CN116211932A - Medicine for treating rhinitis combined with acute pharyngitis caused by wind-heat of lung channel and preparation method thereof - Google Patents

Abstract

The invention belongs to the field of medicines, and discloses a pharmaceutical composition for treating allergic rhinitis and acute pharyngitis caused by wind-heat in lung channels and a preparation method thereof. The formula of the invention is fructus xanthil, flos magnoliae, asarum, radix angelicae, peppermint, wild chrysanthemum, cordate houttuynia, fried semen lepidii and borneol. The invention is a pure traditional Chinese medicine preparation, has the effects of clearing heat and detoxicating, freeing lung qi, relieving sore throat and detumescence, freeing nasal orifices, has definite curative effect and less side effect, can achieve the effect of treating both principal and secondary aspect of disease, and the preparation method is suitable for industrial production and the like, and is convenient for development and application.

Description

Medicine for treating rhinitis combined with acute pharyngitis caused by wind-heat of lung channel and preparation method thereof

Technical Field

The invention relates to the technical field of medicines, in particular to a pharmaceutical composition for treating allergic rhinitis and acute pharyngitis caused by wind-heat of lung meridian and a preparation method thereof.

Background

Allergic rhinitis (allergic rhinitis, AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mediated mainly by immunoglobulin E (IgE) after exposure to allergens (allergens) in atopic individuals, and typical symptoms are paroxysmal sneeze, watery nasal discharge, nasal itching and nasal obstruction, which may be accompanied by ocular symptoms such as itching, tearing, redness and burning sensation. A large number of epidemiological surveys at home and abroad show that the prevalence of AR is remarkably increased in recent years, and the population of 10% -20% of the world is affected, so that the AR becomes a global health problem, and the life quality and the socioeconomic of patients are seriously affected. AR is a frequently occurring disease of otorhinolaryngology, belongs to the category of "allergic rhinitis" and "allergic water" in traditional Chinese medicine, and can be developed all the year round and also can be developed in seasonal.

Acute pharyngitis (acute pharyngitis, AP) is acute infectious inflammation of pharyngeal mucosa, submucosal tissue and lymphoid tissue, and is clinically manifested by pharyngalgia, dry throat, dysphagia, burning sensation, etc. According to epidemiological reports, the number of patients suffering from group A group B hemolytic streptococcal pharyngitis worldwide is more than 61.6 million times per year. In recent years, as the life of residents changes, and the air pollution is increased, the incidence rate of AP is gradually increased, chronic pharyngitis is caused by improper treatment, and throat cancer is caused by worsening after long-term treatment, so that the life quality and life safety of patients are deeply influenced. AP is a common disease and frequently-occurring disease of otorhinolaryngology, belongs to the category of acute pharyngitis in traditional Chinese medicine, and is sporadic and popular, and mostly occurs in autumn, winter and spring.

In traditional Chinese medicine, AR and AP onset are considered to be indistinguishable from lung density. The post-nasal connection is characterized in that the nasal connection is connected with the lung, and the lower part of the nasal connection is connected with the lung, belongs to the lung system, so that the nose is the organ of the lung. Nasal preference is smooth and aversion to choking, smooth breathing, smooth entering and exiting of qi and sensitive smell. The lung governs descending, which is not only beneficial to the qi descending inhaled by the nose to be attributed to Dantian, but also beneficial to descending of turbid qi, so as to keep the smoothness of the nose and exert the normal functions of the nose. The throat is also the weather (i.e. clear qi in nature). The superior laryngeal connection is called the pelteobagrus fulvidraco, the nasal orifice, the inferior airway connection is called the lung, which belongs to the lung system. Therefore, the lung is most closely related to the larynx, which is the root of the larynx. The lung is the palace of viscera, which governs qi, and descending is the descending of lung, so that the lung can descend normally, and the throat is free from congestion and the qi is smooth to go in and go out.

The lung heat theory is that the nose is caused by wind-cold and lung heat steaming upwards, and the Lei Shi Zhen (herbal outline of the materia Medica) records that the nose is cold and the nose is clear, and the brain is in the interior, bao Re; yang Shiying Renzhaizhi describes that "from pathogenic wind between the throats, qi stagnation and heat cause obstruction and sore throat; from its heat, it is generated in the lung and stomach and accumulated in the lung and stomach, and it is known as sore throat. Some doctors consider that "the dry patients are in charge of fire, and the fire is used for smelting gold, the heat is converted into water, no matter the external heat evil or the internal phlegm heat can affect the lung-gold to regulate the water channel function, so that abnormal water metabolism is caused to allergic rhinitis and acute pharyngitis, in Ming's medical finger-palm roll," lung heat and nasal obstruction flow clear water ", and" Tai Ping Sheng Hui Fang "in which if pathogenic wind and hot air are stricken in the spleen and lung, the meridian and collateral obstruction is not smooth, and the pathogenic heat attacks and rushes up to Jiao Yong stagnate, so that the throat is also painful. The lung opens into the nose, the throat is connected with the nose orifice and belongs to the lung system, the lung is a system that is easy to attack by exogenous pathogenic factors, the climate is suddenly changed, the cold and the warm are not regulated, wind evil is invading by deficiency, pathogenic wind heat is accumulated to suppress the lung system, the lung is not dispersed and lowered, pathogenic heat is accumulated to fumigate the nose orifice, and the throat is obstructed upwards, so wind heat in the lung channel is a common pathogenesis causing the attack of AR and AP.

Although the AR can not be thoroughly cured at present, various symptoms of patients can be controlled for a long time through standardized comprehensive prevention and treatment, and the quality of life can be obviously improved. The therapeutic principle of AR is "prevention and cure combination, four-in-one", including environmental control, drug treatment, immunotherapy and health education. Environmental control primarily refers to the avoidance or reduction of exposure to allergens and various irritants. The treatment method of AR comprises symptomatic treatment and causal treatment, wherein the former mainly adopts immunotherapy at present, and the latter comprises drug treatment, surgical treatment and the like. The commonly used therapeutic drugs for AR are classified into first-line drugs including nasal glucocorticoids, second-generation oral and nasal antihistamines, oral leukotriene receptor antagonists, and second-line drugs including oral glucocorticoids, oral and nasal mast cell membrane stabilizers, nasal decongestants, and nasal anticholinergics. However, a large number of clinical studies and system evaluations have shown that the control of AR is not perfect in drug therapy, e.g. some patients are insensitive to antihistamines or have side effects such as central inhibition, side effects which occur with long-term use of nasal spray hormones, and problems such as mucosal hypertrophy caused by long-term decongestants are not negligible. At present, the types of optional therapeutic drugs of AP in the clinic of modern medicine are relatively few, and the treatment of antibiotics, antiviral drugs, iodine lozenge and the like is mainly adopted. The use of antibiotics in the course of treatment is prone to adverse consequences such as drug resistance, double infection and even abuse of antibiotics. The antiviral drugs and iodine tablets also have larger adverse reactions of the drugs. In this case, the traditional Chinese medicine shows unique advantages in treating AR concurrent AP.

In summary, wind-heat in the lung meridian is a common pathogenesis leading to the onset of AR and AP, and there is no radical cure for AR complicated with AP caused by wind-heat in the lung meridian. Therefore, how to adopt the compatibility of traditional Chinese medicines to prepare the method for healthy and effective treatment of AR concurrent AP caused by wind heat in lung channels has important significance. Meanwhile, a traditional Chinese medicine preparation which is nontoxic, can be completely absorbed by organisms, reduces physical and psychological burden of patients and can effectively treat AR concurrent AP caused by wind heat in lung channels is also urgently needed in the market.

Disclosure of Invention

In view of the above, the invention provides a pharmaceutical composition for treating AR complicated with AP caused by wind-heat in lung channel and a preparation method thereof, and the pharmaceutical composition is a pure traditional Chinese medicine preparation, has the effects of clearing heat and detoxicating, ventilating and activating lung qi, relieving sore throat and detumescence, and activating nasal orifices, has definite curative effect and less side effect, can achieve the effect of treating both symptoms and root causes, and the preparation method is suitable for industrial production and is convenient to develop and apply.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

the pharmaceutical composition for treating AR concurrence AP caused by wind-heat in lung channels is prepared from the following medicinal materials in parts by weight: 30-70 parts of cocklebur fruit, 60-90 parts of magnolia flower, 10-20 parts of asarum, 80-120 parts of radix angelicae, 20-30 parts of mint, 20-30 parts of wild chrysanthemum flower, 20-30 parts of cordate houttuynia, 10-20 parts of fried pepperweed seed and 1-1.5 parts of borneol.

Preferably, the pharmaceutical composition for treating AR concurrence AP caused by wind-heat in lung meridian is prepared from the following medicinal materials in parts by weight: 50 parts of fructus xanthil, 75 parts of flos magnoliae, 15 parts of asarum, 100 parts of radix angelicae, 25 parts of mint, 25 parts of wild chrysanthemum, 25 parts of herba houttuyniae, 15 parts of fried semen lepidii and 1.25 parts of borneol.

The pharmaceutical composition is prepared from the medicinal materials or water or organic solvent extracts serving as active ingredients, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

Wherein the preparation is a spray.

The efficacy of each component in the pharmaceutical composition for treating AR concurrence AP caused by wind-heat in lung meridian is as follows:

the cocklebur fruit is pungent and bitter in taste, warm in nature, enters lung meridian, has the effects of dispelling wind-cold, relieving stuffy nose, dispelling wind-dampness and relieving pain, is mild and dredged, is pungent in flavor and free of wind, bitter and dry dampness and turbid, is good for relieving stuffy nose and swelling pain in nose, and is a good medicine for treating nasosinusitis and allergic rhinitis. Xin Yiwei it is effective in dispelling pathogenic wind and cold, regulating the flow of qi of lung and stomach, and relieving stuffy nose, and has the effects of dispersing pathogenic wind and cold, and promoting the circulation of qi of lung and stomach, and relieving stuffy nose. Asarum is pungent in flavor and warm in nature, enters heart, lung and kidney meridians, has the effects of relieving exterior syndrome and dispelling cold, dispelling wind and relieving pain, inducing resuscitation, warming lung and resolving fluid retention, and is a good medicine for treating nasosinusitis. Radix Angelicae Dahuricae is pungent in flavor and warm in nature, enters lung, stomach and large intestine meridians, and has the effects of relieving exterior syndrome, dispelling cold, dispelling wind, relieving pain, freeing nasal orifices, eliminating dampness, stopping leukorrhagia, relieving swelling, expelling pus, dispelling wind, dispelling cold, eliminating dampness, dispersing lung qi, ascending Yang Mingqing qi, freeing nasal orifices and stopping pain. The compatibility of the above medicines together plays a role in inducing resuscitation. Peppermint is pungent in flavor, cool in nature, enters lung and liver meridians, and has the effects of dispelling wind-heat, clearing head and eyes, relieving sore throat, promoting eruption, soothing liver and promoting qi circulation. Wild chrysanthemum flower is bitter and pungent in flavor, slightly cold in nature, enters liver and heart meridians, and has the effects of clearing heat and removing toxicity, purging fire and calming liver. Herba Houttuyniae is pungent in flavor and slightly cold in nature, enters lung meridian, and has effects of clearing heat and removing toxicity, resolving carbuncles and expelling pus, and inducing diuresis and treating stranguria. The wild chrysanthemum and the cordate houttuynia take the meaning of clearing heat and detoxicating, and are combined with the exterior-relieving and cold-dispelling herbs such as fructus Xanthii, flos magnoliae, herba asari and radix angelicae to treat lung heat, on one hand, the nature of cold and warm are mutually restricted to prevent the cold-type herbs from damaging the body resistance, and on the other hand, the remainder of clearing heat is dispersed to eliminate pathogenic factors to prevent the pathogenic factors from remaining. The medicines are mainly used for reflecting compatibility of heat-clearing and toxin-removing medicines and wind-heat-dispelling medicines, and not only can externally dispel wind-heat, but also can detoxify and avoid dirt, so that both clearing and dispelling effects are achieved. Ting Li Zi is pungent and bitter in flavor, has the effect of purging lung and relieving asthma, promoting urination and reducing swelling, and is bitter and pungent in flavor, capable of regulating water passage, especially purging lung water retention and phlegm fire, and treating lung meridian wind-heat with fire to treat lung heat and lung water retention due to heat-polar reaction. Borneol is pungent and bitter in taste, slightly cold in nature, enters heart, spleen and lung meridians, has the effects of inducing resuscitation and refreshing mind, clearing heat and relieving pain, is spicy and fragrant, and is used for inducing menstruation and relieving the purgation, and can not only induce resuscitation to promote medicines to pass through nasal mucosa and pharyngeal mucosa, but also clear heat and detoxify to dissipate fire in lung. The medicines are combined together to play roles of clearing heat and detoxicating, relieving sore throat and detumescence, and promoting the circulation of nose and orifices, and the main symptoms are nasal itching, sneeze, clear nasal discharge, nasal obstruction, pharyngalgia, dysphagia, red or dark red nasal mucosa, turbinate swelling, bright red and swelling of pharyngeal mucosa or cores under the jaw, with fever, aversion to cold, cough, yellow and thick sputum, dry mouth and dysphoria, red tongue, thin and yellow coating, and superficial and rapid or rapid pulse.

The invention also provides a preparation method of the pharmaceutical composition, which comprises the following steps:

(1) Taking fructus Xanthii, flos Magnoliae, herba asari, radix Angelicae Dahuricae, herba Menthae, flos Chrysanthemi Indici, herba Houttuyniae and parched semen Lepidii according to the amount, counting 5 prescription amounts, adding 14 times of water, soaking overnight, extracting with volatile oil extractor for 4-6 h by steam distillation method to obtain volatile oil 1.6-2.4 mL;

(2) Filtering the extracting solution, concentrating to a relative density of 1.1-1.2, adding ethanol until the ethanol concentration is 60% -80%, standing for 24 hours, taking supernatant, recovering ethanol until no ethanol smell exists, and concentrating to 355mL;

(3) 1 to 1.5g of borneol is ground into fine powder, the fine powder and the volatile oil are dissolved in 6 to 10mL of Tween 80, the mixture of borneol and volatile oil is evenly mixed with the concentrated liquid medicine, the PH value of sodium bicarbonate is adjusted to 6 to 7, and water is added to fix the volume to 400mL.

Preferably, in the step (1), cocklebur fruit, magnolia flower, asarum, angelica dahurica, peppermint, wild chrysanthemum flower, houttuynia cordata and fried pepperweed seed are taken according to the amount, 5 prescription amounts are calculated, water with the total weight of 14 times is added, soaking is carried out for overnight, a steam distillation method is adopted, and a volatile oil extractor is used for extracting for 5 hours, so as to obtain 2mL of volatile oil;

preferably, filtering the extracting solution obtained in the step (2), concentrating to a relative density of 1.1-1.2, adding ethanol to an alcohol concentration of 70%, standing for 24 hours, taking supernatant, recovering ethanol until no alcohol smell exists, and concentrating to 355mL;

preferably, 1.25g of borneol is ground into fine powder in the step (3), the fine powder and volatile oil are dissolved in 8mL of Tween 80, the mixture of borneol and volatile oil is uniformly mixed with the concentrated liquid medicine, the PH value of sodium bicarbonate is adjusted to 6-7, and water is added to fix the volume to 400mL.

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

the traditional Chinese medicine composition has the advantages of clearing heat and detoxicating, freeing lung qi, relieving sore throat and detumescence, freeing nasal orifices, obvious curative effect on AR complicated AP caused by wind heat of lung meridian, small toxic and side effects, simple preparation process and convenient use, provides a new choice for patients, and has good application prospect.

Detailed Description

The technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

Example 1:

a pharmaceutical composition for treating AR concurrence AP caused by wind-heat in lung meridian is prepared from the following medicinal materials in parts by weight: 50g of fructus xanthil, 75g of magnolia flower, 15g of asarum, 100g of radix angelicae, 25g of mint, 25g of wild chrysanthemum, 25g of houttuynia cordata, 15g of fried pepperweed seed and 1.25g of borneol.

The preparation method comprises the following steps:

(1) Taking fructus Xanthii, flos Magnoliae, herba asari, radix Angelicae Dahuricae, herba Menthae, flos Chrysanthemi Indici, herba Houttuyniae and parched semen Lepidii according to the amount, counting 5 prescription amounts, adding 14 times of water, soaking overnight, extracting with volatile oil extractor for 5h by steam distillation method to obtain 2mL of volatile oil;

(2) Filtering the extracting solution, concentrating to a relative density of 1.1-1.2, adding ethanol to an ethanol concentration of 70%, standing for 24h, taking supernatant, recovering ethanol until no ethanol smell exists, and concentrating to 355mL;

(3) Grinding Borneolum Syntheticum into fine powder, dissolving with the volatile oil in 8mL Tween 80, mixing Borneolum Syntheticum and volatile oil mixture with the concentrated liquid medicine, adjusting pH to 6-7 with sodium bicarbonate, and adding water to constant volume to 400mL. The combination is used as an effective component to prepare a pharmaceutical composition for treating AR concurrence AP caused by wind-heat of lung meridian.

Example 2: clinical data

Materials and methods

1. Sample of

A pharmaceutical composition for treating AR complicated with AP caused by wind-heat in lung channel comprises 120 sprays per bottle, and the concentration of medicinal liquid is 400mg (crude drug)/ml.

2. Subject

2.1 diagnostic criteria

The diagnosis standard of AR Western medicine is formulated with reference to the allergic rhinitis diagnosis and treatment guidelines (2015, tianjin) issued by the journal of the department of surgery, editing Committee, nasal group, the department of surgery, the department of the science, the department of the surgery, the department of the head, the nose, the throat, and the head, of China:

(1) Clinical symptoms: the symptoms such as sneeze, clear water nasal discharge, nasal itching and nasal obstruction appear for 2 or more, and the symptoms are continuous or accumulated for more than 1 hour every day, and can be accompanied with eye symptoms such as lacrimation, itching eyes and redness eyes.

(2) The physical sign is as follows: pale and edema of nasal mucosa and nasal cavity watery secretions are common.

(3) Allergen detection: at least 1 allergen SPT and/or serum specific IgE positive, or nasal challenge test positive.

Planning textbooks "ear-nose-throat head-neck surgery (8 th edition)" draw:

(1) Clinical manifestations: the general symptoms are relatively acute, the dry, burning and rough feeling of the pharyngeal portion is followed by obvious pharyngalgia, the swallowing is particularly serious, and the pain can be radiated to the ear when the pharyngeal side cable is affected; general symptoms are generally lighter and can include fever, headache, anorexia, soreness of limbs, etc.

(2) Physical examination: the mucosa of the oropharynx is acute diffuse congestion and swelling, the lymph follicles of the pharyngeal rear wall are raised, and yellow-white point-shaped exudates are visible on the surface, so that the uvula and the soft palate are edematous; enlargement of lower collar lymph nodes and tenderness; the nasopharynx and the hypopharynx may be acutely engorged, and epiglottis edema may be seen in severe cases.

With a history of acute episodes, all or part of the symptoms (necessarily sore throat) can be diagnosed for one or more signs.

Planning teaching materials (science of ear nose throat of traditional Chinese medicine (fourth edition of new century)) are formulated:

wind-heat type of lung meridian: itching nose, sneeze, runny nose, nasal obstruction, sore throat, dysphagia, red or dark red nasal mucosa, turbinate swelling, bright red and swollen pharyngeal mucosa or nuclei under the jaw, with fever, aversion to cold, cough, yellow and thick sputum, dry mouth, dysphoria, red tongue, thin and yellow coating, and superficial and rapid or rapid pulse.

2.2 inclusion criteria

(1) Age less than or equal to 18 years old and less than or equal to 50 years old;

(2) Meets the diagnosis standard of the wind-heat type AR concurrence AP of the lung meridian.

2.3 exclusion criteria

(1) The detailed medical history inquiry and the electronic nasopharyngoscopy prompt the patient to have nasal polyps, acute and chronic nasal-sinusitis, drug rhinitis, vascular motility rhinitis and other nasal sinus space occupying lesions;

(2) Pharyngeal symptoms caused by measles, scarlet fever, influenza, granulocytopenia, infectious mononucleosis, leukemia, etc.;

(3) High fever (body temperature not less than 38.5 ℃) with other severe infectious diseases;

(4) Subjects received nasal surgical treatment within 1 year;

(5) Subjects received treatment with glucocorticoids, antihistamines, leukotriene receptor inhibitors, various decongestants or theophyllines via the oral, nasal or systemic route within approximately 3 months;

(6) Respiratory tract infections in subjects over the past 4 weeks, or the presence of overt systemic metabolic diseases (autoimmune diseases, severe cardiovascular diseases, persistent asthma, chronic obstructive pulmonary disease, severe liver and kidney diseases, cancer, etc.);

(7) Subjects participated in other clinical drug study trials within approximately 3 months;

(8) Pregnant or lactating women.

2.4 reject criteria.

(1) Subjects who were not dosed for the prescribed time and dose.

(2) Incomplete data or severe complications affect efficacy or safety judgment.

(3) The subject cannot cooperate or actively require termination of the test.

3. Test design and grouping

3.1 test group

30 subjects used their own front-to-back control protocol.

3.2 methods of treatment

The observation group was treated with a pharmaceutical composition of AR concurrent AP caused by wind-heat in lung meridian. The control group adopts budesonide nasal spray (Shanghai Adikang pharmaceutical Co., ltd., national drug standard J20180023, specification: 64 mug/spray), 1 spray each time on each side, 1 spray each time in the morning and evening each day; amoxicillin capsule (Beijing Qin Wutian pharmaceutical Co., ltd., national drug standard H11022520, specification: 0.25 g/granule) is orally administered at a dose of 0.5g each time, 3 times daily. The treatment time was 7d.

3.3 observations index

Symptom scoring was performed using the patient self-scoring nasal symptom total score table (total nasal symptom score, TNSS). The scale total consisted of 4 individual nasal symptom scores of runny nose, nasal congestion, nasal itching and sneeze. The symptom severity was evaluated in 0-3 categories: 0 is asymptomatic; 1 is classified as mild (mild symptoms, easy to tolerate); 2 is classified as moderate (obvious symptoms, boring but tolerable); the 3 s are classified as severe (symptoms cannot be tolerated, affecting daily life and/or sleep).

Quality of life scores were performed using the nasal conjunctivitis quality of life questionnaire (rhinoconjunctivitis quality of life questionnaire, RQLQ). The scoring table includes 7 aspects, 28 items, each item 0-6 points, with the higher the resulting score, the more pronounced the impact.

A visual analog scale (visual analogue scale, VAS) is used for grading the pharyngalgia degree, a line segment with the length of 10cm is prepared, the line segment is equally divided into 10 parts from small to large, 0 part indicates no pharyngalgia, 10 parts indicates severe pharyngeal pain, and the patient gives a grade according to own pain feeling before and after treatment.

The Chinese medicine syndrome grading and quantifying table is adopted to score the Chinese medicine syndrome, and the detail is shown in table 1. Two groups of Chinese medical condition scores were recorded by the above physicians at the otorhinolaryngology department level of indications.

Table 1 Chinese medical science syndrome classification quantization table

The scores of the traditional Chinese medicine symptoms before and after the treatment of the subjects are recorded, the integral reduction index (SRI) is calculated according to the following formula, the SRI= (pre-treatment integral-post-treatment integral)/pre-treatment integral multiplied by 100%, the larger the SRI value is, the better the curative effect is, the more than 70% is effective, the more than 30% -70% is effective, the less than 30% is ineffective, and the total effective rate = the number of effective cases/the total number of cases multiplied by 100%.

3.4 data processing and result determination

The statistical software SPSS 19.0 for data processing calculates the analysis data. Count data is expressed in terms of rate or composition (%), and χ is used for comparison between groups ² Checking; the measurement data is based on the average standard deviation

The representation of the comparison between groups uses independent sample tAN_SNeAnd (5) checking. The difference of P < 0.05 is statistically significant.

4. Results

4.1 analysis of subject general data

No abscission and withdrawal occurred in the subjects during the observation period. The general data distribution of subjects prior to treatment is shown in Table 2.

Table 2 comparison of sex profiles of two groups of subjects

4.2TNSS score comparison

Table 3 comparison of TNSS scores for two groups of subjects after treatment and prior to treatment

As can be seen from table 3, the subjects were tested for runny nose, nasal congestion, nasal itching, sneezing single symptom score and TNSS score by independent sample t-test compared to pre-treatment, and the differences were statistically significant (P < 0.05). The invention has obvious effect of improving the nasal symptoms of patients with lung meridian wind-heat type AR complicated with AP.

4.3RQLQ score comparison

Table 4 post-treatment two groups of subjects RQLQ scores were compared prior to treatment

As can be seen from table 4, the RQLQ scores after subject treatment were statistically significant (P < 0.05) compared to pre-treatment using independent sample t-test. The invention has obvious effect of improving the life quality of patients with lung meridian wind-heat type AR concurrent AP.

4.4VAS score comparison

Table 5 comparison of the VAS scores of the two groups of subjects after treatment and prior to treatment

As can be seen from table 5, the differences in post-subject treatment VAS scores compared to pre-treatment using independent sample t-test were statistically significant (P < 0.05). The invention has obvious effect of improving pharyngeal pain symptoms of patients with lung meridian wind-heat type AR complicated with AP.

4.5 comparison of Chinese medical Condition scores in two groups of subjects

Table 6 comparison of traditional Chinese medicine Condition scores in two groups of subjects after treatment and before treatment

As can be seen from Table 6, the individual Chinese medicine symptom scores and Chinese medicine syndrome scores of the subjects after treatment of nasal obstruction, nasal itching, sneeze, runny nose, turbinate swelling, nasal mucosa congestion, pharyngalgia, pharyngeal mucosa congestion and swelling, cough and expectoration, fever and aversion to cold, and dry mouth and dysphoria heat are compared with the subjects before treatment by adopting independent sample t test, and the difference has statistical significance (P is less than 0.05). The invention has obvious effect of improving the traditional Chinese medicine symptoms of the lung meridian wind-heat type AR concurrent AP patients.

4.6 efficacy determination and comparison

TABLE 7 comparison of efficacy decisions

As is evident from Table 7, the effective rate was 80.00% (24/30) in 5 cases and 19 cases. The invention has obvious curative effect on patients with lung meridian wind-heat type AR complicated with AP.

2. Typical cases.

Case 1

Ma Mou, female, 36 years old, chemical plant workers, 21 days of 2019, 6 months.

Disorders: the main symptoms of the acute pharyngitis complicated with the lung meridian wind-heat type allergic rhinitis are itching nose, sneeze, clear nasal discharge, nasal obstruction, pharyngalgia, red nasal mucosa, turgescence of nasal turgescence, aversion to cold, cough, dry mouth and dysphoria with smothery sensation, red tongue, thin and yellow fur and superficial and rapid pulse.

Application: the embodiment is prepared from the following medicinal materials in parts by weight: 50 parts of fructus xanthil, 75 parts of flos magnoliae, 15 parts of asarum, 100 parts of radix angelicae, 25 parts of mint, 25 parts of wild chrysanthemum, 25 parts of herba houttuyniae, 15 parts of fried pepperweed seed and 1.25 parts of borneol. Each side is sprayed 1 time each day, 1 time each day in the morning and evening.

Curative effect: the symptoms of subjective nasal itching, nasal obstruction, sneeze and pharyngeal pain of the patient are obviously relieved after 5 days of administration of the embodiment, and nasal mucosa congestion, turbinate turgescence and pharyngeal mucosa bright red are obviously relieved. The occurrence times of spontaneous fever, aversion to cold, cough, dry mouth and dysphoria with smothery sensation are obviously reduced.

Case 2

Sometime, men, 42 years old, accountant, 2021, 7 months, 16 days.

Disorders: the main symptoms of the acute pharyngitis complicated with the lung meridian wind-heat type allergic rhinitis are itching nose, sneezing, runny nose, nasal obstruction, pharyngalgia, red nasal mucosa, turgescence of nasal turgescence and pharyngeal mucosa, fever, aversion to cold, cough, yellow and thick sputum, dry and dysphoria with smothery sensation, red tongue, thin and yellow coating and superficial and rapid pulse.

Application: the embodiment is prepared from the following medicinal materials in parts by weight: 50 parts of fructus xanthil, 75 parts of flos magnoliae, 15 parts of asarum, 100 parts of radix angelicae, 25 parts of mint, 25 parts of wild chrysanthemum, 25 parts of herba houttuyniae, 15 parts of fried pepperweed seed and 1.25 parts of borneol. Each side is sprayed 1 time each day, 1 time each day in the morning and evening.

Curative effect: after the administration of the example, the symptoms of subjective nasal itching, nasal obstruction, clear nasal discharge, sneeze and pharyngeal pain of the patient are obviously relieved, the symptoms of nasal mucosa congestion, turbinate swelling and pharyngeal mucosa bright red are obviously relieved, and the symptoms of fever, aversion to cold, cough, yellow and thick sputum and dry mouth and dysphoria with smothery sensation are basically disappeared.

Case 3

Fan Mou men, 40 years old, teachers, 18 days 8, 2021.

Disorders: the main symptoms of the acute pharyngitis complicated with the lung meridian wind-heat type allergic rhinitis are itching nose, sneeze, clear nasal discharge, nasal obstruction, pharyngalgia, red nasal mucosa, bright red pharyngeal mucosa, fever, aversion to cold, cough, red tongue, thin and yellow tongue fur and superficial and rapid pulse.

Application: the embodiment is prepared from the following medicinal materials in parts by weight: 50 parts of fructus xanthil, 75 parts of flos magnoliae, 15 parts of asarum, 100 parts of radix angelicae, 25 parts of mint, 25 parts of wild chrysanthemum, 25 parts of herba houttuyniae, 15 parts of fried pepperweed seed and 1.25 parts of borneol. Each side is sprayed 1 time each day, 1 time each day in the morning and evening.

Curative effect: after the administration of the example, the symptoms of subjective nasal itching, nasal obstruction, sneeze and pharyngeal pain of the patient are obviously relieved after 7 days, and nasal mucosa congestion and pharyngeal mucosa bright red are obviously relieved. The occurrence times of spontaneous fever, aversion to cold and cough are obviously reduced.

In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant points refer to the description of the method section.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (7)

1. The pharmaceutical composition for treating the allergic rhinitis combined with the acute pharyngitis caused by wind-heat of lung meridian is characterized by being prepared from the following medicinal materials in parts by weight: 30-70 parts of cocklebur fruit, 60-90 parts of magnolia flower, 10-20 parts of asarum, 80-120 parts of radix angelicae, 20-30 parts of mint, 20-30 parts of wild chrysanthemum flower, 20-30 parts of cordate houttuynia, 10-20 parts of fried pepperweed seed and 1-1.5 parts of borneol.

2. The pharmaceutical composition according to claim 1, wherein the composition comprises 50 parts of fructus Xanthii, 75 parts of flos Magnoliae, 15 parts of herba asari, 100 parts of radix Angelicae Dahuricae, 25 parts of herba Menthae, 25 parts of flos Chrysanthemi Indici, 25 parts of herba Houttuyniae, 15 parts of parched semen Lepidii, and 1.25 parts of Borneolum Syntheticum.

3. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is prepared from the medicinal material, or water or organic solvent extract as an active ingredient, and pharmaceutically acceptable auxiliary materials or auxiliary ingredients.

4. A process for the preparation of a pharmaceutical composition according to claims 1-3, comprising the steps of:

(1) Taking fructus Xanthii, flos Magnoliae, herba asari, radix Angelicae Dahuricae, herba Menthae, flos Chrysanthemi Indici, herba Houttuyniae and parched semen Lepidii according to the amount, counting 5 prescription amounts, adding 14 times of water, soaking overnight, extracting with volatile oil extractor for 4-6 h by steam distillation method to obtain volatile oil 1.6-2.4 mL;

(2) Filtering the extracting solution, concentrating to a relative density of 1.1-1.2, adding ethanol until the ethanol concentration is 60% -80%, standing for 20-24h, taking supernatant, recovering ethanol until no ethanol smell exists, and concentrating;

(3) Grinding 1-1.5 g of borneol into fine powder, dissolving the fine powder and volatile oil in 6-10 mL of Tween 80, uniformly mixing the borneol and volatile oil mixed solution with the concentrated liquid medicine, regulating the PH value of sodium bicarbonate to 6-7, adding water and fixing the volume to obtain the pharmaceutical composition.

5. The method of preparing a pharmaceutical composition according to claim 4, wherein the step (1) comprises the steps of taking fructus Xanthii, flos Magnoliae, herba asari, radix Angelicae Dahuricae, herba Menthae, flos Chrysanthemi Indici, herba Houttuyniae, and semen Lepidii (parched) according to the amount, counting 5 prescription amounts, adding 14 times of water, soaking overnight, and extracting with volatile oil extractor by steam distillation for 5h to obtain 2mL of volatile oil.

6. The method of preparing a pharmaceutical composition according to claim 4, wherein the extract obtained in step (2) is filtered, concentrated to a relative density of 1.1-1.2, ethanol is added to an alcohol concentration of 70%, and the mixture is left for 24 hours, the supernatant is taken to recover ethanol until no alcohol smell exists, and the mixture is concentrated to 355mL.

7. The method of preparing the pharmaceutical composition according to claim 4, wherein in step (3), 1.25g of borneol is ground into fine powder, the fine powder and the volatile oil are dissolved in 8mL of Tween 80 together, the mixture of borneol and volatile oil is mixed with the concentrated liquid medicine, the PH value of sodium bicarbonate is adjusted to 6-7, and water is added to fix the volume to 400mL.