阅读说明：本技术 一种中药复方组合物的制备及其治疗上呼吸道感染的应用 (Preparation of traditional Chinese medicine compound composition and application thereof in treating upper respiratory tract infection ) 是由 谭余庆 刘丽 梁烽焱 张�浩 黄灿林 潘洁丽 于 2019-11-04 设计创作，主要内容包括：本发明属于中药技术领域,具体涉及一种中药复方组合物的制备及其治疗上呼吸道感染的应用。本发明的中药复方组合物,包括以下重量份的组分：挥发油包合物20～40份、中药提取物200～300份、甜味剂0.5～6份、硬脂酸镁3～10份、香精2～10份,蔗糖粉,共1000份。本发明通过优选黄芩、连翘、香薷、广藿香、忍冬藤、野菊花、青蒿和三叉苦八味中药作为制备本发明中药复方组合物的药材,对不同的中药施以不同的提取方法,得到固体粉末后与甜味剂、硬脂酸镁、香精等进行干压制粒而得。本发明提供的中药复方组合物制备得到的药物能够有效治疗上呼吸道感染中的常见病毒,具有抗病毒、解热、镇痛、抗炎等有益效果。(The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method of a traditional Chinese medicine compound composition and application of the traditional Chinese medicine compound composition in treating upper respiratory tract infection. The traditional Chinese medicine compound composition comprises the following components in parts by weight: 20-40 parts of volatile oil inclusion compound, 200-300 parts of traditional Chinese medicine extract, 0.5-6 parts of sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder. The invention selects eight traditional Chinese medicines of scutellaria baicalensis, forsythia suspensa, elsholtzia, pogostemon cablin, honeysuckle stem, wild chrysanthemum, sweet wormwood herb and thin evodia leaf as medicinal materials for preparing the traditional Chinese medicine compound composition, different traditional Chinese medicines are subjected to different extraction methods to obtain solid powder, and the solid powder, the sweetener, magnesium stearate, essence and the like are subjected to dry pressing and granulation to obtain the traditional Chinese medicine compound composition. The medicine prepared from the traditional Chinese medicine compound composition provided by the invention can effectively treat common viruses in upper respiratory tract infection, and has the beneficial effects of resisting viruses, relieving fever, easing pain, resisting inflammation and the like.)

1. The traditional Chinese medicine compound composition is characterized by comprising the following components in parts by weight: the volatile oil clathrate compound comprises, by weight, 20-40 parts of a volatile oil clathrate compound, 200-300 parts of traditional Chinese medicine extracts, 0.5-6 parts of a sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder, wherein the volatile oil clathrate compound is obtained by clathrating oily extracts of herba elsholtziae and pogostemon cablin by a cyclodextrin colloid milling method, and the traditional Chinese medicine extracts are water-decocted extracts of scutellaria baicalensis, fructus forsythiae, honeysuckle stems, wild chrysanthemum flowers, sweet wormwood herbs and bitter trigeminal herbs.

2. The traditional Chinese medicine compound composition according to claim 1, which is characterized by comprising the following components in parts by weight: 30-35 parts of volatile oil inclusion compound, 250-300 parts of traditional Chinese medicine extract, 1.2-2 parts of sweetening agent, 5-7 parts of magnesium stearate, 4-5 parts of essence and 1000 parts of sucrose powder.

3. The compound traditional Chinese medicine composition of claim 1, wherein the volatile oil inclusion compound comprises volatile oil and cyclodextrin, the weight ratio of the volatile oil to the cyclodextrin is 1: 10-20, and the raw materials of the volatile oil comprise, by weight, 400-650 parts of elsholtzia and 400-600 parts of pogostemon cablin.

4. The compound traditional Chinese medicine composition as claimed in claim 3, wherein the cyclodextrin is β -cyclodextrin.

5. The compound traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 350-600 parts of scutellaria baicalensis, 400-600 parts of fructus forsythiae, 700-900 parts of honeysuckle stem, 400-650 parts of wild chrysanthemum flower, 300-600 parts of sweet wormwood and 400-600 parts of thin evodia.

6. The compound traditional Chinese medicine composition as claimed in claim 5, wherein the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 400-500 parts of scutellaria baicalensis, 450-550 parts of fructus forsythiae, 750-850 parts of honeysuckle stem, 500-550 parts of wild chrysanthemum flower, 450-520 parts of sweet wormwood herb and 450-550 parts of trifoliate bitter herb.

7. The compound traditional Chinese medicine composition of claim 1, wherein the sucrose powder has a mesh size of 80-120 meshes.

8. The preparation method of the traditional Chinese medicine compound composition according to claim 1, which is characterized by comprising the following steps: taking the sweetening agent, the magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the essence and the sucrose powder according to the formula ratio, mixing uniformly, and performing dry pressing and granulation to obtain the compound.

9. The preparation method of the traditional Chinese medicine compound composition according to claim 8, wherein the preparation method of the volatile oil clathrate compound comprises the following steps: s1, adding water, and extracting herba Moslae and herba Agastaches by steam distillation to obtain volatile oil; s2, including the volatile oil obtained in the step S1 with cyclodextrin, drying and crushing to obtain a volatile oil inclusion compound; s3, decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb, thin evodia leaf and radix scutellariae with water to obtain decoction, filtering the decoction, and concentrating the decoction to obtain extract with the relative density of 1.10-1.14 at 50 ℃; s4, adding ethanol into the extract obtained in the step S3, standing, filtering, concentrating to form thick paste with the relative density of 1.25-1.30 at 50 ℃, drying, and crushing to obtain the traditional Chinese medicine extract.

10. The use of a compound Chinese medicinal composition according to any one of claims 1 to 7 for the treatment of upper respiratory tract infections.

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method of a traditional Chinese medicine compound composition and application of the traditional Chinese medicine compound composition in treating upper respiratory tract infection.

Background

Upper respiratory tract infections are inflammations of the upper respiratory tract caused by viral infections. Clinically, it is manifested as fever, aversion to cold, nasal obstruction, nasal discharge, sneezing, headache, and pharyngalgia. Belongs to the category of 'cold' in traditional Chinese medicine. Common cold is a common clinical disease, which occurs all the year round, especially in winter and spring, and especially in alternate seasons and sudden climate change, the incidence rate is higher. The patients with cold only show symptoms of nasal obstruction, watery nasal discharge, sneezing and the like in light patients, symptoms of high fever, headache, body pain and the like in heavy patients, and even more serious patients can cause deficiency of vital qi after cold, and diseases such as acute bronchitis, pneumonia, nasosinusitis, neuritis and the like are caused secondarily, so that the life is threatened, the work and life of the patients are seriously influenced, and the pain is brought to the patients.

At present, no specific treatment method for upper respiratory tract infection caused by virus is available in Western medicine, and symptomatic or supportive treatment is mainly adopted, and antiviral drugs such as ribavirin and the like are commonly used in Western medicine for symptomatic treatment. The antiviral drug is easy to generate drug resistance after being taken for a long time, and particularly for people with special physique, such as children, pregnant women and old people, the antiviral drug is easy to induce various adverse symptoms such as gastrointestinal discomfort, nausea, vomiting and the like when being used for treating cold. At this time, the upper respiratory tract infection is safer to treat by selecting the traditional Chinese medicine, and the traditional Chinese medicine can treat both symptoms and root causes. Although various Chinese patent medicines for treating upper respiratory tract infection exist in the prior art, compared with western medicines, the Chinese patent medicines are few in types and limited in selection, and have the defects of long treatment period, poor antiviral, antipyretic, analgesic and anti-inflammatory effects and the like. In addition, in the upper respiratory tract infection, most patients have complications such as fever and inflammation, and at the moment, in order to relieve symptoms such as fever and inflammation through taking medicines, various western medicines need to be taken to solve the problem, and the western medicines can damage the liver and the kidney of the human body to a certain extent. Therefore, there is an urgent need to develop a Chinese medicinal composition that can clinically act on upper respiratory symptoms.

Disclosure of Invention

In order to overcome the problems in the prior art, the invention provides a traditional Chinese medicine compound composition which can effectively relieve upper respiratory tract infection symptoms such as cold and the like and has good antiviral, antipyretic, analgesic and anti-inflammatory effects and a preparation method thereof, so as to solve the defects in the prior art.

In order to realize the purpose of the invention, the invention provides a traditional Chinese medicine compound composition which comprises the following components in parts by weight: the volatile oil clathrate compound comprises, by weight, 20-40 parts of a volatile oil clathrate compound, 200-300 parts of traditional Chinese medicine extracts, 0.5-6 parts of a sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder, wherein the volatile oil clathrate compound is obtained by clathrating oily extracts of herba elsholtziae and pogostemon cablin by a cyclodextrin colloid milling method, and the traditional Chinese medicine extracts are water-decocted extracts of scutellaria baicalensis, fructus forsythiae, honeysuckle stems, wild chrysanthemum flowers, sweet wormwood herbs and bitter trigeminal herbs.

Further, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 30-35 parts of volatile oil inclusion compound, 250-300 parts of traditional Chinese medicine extract, 1.2-2 parts of sweetening agent, 5-7 parts of magnesium stearate, 4-5 parts of essence and 1000 parts of sucrose powder.

Preferably, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 34 parts of volatile oil inclusion compound, 266 parts of traditional Chinese medicine extract, 2 parts of sweetener, 5 parts of magnesium stearate, 4 parts of essence and 689 parts of sucrose powder.

Further, the volatile oil inclusion compound comprises volatile oil and cyclodextrin, the weight ratio of the volatile oil to the cyclodextrin is 1: 10-20, and the raw materials of the volatile oil comprise, by weight, 400-650 parts of elsholtzia and 400-600 parts of pogostemon cablin.

Preferably, the weight ratio of the volatile oil to the cyclodextrin is 1: 16.

Preferably, the Chinese mosla herb is 450-550 parts by weight, and the patchouli is 450-550 parts by weight.

Preferably, the Chinese mosla herb is 500 parts by weight, and the patchouli is 500 parts by weight.

Further, the cyclodextrin is β -cyclodextrin.

Further, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 350-600 parts of scutellaria baicalensis, 400-600 parts of fructus forsythiae, 700-900 parts of honeysuckle stem, 400-650 parts of wild chrysanthemum flower, 300-600 parts of sweet wormwood and 400-600 parts of thin evodia.

Further, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 450-500 parts of scutellaria baicalensis, 450-550 parts of fructus forsythiae, 750-850 parts of honeysuckle stem, 500-550 parts of wild chrysanthemum flower, 450-520 parts of sweet wormwood herb and 450-550 parts of trifoliate bitter herb.

Preferably, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 500 parts of scutellaria baicalensis, 500 parts of fructus forsythiae, 833.3 parts of honeysuckle stem, 500 parts of wild chrysanthemum flower, 500 parts of sweet wormwood and 500 parts of thin evodia.

Furthermore, the mesh number of the sucrose powder is 80-120 meshes.

The invention also provides a preparation method of the traditional Chinese medicine compound composition, which comprises the following steps: taking the sweetening agent, the magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the essence and the sucrose powder according to the formula ratio, mixing uniformly, and performing dry pressing and granulation to obtain the compound.

Further, the preparation method of the volatile oil inclusion compound comprises the following steps: s1, adding water, and extracting herba Moslae and herba Agastaches by steam distillation to obtain volatile oil; s2, including the volatile oil obtained in the step S1 with cyclodextrin, drying and crushing to obtain a volatile oil inclusion compound;

further, the preparation method of the traditional Chinese medicine extract comprises the following steps: s3, decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb, thin evodia leaf and radix scutellariae with water to obtain decoction, filtering the decoction, and concentrating the decoction to obtain extract with the relative density of 1.10-1.14 at 50 ℃; s4, adding ethanol into the extract obtained in the step S3, standing, filtering, concentrating to form thick paste with the relative density of 1.25-1.30 at 50 ℃, drying, and crushing to obtain the traditional Chinese medicine extract.

Preferably, in step S1, the weight of water is 6 times of the weight of the elsholtzia and pogostemon cablin.

Further, in step S1, the extraction time is 3-5 h.

Preferably, in step S1, the extraction time is 4 h.

Further, in step S3, the number of times of water decoction is 2, the first time of decoction is added with 6-10 times (by weight) of water, and the decoction is carried out for 1-3 hours, the second time of decoction is added with 5-8 times (by weight) of water, and the decoction is carried out for 1-3 hours, and the decoctions are combined to obtain a decoction, and the decoction is filtered and concentrated to an extract with a relative density of 1.10-1.14 at 50 ℃; in step S3, the charging sequence of the traditional Chinese medicines is as follows: decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb and thin evodia leaf in water until the temperature of a water extracting solution reaches 85-95 ℃, and then adding scutellaria baicalensis.

Preferably, in step S3, the number of times of water decoction is 2, 8 times of water is added for the first time of decoction and 1.5 hours of decoction, 6 times of water is added for the second time of decoction and 1.5 hours of decoction, the decoctions are combined to obtain a decoction, the decoction is filtered and concentrated to an extract with a relative density of 1.10-1.14 at 50 ℃; in step S3, the charging sequence of the traditional Chinese medicines is as follows: decocting fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, and thin Evodia in water, adding Scutellariae radix when the water extractive solution reaches 90 deg.C.

Further, in step S4, the volume ratio of the ethanol to the extract is 6-10: 3.

Preferably, in step S4, ethanol is added to the extract in step S3, and the volume ratio of the ethanol to the extract is 7: and 3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, vacuum-drying at 75 ℃, and crushing.

The invention also provides application of the traditional Chinese medicine compound composition in a medicine for treating upper respiratory tract infection.

Further, the preparation form of the medicine is liquid preparation, tablet, capsule, granule, pill, powder or paste.

Scutellaria baicalensis: the product is prepared from plants of Scutellaria of Labiatae; bitter and cold; it enters lung, gallbladder, spleen, stomach, large intestine and small intestine meridians; has effects in clearing away heat, eliminating dampness, purging pathogenic fire, removing toxic substances, stopping bleeding, and preventing miscarriage; it can be used for treating chest distress, emesis, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion.

Fructus forsythiae: the product is fruit of Forsythia suspensa (Thunb.) Vahl) belonging to the family Oleaceae; bitter and slightly cold; it enters lung, heart and gallbladder meridians; has the effects of clearing away heat and toxic materials, eliminating carbuncle and resolving hard mass, and can be used for treating affection of exogenous wind-heat, fever due to epidemic febrile disease, pyocutaneous disease, swelling and pain, and lymphoid tuberculosis.

Herba Moslae: the product is prepared from plants of Elsholtzia of Labiatae; pungent taste and slightly warm nature; entering lung and stomach meridians; has effects of inducing sweat, relieving exterior syndrome, eliminating dampness, regulating the middle warmer, inducing diuresis, and relieving edema, and can be used for treating summer-heat and dampness exterior syndrome, edema and dysuresia.

Patchouli: the product is Labiatae plant, perennial upright plant of herbaceous plant; pungent and mild-warm; spleen, stomach and lung meridians entered; has the effects of eliminating turbid pathogen with aromatics, regulating the middle warmer, relieving vomit, relieving exterior syndrome, and relieving summer-heat; it can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, summer-heat, abdominal pain, emesis, diarrhea, nasosinusitis, headache, etc.

Honeysuckle stem: the product is a plant belonging to Caprifoliaceae of Rubiales; sweet and cold; entering heart and lung meridians; has effects of clearing away heat and toxic materials, and dredging collaterals; it is mainly used for treating fever due to epidemic febrile disease, dysentery with bloody stool due to heat toxin, infectious hepatitis, carbuncle, swelling, sore, and arthralgia and myalgia.

Wild chrysanthemum flower: the product is perennial herb of Compositae; bitter, pungent and slightly cold; entering liver and heart meridians; has effects of clearing away heat and toxic materials, purging pathogenic fire, and calming liver; it can be used for treating furuncle, carbuncle, swelling, conjunctival congestion, swelling and pain, headache, and vertigo.

Sweet wormwood herb: the product is dried aerial part of Artemisia annua L of Compositae; bitter, pungent and cold; it enters liver and gallbladder meridians; has effects in clearing away summer-heat, removing steam, and preventing malaria; can be used for treating fever due to summer-heat, fever due to yin deficiency, night fever with early coolness, malaria with cold and heat, damp-heat jaundice, etc.

Bitter taste in trigeminal: the product is Rutaceae plant; bitter taste and cold nature; the Chinese medicinal composition has effects of clearing away heat and toxic materials, dispelling pathogenic wind, and removing dampness; can be used for treating swelling and pain of throat, rheumatalgia, malaria, jaundice, eczema, dermatitis, traumatic injury, insect bite, snake bite, etc.

The applicant discovers that main chemical components in the sweet wormwood comprise flavonoids, coumarins, terpenoids, phenylpropanoids, various volatile oils, coumarins scopoletin and the like through component analysis of eight traditional Chinese medicines, wherein most of the chemical components in the sweet wormwood extract are fat-soluble, and the applicant discovers that the effect of water-soluble components in the sweet wormwood extract on upper respiratory infection symptoms is more remarkable than that of the fat-soluble components in the test process. The eight traditional Chinese medicines are classified, and volatile oil extracted from the elsholtzia and the patchouli is included by cyclodextrin, so that effective ingredients acting on upper respiratory tract infection in the elsholtzia and the patchouli can be better reserved.

Therefore, compared with the prior art, the traditional Chinese medicine compound composition has the following beneficial effects:

(1) the traditional Chinese medicine compound composition has good inhibition effect on H1N1 influenza virus (FM1/PR8 strain) and respiratory syncytial virus, can obviously reduce the virus expression level, and has good effect when being applied to the preparation of the medicine for treating upper respiratory infection.

(2) Compared with western medicines, the traditional Chinese medicine compound composition also has good antipyretic, analgesic and anti-inflammatory effects. Compared with western medicines, the antipyretic, analgesic and anti-inflammatory effects can be realized by patients without taking various medicines, and the safety of medication is greatly improved.

Detailed Description

The present invention is further illustrated by the following description of specific embodiments, which are not intended to limit the invention, and various modifications and improvements can be made by those skilled in the art based on the basic idea of the invention, but within the scope of the invention, without departing from the basic idea of the invention.