阅读说明：本技术 一种抗疫中药组合物及其制备方法与制药应用 (Epidemic-resistant traditional Chinese medicine composition, preparation method and pharmaceutical application thereof ) 是由 奚肇庆 束雅春 周贤梅 刘志辉 倪文澎 王中秋 汤忠华 芮庆林 周江 姜誉弘 于 2020-02-26 设计创作，主要内容包括：本发明公开了一种抗疫中药组合物,包含以下重量份的各个组分：羌活5～15份、紫苏叶5～30份、佩兰3～20份、藿香5～12份、麸炒苍术3～15份、柴胡3～15份、蜜枇杷叶3～12份、青蒿5～30份、薄荷2～12份、焦六神曲3～15份、甘草2～12份。相比较于现有技术,本发明针对病毒性上呼吸道感染疾病湿毒郁肺,脾胃失运的病因病机特点,设立此方辨证治疗；并且本发明中药复方制备工艺设计合理,绿色环保,可制备成各种剂型,方便使用。本申请组合物通过临床试验确定其具有显著疗效,具有广阔的市场应用前景。(The invention discloses an epidemic prevention traditional Chinese medicine composition which comprises the following components in parts by weight: 5-15 parts of notopterygium root, 5-30 parts of perilla leaf, 3-20 parts of fortune eupatorium herb, 5-12 parts of wrinkled gianthyssop herb, 3-15 parts of bran-fried rhizoma atractylodis, 3-15 parts of radix bupleuri, 3-12 parts of melia japonica leaf, 5-30 parts of sweet wormwood herb, 2-12 parts of mint, 3-15 parts of charred medicated leaven and 2-12 parts of liquorice. Compared with the prior art, the invention aims at the pathogenesis characteristics of viral upper respiratory tract infection diseases such as stagnation of damp toxin in the lung and dysfunction of the spleen and stomach, and establishes the dialectical treatment of the formula; the preparation process of the traditional Chinese medicine compound is reasonable in design, green and environment-friendly, can be prepared into various dosage forms, and is convenient to use. The composition has remarkable curative effect and wide market application prospect as determined by clinical tests.)

1. An anti-epidemic traditional Chinese medicine composition is characterized by comprising the following components in parts by weight: 5-15 parts of notopterygium root, 5-30 parts of perilla leaf, 3-20 parts of fortune eupatorium herb, 5-12 parts of wrinkled gianthyssop herb, 3-15 parts of bran-fried rhizoma atractylodis, 3-15 parts of radix bupleuri, 3-12 parts of melia japonica leaf, 5-30 parts of sweet wormwood herb, 2-12 parts of mint, 3-15 parts of charred medicated leaven and 2-12 parts of liquorice.

2. The epidemic prevention traditional Chinese medicine composition according to claim 1, which comprises the following components in parts by weight: 10 parts of notopterygium root, 10 parts of perilla leaf, 10 parts of eupatorium, 10 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of radix bupleuri, 10 parts of loquat leaf, 10 parts of sweet wormwood herb, 6 parts of mint, 12 parts of charred medicated leaven and 3 parts of liquorice.

3. The method for preparing the epidemic prevention Chinese medicinal composition of claim 1 or 2, which is characterized by comprising the following steps:

(1) distilling herba Menthae, herba Artemisiae Annuae, folium Perillae and Notopterygii rhizoma with water, separating and collecting volatile oil, and collecting residue;

(2) mixing the residue of step (1) with herba Eupatorii, herba Agastaches, rhizoma Atractylodis parched with bran, bupleuri radix, folium Eriobotryae, Massa Medicata Fermentata preparata and Glycyrrhrizae radix, decocting in water, and concentrating the decoction to obtain fluid extract; adding ethanol, refrigerating for 12-24 hr, filtering to obtain water extraction and ethanol precipitation solution, recovering ethanol, and concentrating to obtain extract;

(3) drying and crushing the extract obtained in the step (2), adding auxiliary materials and the volatile oil obtained in the step (1) to prepare a preparation.

4. The preparation method according to claim 3, wherein in the step (1), the amount of water added to the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root is 8-12 times of the weight of each component, and the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root are soaked for 0.5-1 hour and then distilled.

5. The preparation method according to claim 3, wherein in the step (2), the decoction dregs and the decoction pieces are combined and decocted for two times, the amount of water added for each time is at least 5 times of the weight of the decoction pieces, the decoction for each time is at least 0.5 hour, the two decoction liquids are combined and concentrated to obtain the clear paste with the relative density of 1.10-1.15.

6. The method according to claim 5, wherein the Eupatorium fortunei, Agastache rugosus, Atractylodes lancea rhizome stir-fried with bran, Bupleurum chinense, Eriobotrya japonica leaf, Massa Medicata Fermentata preparata and Glycyrrhizae radix are soaked in water for 0.5 hour in advance.

7. The preparation method according to claim 3, wherein in the step (2), ethanol is added into the clear paste to make the weight content of the ethanol be 60%, the mixture is uniformly mixed, refrigerated for 12-24 hours, filtered to obtain water extraction and ethanol precipitation solution, the ethanol is recovered, and the mixture is continuously concentrated to obtain the extract with the relative density of more than 1.30.

8. The method according to claim 3, wherein in the step (3), the preparation is granules, oral liquid, powder, tablets, capsules, pills, or the like.

9. Use of the epidemic prevention Chinese medicinal composition of claim 1 or 2 in the preparation of a medicament for treating viral upper respiratory infection.

10. Use of the epidemic prevention Chinese medicinal composition of claim 1 or 2 in combination with an antiviral agent in the preparation of a medicament for treating viral upper respiratory infection.

Technical Field

The invention belongs to the traditional Chinese medicine technology, and particularly relates to an epidemic prevention traditional Chinese medicine composition, and a preparation method and pharmaceutical application thereof.

Background

Since 12 th month in 2019, a plurality of novel patients with coronavirus pneumonia are discovered, and the cases occur secondarily worldwide along with the spread of epidemic situations. The new type coronavirus (2019-nCoV) is formally named as SARS-CoV-2 by the international committee for virus classification, and the resulting NCP is the B-type infectious disease in China and is brought into the management of the A-type infectious disease. The transmission way is a non-body fluid transmission way, and comprises transmission ways such as respiratory droplets, close contact, aerosol, digestive tract and the like, and the virus has strong infectivity and high serious risk.

The current epidemiological data suggest that the severity rate of the disease is about 2.7%, and most patients are light or common. At present, no effective antiviral drug is used for treating the disease, and no current clinical research data are published on potential anti-epidemic drugs based on SARS and MERS research results, such as Favipiravir, chloroquine phosphate, Reidesvir and the like. Therefore, the method has important significance for the research on the traditional Chinese medicine differentiation and treatment characteristics of the light or common type new coronary pneumonia. The curative effect evaluation data of the early traditional Chinese medicine for treating the new coronary pneumonia show that the traditional Chinese medicine has remarkable advantages for improving the symptoms of patients and shortening the recovery time. The novel coronavirus pneumonia belongs to the categories of epidemic diseases and pestilence in the traditional Chinese medicine. The history of traditional Chinese medicine diagnosis and treatment of pestilence diseases is long-running, and the "saying" the spreading characteristics of epidemic diseases in epidemic patients and people "indicates that the epidemic diseases are also spreading. Su Wen heritage, St.P. treatise on Style of academy of flexure (cloud): "all epidemic diseases are easily infected, have no question about the size and similar symptoms", wu jutong "Wen Bing" (differentiation of epidemic diseases): the epidemic disease is characterized by the infectivity and pathogenesis of epidemic diseases, such as epidemic disease, epidemic disease with foul odor, and home like work. Wu He can also be indicated in pestilence treatise: the disease is caused by cold, summer-heat and damp, and is caused by foreign qi in the world. The scope of 'six excesses' is broken through for the first time, the 'foreign qi' is clearly indicated as an important cause of the plague, meanwhile, the 'foreign qi' is also indicated as a disease, one qi becomes a disease, and the 'foreign qi' is emphasized to be different in types, different diseases are caused, and organ parts invaded by the 'foreign qi' are different.

The new type coronavirus (SARS-CoV-2) is structurally very similar to SARS-CoV and MERS-CoV, but the clinical syndromes and the onset characteristics of the diseases caused by them are different. The clinical characteristics of the novel coronavirus pneumonia and the research results of the traditional Chinese medicine syndromes are comprehensively analyzed, and the cold, heat, dampness and toxicity are main pathological factors of the early and middle stages of the pneumonia, wherein the dampness is the core of disease change, and the disease position is mainly in the lung and relates to the spleen and the stomach. The disease is caused by the end of the year 2019, and scholars analyze the disease as the pathogenic dampness-toxin according to the theory of five fortune and six qi. In clinical terms, patients often have symptoms of weakness, body weakness, expectoration, chest distress, poor appetite, loose stool, greasy tongue coating and the like, and the symptoms are consistent with the syndrome of dampness pathogen. In winter, damp pathogen is easy to combine with cold, while pathogenic factors of epidemic toxin have fire-heat property, and patients have different constitutions, so it can have different cold-dampness and damp-heat, which is the same as syndrome differentiation and classification part of TCM, "pneumonia treatment scheme for novel coronavirus infection (trial sixth edition). The leaf-tianshiyun' is warm and pathogenic factors are attacked first and invades the lung, and patients with new coronary pneumonia mostly have respiratory symptoms such as cough, expectoration, chest distress and the like, so the pathological changes are in the lung. However, the spleen governs transportation and transformation of water-dampness, and dampness-toxicity invades externally and stays internally in the spleen, so that dampness-toxicity is difficult to remove and lingering and difficult to heal due to dysfunction of transportation and transformation.

Disclosure of Invention

The purpose of the invention is as follows: aiming at the problems in the prior art, the invention provides an epidemic prevention traditional Chinese medicine composition, a preparation method and pharmaceutical application thereof.

The technical scheme is as follows: the epidemic prevention traditional Chinese medicine composition comprises the following components in parts by weight: 5-15 parts of notopterygium root, 5-30 parts of perilla leaf, 3-20 parts of fortune eupatorium herb, 5-12 parts of wrinkled gianthyssop herb, 3-15 parts of bran-fried rhizoma atractylodis, 3-15 parts of radix bupleuri, 3-12 parts of melia japonica leaf, 5-30 parts of sweet wormwood herb, 2-12 parts of mint, 3-15 parts of charred medicated leaven and 2-12 parts of liquorice.

Preferably, the epidemic prevention traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts of notopterygium root, 10 parts of perilla leaf, 10 parts of eupatorium, 10 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of radix bupleuri, 10 parts of loquat leaf, 10 parts of sweet wormwood herb, 6 parts of mint, 12 parts of charred medicated leaven and 3 parts of liquorice.

Further, the preparation method of the epidemic prevention traditional Chinese medicine composition comprises the following steps:

(1) distilling herba Menthae, herba Artemisiae Annuae, folium Perillae and Notopterygii rhizoma with water, separating and collecting volatile oil, and collecting residue;

(2) mixing the residue of step (1) with herba Eupatorii, herba Agastaches, rhizoma Atractylodis parched with bran, bupleuri radix, folium Eriobotryae, Massa Medicata Fermentata preparata and Glycyrrhrizae radix, decocting in water, and concentrating the decoction to obtain fluid extract; adding ethanol, refrigerating for 12-24 hr, filtering to obtain water extraction and ethanol precipitation solution, recovering ethanol, and concentrating to obtain extract;

(3) drying and crushing the extract obtained in the step (2), adding auxiliary materials and the volatile oil obtained in the step (1) to prepare a preparation.

In the step (1), the water adding amount of the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root is 8-12 times of the weight of each component, and the components are soaked for 0.5-1 hour and then distilled.

In the step (2), the decoction dregs and the decoction pieces are mixed and decocted for two times, the water adding amount is at least 5 times of the weight of the decoction pieces each time, the decoction is decocted for at least 0.5 hour each time, the decoction liquids in the two times are mixed, and the mixture is concentrated to clear paste with the relative density of 1.10-1.15. Wherein the eupatorium, the wrinkled gianthyssop herb, the rhizoma atractylodis stir-fried with bran, the radix bupleuri, the loquat leaf, the burnt medicated leaven and the liquorice are soaked in water for 0.5 hour in advance. Preferably, when the decoction is combined and decocted, the water adding amount of the two times is 8 times of the total decoction piece amount.

And (3) adding ethanol into the clear paste in the step (2) until the weight content of the ethanol is 60%, uniformly mixing, refrigerating for 12-24 hours, filtering to obtain water extraction and ethanol precipitation liquid, recovering the ethanol, and continuously concentrating to obtain an extract with the relative density of more than 1.30.

In the step (3), the extract is dried under reduced pressure and crushed into fine powder, corresponding auxiliary materials are added according to the requirements of dosage forms, and various oral dosage forms including granules, powder, tablets, capsules or pills are prepared by the conventional process; or directly diluting the extract with water, and making into oral liquid. Preferably, the preparation is granules, oral liquid or powder. Wherein, when preparing the granules, the obtained fine powder is mixed according to the proportion of 1: adding dextrin into the mixture according to the proportion of 1-3, uniformly mixing, preparing granules, drying and spraying the volatile oil separated in the step (1).

The application of the epidemic prevention traditional Chinese medicine composition in preparing the medicines for treating viral upper respiratory tract infection is also within the protection scope of the invention. The viral upper respiratory infection diseases comprise symptoms of fever (abnormal body temperature), cough, nasal obstruction, watery nasal discharge, nausea and the like.

The epidemic prevention traditional Chinese medicine composition is combined with an antiviral drug to be applied to preparation of a drug for treating viral upper respiratory infection. The antiviral drug is selected from: oseltamivir and the like.

The inventor establishes the dialectical treatment according to the formula, aims at the pathogenesis characteristics of the disease, and creates the Qiang Huo dampness-eliminating and plague-clearing mixture for treating the syndrome of the early and middle stage dampness-toxicity stagnation of the lung and the spleen and stomach transportation failure of the novel coronavirus pneumonia. In the formula, notopterygium root and rhizoma atractylodis, radix et rhizoma rhei and rhizoma atractylodis are monarch drugs for dispelling dampness; folium Perillae, herba Eupatorii, herba Agastaches, aromatic for removing filth, herba Artemisiae Annuae, bupleuri radix, and herba Menthae as ministerial drugs; loquat leaf and medicated leaven can ease qi of lung and spleen, and licorice root can coordinate the actions of the other drugs in the recipe, which are guiding drugs. The medicines are combined to play the role of eliminating dampness and clearing plague, and clinical tests prove that the traditional Chinese medicine has obvious curative effect.

The notopterygium root in the invention is derived from dried rhizome and root of notopterygium root or notopterygium root with wide leaves of Umbelliferae family. Has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, removing dampness, relieving pain, etc. Can be used for treating wind cold, headache, stiff neck, rheumatalgia, and soreness of shoulder and back. The main chemical components are active components such as coumarins, volatile oil and terpenes, sugar and glycosides, organic acid and phenols, polyacetylene, etc., wherein the volatile oil and terpenes, coumarins, organic acid and phenols in Notopterygii rhizoma are contained in large amount. The notopterygium root has various pharmacological activities, and modern researches show that the notopterygium root has obvious activities of resisting inflammation, oxidation, arrhythmia, bacteria, cancer cell proliferation, fever and pain, and the like.

The Perilla leaf is derived from dried leaves (or twigs with twigs) of Perilla frutescens (L.) Britt, which belongs to Labiatae, has the effects of relieving exterior syndrome, dispelling cold, promoting qi circulation, regulating stomach and the like, is used for treating cold, cough, vomit, vomiting of pregnancy, fish and crab poisoning, and has the pharmacological effects of (1) antibacterial and antiviral, (2) hemostatic effects, ① sedative and analgesic effects, (3) antioxidant effect and (4) antitumor effect.

Eupatorium fortunei is derived from the dried aerial part of Eupatorium fortunei Turcz. Has the effects of aromatizing, eliminating dampness, activating spleen, stimulating appetite, relieving exterior syndrome, relieving summer heat and the like. Can be used for treating damp obstruction in middle energizer, gastric fullness, emesis, halitosis, sialism, summer-heat, damp exterior syndrome, fever, listlessness, and chest distress. The eupatorium contains mainly volatile oil compounds, and has antiinflammatory, expectorant, and antitumor effects.

Herba Agastaches is derived from dried aerial parts of herba Agastaches of Labiatae. Has the functions of eliminating turbid pathogen with aromatics, regulating the middle warmer, relieving vomiting, relieving exterior syndrome, relieving summer heat, etc. Can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness exterior syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, summer-heat, abdominal pain, emesis, diarrhea, nasosinusitis, and headache. The agastache rugosus mainly contains volatile oil, flavonoid components, trace elements and other components, and the volatile oil is mostly a small molecular terpenoid compound, has strong fragrance and good pharmacological action. Modern researches show that agastache rugosus has the effects of protecting gastrointestinal tract, resisting pathogenic microorganisms, resisting inflammation, relieving pain, relieving fever, stopping vomiting, relieving cough, reducing phlegm, relaxing bowels, resisting oxidation and tumors, regulating immune system and the like.

Rhizoma Atractylodis is derived from dried rhizome of Atractylodes lancea DC or Atractylodes chinensis Koidz of Compositae. Has the effects of eliminating dampness, strengthening spleen, dispelling pathogenic wind, dispelling cold, improving eyesight, etc. Used for damp obstruction of middle energizer, abdominal distention, diarrhea, edema, tinea pedis, etc. . Rheumatic arthralgia, wind-cold type common cold, night blindness, dim eyesight and eye dryness. The chemical components of rhizoma atractylodis are mainly sesquiterpene, eneyne, triterpene, steroid, aromatic glycoside and the like. Modern researches prove that the rhizoma atractylodis has the effects of resisting inflammation, reducing blood sugar, resisting anoxia, resisting bacteria and viruses, protecting liver, regulating digestive system and nervous system, and the like.

The bupleuri radix is derived from dried root of Bupleurum scorzonerifolium DC or Bupleurum scorzonerifolium Willd. Has the effects of dispelling heat, relieving fever, soothing liver, relieving depression, and lifting yang qi. Can be used for treating common cold, fever, alternating chills and fever, distending pain in chest and hypochondrium, menoxenia, uterine prolapse, and proctoptosis. Modern pharmacological studies prove that the bupleurum has the effects of relieving fever, calming, easing pain, resisting inflammation, resisting bacteria, enhancing immunity, resisting depression, resisting tumors and the like.

The loquat leaves are derived from dry leaves of L ind. of Eriobotrya japonica (Thunb.) of Rosaceae, have the effects of clearing lung-heat, relieving cough, lowering adverse flow of qi, preventing vomiting and the like, and are used for treating cough with lung heat, asthma and dyspnea with rapid onset of the adverse flow of qi, vomiting due to stomach heat, dysphoria with smothery sensation and thirst.

The sweet wormwood herb is derived from dry overground part of Artemisia annua L belonging to Compositae, has the effects of removing deficiency-type heat, removing bone steaming, relieving summer-heat, preventing malaria, removing jaundice and the like, is used for warming pathogenic yin, relieving fever at night, cooling early, fever due to yin deficiency, bone steaming fever, fever due to summer-heat, malaria cold and heat, damp-heat jaundice and the like.

The mint is from dry overground part of mint Mentha haplocalyx Briq, which belongs to the family of Labiatae, has the effects of dispelling wind heat, clearing head and eyes, relieving sore throat, promoting eruption, soothing liver, promoting qi circulation and the like, is used for wind heat cold, early wind temperature, headache, conjunctival congestion, throat obstruction, aphtha, rubella, measles and chest and hypochondrium swelling, and the mint mainly comprises (1) mint oil and (2) nonvolatile components, namely ① phenolic compounds ② amino acids ③ microelements and the like, and modern researches show that the mint oil has the effects of ① cooling, relieving itching and promoting penetration of ③ of central nervous system ③ promoting effects of ④ on resisting early pregnancy, resisting nidation, inhibiting uterine contraction ⑤ and resisting fungi and viruses.

Medicated leaven is prepared by fermenting coarse powder of herba Polygoni Hydropiperis, herba Artemisiae Annuae, herba Xanthii, semen Phaseoli, and semen Armeniacae amarum, adding flour and testa Tritici. Has the effects of strengthening spleen and stomach, promoting digestion and regulating middle warmer. Can be used for treating food stagnation, chest distress, abdominal distention, emesis, dysentery, and infantile abdominal mass. Contains digestive enzyme, vitamin B complex, ergosterol, volatile oil, flavonoid and glycoside. Modern researches show that the compound has various pharmacological activities of enhancing gastrointestinal motility, promoting gastric acid secretion, improving intestinal flora disorder, promoting intestinal movement and the like.

The licorice is from dried root and rhizome of Glycyrrhiza inflata Fisch, Leguminosae, and Glycyrrhiza glabra Glabra L, and has the effects of invigorating spleen, benefiting qi, clearing away heat and toxic materials, eliminating phlegm, relieving cough, relieving spasm and pain, and harmonizing the effects of the above drugs.

Has the advantages that: compared with the prior art, the invention aims at the pathogenesis characteristics of viral upper respiratory tract infection diseases such as stagnation of damp toxin in the lung and dysfunction of the spleen and stomach, and establishes the dialectical treatment of the formula; the preparation process of the traditional Chinese medicine compound is reasonable in design, green and environment-friendly, can be prepared into various dosage forms, and is convenient to use. The composition has remarkable curative effect and wide market application prospect as determined by clinical tests.

Detailed Description

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