阅读说明：本技术 一种治疗过敏性鼻炎的中药组合物及其应用 (Traditional Chinese medicine composition for treating allergic rhinitis and application thereof ) 是由 王剑 于 2021-01-25 设计创作，主要内容包括：本发明公开一种治疗过敏性鼻炎的中药组合物及其应用。该中药组合物由丁香酚、黄芪总皂苷组成。该中药组合物制成的喷鼻剂,通过局部鼻部给药,可用于治疗过敏性鼻炎,实验药效优于一线治疗药物,且起效快,在喷后1～3分钟即能起效,减少鼻塞、流涕等,无副作用,对部分人群可起到根治效果。给药大鼠后,结果说明：本发明的丁黄组鼻喷雾剂在降低过敏主要介质IgE、降低鼻粘膜分泌性粘蛋白MUC5AC、改善鼻炎病理方面优于曲安奈德(阳性对照组),丁香酚与黄芪总皂苷配合,发挥了协同效应,效果超过单用丁香酚和单用黄芪总皂苷。(The invention discloses a traditional Chinese medicine composition for treating allergic rhinitis and application thereof. The Chinese medicinal composition comprises eugenol and total saponins of radix astragali. The nasal spray prepared from the traditional Chinese medicine composition can be used for treating allergic rhinitis by local nasal administration, has an experimental drug effect superior to that of first-line treatment drugs, is quick in effect, can take effect 1-3 minutes after being sprayed, reduces nasal obstruction, watery nasal discharge and the like, has no side effect, and can achieve a radical treatment effect on part of people. After administration to rats, the results show that: the clove yellow nasal spray is superior to triamcinolone acetonide (positive control group) in reducing main allergic medium IgE, reducing mucoprotein secreted by nasal mucosa MUC5AC and improving rhinitis pathology, and the eugenol and the astragalus total saponin are matched to play a synergistic effect, so that the effect is superior to that of the eugenol and the astragalus total saponin which are used singly.)

1. A traditional Chinese medicine composition for treating allergic rhinitis is characterized in that: the traditional Chinese medicine composition consists of a clove extract and an astragalus extract, or consists of eugenol and total saponins of astragalus.

2. The traditional Chinese medicine composition for treating allergic rhinitis according to claim 1, which is characterized in that:

the effective component in the clove extract is eugenol, and the purity of the eugenol is more than or equal to 50 percent;

the astragalus extract is rich in total saponins of astragalus, and the purity of the astragalus extract is more than or equal to 50 percent.

3. The Chinese medicinal composition for treating allergic rhinitis according to claim 2, wherein:

the effective component in the clove extract is eugenol, and the purity of the eugenol is more than or equal to 70 percent;

the astragalus extract is rich in total saponins of astragalus, and the purity of the astragalus extract is more than or equal to 70 percent.

4. The Chinese medicinal composition for treating allergic rhinitis according to any one of claims 1 to 3, which is characterized in that:

the mass ratio of eugenol to total saponins of astragalus in the clove extract and the astragalus extract is 0.1: 1-1: 0.1;

alternatively, the first and second electrodes may be,

the mass ratio of the eugenol to the total astragalosides in the astragalus extract is 0.1: 1-1: 0.1;

alternatively, the first and second electrodes may be,

the mass ratio of the eugenol to the total saponins of astragalus is 0.1: 1-1: 0.1.

5. the Chinese medicinal composition for treating allergic rhinitis according to any one of claims 1 to 3, which is characterized in that:

the preparation method of the clove extract comprises the following steps:

adding water into flos Caryophylli, steam distilling to obtain extract containing eugenol, distilling for 2 times, and vacuum concentrating at low temperature to obtain flos Caryophylli extract; or pulverizing flos Caryophylli into coarse powder, extracting, and resolving to obtain yellowish semitransparent extract.

6. The Chinese medicinal composition for treating allergic rhinitis according to claim 5, wherein:

the ratio of the volume of the added water to the mass of the clove is 2 mL-30 mL: 1g of a compound;

the purity of eugenol in the clove extract is more than or equal to 50 percent;

the extraction conditions are that the pressure is 15-35 MPa and the temperature is 40-65 ℃;

the analysis conditions are that the pressure is 3-10 MPa and the temperature is 30-60 ℃;

the mass ratio of the clove extract to the mass of the clove is 0.05-0.2 g: 1g of the total weight of the composition.

7. The Chinese medicinal composition for treating allergic rhinitis according to any one of claims 1 to 3, which is characterized in that:

the preparation method of the astragalus extract comprises the following steps:

extracting radix astragali with 50-70% ethanol for 2 times, volatilizing the ethanol, adding into a D101 resin column, adsorbing, washing with 5 times of column volume of clear water, washing the column with 0.1-1% NaOH, washing with clear water to neutrality, washing with 10-30% ethanol, washing with 50-90% ethanol, collecting, volatilizing the ethanol, and drying to obtain radix astragali extract rich in total saponins of radix astragali;

or extracting radix astragali with water for 2 times, concentrating, extracting with water saturated n-butanol, collecting n-butanol layer liquid, volatilizing n-butanol, washing with anhydrous ethanol, and drying to obtain radix astragali extract rich in total saponins of radix astragali.

8. The Chinese medicinal composition for treating allergic rhinitis according to claim 7, wherein:

the ratio of the volume of the added 50-70% ethanol to the mass of the astragalus membranaceus is 2-20 mL: 1g of a compound;

the purity of the total saponins of astragalus in the astragalus extract rich in the total saponins of astragalus is more than or equal to 50 percent;

the ratio of the volume of the added water to the mass of the astragalus membranaceus is 2-20 mL: 1g of a compound;

the ratio of the mass of the astragalus extract to the mass of the astragalus is 1-5 g: 100 g.

9. Use of the Chinese medicinal composition for treating allergic rhinitis according to any one of claims 1 to 8 in the preparation of a product for treating allergic rhinitis.

10. Use according to claim 9, characterized in that:

the dosage forms of the product comprise nasal spray, nasal drops, nasal gel and nasal suppository;

when the product is in the form of nasal spray, the preparation steps are as follows:

taking the traditional Chinese medicine composition for treating allergic rhinitis according to any one of claims 1 to 8, adding propylene glycol or glycerol with the total volume of 2-10%, and subpackaging to prepare a nasal spray or nasal drops;

when the product is in the form of nasal gel, the preparation steps are as follows:

dispersing the Chinese medicinal composition for treating allergic rhinitis according to any one of claims 1 to 8 into a gel with 0.1 to 1 percent of carbomer as a matrix, homogenizing and uniformly forming the gel by triethanolamine procoagulant, adding water to prepare a nasal cavity gel, and subpackaging; when in use, a proper amount of gel is taken by a cotton swab and is coated into the nasal cavity.

Technical Field

The invention relates to a nasal spray and nasal drops for treating allergic rhinitis by combining effective components of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating allergic rhinitis and application thereof. The Chinese medicinal composition comprises eugenol and total saponins of radix astragali. The nasal spray prepared from the traditional Chinese medicine composition can be used for treating allergic rhinitis, and the experimental efficacy is superior to that of first-line treatment medicines: the corticosteroid preparation has no side effect of hormone medicine.

Background

Allergic rhinitis (allergic rhinitis) is a disease mainly including immune allergy and chronic inflammation, which is a main clinical symptom including sneezing, watery nasal discharge, nasal obstruction and rhinocnesmus, affects the quality of life of more than 20% of people worldwide, and in recent years, the incidence rate of the disease in various countries including China is in an increasing trend.

At present, the treatment effect of western medicine is not satisfactory clinically, and the nasal cavity is mainly treated by applying cortical hormone to resist allergy locally and applying ephedrine to constrict blood vessels locally. Topical application of cortical stimulation to the nasal cavity for a long period of time will be absorbed into the blood, causing systemic hormonal side effects. Ephedrine for nasal administration can cause atrophy of nasal mucosa. Therefore, there is an urgent need to develop a product for treating allergic rhinitis with rapid onset of action and no side effects.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention aims to provide the traditional Chinese medicine composition for treating allergic rhinitis. The traditional Chinese medicine composition is prepared by combining traditional Chinese medicine extract eugenol and total saponins of astragalus, and is administrated through local nose. The spray has quick response, can take effect after being sprayed for 1-3 minutes, reduces nasal obstruction, watery nasal discharge and the like, has no side effect, and can achieve the effect of radical treatment on partial crowds.

In addition, eugenol is not the same substance as methyl eugenol which has been reported to have a therapeutic effect on rhinitis, and eugenol CAS No.: 97-53-0, methyl eugenol CAS number: 93-15-2.

The purpose of the invention is realized by the following technical scheme:

a Chinese medicinal composition for treating allergic rhinitis comprises flos Caryophylli extract and radix astragali extract, or eugenol and radix astragali total saponin.

The effective component in the clove extract is eugenol, and the purity of the eugenol is more than or equal to 50 percent; the further purity is more than or equal to 70 percent; further, the purity is more than or equal to 80 percent.

The astragalus extract is rich in total saponins of astragalus, and the purity of the astragalus extract is more than or equal to 50 percent; further, the purity is more than or equal to 70 percent.

Preferably, the mass ratio of eugenol to total saponins of astragalus in the clove extract and the astragalus extract is 0.1: 1-1: 0.1; further 0.2: 1-1: 0.2, and more specifically 0.5: 1-1: 0.5, and still further 1: 0.875.

preferably, the mass ratio of the eugenol to the total astragalosides in the astragalus extract is 0.1: 1-1: 0.1; further 0.2: 1-1: 0.2, and more specifically 0.5: 1-1: 0.5, and still further 1: 0.875.

the mass ratio of the eugenol to the total saponins of astragalus is 0.1: 1-1: 0.1; further 0.2: 1-1: 0.2, and more specifically 0.5: 1-1: 0.5.

the eugenol and the total saponins of astragalus can be purchased commercially, and the purity is more than 70 percent, and further more than 90 percent;

further, the preparation method of the clove extract comprises the following steps:

adding water into flos Caryophylli, steam distilling to obtain extract containing eugenol, distilling for 2 times, and vacuum concentrating at low temperature to obtain flos Caryophylli extract; or pulverizing flos Caryophylli into coarse powder, extracting, and resolving to obtain yellowish semitransparent extract;

the ratio of the volume of the added water to the mass of the clove is 2 mL-30 mL: 1g of a compound; further 6 mL: 1g of the total weight of the composition.

The purity of eugenol in the clove extract is more than or equal to 50 percent; further more than or equal to 70 percent.

Preferably, the extraction conditions are that the pressure is 15-35 MPa and the temperature is 40-65 ℃; further, the pressure was 25MPa and the temperature was 55 ℃.

Preferably, the analysis conditions are that the pressure is 3-10 MPa and the temperature is 30-60 ℃; further the pressure is 6MPa, and the temperature is 40 ℃;

preferably, the mass ratio of the clove extract to the mass of the clove is 0.05-0.2 g: 1g of a compound; further 0.1 g: 1g of the total weight of the composition.

Further, the preparation method of the astragalus extract comprises the following steps:

extracting radix astragali with 50-70% ethanol (preferably 70% ethanol) for 2 times, volatilizing ethanol, adding into a D101 resin column, adsorbing, washing with 5 times of column volume of clear water, washing the column with 0.1-1% NaOH (preferably 0.2% NaOH), washing with clear water to neutrality, washing with 10-30% ethanol (preferably 20% ethanol), washing with 50-90% ethanol (preferably 70% ethanol), collecting, volatilizing ethanol, and drying to obtain radix astragali extract rich in total saponins;

or extracting radix astragali with water for 2 times, concentrating, extracting with water saturated n-butanol, collecting n-butanol layer liquid, volatilizing n-butanol, washing with anhydrous ethanol, and drying to obtain radix astragali extract rich in total saponins of radix astragali.

The ratio of the volume of the added 50-70% ethanol to the mass of the astragalus membranaceus is 2-20 mL: 1g of a compound; further 5 mL: 1g of the total weight of the composition.

The purity of the total saponins of astragalus in the astragalus extract rich in the total saponins of astragalus is more than or equal to 50 percent; the further purity is more than or equal to 70 percent;

the ratio of the volume of the added water to the mass of the astragalus membranaceus is 2-20 mL: 1g of a compound; further 5 mL: 1g of the total weight of the composition.

Preferably, the ratio of the mass of the astragalus extract to the mass of the astragalus is 1-5 g: 100g of the total weight of the mixture; further 2 g: 100 g.

The application of the traditional Chinese medicine composition for treating allergic rhinitis in preparing products for treating allergic rhinitis.

The dosage forms of the product comprise nasal spray, nasal drops, nasal gel, nasal suppository and the like;

the preparation form of the product is nasal spray, and the preparation steps are as follows:

according to the ratio, mixing the clove extract and the astragalus extract (or mixing the eugenol and the astragalus extract or mixing the eugenol and the total astragalosides), adding propylene glycol or glycerol with the total volume of 2-10% (preferably 5%) of the total astragalosides, subpackaging and preparing the nasal spray or the nasal drops.

Preferably, the content of eugenol in the nasal spray or nasal drops is 0.1-10% (m/v); further 0.1-1.5%; further 0.2 to 1%; further 0.3-0.6%;

the product is a nasal gel preparation, and the preparation steps are as follows:

dispersing the clove extract and the astragalus extract (or eugenol and astragalus extract or eugenol and astragalus total saponin) into gel taking 0.1-1% carbomer (preferably 0.25% carbomer) as a matrix according to the ratio, homogenizing uniformly, forming gel by using triethanolamine, adding water to prepare a nasal cavity gel, and subpackaging; when in use, a proper amount of gel is taken by a cotton swab and is coated into the nasal cavity.

Preferably, the total mass of the eugenol and the astragalus total saponin in each kilogram of the nasal cavity gel is 1-9 g; further 6 g.

Compared with the prior art, the invention has the following advantages and effects:

(1) the traditional Chinese medicine composition of the invention consists of clove extract containing eugenol and astragalus extract rich in total saponins of astragalus, and is prepared into nasal spray, and after the nasal spray is administrated to rats, the result shows that: the clove yellow nasal spray is superior to triamcinolone acetonide (positive control group) in reducing main allergic medium IgE, reducing mucoprotein secreted by nasal mucosa MUC5AC and improving rhinitis pathology, and the eugenol and the astragalus total saponin are matched to play a synergistic effect, so that the effect is superior to that of the eugenol and the astragalus total saponin which are used singly.

(2) After the nasal spray prepared by the invention is sprayed on patients with nasal allergic rhinitis, the total effective rate of the butyl yellow group is 95%, the positive control group is 85%, particularly in the aspect of cure rate, the butyl yellow group (70%) is obviously superior to the positive control group (25%), and the difference has statistical significance (P is less than 0.05).

Drawings

FIG. 1 is an HPLC plot of total saponins of Astragalus membranaceus in the nasal spray of example 1.

FIG. 2 is a graph showing the results of gas chromatography-mass spectrometry (Agilent 19095F-123) of the nasal spray of example 1, in which eugenol is the main volatile component.

FIG. 3 is a microscopic observation result of HE staining of nasal mucosa of rats in the normal group.

Fig. 4 is a microscopic observation of HE staining of the nasal mucosa pathology in the model group.

Fig. 5 is a microscopic observation result of HE staining of nasal mucosa pathology in the group of bufalin.

Fig. 6 is a microscopic observation result of HE staining of nasal mucosa pathology of the positive control group.

Fig. 7 is a microscopic observation of HE staining of nasal mucosa pathology of eugenol group alone.

FIG. 8 is the microscopic observation result of pathological HE staining of the nasal mucosa of the group of the total saponins of astragalus alone.

FIG. 9 is the immunohistochemical microscopic observation result of the secretory mucin MUC5AC of the nasal mucosa of the normal group of rats, with a length of 50 μm.

FIG. 10 is the immunohistochemical microscopic observation of the secreted mucin MUC5AC of the nasal mucosa of the model group rat.

FIG. 11 shows the immunohistochemical microscopic observation of the secreted mucin MUC5AC in the nasal mucosa of the Tyranus nudus group rats.

FIG. 12 is an immunohistochemical microscopic observation result of the nasal mucosa secretory mucin MUC5AC of the positive control group rat.

FIG. 13 is an immunohistochemical microscopic observation of the nasal mucosa secretory mucin MUC5AC of individual eugenol group rats.

FIG. 14 is an immunohistochemical microscopic observation result of the secretory mucin MUC5AC of the nasal mucosa of a rat of the single radix astragali total saponin group.

In each of fig. 10 to 14, the same scale size as that in fig. 10 is used.

Detailed Description

The present invention will be described in further detail with reference to examples and drawings, but the present invention is not limited thereto.

The test methods in the following examples, in which specific experimental conditions are not specified, are generally performed according to conventional experimental conditions or according to the experimental conditions recommended by the manufacturer. The materials, reagents and the like used are, unless otherwise specified, reagents and materials obtained from commercial sources.

Example 1

Adding 6000mL of water into 1000g of clove, performing steam distillation to obtain an extract containing eugenol (the purity of the eugenol is 80%), and performing distillation for 2 times to obtain 10000mL of final volume, namely clove extract solution; vacuum concentrating at low temperature to obtain flos Caryophylli extract (about 100g), wherein the purity of eugenol is 80%.

Extracting 1000g of radix astragali with 5000mL of 70% ethanol for 2 times, volatilizing the ethanol, adding into a D101 resin column, adsorbing for half an hour, washing with 5 times column volume of clear water, washing the column with 0.2% NaOH, washing with clear water to neutrality, washing the column with 20% ethanol, washing the column with 70% ethanol, collecting, volatilizing the ethanol to obtain 2000mL of radix astragali extract solution rich in total saponins of radix astragali (the purity of total saponins of radix astragali is 70%), and adding 0.3% potassium sorbate for use. Wherein, after the ethanol is volatilized, the astragalus extract (about 20g) can be obtained after drying, and the purity of the total saponins of the astragalus is 70 percent.

Mixing 1000mL of flos Caryophylli extract solution and 1000mL of radix astragali extract solution rich in radix astragali total saponin, adding propylene glycol with 5% of total volume, and packaging into 200 bottles of nasal spray according to 10mL per bottle.

Adding propylene glycol with a volume of 5% into 1000mL of flos Caryophylli extract solution, and packaging into 100 bottles of nasal spray, i.e. eugenol nasal spray, according to 10mL per bottle.

Taking 1000mL of radix astragali extract solution rich in radix astragali total saponin, adding propylene glycol with the total volume of 5%, and subpackaging 100 bottles of nasal spray, namely the radix astragali total saponin nasal spray, according to 10mL per bottle.

Example 2

10g of eugenol (purity 90%) is purchased from the market, dissolved in Tween 80 and diluted to 1000 mL; 20g of astragalus total saponins (purity 90%) purchased from the market are dissolved by tween 80 and diluted to 1000 mL; according to the following steps: 1, and subpackaging into 200 bottles of 10mL nasal drops.

Example 3

Pulverizing 1000g of clove into coarse powder, placing the coarse powder in supercritical extraction equipment, extracting at the pressure of 25MPa and the temperature of 55 ℃, resolving at the pressure of 6MPa and the temperature of 40 ℃ to obtain 100g of light yellow semitransparent extract (the purity of eugenol is 80%), adding Tween 80 serving as a solubilizer, and diluting to obtain the clove extract solution with the volume of 10000 mL.

Extracting 1000g radix astragali with 5000mL water for 2 times, concentrating, extracting with water saturated n-butanol, collecting n-butanol layer liquid, volatilizing n-butanol, washing with anhydrous ethanol, dissolving with water to obtain 2000mL extract solution rich in radix astragali total saponin (radix astragali total saponin purity 70%), and adding 0.3% potassium sorbate for use. Wherein, after being washed by absolute ethyl alcohol and dried, the astragalus extract (about 20g) can be obtained, and the purity of the astragalus total saponin is 70 percent.

Mixing 1000mL of flos Caryophylli extract solution and 1000mL of radix astragali extract solution rich in radix astragali total saponin, adding propylene glycol with 5% of total volume, and packaging into 200 bottles of nasal spray according to 10mL per bottle.

EXAMPLE 4 nasal gel preparation

400mL of the eugenol-containing clove extract solution prepared in the example 1 and the astragalus root extract solution rich in the total astragalosides are respectively dispersed into gel taking 0.25% carbomer as a matrix, the gel is homogenized and formed by triethanolamine procoagulant, water is added to the total mass of 1000g, and 100 bottles are respectively filled with 10g of the solution. When in use, a proper amount of gel is taken by a cotton swab and is coated into the nasal cavity.

Effect example 1 pharmacological test

1. Materials and methods

1.1 animals

The weight of the rat is 200g +/-30 g, and the rat is 60 in each half of male and female.

1.2 major drugs and reagents

Triamcinolone acetonide nasal spray (corticoid drugs, produced by Jiangxi Zhenzhen pharmacy Co., Ltd.), nasal spray (self-made) of example 1, Ovalbumin (OVA), aluminum hydroxide, 10% neutral formaldehyde fixing solution, hematoxylin eosin staining solution, rat IgE enzyme linked immunosorbent assay kit (Nanjing Biotech Co., Ltd.), and Mucin5AC antibody (England abcam Co., Ltd.).

Nasal spray agent astragalus total saponin content high performance liquid phase evaporation light detection map

Chromatographic conditions are as follows:

a chromatographic column: inertsil ODS-SP (5 μm, 4.6X 250mm)

Mobile phase: acetonitrile-water 32: 68

Flow rate: 1ml/min

A detector: ELSD-UM3000

As can be seen from fig. 1, the nasal spray of example 1, which was detected by hplc, contains the major ingredient of total saponins of astragalus membranaceus, and the purity of total saponins of astragalus membranaceus is 70%. As can be seen from FIG. 2, the nasal spray of example 1 was analyzed by GC (Agilent 19095F-123) to find that the main component was eugenol, which had a purity of 80%.

1.3 model preparation and treatment in groups

After one week of adaptive feeding of rats, 60 male and female rats are respectively half randomly molded by adopting an ovalbumin OVA sensitization method: intraperitoneal injection of 1mL OVA suspension (containing 0.9% sodium chloride, 20mg OVA and 30mg aluminum hydroxide) is carried out once every other day for 8 times (15d) to carry out basic sensitization; on day 16, rats were instilled with 10% OVA saline solution into both anterior nares, 50 μ L each side, 1 time daily for 10 consecutive days to stimulate allergic rhinitis. After the molding is successful, a model group, a positive control group, a clove yellow group (the nasal spray of the embodiment 1, eugenol and total astragalosides are compounded and cooperated), a eugenol group (the eugenol nasal spray of the embodiment 1 is used alone), and a total astragalosides group (the total astragalosides nasal spray of the embodiment 1 is used alone) are randomly selected; the number of each group is 10, and another 10 groups are used as normal groups, and are subjected to intraperitoneal injection and nasal drip as before, but the administered medicines are physiological saline.

Normal group and model group are dripped into nose with normal saline, positive control group is dripped into nose with triamcinolone acetonide nasal spray, the Chinese medicinal components are respectively dripped with corresponding Chinese medicinal materials, each administration group is administered at 50 μ L for 1 time/day for 2 weeks, and is dripped into nostrils at two sides of rat by using a liquid transfer gun.

1.4 detection index

1.4.1 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.

1.4.2 histomorphometry

After blood is taken from a rat, the nose is quickly cut off, the nasal mucosa is separated out, neutral formaldehyde is fixed, paraffin sections with the thickness of 3 mu m are manufactured by conventional dehydration, transparence, wax dipping and embedding, HE staining is carried out, and the pathological conditions of local mucosa mucus gland hyperplasia and inflammation are observed under an optical microscope.

1.4.3 immunohistochemical detection

Rat nasal mucosa paraffin section, and according to SABC method immunohistochemistry, under the light microscope observation local mucosa goblet cell secretion mucin MUC5AC pathological condition.

1.5 statistical analysis method

Data were processed through SPSS 17.0 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.

2 results

2.1 detection results of IgE content in blood of rats in each group

TABLE 1 results of measurement of IgE content in blood of rats in each treatment group

Group of	After 2 weeks of treatment
		Normal group	0.376±0.121
Model set	1.161±0.252*
		Positive control group	0.6206±0.170#
Dinghuang group	0.4597±0.116#◆
		Eugenol group	0.753±0.120#
Radix astragali total saponin group	0.770±0.150#

P <0.05 compared to normal group; compared to the model group, # P < 0.05; p <0.05 in comparison to the positive control.

The results in table 1 show that the nasal spray of the clove bud group in example 1 of the present invention is superior to the corticosteroid drug triamcinolone acetonide (positive control group) in reducing the IgE of the main allergic medium, and the eugenol and the total astragalosides cooperate to exert a synergistic effect, and the effect is superior to that of the eugenol and the total astragalosides.

2.2 pathological Observation of nasal mucosa

When rat nasal mucosa was observed under an optical microscope at a magnification of 100, the thickening of turbinate mucosal epithelium and the massive proliferation of mucus glands (indicated by arrows) were observed in the model group (fig. 4) compared with the normal group (fig. 3), which exhibited typical pathological features of allergic rhinitis. The swelling and congestion degree of mucous membranes of the clove yellow group (figure 5) and the positive control group (figure 6) is lower, the mucous gland hyperplasia is obviously reduced, the effect of the clove yellow group for reducing the mucous glands is better than that of the positive control group, and the effect of the eugenol group (figure 7) and the effect of the astragalus total saponin group (figure 8) show that the pathology is not improved as compared with that of the clove yellow group.

2.3 immunohistochemical pathological observation of the secreted mucin MUC5AC of the nasal mucosa

Compared with the normal nasal mucosa (FIG. 9), the brown-yellow mucin MUC5AC positive reaction product of the model group (FIG. 10) was significantly increased. Compared with the model group, the positive control group (figure 12), the radix astragali total saponin group (figure 14), the eugenol group (figure 13) and the clove yellow group (figure 11) can reduce MUC5AC positive reaction products, wherein the clove yellow group is most obvious, which shows that the radix astragali total saponin and eugenol are combined to play a synergistic effect.

Effect example 2 population test

1. Grouping

The allergic rhinitis patients are divided into two groups, namely a positive control group and a yellow-butyl group, and 20 patients respectively. The Western diagnosis standard of allergic rhinitis refers to the diagnosis standard in the guidance 2015 for diagnosis and treatment of allergic rhinitis.

2. Medicine

Triamcinolone acetonide nasal spray (Jiangxi Zhenshiming pharmaceutical Co., Ltd., lot No. 191104) was used for the positive control group, and a self-made nasal spray (containing eugenol and total saponins of Astragalus membranaceus, prepared by the method of example 1) was used for the butylbenzene group.

The nasal sprays were applied 3 times per day in the morning, at noon and evening, and 2 sprays per nostril. The treatment course is 2 weeks.

3. Evaluation criteria

Refer to the diagnosis and treatment principles and recommended protocol of allergic rhinitis (2004, Lanzhou) to determine the therapeutic efficacy. And (3) curing: the symptoms completely disappeared, and the symptom score was 0; the effect is shown: the reduction of symptom score is more than or equal to 65%; the method has the following advantages: the reduction of symptom score is 26-65%; and (4) invalidation: the reduction in symptom score is less than or equal to 25%.

4. Statistical treatment

Statistical analysis is carried out by using SPSS 24.0 software, the measurement data are expressed by mean plus or minus standard deviation, the comparison among groups is carried out by using an independent sample t test, the counting data are expressed by percentage (%) and are statistically significant by using chi-square test, and the difference is P < 0.05.

5. Results

Comparison of clinical efficacy in two groups of patients

The butyl yellow group has quick response, and can take effect 1-3 minutes after being sprayed;

after 2 weeks of treatment, the total effective rate of the yellow-tinged group is 95%, the positive control group is 85%, particularly in the aspect of cure rate, the yellow-tinged group is obviously superior to the positive control group, and the difference has statistical significance (P is less than 0.05). See table 2.

TABLE 2 results of clinical efficacy of the positive control group and the Dinghuang group

P <0.05 compared to positive control group.

The above embodiments are preferred embodiments of the present invention, but the present invention is not limited to the above embodiments, and any other changes, modifications, substitutions, combinations, and simplifications which do not depart from the spirit and principle of the present invention should be construed as equivalents thereof, and all such changes, modifications, substitutions, combinations, and simplifications are intended to be included in the scope of the present invention.