CN112057561B

CN112057561B - Traditional Chinese medicine nasal spray for treating allergic rhinitis

Info

Publication number: CN112057561B
Application number: CN202011014297.9A
Authority: CN
Inventors: 李谊; 董伟; 邢培梅
Original assignee: 988th Hospital of the Joint Logistics Support Force of PLA
Current assignee: 988th Hospital of the Joint Logistics Support Force of PLA
Priority date: 2020-09-24
Filing date: 2020-09-24
Publication date: 2022-02-01
Anticipated expiration: 2040-09-24
Also published as: CN112057561A

Abstract

The invention provides a traditional Chinese medicine nasal spray for treating allergic rhinitis, and relates to the field of traditional Chinese medicine pharmacy. The traditional Chinese medicine nasal spray is prepared from myrtle fruit, cocklebur fruit, cassia twig, perilla leaf, notopterygium root, asarum, flos farfarae, stalactite, puffball, gastrodia elata, stiff silkworm and cortex albiziae. The myrtle fruit is taken as a monarch drug, so that the anti-inflammatory and anti-allergic reaction effects are achieved; fructus xanthil, cassia twig, perilla leaf, notopterygium root and stalactite are taken as ministerial drugs, so that the traditional Chinese medicine has the effects of tonifying kidney and spleen, treating sneeze and relieving itching, dispelling wind and removing dampness and dredging orifices; asarum, tussilago farfara, puffball and gastrodia elata are taken as adjuvant drugs to warm yang and tonify qi, warm lung and receive qi, and tonify deficiency; cortex albiziae and stiff silkworm are used as conductant drugs, and monarch drugs, minister drugs, assistant drugs and conductant drugs supplement each other, so that the patients with various types of allergic rhinitis are treated according to syndrome differentiation. The traditional Chinese medicine nasal spray disclosed by the invention has the effects of warming and nourishing lung qi, dispelling wind and cold, tonifying kidney and spleen, warming yang and tonifying qi, can effectively treat sneeze and relieve itching, improves symptoms of sneeze and watery nasal discharge and the like, and has the effects of enhancing resistance, and stopping fatigue and changing the resistance, and is capable of strengthening the body resistance and strengthening the standard.

Description

Traditional Chinese medicine nasal spray for treating allergic rhinitis

Technical Field

The invention relates to the field of traditional Chinese medicine pharmacy, in particular to a traditional Chinese medicine nasal spray for treating allergic rhinitis.

Background

Allergic rhinitis, also known as Allergic Rhinitis (AR), is a nasal mucosa non-infectious inflammatory disease which causes inflammatory mediator release and acts on effector organs by immunoglobulin (IgE) as an intermediate medium after specific allergen is contacted with specific individual, and is mainly clinically manifested by nasal itching, sneezing, watery nasal discharge and/or nasal obstruction, and nasal mucosa pallor edema, nasal turbinate hypertrophy and more cool and refreshing secretions in nasal cavity can be seen in physical examination. AR is classified into persistent and indirect types according to onset, and often causes diseases simultaneously or after being induced by diseases such as allergic asthma and allergic conjunctivitis.

Most patients with allergic rhinitis suffer from physical exhaustion, mood fluctuation, sleep disorder and other conditions in the course of disease, and even more, psychological diseases such as depression. Anxiety, alcoholism and the like have adverse effects on children such as hyperactivity and sleep disorder, seriously affect the daily life and work of people and cause huge social and economic burden. In recent years, the disease has a tendency of increasing incidence rate in the global scope, and is a common and difficult disease which seriously troubles patients and has high incidence rate and easy relapse. At present, western medicine intervention is mainly used for AR treatment, nasal glucocorticoids, antihistamine medicines, leukotriene receptor antagonists and the like are mainly used, the medicines can only relieve symptoms generally but cannot radically cure the symptoms and are easy to relapse, and long-term taking of the medicines can generate large side effects on the body, so researchers still need to search for more complete treatment strategies.

Allergic rhinitis belongs to the category of allergic rhinitis in the traditional Chinese medicine, is proved by basic questions and pulse clearing, and records that the allergic rhinitis is caused by nasal discharge and cold brain and lung in the key formula for syndrome treatment, and is mainly caused by deficiency of kidney, deficiency of vital qi, loose skin and skin striae due to weak spleen and lung, deficiency of exogenous pathogenic factors and nasal obstruction, positive pulsation, failure of lung qi to dredge and obstruction of nasal orifices, and sneezing, flow and nasal discharge due to failure of lung qi. Traditional Chinese medicine doctors in the past developed a plurality of treatment formulas and methods, such as cassia twig decoction and ephedra decoction for warming lung and dispelling cold, jade screen powder for tonifying qi and strengthening exterior, middle-jiao and qi tonifying decoction for tonifying qi, invigorating spleen and invigorating yang, Zhenwu decoction for warming yang and inducing diuresis, and Yinqiao powder for dispelling wind and dissipating heat, and the formulas have certain curative effects on improving physique and relieving symptoms, but a plurality of symptoms of allergic reaction of the nose cannot be eradicated, and are difficult to cure.

Disclosure of Invention

Technical problem to be solved

Aiming at the defects of the prior art, the invention provides a traditional Chinese medicine nasal spray for treating allergic rhinitis.

(II) technical scheme

In order to achieve the purpose, the invention is realized by the following technical scheme:

the invention provides a traditional Chinese medicine nasal spray for treating allergic rhinitis, which mainly comprises the following traditional Chinese medicine components in parts by weight: 50-250g of myrtle fruit, 50-250g of cocklebur fruit, 50-250g of cassia twig, 50-250g of perilla leaf, 50-250g of notopterygium root, 50-250g of asarum, 50-250g of tussilago farfara, 50-250g of stalactite, 50-250g of puffball, 50-250g of gastrodia elata, 50-250g of stiff silkworm and 50-250g of cortex albiziae.

Further, as the optimization of the traditional Chinese medicine nasal spray for treating allergic rhinitis, the traditional Chinese medicine nasal spray comprises the following traditional Chinese medicine components in parts by weight: 150g of myrtle fruit, 150g of siberian cocklebur fruit, 200g of cassia twig, 150g of perilla leaf, 200g of notopterygium root, 150g of asarum, 200g of tussilago farfara, 150g of stalactite, 200g of puffball, 150g of tall gastrodia tuber, 200g of tall gastrodia tuber, 150g of stiff silkworm and 200g of cortex albiziae.

Further, as the optimization of the traditional Chinese medicine nasal spray for treating allergic rhinitis, the traditional Chinese medicine nasal spray comprises the following traditional Chinese medicine components in parts by weight: 200g of myrtle fruit, 200g of cocklebur fruit, 200g of cassia twig, 200g of perilla leaf, 200g of notopterygium root, 200g of asarum, 200g of tussilago farfara, 200g of stalactite, 200g of puffball, 200g of gastrodia elata, 150g of stiff silkworm, 200g of albizia bark.

The invention also provides a preparation method of the traditional Chinese medicine nasal spray for treating allergic rhinitis, which comprises the following steps:

(1) accurately weighing the following traditional Chinese medicine components by weight: 50-250g of myrtle fruit, 50-250g of cocklebur fruit, 50-250g of cassia twig, 50-250g of perilla leaf, 50-250g of notopterygium root, 50-250g of asarum, 50-250g of tussilago farfara, 50-250g of stalactite, 50-250g of puffball, 50-250g of gastrodia elata, 50-250g of stiff silkworm and 50-250g of cortex albiziae;

(2) cleaning the Chinese medicinal materials, oven drying, pulverizing to 50-100 mesh, and mixing to obtain Chinese medicinal powder;

(3) adding 4800g of water into the Chinese medicinal powder, decocting with slow fire for 30 min, cooling to room temperature, filtering, and making into nasal spray.

The invention is suitable for various allergic rhinitis, the usage and dosage are 3-4 times per day, and 2 times of spraying are respectively carried out on the left side and the right side of the nose.

The invention relates to the pharmacological action of the traditional Chinese medicines:

myrtle fruit: sweet and astringent taste, neutral in nature, entering liver and spleen meridians; has the effects of nourishing blood, stopping bleeding, astringing intestine and securing meridian; can be used for treating blood deficiency, asthenia, hematemesis, overstrain, hemoptysis, and dysentery; the myrtle fruits contain active substances such as flavonoid glycoside, phenols, polysaccharides and the like, have pharmacological activities such as oxidation resistance, antibiosis, antivirus and blood sugar reduction, are mainly used for treating diseases of respiratory systems and ear-nose-throat clinically, can dissolve mucus, stimulate glandular secretion, dilute viscous secretions of upper and lower respiratory tracts, promote cilium swing of respiratory tracts, accelerate liquid flow, promote secretion elimination, improve acid-base environment of nasal mucosa, and promote reconstruction of epithelial tissue structure and functional recovery of the nasal mucosa.

Fructus xanthil: bitter, sweet and pungent in flavor, warm in nature, entering lung and liver meridians; has the effects of dispersing wind-cold, relieving stuffy nose, expelling wind-damp, relieving pain and the like; can be used for treating wind-cold type common cold, nasosinusitis, rheumatalgia, rubella, pruritus, etc.; the cocklebur fruit mainly contains various chemical components such as volatile oil, fatty acid, phenolic acid, lignans, sesquiterpene lactone, thiazine diketone heterocycle and the like, has pharmacological effects of resisting inflammation, easing pain, resisting bacteria, resisting virus, reducing blood sugar, reducing blood fat, resisting tumor and the like, and is clinically used for treating allergic rhinitis.

Cassia twig: pungent and sweet in flavor, warm in nature, entering heart, lung and bladder meridians; has effects of inducing sweat, relieving exterior syndrome, dispelling cold, relieving pain, activating yang, and regulating qi-flowing; can be used for treating common cold due to wind-cold, pain due to cold accumulation and blood stagnation, phlegm and fluid retention, and palpitation; the cassia twig mainly contains volatile oil, the main component of the volatile oil is cinnamyl aldehyde, and the modern pharmacological research shows that the cassia twig has the effects of resisting virus, bacteria, inflammation and allergy, relieving fever and pain, promoting urination and the like.

Perilla leaf: pungent in flavor and warm in nature, entering lung and spleen meridians; has the effects of relieving exterior syndrome, dispelling cold, promoting qi circulation, and regulating stomach function; can be used for treating common cold due to wind-cold, cough, emesis, and nausea; the perilla leaves mainly contain a plurality of chemical components such as flavone and flavonoid glycoside compounds, geraniol, terpenes, citronellol, minerals, vitamins and the like; modern pharmacological studies show that the perilla leaves have the effects of protecting cardiovascular and cerebrovascular systems, resisting oxidation, inhibiting bacteria, reducing blood fat, reducing blood sugar and the like.

Notopterygium root: pungent and bitter in flavor, entering bladder and kidney meridians; has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, eliminating dampness, and relieving pain; can be used for treating wind-cold type common cold, arthralgia due to wind-cold-dampness, neck stiffness, spasm of muscles, joint pain, and edema; notopterygii rhizoma mainly contains terpenoids, volatile oils, coumarins, organic acids, phenols, etc.; modern pharmacological studies show that Qiang Hu has the effects of inhibiting cancer cell proliferation, resisting oxidation, resisting inflammation, resisting arrhythmia, suppressing immunity, relieving fever and relieving pain.

Asarum: pungent taste, warm nature, slight toxicity, entering heart, lung and kidney meridians; has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, dredging orifice, warming lung, and eliminating phlegm; can be used for treating wind-cold type common cold, headache, toothache, rheumatalgia, nasosinusitis, cough due to lung cold, etc.; modern pharmacological studies show that asarum has the effects of relieving fever, resisting inflammation, relieving pain, tonifying heart, regulating blood pressure, suppressing immunity, resisting bacteria, viruses, resisting allergy and the like.

And (3) common coltsfoot flower: pungent, slightly bitter and warm in nature, entering lung meridian; has the effects of moistening lung, descending qi, relieving cough and reducing sputum; can be used for treating chronic cough, cough with excessive phlegm, and hemoptysis; flos Farfarae contains volatile oil, phenolic acid, flavone, polysaccharide, sterol, alkaloid, and terpenoid, and has pharmacological effects of resisting blood platelet aggregation, resisting inflammation, resisting allergy, and resisting tumor.

Stalactite: sweet in taste, warm in nature, entering lung, kidney and stomach meridians; has the effects of warming lung, relieving asthma, etc.; can be used for treating cough, reversed flow of qi, cold phlegm, cough and asthma.

Puffball: mild in nature, pungent in flavor and entering lung meridian; has the effects of clearing away lung-heat, relieving sore-throat, stopping bleeding, removing toxic substances, and relieving swelling; the traditional Chinese medicine composition is mainly used for cooling and refreshing lung heat, dissipating blood stagnation, relieving heat toxin and the like; it contains polypeptide, steroid, terpenoid, polysaccharide, quinone, etc. and has the functions of resisting inflammation, resisting tumor, stopping bleeding, etc. in clinical pharmacology.

Gastrodia elata: sweet in flavor, neutral in nature, entering liver meridian; has effects in calming endogenous wind, relieving spasm, suppressing liver yang, dispelling pathogenic wind, and dredging collaterals; can be used for treating infantile convulsion, epilepsy, convulsion, tetanus, headache, vertigo, paralysis of limbs, numbness of limbs, and rheumatalgia; the gastrodia elata contains phenols, organic acids, polypeptides and other chemical components, and modern pharmacological research shows that the gastrodia elata has various pharmacological effects of benefiting intelligence, protecting brain, easing pain, calming and hypnotizing, resisting epilepsy, resisting dizziness, reducing blood pressure, reducing blood fat, resisting oxidation, protecting liver, resisting tumors, enhancing immunity and the like;

stiff silkworm: salty and pungent in flavor, neutral in nature, entering liver, lung and stomach meridians; has the effects of dispelling pathogenic wind, arresting convulsion, eliminating phlegm and resolving masses; can be used for treating headache due to wind-heat evil, conjunctival congestion, pharyngalgia, rubella, pruritus, epilepsy, and convulsion; the main active ingredients of the stiff silkworm comprise protein, fat, ammonium oxalate and a small amount of trace elements; bombyx Batryticatus has anticoagulant, antithrombotic, antibacterial, anticonvulsant, anticancer, and hypnotic effects.

Silktree albizzia bark: sweet in taste, neutral in nature, and entering heart and liver meridians; has effects in relieving depression, tranquilizing mind, promoting blood circulation, and relieving swelling, and can be used for treating uneasiness, depression, insomnia, skin ulcer, traumatic injury, etc.; the main components of the cortex albiziae comprise triterpenes, lignans, flavones, sterols and the like; pharmacological research shows that the compound has various pharmacological effects of resisting tumor, bacteria, anxiety, depression, inflammation, fertility, immunity enhancement, oxidation and the like.

(III) advantageous effects

The invention provides a traditional Chinese medicine nasal spray for treating allergic rhinitis, which is prepared from twelve traditional Chinese medicines, such as myrtle fruit, cocklebur fruit, cassia twig, perilla leaf, notopterygium root, asarum and the like. The invention applies the principle of dialectical treatment in traditional Chinese medicine, takes myrtle fruits as monarch drug, has anti-inflammatory and anti-allergic reaction, and takes care of life in a day; fructus xanthil, cassia twig, perilla leaf, notopterygium root and stalactite are taken as ministerial drugs, the kidney is tonified, the spleen is strengthened, sneeze is treated, the itching is relieved, the wind is dissipated, the dampness is removed, the orifice is cleared, and the main nourishment is suitable for people; asarum, tussilago farfara, puffball and gastrodia elata are used as adjuvant drugs to warm yang and tonify qi, warm lung and receive qi, tonify qi and tonify deficiency and damage, and are mainly used for treating diseases according to the needs; cortex albiziae and stiff silkworm are used as conductant drugs, and monarch drugs, minister drugs, assistant drugs and conductant drugs supplement each other, so that the treatment is carried out according to syndrome differentiation, and the patients with various allergic rhinitis are treated together. The traditional Chinese medicine nasal spray has the effects of warming and invigorating lung qi, dispelling wind and cold, tonifying kidney and spleen, warming yang and tonifying qi, can effectively treat sneeze and relieve itching, improves symptoms of sneeze and watery nasal discharge and the like, and has the effects of enhancing resistance, changing the location of the resistance, and strengthening the body resistance.

Drawings

FIG. 1 compares the number of sneezes from day 1 to day 16 of challenge for the groups of mice.

FIG. 2 comparison of nasal paw counts from day 1 to day 16 of challenge for each group of mice.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are some embodiments of the present invention, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example 1

A traditional Chinese medicine nasal spray for treating allergic rhinitis is prepared according to the following steps:

(1) accurately weighing the following traditional Chinese medicine components by weight: 50g of myrtle fruit, 50g of cocklebur fruit, 50g of cassia twig, 50g of perilla leaf, 50g of notopterygium root, 50g of asarum, 50g of tussilago farfara, 50g of stalactite, 50g of puffball, 50g of gastrodia elata, 50g of stiff silkworm and 50g of cortex albiziae;

(3) adding 4000-5200g of water into the traditional Chinese medicine powder, decocting with slow fire for 30 minutes, cooling to room temperature, filtering, and taking the filtrate to prepare the traditional Chinese medicine nasal spray.

The application method comprises applying the composition to the left and right sides of nose respectively 3-4 times daily, 2 times per time.

Example 2

This example differs from example 1 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 150g of myrtle fruit, 150g of cocklebur fruit, 150g of cassia twig, 150g of perilla leaf, 150g of notopterygium root, 150g of asarum, 150g of tussilago farfara, 150g of stalactite, 150g of puffball, 150g of gastrodia elata, 150g of stiff silkworm and 150g of cortex albiziae.

Example 3

This example differs from example 1 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 200g of myrtle fruit, 200g of cocklebur fruit, 200g of cassia twig, 200g of perilla leaf, 200g of notopterygium root, 200g of asarum, 200g of tussilago farfara, 200g of stalactite, 200g of puffball, 200g of gastrodia elata, 200g of stiff silkworm and 200g of cortex albiziae.

Example 4

This example differs from example 1 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 100g of myrtle fruit, 100g of cocklebur fruit, 100g of cassia twig, 100g of perilla leaf, 100g of notopterygium root, 100g of asarum, 100g of tussilago farfara, 100g of stalactite, 100g of puffball, 100g of gastrodia elata, 100g of stiff silkworm and 100g of cortex albiziae.

Example 5

This example differs from example 1 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 250g of myrtle fruit, 250g of cocklebur fruit, 250g of cassia twig, 250g of perilla leaf, 250g of notopterygium root, 250g of asarum, 250g of tussilago farfara, 250g of stalactite, 250g of puffball, 250g of gastrodia elata, 250g of stiff silkworm and 250g of cortex albiziae.

Comparative example 1

This example differs from example 5 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 200g of cocklebur fruit, 200g of perilla leaf, 200g of notopterygium root, 200g of asarum, 200g of stalactite, 200g of puffball, 200g of gastrodia elata, 200g of stiff silkworm and 200g of cortex albiziae.

Comparative example 2

This example differs from example 5 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 200g of myrtle fruit, 200g of cassia twig, 200g of notopterygium root, 200g of tussilago farfara, 200g of stalactite, 200g of puffball, 200g of gastrodia elata, 200g of stiff silkworm and 200g of cortex albiziae.

Comparative example 3

This example differs from example 5 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 200g of myrtle fruit, 200g of cocklebur fruit, 200g of cassia twig, 200g of perilla leaf, 200g of asarum, 200g of tussilago farfara, 200g of puffball, 200g of gastrodia elata and 200g of stiff silkworm.

Comparative example 4

This example differs from example 5 in that:

the traditional Chinese medicine comprises the following components in parts by weight: 200g of myrtle fruit, 200g of cocklebur fruit, 200g of cassia twig, 200g of perilla leaf, 200g of notopterygium root, 200g of asarum, 200g of tussilago farfara, 200g of stalactite and 200g of cortex albiziae.

To further illustrate the therapeutic efficacy of the nasal spray of the present invention, the following tests are provided for illustration and explanation.

Test example 1

160 patients with allergic rhinitis were selected from outpatients treated in my hospital between 2018 and 2019,

months

9 and 3, with the ages of 16-60 years, 30.6 years on average, the course of disease of 3-2 years, and 11 months on average. Patients were randomized into 5 groups, trial 1-trial 5, 32 patients in each group, with no significant difference in age, disease course and severity (P > 0.05).

The test groups 1 to 5 respectively correspond to the traditional Chinese medicine nasal spray prepared in the examples 1 to 5, the usage amount is 3 to 4 times per day, 2 sprays are respectively applied to the left side and the right side of the nose, and after 14 days of continuous medication, the clinical symptoms of patients in each group are observed and counted. The results are shown in Table 1.

Criteria for improvement of clinical symptoms:

sneezing

++++: no attack was seen every day.

+++: occasional attacks are made each day, either morning or evening, or after exposure to allergens.

++: attacks 2 to 3 times per day, beginning in the morning or at night or after allergen exposure.

+: there are still several paroxysmal episodes per day, more than 3 each, beginning in the morning or at night or immediately after allergen exposure.

And (2) preparing: sneezing symptoms are the same as those described above.

Clear nasal discharge

++++: no clear watery nasal discharge was observed to flow out of the nasal cavity every day.

+++: occasionally, clear watery nasal discharge flows out of the nasal cavity every day.

++: clear watery nasal discharge intermittently flows out of nasal cavity every day.

+: a large amount of clear water like nasal discharge may be unintentionally dripped from the nostrils.

And (2) preparing: the symptoms of thin nasal discharge are the same as before.

Nasal obstruction

++++: no nasal obstruction was seen every day.

+++: nasal obstruction symptoms occur occasionally every day, unilateral or bilateral, and the degree of severity varies.

++: the nasal obstruction symptoms are intermittently seen every day, and the degree of the nasal obstruction is different on one side or two sides.

+: intermittent or continuous nasal obstruction, unilateral or bilateral, and different degrees of severity.

And (2) preparing: the symptoms of nasal obstruction are as before.

Itching of nose

++++: no nasal itching symptom is seen every day.

+++: occasionally, the nose is itchy, unilateral or bilateral, with varying degrees of severity.

++: the nasal itching symptoms are intermittent, unilateral or bilateral, and the degree of severity is different every day.

+: intermittent or continuous nasal itching, unilateral or bilateral, of varying severity.

And (2) preparing: the symptoms of nasal itching are the same as before.

TABLE 1 comparison of improvement of clinical symptoms after 14 days of treatment of allergic rhinitis with Chinese medicinal nasal sprays of examples 1-5

Grouping	Sneezing	Clear nasal discharge	Nasal obstruction	Itching of nose
					Test group
1	+	+	+	++
					Test group 2	++	++	+	++
Test group 3	+++	++	+	+++
					Test group 4	++++	++++	++++	++++
Test group 5	++++	++++	++++	++++

The results in table 1 show that the traditional Chinese medicine formula of the invention can relieve and improve the symptoms of sneezing, thin nasal discharge, nasal obstruction, rhinocnesmus and the like of allergic rhinitis patients and has obvious effect; with the increase of the dosage of each medicament, the traditional Chinese medicine nasal spray has more remarkable treatment effect; after treatment, both test group 4 and test group 5 can greatly alleviate the clinical symptoms of patients with allergic rhinitis, but the traditional Chinese medicine nasal spray used in test group 5 has too large dosage of each medicine, so the traditional Chinese medicine nasal spray of embodiment 4 is preferred.

Test example 2

Test method 1

Animals and groups: 70 SD rats with 4 weeks of age, the body weights (95 +/-5 g), the male and female parts and the rats are randomly divided into 7 groups: normal group, model group, test group, control group 1, control group 2, control group 3,

control group

4, 10 of each group.

Molding: 20 mu g of Ovalbumin (OVA), 1 mg of aluminum hydroxide gel and 0.5 mL of normal saline are mixed uniformly and injected into the abdominal cavity of rats on the 1 st and 11 th days. Nasal cavity challenge was performed starting on day 15, with nasal drops of 5% OVA solution in 0.1 mol/L PBS, 30 μ L each time for 16 consecutive days. In the normal group, 1 mg of aluminum hydroxide gel and 0.5 mL of normal saline are injected into the abdominal cavity, the normal saline is dripped into the nose, and the time and the dosage are the same as the model.

The treatment method comprises the following steps: treatment was started on day 21, and the normal group did not receive any treatment; the model group is used for nasal drip of physiological saline for 1 time every day for 10 days; the test group used the traditional Chinese medicine nasal spray prepared in example 4 1 time a day, 50 μ g each time, for 10 consecutive days; the Chinese medicinal nasal spray prepared in comparative examples 1-4 is applied for 10 days 1 times per day, 50 μ g each time.

And (4) observing behaviors: during the treatment period, the mice were observed for 15min immediately after each challenge, and the number of sneezes and nasal irritations were recorded.

After the treatment is finished, the serum histamine and leukotriene level detection is carried out by adopting a double-antibody sandwich ELISA method.

2 test results and discussion

2.1 number of sneezes

As shown in figure 1, after the test group and the control groups 1-4 are used, the number of sneezes is gradually reduced and is obviously lower than that of the model group, and the difference is extremely significant (P < 0.01); the difference of the test group is 1-4 lower than that of the control group, and the difference is significant (P is less than 0.05); the normal group was lower than the other groups, and the difference was significant (P < 0.05).

2.2 nasal Care

As shown in figure 2, after the test group and the control group 1-4 are taken, the number of nasal grabbing times is gradually reduced and is obviously lower than that of the model group, and the difference is extremely significant (P is less than 0.01); the difference of the test group is 1-4 lower than that of the control group, and the difference is significant (P is less than 0.05); the normal group was lower than the other groups, and the difference was significant (P < 0.05).

2.3 measurement of serum Histamine and leukotriene levels in rats before and after treatment

The changes in serum histamine and leukotriene levels of the rats in each group before and after treatment are shown in Table 2.

TABLE 2 serum histamine and leukotriene levels in rats after treatment of each group

Grouping	Number of animals (only)	Serum histamine (mg/L)	Leukotriene (pg/mL)
				Normal group	10	6.41±0.82^a	298.31±198.66^a
Model set	10	12.34±1.33	1406.59±573.61
				Test group	10	6.71±0.70^a	423.71±231.02^a
Control group 1	10	7.98±0.93^a	799.61±261.34^a
				Control group 2	10	7.74±0.79^a	754.19±287.19^a
Control group 3	10	7.20±1.00^a	684.81±201.98^a
				Control group 4	10	8.51±1.03^a	831.74±189.52^a

Note: comparison with model group^aP＜0.05。

As can be seen from the results in Table 2, the serum histamine and leukotriene contents in the normal group are significantly lower than those in the model group (P is less than 0.05) compared with those in the model group, which indicates that the molding is successful; comparing the test group and the control group 1-4 with the model group, wherein the serum histamine and the leukotriene content of the test group and the control group 1-4 are lower than that of the model group (P is less than 0.05); compared with the control groups 1-4, the serum histamine and the leukotriene content of the test group are lower than those of the control groups 1-4, and the difference is not significant compared with the normal group.

The test results show that after 3 days of administration, the symptoms of sneezing, nasal obstruction and the like of the animals in the test group and the animals in the control group 1-4 are obviously improved compared with the symptoms in the model group, wherein the symptom relieving degree of the animals in the test group from the beginning of treatment is better than that of the animals in the control group 1-4; the traditional Chinese medicine nasal spray has the obvious effect of inhibiting the clinical symptoms of allergic rhinitis, wherein the effect of a test group is superior to that of a control group 1-4. After administration of the treatment, the test group and the control groups 1 to 4 were able to lower the serum histamine and leukotriene levels of the rats and reduce the release of inflammatory mediators, wherein the test group had the best effect and the serum histamine and leukotriene levels of the test group were not significantly different from those of the normal group by the treatment. The above results show that the traditional Chinese medicine nasal spray can obviously alleviate the clinical symptoms of allergic rhinitis, can effectively reduce the levels of serum histamine and leukotriene, inhibit the release of inflammatory mediators, and play an important role in the process of inhibiting the immune response of allergic rhinitis. The allergic rhinitis treatment composition is prepared from myrtle fruit, cocklebur fruit, cassia twig, perilla leaf, notopterygium root, asarum, flos farfarae, stalactite, puffball, gastrodia elata, stiff silkworm and cortex albiziae by reasonably mixing according to the syndrome differentiation and treatment principle of the traditional Chinese medicine, the effects of all the medicines are fully exerted, the medicines coordinate and gain the efficacy together, and the ingredients in the formula are all absent.

Test example 3

1000 patients with allergic rhinitis were selected from outpatient service treatment in my hospital from 2017, 9 to 2019, with age 14-65, mean age 33.1, course of disease 6-3, mean 21 months. Patients were randomized into 2 groups, a treatment group and a control group, each group comprising 500 patients, who were not significantly different in age, course and severity (P > 0.05).

The treatment group uses the traditional Chinese medicine nasal spray prepared in example 4, the control group uses the budesonide nasal spray, the application dosage is 3-4 times per day, 2 sprays are respectively applied to the left side and the right side of the nose every time, and after continuous medication for 1 month, clinical symptoms of patients in each group are observed and counted. The results are shown in Table 3.

The allergic rhinitis cure standard is as follows:

and (3) curing: clinically, the nasal paste has no symptoms of nasal itching, nasal obstruction, thin nasal discharge, sneeze and the like, and achieves clinical cure.

Improvement: clinically, symptoms such as nasal itching, nasal obstruction, thin nasal discharge, sneeze and the like are occasionally caused or obviously improved.

And (4) invalidation: clinically, symptoms such as nasal itching, nasal obstruction, thin nasal discharge, sneeze and the like still exist, or the symptoms are not obviously improved.

TABLE 3 comparison of clinical improvement 1 month after allergic rhinitis treatment in the treatment group and the control group [ n, (%) ]

Grouping	Number of patients	Cure of disease	Improvement of life	Invalidation
					Treatment group	500	380 (76.00)	111 (22.20)	9 (1.80)
Control group	500	300 (60.00)	150 (30.00)	50 (10.00)

The results show that the total effective rate of the traditional Chinese medicine nasal spray for treating allergic rhinitis patients reaches 89.2 percent, and the cure rate reaches 76 percent; the total effective rate of the budesonide nasal spray for treatment is 90 percent, the cure rate is 60 percent, and the treatment effect of the traditional Chinese medicine nasal spray is obviously better than that of the budesonide nasal spray. The traditional Chinese medicine nasal spray is a pure traditional Chinese medicine formula, has no toxic or side effect on human bodies, is suitable for various patients with allergic rhinitis, and has high safety and excellent treatment effect.

Typical cases are as follows:

1) li A. male, 19 years old. Nasal obstruction, nasal itching, sneezing, clear nasal discharge for more than 2 months, and frequent smell and eating accompanied by palpitation. Nasal endoscopy: moderate edema of the inferior turbinate on both sides, pale nasal mucosa on both sides, and clear watery secretion in the inferior nasal passage. The tongue is normal, the coating is thin and white, and the pulse is thready. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times a day, and 2 sprays/side each time. The upper part is cured after 1 month.

2) Zhao somesome, woman, 25 years old. In the morning, the nose is itchy, and sneezes (more than 3 in each time) are continuously caused for four years, with nasal obstruction, and the nasal obstruction is usually caused by cold air. Nasal endoscopy: mild edema of the inferior turbinate on both sides, pale nasal mucosa on both sides, smooth surface, slightly purple lip mucosa, dark and dark complexion, pale tongue with teeth marks, and thready pulse. Nasal secretion smears had eosinophils of 22%. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times a day, and 2 sprays/side each time. The upper part is cured after 1 month.

3) Lung qi deficiency cold type: wang somebody, man, age 27. The nasal itching comes about in 3 months, sneezing continuously (more than 3 times each time), running and thin nasal discharge, and the nasal itching occurs every day and is started in the morning when cold air comes. There is a history of bronchitis. Easy to adjust, thin tongue coating and thready and smooth pulse. Nasal endoscopy: moderate edema of the inferior turbinate on both sides, pale nasal mucosa on both sides, smooth surface, and abundant thin nasal discharge. The pattern is of lung qi deficiency and cold type. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times per day, 2 sprays/side and upper part of the nasal cavity are continuously used for 1 month for healing.

4) Yang deficiency and lung cold type: wang somebody, man, 57 years old. In recent 5 years, the nose is itchy, sneezes continuously (more than 3 at a time), and the nose is thin and has no seasonality. Recently, the nasal obstruction is frequent, the nasal obstruction is in day and night, the nasal discharge is not stopped, the whole body is weak, the dizziness is deep, the anorexia is poor, and the stool is dry. A pale tongue with thin and moist coating and a thready, slippery and deep pulse. Nasal endoscopy: the nasal mucosa is pale and edema, moderate edema of the middle and lower nasal concha on both sides, and the middle and lower nasal passages are completely blocked, with outflow of excessive serous fluid. Pharynx red, swollen tonsil, clean surface. This is due to lung deficiency, wind-cold obstruction. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times a day, and 2 sprays/side each time. The upper part is cured after 1 month.

5) Lung-spleen qi deficiency type: zhangzhi, male, age 22. Episodic rhinocnesmus with continuous sneezing (more than 3 per time) in recent 2 years has a thin nasal discharge, with episodes every day and mild asthma at night. Aversion to cold in normal times, easy sweating, mental fatigue, poor appetite, loose stool and uncomfortable gastric cavity. A pale tongue with thin coating and a deep and thready pulse. The color of nasal mucosa is light, mild edema of middle and lower turbinates on both sides, and nasal passage is clean. The syndrome belongs to the deficiency of lung and spleen. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times a day, and 2 sprays/side each time. The upper part is cured after 1 month.

6) Lung-kidney yang deficiency type: dong Di (Dong in her), woman (N.Y.), age 46. Itching, sneezing and clear nasal discharge of the nose have been known for more than 6 years. The traditional Chinese medicine composition almost attacks every day in the last 1 year, and is aversion to cold and warm, soreness and pain of waist and foot, and edema of foot and ankle in the afternoon in normal times. Good appetite, convenient adjustment, thin tongue coating and deep and thready pulse. Nasal endoscopy: moderate edema of the inferior turbinate on both sides, pale nasal mucosa on both sides, and clear watery secretion in the inferior nasal passage. The syndrome is lung and kidney deficiency. The nasal cavity is dripped with the prepared traditional Chinese medicine nasal spray (example 4) 3-4 times a day, and 2 sprays/side each time. The upper part is cured after 1 month.

The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.

Claims

1. The traditional Chinese medicine nasal spray for treating allergic rhinitis is characterized by comprising the following traditional Chinese medicine components in parts by weight: 50-250g of myrtle fruit, 50-250g of cocklebur fruit, 50-250g of cassia twig, 50-250g of perilla leaf, 50-250g of notopterygium root, 50-250g of asarum, 50-250g of tussilago farfara, 50-250g of stalactite, 50-250g of puffball, 50-250g of gastrodia elata, 50-250g of stiff silkworm and 50-250g of cortex albiziae; the traditional Chinese medicine nasal spray is prepared according to the following method:

(1) accurately weighing the traditional Chinese medicine components in parts by weight; (2) cleaning, drying, crushing the traditional Chinese medicine components to 50-100 meshes, and uniformly mixing to obtain traditional Chinese medicine powder; and (3) adding 4800g of water into the traditional Chinese medicine powder, decocting the traditional Chinese medicine powder for 30 minutes with slow fire, cooling the decoction to room temperature, filtering the decoction, and taking the filtrate to prepare the traditional Chinese medicine nasal spray.

2. The traditional Chinese medicine nasal spray for treating allergic rhinitis according to claim 1, which is characterized by comprising the following traditional Chinese medicine components in parts by weight: 150g of myrtle fruit, 150g of siberian cocklebur fruit, 200g of cassia twig, 150g of perilla leaf, 200g of notopterygium root, 150g of asarum, 200g of tussilago farfara, 150g of stalactite, 200g of puffball, 150g of tall gastrodia tuber, 200g of tall gastrodia tuber, 150g of stiff silkworm and 200g of cortex albiziae.

3. The traditional Chinese medicine nasal spray for treating allergic rhinitis according to claim 1, which is characterized by comprising the following traditional Chinese medicine components in parts by weight: 200g of myrtle fruit, 200g of cocklebur fruit, 200g of cassia twig, 200g of perilla leaf, 200g of notopterygium root, 200g of asarum, 200g of tussilago farfara, 200g of stalactite, 200g of puffball, 200g of gastrodia elata, 150g of stiff silkworm, 200g of albizia bark.