阅读说明：本技术 一种治疗血管运动性鼻炎的药物组合物及其制备方法 (Pharmaceutical composition for treating vasomotor rhinitis and preparation method thereof ) 是由 杨关林 闵冬雨 李记泉 龚伟 刘勇明 谢思梦 关乐 于 2020-05-09 设计创作，主要内容包括：本发明属于中药制剂领域,具体涉及一种治疗血管运动性鼻炎的药物组合物及其制备方法。一种治疗血管运动性鼻炎的药物组合物,其由以下重量份的原料药组成：细辛70-90份,辛夷30-50份,鹅不食草30-50份,苍耳子70-90份,葛花30-50份,枳椇子30-50份,赶黄草30-50份。本发明提供的药物组合物为纯中药制剂,具有宣通鼻窍、疏风散寒、调肝解酒醒脾的功效,疗效确切、副作用少,能起到标本兼治的效果,并且其制备方法适合工业化生产等优点,便于开发应用。该药物组合物所用的原料均来源于国家药用目录,安全无毒,具有潜在的社会效益和经济效益。(The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a pharmaceutical composition for treating vasomotor rhinitis and a preparation method thereof. A pharmaceutical composition for treating vasomotor rhinitis comprises the following raw material medicines in parts by weight: 70-90 parts of asarum, 30-50 parts of biond magnolia flower, 30-50 parts of centipeda minima, 70-90 parts of cocklebur fruit, 30-50 parts of flower of kudzuvine, 30-50 parts of hovenia dulcis thumb and 30-50 parts of penthorum chinense. The pharmaceutical composition provided by the invention is a pure traditional Chinese medicine preparation, has the effects of freeing nasal orifices, dispelling wind and cold, regulating liver, dispelling alcohol effects and activating spleen, has definite curative effect and few side effects, can achieve the effect of treating both symptoms and root causes, has the advantages of suitability for industrial production and the like, and is convenient to develop and apply. The raw materials used by the pharmaceutical composition are all from the national pharmaceutical catalogue, are safe and nontoxic, and have potential social and economic benefits.)

1. The pharmaceutical composition for treating vasomotor rhinitis is characterized by comprising the following raw material medicines in parts by weight: 70-90 parts of asarum, 30-50 parts of biond magnolia flower, 30-50 parts of centipeda minima, 70-90 parts of cocklebur fruit, 30-50 parts of flower of kudzuvine, 30-50 parts of hovenia dulcis thumb and 30-50 parts of penthorum chinense.

2. The pharmaceutical composition for treating vasomotor rhinitis according to claim 1, which is prepared from the following raw material medicines in parts by weight: 80 parts of asarum, 40 parts of biond magnolia flower, 40 parts of centipeda minima, 80 parts of cocklebur fruit, 40 parts of kudzuvine flower, 40 parts of hovenia dulcis thumb and 40 parts of penthorum chinense pursh.

3. A preparation method of a pharmaceutical composition for treating vasomotor rhinitis is characterized by comprising the following steps:

(1) extracting volatile oil: weighing asarum, centipeda minima, biond magnolia flower, cocklebur fruit, pueraria flower, hovenia dulcis thunb and penthorum chinense pursh according to parts by weight, adding water with the weight being 15-25 times of the total weight, soaking for 0.5-1.5 h, and extracting for 4-6 h by a volatile oil extractor by adopting a 100 ℃ steam distillation method to obtain volatile oil and a water extracting solution;

(2) and (3) extracting the rest components: adding 60-80% of ethanol into the water extract, standing, filtering, and concentrating the filtrate until no alcohol smell exists;

(3) the volatile oil obtained in the step (1), the concentrated solution obtained in the step (2), water and Tween 80 are combined to be used as drug effect components to prepare the pharmaceutical composition for treating rhinitis.

4. The method for preparing a pharmaceutical composition for treating vasomotor rhinitis according to claim 3, wherein the step (1) of extracting volatile oil comprises: weighing asarum, centipeda minima, biond magnolia flower, cocklebur fruit, pueraria flower, hovenia dulcis thunb and penthorum chinense pursh according to the parts by weight, adding water with the weight being 20 times of the total weight, soaking for 1 hour, and extracting for 5 hours by a volatile oil extractor by adopting a steam distillation method at 100 ℃.

5. The method for preparing a pharmaceutical composition for treating vasomotor rhinitis according to claim 3, wherein the extract of step (2) is concentrated to a relative density of 1.1-1.2 g/ml, ethanol is added to the water extract to an alcohol concentration of 70%, the mixture is allowed to stand for 24 hours, filtered, and the filtrate is concentrated until no alcohol smell is produced.

6. The preparation method of the pharmaceutical composition for treating vasomotor rhinitis according to claim 3, wherein the volatile oil obtained in the step (1) is combined with the extraction of the rest components in the step (2), and the ph value is adjusted to 6-7 by adding water, Tween 80 and sodium bicarbonate to obtain the liquid medicine.

Technical Field

The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a pharmaceutical composition for treating vasomotor rhinitis and a preparation method thereof.

Background

Rhinitis, an inflammatory disease of the nasal cavity, is an inflammation of the mucous membrane of the nasal cavity caused by viruses, bacteria, allergens, various physicochemical factors and certain systemic diseases. Rhinitis can be classified into allergic rhinitis and non-allergic rhinitis depending on whether it is allergen-specific IgE-mediated. Vasomotor rhinitis is the most common type of non-allergic rhinitis, accounting for about 6-71 percent, and is high-reactivity rhinitis caused by imbalance of mucous membranes, blood vessels and glands of a nose, which is a target organ regulated by a neuroendocrine system in vivo. The main pathogenesis of the nasal mucosa epithelial cell is related to environmental factors such as temperature, air humidity, air pressure and pungent smell, psychosocial factors and physiological changes of a human body, the pathogenesis of the nasal mucosa epithelial cell is related to the permeability increase of nasal mucosa epithelium, non-IgE mediated inflammatory reaction induced by the above stimulation factors and the changes of immunoreaction abnormity, resistance reduction, inflammatory cell infiltration, vascular congestion swelling, interstitial edema and the like caused by local autonomic nerve dysfunction, and the female middle-aged and old people with the age of 30-60 frequently suffer from diseases. In recent years, the onset of vasomotor rhinitis is a trend of youthfulness, and people with severe symptoms can harm the whole body function and affect the psychology, so that the rhinitis treatment method is one of public health problems which seriously affect the health and the life quality of people in the whole society, and therefore, sufficient attention should be paid to the rhinitis treatment method, and particularly, the rhinitis treatment method should be performed in the early stage of rhinitis symptoms to reduce the damage to organisms caused by severe stages.

The clinical manifestations of vasomotor rhinitis are repeated and alternate outbreaks of nasal obstruction, watery nasal discharge, paroxysmal sneeze and other symptoms induced by external stimulus factors or psychopsychological factors, lasting for more than 1h, and can be accompanied with tinnitus, olfactory decline and hearing loss to produce the symptoms of chronic pharyngitis, cough, headache, dizziness, insomnia, easy fatigue, anorexia, listlessness, hypomnesis and the like. Its signs are pale or congested nasal mucosa, swollen inferior turbinates, accompanied by watery or white, viscous secretions. The allergen skin spot detection is negative, and the allergen serum specificity IgE detection is negative; eosinophil count was normal.

According to traditional Chinese medicine, vasomotor rhinitis belongs to the categories of nasosinusitis, nasal asphyxia, allergic rhinitis and the like, and the disease is considered to be caused by the interaction of internal factors and external factors, most of the internal factors are responsible for the deficiency of qi of internal organs, particularly three organs of lung, spleen and kidney; the external factors are involved in the attack of pathogenic cold and fire-heat. Or suffocation due to heat accumulation in heart and lung, stagnation of nose, and obstruction of nose due to heat induced by nose, obstruction of qi flow, and obstruction of the channels; or suffocation due to obstruction of qi and blood circulation between nasal orifices and muscle membranes caused by lung deficiency, weak defense, cold stagnation in nasal orifices, and retention of cold turbidity; or lung and spleen deficiency and phlegm dampness retention, one is failure of yang-clearing and nasal orifices to nourish, and the other is failure of water-dampness to transform and dampness pathogen to invade the nasal orifices to stagnate; or qi and blood stagnation, obstruction of nasal vessels, swelling of nasal turbinates, obstruction of clear orifices, and obstruction of qi and blood in the throat. At present, the commonly used Chinese patent medicines comprise rhinitis tablets, rhinitis drops, orifice-opening rhinitis capsules, orifice-opening rhinitis granules, orifice-opening rhinitis water, qianbai rhinitis tablets and the like, the treatment effect mostly aims at relieving symptoms, and patients have certain side effects after using the traditional Chinese medicine. The traditional Chinese medicine external treatment methods such as a closed therapy, an acupuncture therapy, an auricular point therapy and the like are rarely applied.

For the treatment of vasomotor rhinitis, modern medicine mostly adopts external environment control, inflammation diminishing, pain relieving, antiallergic, anti-edema and operation treatment, local and whole body causes should be found for the treatment of the causes, and nasosinusitis, nasal septum deflection, systemic chronic diseases and other primary diseases should be treated in time; for topical treatment, nasal glucocorticoids and oral antihistamines are usually used, which is the currently internationally accepted effective treatment method, but the side effects are serious. The nasal cavity of the patient with more or more viscous nasal secretion can be cleaned by normal saline to remove the nasal secretion and improve the nasal ventilation, but the radical treatment effect cannot be achieved; the nasal decongestant can be an oxymetazoline hydrochloride spray to shrink nasal mucosa blood vessels, relieve tissue swelling and effectively improve nasal cavity ventilation, and is not suitable for continuous application for more than 7 days to avoid drug rhinitis. If the nasal cavity structure is abnormal and the main symptoms are not obviously relieved by the treatment of the standardized medicaments, the surgical intervention can be considered. The surgical operation method mainly achieves the purposes of improving ventilation, improving life quality and the like by correcting nasal septum, cutting off partial inferior turbinate and the like, but the postoperative side effects of easy relapse, easy headache and insomnia of patients, abnormal work and the like are also caused.

In conclusion, no radical treatment is available for vasomotor rhinitis at present, and no particularly effective treatment medicine is available in markets at home and abroad. Therefore, the method for healthily and effectively treating the vasomotor rhinitis is of great significance. Meanwhile, the market also urgently needs a medicine which is nontoxic, can be completely absorbed by organisms, can lighten the physical and psychological burden of patients and can effectively treat vasomotor rhinitis.

Disclosure of Invention

In order to solve the problems in the prior art, the invention provides the pharmaceutical composition for treating vasomotor rhinitis and the preparation method thereof, the pharmaceutical composition provided by the invention is a pure traditional Chinese medicine preparation, has the effects of dredging nasal orifices, dispelling wind and cold, regulating liver and dispelling alcohol effects and activating spleen, has definite curative effect and few side effects, can achieve the effect of treating both symptoms and root causes, and the preparation method thereof is suitable for industrial production and the like, and is convenient to develop and apply.

A pharmaceutical composition for treating vasomotor rhinitis comprises the following raw material medicines in parts by weight: 70-90 parts of asarum, 30-50 parts of biond magnolia flower, 30-50 parts of centipeda minima, 70-90 parts of cocklebur fruit, 30-50 parts of flower of kudzuvine, 30-50 parts of hovenia dulcis thumb and 30-50 parts of penthorum chinense.

Further, the pharmaceutical composition for treating vasomotor rhinitis comprises the following raw material medicines in parts by weight: 80 parts of asarum, 40 parts of biond magnolia flower, 40 parts of centipeda minima, 80 parts of cocklebur fruit, 40 parts of kudzuvine flower, 40 parts of hovenia dulcis thumb and 40 parts of penthorum chinense pursh.

The pharmacological action and the efficacy of each component in the pharmaceutical composition for treating vasomotor rhinitis provided by the invention are as follows.

The herba asari is dry root and rhizome of Aristolochiaceae plant herba asari, herba asari Forbesii or herba asari Sinici, has pungent taste, warm nature, and effects of invigorating heart, lung, and kidney channels, relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, relieving pain, inducing resuscitation, warming lung, and promoting fluid retention, and can be used for treating wind-cold type common cold, headache, toothache, nasal obstruction, rhinopathy, nasosinusitis, rheumatalgia, phlegm-fluid retention, and cough and asthma.

Flos Magnoliae is dry flower bud of Magnolia biondii, Magnolia denudata or Magnolia wushuensis of Magnoliaceae, has pungent and warm properties, enters lung and stomach channels, has effects of dispelling pathogenic wind cold and relieving nasal obstruction, and can be used for treating wind cold headache, nasal obstruction, nasal discharge, allergic rhinitis, and nasosinusitis.

Herba Centipedae is dry whole plant of herba Centipedae of Compositae, has pungent taste and warm property, enters lung meridian, has effects of dispelling pathogenic wind and cold, dredging nasal orifice and relieving cough, and can be used for treating wind-cold headache, cough with excessive phlegm, stuffy nose, nasal obstruction, and watery nasal discharge.

Fructus Xanthii is dry mature fruit with involucre of Xanthium strumarium of Compositae, is pungent, bitter, warm in nature, enters lung channel, has effects of dispelling pathogenic wind cold, dredging nasal orifice, and dispelling pathogenic wind and dampness, and can be used for treating wind cold headache, nasal obstruction, nasal discharge, allergic rhinitis, nasosinusitis, rubella pruritus, and damp spasm.

Flos Puerariae Lobatae is flower of Pueraria lobata or Pueraria thomsonii of Leguminosae, has sweet taste and cool nature, enters stomach channel, has effects of relieving hangover, activating spleen, and stopping bleeding, and can be used for treating dysphoria with smothery sensation, thirst, headache, dizziness, abdominal distention, vomiting, acid regurgitation, anorexia, hematemesis, and intestinal wind induced hemorrhage.

The semen Hoveniae is fruit or seed of Hovenia dulcis Thunb of Rhamnaceae with fleshy fruit stem, has sweet and sour taste, mild nature, and heart and spleen channels, and can be used for treating alcoholic intoxication, dysphoria, thirst, emesis, and constipation.

The penthorum chinense pursh is a penthorum chinense pursh plant of the genus garnetitum of the family Crassulaceae, is sweet in taste and warm in nature by using the whole plant as a medicine, has the effects of promoting diuresis, removing dampness, removing blood stasis and relieving pain, is used for treating jaundice and edema, and is externally used for treating traumatic injury.

A preparation method of a pharmaceutical composition for treating vasomotor rhinitis comprises the following specific steps:

(1) extracting volatile oil: weighing asarum, centipeda minima, biond magnolia flower, cocklebur fruit, pueraria flower, hovenia dulcis thunb and penthorum chinense pursh according to parts by weight, adding water with the weight being 15-25 times of the total weight, soaking for 0.5-1.5 h, extracting for 4-6 h by a volatile oil extractor by adopting a 100 ℃ steam distillation method, and obtaining 2.4-3.2 ml of volatile oil and water extract.

(2) And (3) extracting the rest components: adding 60-80% ethanol into the water extract, standing, filtering, and concentrating the filtrate until no alcohol smell is generated.

(3) The volatile oil obtained in the step (1), the concentrated solution obtained in the step (2), water and Tween 80 are combined to be used as drug effect components to prepare the pharmaceutical composition for treating rhinitis.

Further, extracting volatile oil in the step (1): weighing herba asari, herba Centipedae, flos Magnoliae, fructus Xanthii, flos Puerariae Lobatae, semen Hoveniae, and herba Penthori chinensis according to weight parts, adding 20 times of water, soaking for 1 hr, and extracting with volatile oil extractor by steam distillation at 100 deg.C for 5 hr to obtain volatile oil 2.8 ml.

Further, concentrating the extracting solution obtained in the step (2) to a relative density of 1.1-1.2 g/ml, adding ethanol into the water extracting solution until the alcohol concentration is 70%, standing for 24 hours, filtering, and concentrating the filtrate until no alcohol smell exists.

Further, extracting the rest components in the step (2), mixing the volatile oil obtained in the step (1), adding water, tween 80 and sodium bicarbonate to adjust the pH value to be 6-7, and obtaining liquid medicine 1000m L in total.

The pharmaceutical composition for treating vasomotor rhinitis provided by the invention is compatible for use, can ventilate nasal orifices, dispel wind and cold, regulate liver, relieve alcoholism and activate spleen, and enable lung to disperse and descend, and the nasal orifices to be unblocked, and is particularly suitable for treating heavy blockage after drinking. The lung can dredge nasal orifices, and the nose is blocked without pain when the lung fails to disperse, descend and descend; the nasal diseases are mainly caused by the lung which is in the upper energizer and mainly involves the skin and hair, so they are treated by the methods of dispersing and dispersing according to the guiding of the body. Therefore, the basic formula of the traditional Chinese medicine is asarum, biond magnolia flower, centipeda minima and xanthium sibiricum, and the asarum, the biond magnolia flower, the centipeda minima and the xanthium sibiricum are pungent and warm in nature and can disperse wind and remove cold and ventilate nasal orifices. For the case of aggravated block after drinking, flos Puerariae Lobatae and semen Hoveniae can be added to relieve hangover and activate spleen, herba Penthori chinensis can promote diuresis and remove dampness, remove blood stasis and relieve pain to regulate liver and regulate spleen. The medicines are combined to play the effects of freeing nasal orifices, dispelling wind and cold, regulating liver and dispelling alcohol effect and enlivening spleen, and the traditional Chinese medicine is particularly suitable for patients with vasomotor rhinitis and patients with severe obliteration after drinking.

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

The pharmaceutical composition for treating vasomotor rhinitis provided by the invention has the effects of dredging nasal orifices, dispelling wind and cold, regulating liver and dispelling alcohol effect and activating spleen, and has a remarkable curative effect on vasomotor rhinitis. The pharmaceutical composition for treating vasomotor rhinitis is not easy to relapse after rehabilitation, and has no other toxic or side effect in clinical manifestation during medication.

Detailed Description

The present invention will be described in further detail with reference to specific examples.