5 hours, and filtering; adding 8-9 times of water for the second time, decocting for 0.5-1 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.20 to obtain radix Isatidis extract 1;
refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding ethanol until the ethanol content is 75% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain radix Isatidis extract 2;
re-refining: refining the isatis root extract 2 prepared in the step (2) as a starting raw material for 1-2 times according to the method in the step (2) to obtain an isatis root extract;
the preparation method of the houttuynia cordata extract comprises the following steps:
extraction: taking herba Houttuyniae, adding 8-10 times of water for the first time, soaking for 30 minutes, decocting for 1-2 hours, and filtering; adding 7-8 times of water for the second time, decocting for 1-1.5 hr, and filtering; mixing filtrates, and concentrating to relative density of 1.15 to obtain herba Houttuyniae extract 1;
refining: taking the isatis root extract 1 prepared in the step (1) as a starting raw material, adding acetone until the acetone content is 10% -80%, and standing for 24 hours; collecting supernatant, and concentrating to relative density of 1.30 to obtain herba Houttuyniae extract 2;
re-refining: refining the houttuynia cordata extract 2 prepared in the step (2) as a starting material for 1-2 times according to the method in the step (2) to obtain the houttuynia cordata extract;
the butyrolactone modified sulfobutyl-beta-cyclodextrin sodium has an average molecular weight of 7000-8500 and a PDI of not more than 1.35;
the preparation method of the butyrolactone modified sulfobutyl-beta-cyclodextrin sodium comprises the following steps: under the protection of N2, adding sulfobutyl-beta-cyclodextrin, butyrolactone and stannous octoate into an N, N-dimethylformamide solvent, mixing, heating to 100 ℃, reacting for 10 hours, cooling to room temperature, adding the reaction mixture into diethyl ether, precipitating, and recrystallizing with absolute ethyl alcohol to obtain butyrolactone-modified sulfobutyl-beta-cyclodextrin sodium.
2. The traditional Chinese medicine composition according to claim 1, characterized in that: the weight ratio of the honeysuckle extract to the isatis root extract to the houttuynia cordata extract to the borneol is 23.2.
3. A method for preparing the traditional Chinese medicine composition of claim 1, which comprises the following steps:
adding butyrolactone modified sulfobutyl-beta-cyclodextrin sodium into flos Lonicerae extract, radix Isatidis extract and herba Houttuyniae extract, heating to 40-50 deg.C, stirring for 1-2 hr until it is clear brown solution, and adding Borneolum; filtering to obtain Chinese medicinal composition liquid 1 with a particle size of 0.45 μm;
adding a penetrant into the liquid medicine 1, and stirring for 25-30 minutes; adding the rest of water for injection; obtaining a Chinese medicinal composition liquid 2;
the Chinese medicinal composition is filled into bottles to prepare nasal spray and nasal drop.
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