Traditional Chinese medicine composition for treating rhinitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating rhinitis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The preparation method comprises the following steps: mixing herba ephedrae, radix aconiti carmichaeli, herba asari, radix astragali, rhizoma atractylodis macrocephalae, radix saposhnikoviae, fructus xanthii, flos magnoliae and water, distilling to extract volatile oil, mixing the volatile oil with a water-soluble carrier material, and melting and extruding to obtain a medicine A; mixing and decocting medicine residues after volatile oil extraction and water, filtering, collecting filtrate, adding 85-95% ethanol for precipitation, recovering an ethanol solution, concentrating the ethanol solution into extract, and drying to obtain an extract; the extract and a carrier material are dissolved in an organic solvent, mixed and subjected to ultrasonic treatment for 35-45 min, then spray drying is conducted, and a medicine B is obtained; granulating the medicine A and the medicine B to obtain the traditional Chinese medicine composition for treating rhinitis. The traditional Chinese medicine components are synergistically compatible, the nasal obstruction symptom can be relieved, allergic rhinitis, acute and chronic rhinitis, nasosinusitis and the like can be effectively treated, and the solubility, stability and bioavailability of the traditional Chinese medicine are improved through the carrier material.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating rhinitis and a preparation method thereof. Background Art

[0002] Rhinitis is an inflammatory disease of the nasal cavity, which is an inflammation of the nasal mucosa caused by viruses, bacteria, allergens, various physical and chemical factors, and certain systemic diseases. The main pathological changes of rhinitis are congestion, swelling, exudation, hyperplasia, atrophy or necrosis of the nasal mucosa.

[0003] The causes of rhinitis can be roughly divided into the following three aspects: (1) Systemic causes: long-term chronic diseases, such as endocrine disorders, long-term constipation, kidney disease and cardiovascular disease, which can cause long-term or recurrent congestion or congestion of the nasal mucosa. Vitamin deficiency, such as vitamin A or C. Long-term use of antihypertensive drugs such as reserpine can cause nasal vasodilation and produce symptoms similar to rhinitis. (2) Local causes: repeated attacks of acute rhinitis or incomplete treatment can develop into chronic rhinitis. Due to long-term stimulation or deformity of adjacent chronic inflammation, the nose may have poor ventilation or drainage obstruction, such as chronic sinusitis, nasal septum deviation, chronic tonsillitis or adenoid hypertrophy. (3) Environmental factors: workers in environments with cement, tobacco, coal dust, flour or chemicals, the nasal mucosa is stimulated and damaged by physical and chemical factors, which can cause chronic rhinitis. Workers in workshops where temperature and humidity change rapidly, such as steelmaking, refrigeration, and baking, are also more likely to develop chronic rhinitis. Chronic rhinitis (including chronic simple rhinitis and chronic simple hypertrophic rhinitis) is a common clinical disease. Due to the many pathogenic factors and the unknown exact cause, modern medicine mainly treats this disease with local symptomatic treatment, and there is no ideal causal treatment drug.

[0004] At present, Western medicine mainly adopts drug therapy and surgical treatment for the treatment of rhinitis. Drug therapy mainly includes nasal mucosal contractants, antibiotics and adrenocortical hormones. Intranasal glucocorticoids are the first choice for chronic rhinitis. They have good anti-inflammatory effects and ultimately produce a decongestion effect. However, glucocorticoids can only temporarily relieve symptoms. Moreover, long-term use of glucocorticoids in the nasal cavity has varying degrees of damage to the liver, kidneys and cardiopulmonary functions. Oxymetazoline hydrochloride spray, as an intranasal decongestant, also has the effect of relieving rhinitis, but its continuous use should not exceed 7 days, otherwise it will damage the nasal mucosal ciliary structure. Surgical treatment is mainly nasal endoscopic functional minimally invasive surgery. Although these therapies are effective, they often only treat the symptoms and not the root cause. The results are not ideal, and many patients often do not recover for a long time. Summary of the invention

[0005] In view of this, the object of the present invention is to provide a Chinese medicine composition for treating rhinitis and a preparation method thereof.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The invention provides a traditional Chinese medicine composition for treating rhinitis, comprising the following raw materials in parts by weight: 6-12 parts of ephedra, 5-10 parts of aconite, 3-7 parts of asarum, 25-35 parts of astragalus, 5-15 parts of atractylodes, 2-4 parts of siler, 12-18 parts of xanthium sibiricum and 10-15 parts of magnolia.

[0008] The present invention also provides a method for preparing the Chinese medicine composition for treating rhinitis, comprising the following steps:

[0009] 1) mixing ephedra, aconite root, asarum, astragalus, atractylodes, siler, xanthium sibiricum, magnolia bud and water, extracting volatile oil by distillation, mixing the volatile oil with a water-soluble carrier material, and obtaining drug A by melt extrusion;

[0010] 2) mixing the residue after extracting the volatile oil with water and boiling, filtering, collecting the filtrate, adding 85-95% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, and drying to obtain an extract;

[0011] 3) dissolving the extract and the carrier material in an organic solvent, mixing, ultrasonicating for 35 to 45 minutes, and then spray drying to obtain drug B;

[0012] 4) Mixing the drug A and the drug B, grinding them, and granulating them to obtain a Chinese medicine composition for treating rhinitis.

[0013] Preferably, in step 1), the water-soluble carrier material is polyvinyl pyrrolidone, and the mass ratio of the volatile oil to the water-soluble carrier material is 1:16-18.

[0014] Preferably, the operating temperature of the melt extrusion in step 1) is 140-150° C., and the screw speed is 120-140 rpm.

[0015] Preferably, in step 2), the decoction is performed 1 to 3 times, and the decoction time is 1 to 3 hours per time; and the relative density is 1.2 to 1.3 when concentrated to 65°C.

[0016] Preferably, in step 3), the carrier material is polyoxyethylene and sorbitol, and the mass ratio of polyoxyethylene to sorbitol is 3 to 5:1.

[0017] Preferably, in step 3), the mass ratio of the extract to the carrier material is 1:2-4; and the organic solvent is acetonitrile.

[0018] Preferably, the inlet air temperature of the spray drying in step 3) is 80-100°C, and the outlet air temperature is 50-70°C.

[0019] Preferably, the amount of water used in step 1) is 12 to 18 times the sum of the mass of ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium and magnolia; and the mass ratio of the Chinese medicinal residue to water in step 2) is 1 to 3:8 to 12.

[0020] Compared with the prior art, the present invention has the following beneficial effects:

[0021] The Chinese medicinal ingredients of the present invention are synergistically compatible and cooperate with each other to achieve the effects of dispelling wind and clearing the orifices, relieving itching and removing nose, relieving mucosal swelling, helping to relieve nasal congestion symptoms, stimulating nasal nerve endings, and promoting mucosal repair and regeneration, thereby effectively treating allergic rhinitis, acute and chronic rhinitis, sinusitis, etc.

[0022] The invention can collect volatile oil in the raw material through heating distillation extraction, improve the dissolution and solubility of the traditional Chinese medicine through hot melt extrusion, and has the effect of masking the taste; the medicinal residue is heated and boiled to extract the active ingredients so as to improve the extraction rate of the active ingredients, and the purity of the active ingredients is improved through ethanol precipitation and concentration; the solubility of the medicine is increased by mixing the volatile oil and the extract with the carrier material, and the stability and bioavailability of the medicine are improved. DETAILED DESCRIPTION

[0023] The invention provides a traditional Chinese medicine composition for treating rhinitis, comprising the following raw materials in parts by weight: 6-12 parts of ephedra, 5-10 parts of aconite, 3-7 parts of asarum, 25-35 parts of astragalus, 5-15 parts of atractylodes, 2-4 parts of siler, 12-18 parts of xanthium sibiricum and 10-15 parts of magnolia.

[0024] In the present invention, the dosage of ephedra is preferably 8 to 11 parts; the herbaceous stems of Ephedra sinica, Ephedra equisetum or Ephedra intermedia of the Ephedraceae family are warm in nature, pungent and slightly bitter in taste, and have the effects of sweating and dispelling cold, clearing the lungs and relieving asthma, promoting diuresis and reducing swelling, and can treat colds, chest tightness, cough, wind and water edema, bronchial asthma and other diseases.

[0025] In the present invention, the dosage of the aconite is preferably 6 to 9 parts; aconite tastes pungent and sweet, is very hot in nature, enters the heart, kidney, and spleen meridians, restores yang and rescues adverse conditions, replenishes fire and assists yang, dispels cold and relieves pain, and is used for yang loss and collapse, cold limbs and weak pulse, insufficient heart yang, chest pain, vomiting and diarrhea due to deficiency cold, cold pain in the abdomen, deficiency of kidney yang, impotence and cold uterus, yin-cold edema, yang deficiency and exogenous infection, and cold-damp arthralgia.

[0026] In the present invention, the dosage of Asarum is preferably 4 to 6 parts; Asarum is pungent and warm in nature, enters the heart, lung and kidney meridians, relieves exterior symptoms and dispels cold, dispels wind and relieves pain, opens the orifices, warms the lungs and transforms fluid, and is used for wind-cold colds, headaches, toothaches, rheumatic arthralgia, sinusitis, and lung-cold coughs.

[0027] In the present invention, the dosage of the astragalus is preferably 28 to 32 parts; astragalus is sweet and slightly warm in nature; it enters the spleen and lung meridians, and has the effects of invigorating qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood, relieving stagnation and relieving arthritis, expelling toxins and discharging pus, and healing sores and promoting tissue regeneration.

[0028] In the present invention, the dosage of Atractylodes macrocephala is preferably 8 to 12 parts; Atractylodes macrocephala is bitter, sweet, warm in nature, and enters the spleen and stomach meridians, and has the effects of invigorating qi and strengthening the spleen, stopping diarrhea and strengthening the kidney, removing dampness and resolving phlegm, etc.

[0029] In the present invention, the dosage of the fangfeng is preferably 3 parts; fangfeng tastes pungent and sweet, is slightly warm in nature, enters the bladder, spleen, and liver meridians, dispels wind and relieves exterior symptoms, overcomes dampness and relieves pain, and stops spasms. It is used for external symptoms, urticaria itching, rheumatic arthralgia, tetanus, and spleen deficiency and dampness.

[0030] In the present invention, the dosage of Xanthium sibiricum is preferably 14 to 16 parts; Xanthium sibiricum is bitter, pungent, slightly cold, and slightly toxic. It can dispel wind, dissipate heat, remove dampness, and detoxify, and is used for colds, headaches, dizziness, sinusitis, red eyes, eye opacity, wind-heat arthralgia, cramps and numbness, wind leprosy, furuncle, scabies, skin itching, hemorrhoids, dysentery, etc.

[0031] In the present invention, the dosage of the magnolia is preferably 11 to 14 parts; magnolia has the effects of warming the lungs and clearing the orifices, dispelling wind and cold, and is mainly used to treat colds, sinusitis, toothache, headache and the like.

[0032] The present invention also provides a method for preparing the Chinese medicine composition for treating rhinitis, comprising the following steps:

[0033] 1) mixing ephedra, aconite root, asarum, astragalus, atractylodes, siler, xanthium sibiricum, magnolia bud and water, extracting volatile oil by distillation, mixing the volatile oil with a water-soluble carrier material, and obtaining drug A by melt extrusion;

[0034] 2) mixing the residue after extracting the volatile oil with water and boiling, filtering, collecting the filtrate, adding 85-95% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, and drying to obtain an extract;

[0035] 3) dissolving the extract and the carrier material in an organic solvent, mixing, ultrasonicating for 35 to 45 minutes, and then spray drying to obtain drug B;

[0036] 4) Mixing the drug A and the drug B, grinding them, and granulating them to obtain a Chinese medicine composition for treating rhinitis.

[0037] In the present invention, ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia and water are mixed, volatile oil is extracted by distillation, the volatile oil is mixed with a water-soluble carrier material, and melt extrusion is performed to obtain drug A. The amount of water is preferably 12 to 18 times the sum of the mass of ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia, and the amount of water is preferably 14 to 16 times the sum of the mass of ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia; the water-soluble carrier material is polyvinyl pyrrolidone, the mass ratio of the volatile oil to the water-soluble carrier material is preferably 1:16 to 18, and more preferably 1:17; the operating temperature of the melt extrusion is preferably 140 to 150°C, and more preferably 142 to 148°C; the screw speed is preferably 120 to 140 rpm, and more preferably 125 to 135 rpm.

[0038] In the present invention, the residues after extracting volatile oil are mixed with water and boiled, filtered, the filtrate is collected, 85-95% ethanol is added for precipitation, the ethanol solution is recovered and concentrated into an extract, and dried to obtain an extract; the mass ratio of the residues to water is preferably 1-3:8-12, and more preferably 2:9-11; the number of decoctions is preferably 1-3 times, and more preferably 2 times; the decoction time is preferably 1-3h / time, and more preferably 1.5-2.5h / time; the relative density is 1.2-1.3 when concentrated to 65°C, and the relative density is 1.22-1.28 when further concentrated to 65°C.

[0039] In the present invention, the extract and the carrier material are dissolved in an organic solvent, mixed, ultrasonicated for 35 to 45 minutes, and then spray-dried to obtain drug B. The carrier material is polyoxyethylene and sorbitol, and the mass ratio of polyoxyethylene and sorbitol is preferably 3 to 5:1, and more preferably 4:1; the mass ratio of the extract and the carrier material is preferably 1:2 to 4, and more preferably 1:3; the organic solvent is acetonitrile; the ultrasonic time is preferably 38 to 42 minutes; the inlet air temperature of the spray drying is preferably 80 to 100°C, and more preferably 85 to 95°C; the outlet air temperature is preferably 50 to 70°C, and more preferably 55 to 65°C. Drug A and drug B are mixed, crushed, and granulated to obtain a traditional Chinese medicine composition for treating rhinitis.

[0040] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0041] Example 1

[0042] The Chinese medicine composition for treating rhinitis in this embodiment is prepared from the following raw materials in parts by weight: 10 parts of ephedra, 8 parts of aconite, 5 parts of asarum, 30 parts of astragalus, 10 parts of atractylodes, 3 parts of siler, 15 parts of xanthium sibiricum, and 12 parts of magnolia.

[0043] The preparation method comprises the following steps: mixing ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia and water of 15 times the weight thereof, extracting volatile oil by distillation, mixing volatile oil with polyvinyl pyrrolidone at a mass ratio of 1:17, and subjecting to melt extrusion (operating temperature 145°C, screw speed 130rpm) to obtain drug A. Mixing the drug residue after extracting volatile oil with water at a mass ratio of 1:5, decocting twice, 2h / time, filtering, collecting the filtrate, adding 90% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, the relative density of which is 1.25 when concentrated to 65°C, and drying to obtain an extract; dissolving the extract and a carrier material (polyoxyethylene and sorbitol at a mass ratio of 4:1) in an organic solvent acetonitrile at a mass ratio of 1:3, mixing, ultrasonicating for 40 minutes, and then spray drying, with an air inlet temperature of 90°C and an air outlet temperature of 60°C, to obtain drug B. Mixing drug A and drug B, crushing, and granulating to obtain a traditional Chinese medicine composition for treating rhinitis.

[0044] Example 2

[0045] The Chinese medicine composition for treating rhinitis in this embodiment is prepared from the following raw materials in parts by weight: 6 parts of ephedra, 5 parts of aconite, 3 parts of asarum, 25 parts of astragalus, 5 parts of atractylodes, 2 parts of siler, 12 parts of xanthium sibiricum, and 10 parts of magnolia.

[0046] The preparation method comprises the following steps: mixing ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia and water of 12 times the weight of the total, extracting volatile oil by distillation, mixing volatile oil and polyvinyl pyrrolidone at a mass ratio of 1:16, and subjecting to melt extrusion (operating temperature 140°C, screw speed 120rpm) to obtain drug A. Mixing the drug residue after extracting volatile oil with water at a mass ratio of 1:8, decocting once, 1h / time, filtering, collecting the filtrate, adding 85% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, the relative density of which is 1.2 when concentrated to 65°C, and drying to obtain an extract; dissolving the extract and a carrier material (polyoxyethylene and sorbitol at a mass ratio of 3:1) in an organic solvent acetonitrile at a mass ratio of 1:2, mixing, ultrasonicating for 35 minutes, and then spray drying, with an air inlet temperature of 80°C and an air outlet temperature of 50°C, to obtain drug B. Mixing drug A and drug B, pulverizing, and granulating to obtain a traditional Chinese medicine composition for treating rhinitis.

[0047] Example 3

[0048] The Chinese medicine composition for treating rhinitis in this embodiment is prepared from the following raw materials in parts by weight: 12 parts of ephedra, 10 parts of aconite, 7 parts of asarum, 35 parts of astragalus, 15 parts of atractylodes, 4 parts of siler, 18 parts of xanthium sibiricum, and 15 parts of magnolia.

[0049] The preparation method comprises the following steps: mixing ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium, magnolia and water 18 times the weight of the total of the ephedra, extracting volatile oil by distillation, mixing volatile oil and polyvinyl pyrrolidone at a mass ratio of 1:18, and subjecting to melt extrusion (operating temperature 150°C, screw speed 140rpm) to obtain drug A. Mixing the drug residue after extracting the volatile oil with water at a mass ratio of 1:4 and boiling for 3 times, 3 hours / time, filtering, collecting the filtrate, adding 95% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, the relative density of which is 1.3 when concentrated to 65°C, and drying to obtain an extract; dissolving the extract and a carrier material (polyoxyethylene and sorbitol at a mass ratio of 5:1) in an organic solvent acetonitrile at a mass ratio of 1:4, mixing, ultrasonicating for 45 minutes, and then spray drying, with an air inlet temperature of 100°C and an air outlet temperature of 70°C, to obtain drug B. Mixing drug A and drug B, crushing, and granulating to obtain a traditional Chinese medicine composition for treating rhinitis.

[0050] Comparative Example 1

[0051] The Chinese medicine composition for treating rhinitis in this comparative example is prepared from the following raw materials in parts by weight: 15 parts of ephedra, 15 parts of aconite, 10 parts of asarum, 40 parts of astragalus, 20 parts of atractylodes, 5 parts of siler, 20 parts of xanthium, and 20 parts of magnolia. The preparation method is the same as that in Example 1.

[0052] Comparative Example 2

[0053] The Chinese medicine composition for treating rhinitis in this comparative example is prepared from the following raw materials in parts by weight: 5 parts of Ephedra, 3 parts of Aconite, 2 parts of Asarum, 20 parts of Astragalus, 3 parts of Atractylodes, 1 part of Saposhnikovia, 10 parts of Xanthium sibiricum, and 8 parts of Magnolia officinalis. The preparation method is the same as that in Example 1.

[0054] Comparative Example 3

[0055] The Chinese medicine composition for treating rhinitis in this comparative example is prepared from the following raw materials in parts by weight: 10 parts of Ephedra, 30 parts of Astragalus, 10 parts of Atractylodes macrocephala, 3 parts of Saposhnikovia divaricata, 15 parts of Xanthium sibiricum, and 12 parts of Magnolia officinalis. The preparation method is the same as that of Example 1.

[0056] Comparative Example 4

[0057] The Chinese medicine composition for treating rhinitis in this comparative example is prepared from the following raw materials in parts by weight: 10 parts of ephedra, 8 parts of aconite, 5 parts of asarum, 30 parts of astragalus, 10 parts of atractylodes, 3 parts of siler, 15 parts of xanthium, 12 parts of magnolia, 15 parts of schizonepeta, and 10 parts of physalis. The preparation method is the same as that in Example 1.

[0058] Comparative Example 5

[0059] The Chinese medicine composition for treating rhinitis in this comparative example is prepared from the following raw materials in parts by weight: 10 parts of Ephedra, 8 parts of Angelica dahurica, 5 parts of Angelica dahurica, 30 parts of Astragalus, 10 parts of Atractylodes macrocephala, 3 parts of Saposhnikovia divaricata, 15 parts of Xanthium sibiricum, and 12 parts of Magnolia officinalis. The preparation method is the same as that in Example 1.

[0060] Comparative Example 6

[0061] Except that the polyvinyl pyrrolidone in Example 1 is replaced by povidone, the rest is the same as Example 1.

[0062] Comparative Example 7

[0063] Except that the carrier material (polyoxyethylene and sorbitol in a mass ratio of 4:1) in Example 1 is replaced by xylitol and povidone in a mass ratio of 1:2, everything else is the same as Example 1.

[0064] Test Example 1

[0065] 300 patients with rhinitis were selected, aged between 20 and 40 years old, with an average age of 28 years old. The symptoms of the patients included dryness and itching in the nose, burning sensation, followed by nasal congestion, nasal itching, sneezing and watery nasal discharge. In severe cases, there will also be hyposmia, obstructive nasal sounds, headaches and dizziness. If the patient is also infected with bacteria, the nasal discharge will become mucous or purulent. When some patients are infected more seriously, the upper and lower respiratory tract mucosa may be involved, causing pharyngitis, otitis media or bronchitis, etc. When the lesion is serious, systemic symptoms such as fever may also occur. The patients were randomly divided into 10 groups, 30 people in each group, and 1 to 10 groups were successively used, wherein 1 to 3 groups corresponded to the use of the Chinese medicine composition of Examples 1 to 3 for treatment, and 4 to 10 groups corresponded to the use of the Chinese medicine composition of Comparative Examples 1 to 7 for treatment, which was used continuously for 1 week, and the method of use was oral, three times a day, 2 to 3 grams each time, taken after meals, and the patient's condition was recorded after 1 week.

[0066] Efficacy criteria:

[0067] Recovery: Subjective symptoms disappear, objective examination is close to normal, or there is a small amount of secretion in the middle nasal cavity and nasal floor, and the nasal mucosa is ruddy;

[0068] Significantly effective: Subjective symptoms disappear, and there is a little secretion and thin crust in the middle nasal cavity and nasal floor, and the mucosa is slightly dry;

[0069] Improvement: Various symptoms were alleviated, but not completely eliminated;

[0070] Ineffective: There was no significant improvement in symptoms after 1 week of medication.

[0071] Experimental results: as shown in Table 1.

[0072] Table 1 The therapeutic effects of different treatment groups

[0073]

[0074]

[0075] As can be seen from Table 1, the Chinese medicine compositions of Examples 1 to 3 have better therapeutic effects on rhinitis. The dosages of the compositions of Comparative Examples 1 and 2 are not within the ratio range of the compositions of Examples 1 to 3, and their therapeutic effects on rhinitis are reduced, indicating that the ratio of the compositions of Examples 1 to 3 is optimal.

[0076] The composition of Comparative Example 3 reduces the medicinal ingredients of Aconite and Asarum based on the composition of Example 1, and its therapeutic effect on rhinitis is reduced, indicating that the composition of Examples 1 to 3 is the best.

[0077] Comparative Example 4 adds Schizonepeta and Phyllanthus chinensis to Example 1, and its therapeutic effect on rhinitis is reduced, indicating that adding a few medicinal materials to Example 1 cannot increase the efficacy.

[0078] The composition of Comparative Example 5 replaces the aconite and asarum in the composition of Example 1 with similarly effective Angelica dahurica and Angelica dahurica. Although the functions of the Chinese medicines are similar, the therapeutic effect of Comparative Example 5 on rhinitis is reduced due to the different compositions, indicating that replacing the medicinal materials with the same or similar effects on the basis of Example 1 cannot achieve the therapeutic effect of the example.

[0079] During the preparation process of the composition of Comparative Example 6, the water-soluble carrier material was replaced, and its therapeutic effect on rhinitis was reduced, indicating that other water-soluble carrier materials are not as good as polyvinyl pyrrolidone and cannot achieve the effect of fully improving the solubility and dissolution rate of traditional Chinese medicine.

[0080] In the preparation process of the composition of Comparative Example 7, the carrier material was replaced, and its therapeutic effect on rhinitis was reduced, indicating that other carrier materials are not as good as polyoxyethylene and sorbitol, and cannot fully improve the stability and bioavailability of the drug.

[0081] Test Example 2

[0082] Intervention effects on the reactive behavior of the mouse model of allergic rhinitis:

[0083] Experimental animals: Male SPF guinea pigs, weighing 180-200 g, were provided by the Experimental Animal Center of Shanghai Seventh People's Hospital and were raised under standard conditions with free access to water and food.

[0084] Drugs and reagents:

[0085] The Chinese medicine compositions prepared in Examples 1 to 3 and Comparative Examples 1 to 7 were dissolved in water to prepare a solution having a crude drug content of 1.8 g / mL;

[0086] Chicken ovalbumin (OVA) (Sigma, USA);

[0087] Chloral hydrate (Guangxi Nanning Rongyi Experimental Equipment Co., Ltd.);

[0088] AI(OH)3 (Guangxi Nanning Rongyi Experimental Equipment Co., Ltd.);

[0089] Loratadine tablets (Shanghai Schering-Plough Pharmaceutical Co., Ltd., batch number 05HRXF1011Y).

[0090] Grouping and modeling:

[0091] 130 male SPF guinea pigs were randomly divided into 13 groups, 10 in each group, including normal group, model group, positive group, experimental group (Examples 1-3 and Comparative Examples 1-7), and all groups except the normal group were sensitized groups. After acclimatization for 1 week, sensitization modeling was performed. The sensitized groups first selected OVA: AI (OH) 3 in a ratio of 1:5 and prepared with normal saline, so that the OVA concentration was 1 mg / ml, and each side of the bilateral nostrils was 20 μL each time, twice a day, for 10 consecutive days. The normal control group was first replaced by 5 mg / ml Al (OH) 3 solution for nasal drops; after an interval of 5 days, the model group was stimulated with 5% OVA solution nasal drops, 20 μL per nostril, and stimulated once every 3 days for 11 consecutive times, while the normal control group was stimulated with normal saline instead. Starting from self-administration of allergens, the severity, frequency, and duration of nasal itching, sneezing, and runny nose were used as scoring criteria and recorded. Each observation was for 20 minutes. The model was successful if the cumulative score of each symptom reached 5 points or more. The scoring table is shown in Table 2.

[0092] Table 2 Allergic reaction behavioral scoring table

[0093]

[0094] All groups were given drugs by gavage on the first day after successful modeling.

[0095] Normal group: intragastric administration of normal saline 2 ml / time / d;

[0096] Model group: intragastric administration of normal saline 2 ml / time / d;

[0097] Positive group: loratadine suspension 0.1 mg / kg / d;

[0098] Examples 1 to 3 and Comparative Examples 1 to 7: crude drug dosage 1.8 mg / kg / d.

[0099] Symptoms were observed and the number of times the guinea pigs rubbed their noses, sneezed and had runny noses within 30 minutes after the 11th challenge, the 7th day after administration and the 14th day after administration were recorded and scored and compared. The results of the changes in symptoms of the guinea pigs in each group after medication are shown in Table 3.

[0100] Table 3 Symptom scores of each group after 14 days of medication

[0101]

[0102] As shown in Table 3, the scores of nose wiping, sneezing and runny nose of the mice in Examples 1 to 3 were much lower than those of the mice in the positive group, the number of nose wiping and sneezing was significantly reduced, and the degree of fluid was alleviated. The scores of nose wiping, sneezing and runny nose of the mice in Comparative Examples 1 to 7 were lower than those in the model group, but the effect was far less than that of Examples 1 to 3. It can be seen that the Chinese medicine composition prepared by the present invention can effectively alleviate various symptoms of allergic rhinitis mice.

[0103] It can be seen from the above embodiments and test examples that the synergistic combination of the Chinese medicinal ingredients of the present invention can help relieve nasal congestion symptoms and can effectively treat allergic rhinitis, acute and chronic rhinitis, sinusitis, etc.

[0104] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating rhinitis, characterized in that: The invention comprises the following raw materials in parts by weight: 6-12 parts of ephedra, 5-10 parts of aconite, 3-7 parts of asarum, 25-35 parts of astragalus, 5-15 parts of atractylodes, 2-4 parts of siler, 12-18 parts of xanthium sibiricum and 10-15 parts of magnolia.

2. The method for preparing the Chinese medicine composition for treating rhinitis according to claim 1, characterized in that: The following steps are involved: 1) mixing ephedra, aconite root, asarum, astragalus, atractylodes, siler, xanthium sibiricum, magnolia bud and water, extracting volatile oil by distillation, mixing the volatile oil with a water-soluble carrier material, and obtaining drug A by melt extrusion; 2) mixing the residue after extracting the volatile oil with water and boiling, filtering, collecting the filtrate, adding 85-95% ethanol for precipitation, recovering the ethanol solution and concentrating it into an extract, and drying to obtain an extract; 3) dissolving the extract and the carrier material in an organic solvent, mixing, ultrasonicating for 35 to 45 minutes, and then spray drying to obtain drug B; 4) Mixing the drug A and the drug B, grinding them, and granulating them to obtain a Chinese medicine composition for treating rhinitis.

3. The preparation method according to claim 2, characterized in that: In step 1), the water-soluble carrier material is polyvinyl pyrrolidone, and the mass ratio of the volatile oil to the water-soluble carrier material is 1:16-18.

4. The preparation method according to claim 2, characterized in that: The operating temperature of the melt extrusion in step 1) is 140-150° C., and the screw speed is 120-140 rpm.

5. The preparation method according to claim 2, characterized in that: In step 2), the decoction is performed 1 to 3 times, and the decoction time is 1 to 3 hours per time; and the relative density is 1.2 to 1.3 when the concentration is to 65°C.

6. The preparation method according to claim 2, characterized in that: In step 3), the carrier material is polyoxyethylene and sorbitol, and the mass ratio of polyoxyethylene to sorbitol is 3-5:

1.

7. The preparation method according to claim 2, characterized in that: In step 3), the mass ratio of the extract to the carrier material is 1:2-4; and the organic solvent is acetonitrile.

8. The preparation method according to claim 2, characterized in that: The inlet air temperature of the spray drying in step 3) is 80-100°C, and the outlet air temperature is 50-70°C.

9. The preparation method according to claim 2, characterized in that: The amount of water used in step 1) is 12 to 18 times the sum of the mass of ephedra, aconite, asarum, astragalus, atractylodes, siler, xanthium and magnolia; and the mass ratio of the Chinese medicine residue to water in step 2) is 1 to 3:8 to 12.

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