WO2021155751A1 - 一种具有清肺排毒功能的中药复方及其应用 - Google Patents

一种具有清肺排毒功能的中药复方及其应用 Download PDF

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WO2021155751A1
WO2021155751A1 PCT/CN2021/073829 CN2021073829W WO2021155751A1 WO 2021155751 A1 WO2021155751 A1 WO 2021155751A1 CN 2021073829 W CN2021073829 W CN 2021073829W WO 2021155751 A1 WO2021155751 A1 WO 2021155751A1
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chinese medicine
decoction
traditional chinese
medicine compound
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葛又文
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中国中医科学院中医临床基础医学研究所
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Priority to JP2022546454A priority Critical patent/JP7424684B2/ja
Priority to CA3168659A priority patent/CA3168659A1/en
Priority to KR1020227028314A priority patent/KR20220137663A/ko
Publication of WO2021155751A1 publication Critical patent/WO2021155751A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/17—Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A—HUMAN NECESSITIES
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    • A61K36/06—Fungi, e.g. yeasts
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Definitions

  • the invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine compound with functions of clearing lungs and detoxification.
  • Viral pneumonia is the inflammation of the upper respiratory tract that spreads down to the lower respiratory tract, until the bronchi and lungs. Influenza virus infection is the most common.
  • 2019-nCoV 2019-nCoV
  • 2019-nCoV World Health Organization
  • Symptoms of the virus are generally fever, fatigue, dry cough, and gradual dyspnea and other viral pneumonia symptoms. In severe cases, it manifests as acute respiratory distress syndrome, septic shock, and difficult to correct metabolic acidosis and coagulation dysfunction.
  • the virus has been confirmed to have human-to-human transmission, the incubation period is infectious, and the disease caused by it has no specific treatment.
  • the purpose of the present invention is to provide a traditional Chinese medicine compound with functions of clearing lungs and detoxification and its application, so as to realize the treatment of viral pneumonia, especially for the 2019 new coronavirus and its mutant viruses.
  • the resulting viral pneumonia provides an effective treatment plan.
  • the present invention provides a traditional Chinese medicine compound with functions of clearing lungs and detoxification. Its raw materials include the following Chinese medicinal materials by weight:
  • the prescriptions of the traditional Chinese medicine compound of the present invention refer to Zhang Zhongjing's "Treatise on Febrile and Miscellaneous Diseases" in Han Dynasty, a classic work of traditional Chinese medicine, consisting of Mahuang Almond Gancao Gypsum Decoction (referred to as Maxing Shigan Decoction, Treatise on Febrile Diseases 63) and Xiao Chaihu Decoction (Treatise on Febrile Diseases 96) , Wulingsan (Treatise on Febrile Diseases 71), Shegan Mahuang Decoction (Synopsis of the Golden Chamber. Lung wilt, Lung carbuncle, Cough, Shangqi disease, pulse syndrome and treatment seventh).
  • the Chinese yam, Citrus aurantium, tangerine peel and Huoxiang in the recipe are for the addition and subtraction of the clinical symptoms of pneumonia caused by the new coronavirus infection.
  • Maxing Shigan Decoction to promote the lungs through evil Wuling powder to dispel dampness and turbidity, to benefit the triple burn, wet urine, so that moisture from the pores and urine is removed; Xiao Chaihu Decoction to comb Shaoyang cardinal; Shegan Mahuang Decoction Phenomenon drink the qi to relieve cough; Huoxiang, Zhishi, and tangerine peel regulate the spleen and stomach qi, the aroma promotes qi and turbidity, so that the turbidity in the chest and abdomen is eliminated and the breathing is smooth; there are more yam to replenish the spleen and kidney, and support the right qi.
  • the whole prescription has the effects of dispelling dampness and turbidity, clearing the lungs through evil, and reconciling qi.
  • the raw materials of the traditional Chinese medicine compound include the following Chinese medicinal materials in parts by weight: 9 parts of ephedra, 6 parts of roasted licorice, 9 parts of almonds, 15-30 parts of raw gypsum, 9 parts of cinnamon sticks, 9 parts of Alisma, 9 parts of Polyporus umbellatus , 9 parts of Atractylodes macrocephala, 15 parts of Poria cocos, 16 parts of Bupleurum, 6 parts of Scutellaria baicalensis, 9 parts of Ginger Pinellia 9 parts, 9 parts of Ginger, 9 parts of Asters, 9 parts of Winter Flower, 9 parts of Shegan, 6 parts of Asarum, 12 parts of Chinese Yam, Citrus aurantium 6 parts, 6 parts of tangerine peel, 9 parts of Huoxiang.
  • Chinese medicinal materials in parts by weight: 9 parts of ephedra, 6 parts of roasted licorice, 9 parts of almonds, 15-30 parts of raw gypsum, 9 parts of cinnamon sticks, 9 parts of A
  • the amount of gypsum can be adjusted according to whether the patient has a fever. If the patient does not have a fever, the dosage of the gypsum should be small, and if the patient has a fever or strong heat, the dosage of the gypsum should be increased.
  • the dosage form of the traditional Chinese medicine compound can be decoction (decoction), granule, ointment, pill, powder, pill or tablet, but it is not limited thereto.
  • the specific preparation method of the above dosage forms can be carried out by conventional preparation methods in the art, and it is preferable to use water decoctions and granules to exert the therapeutic effect of the medicine.
  • the present invention takes water decoction (decoction) and granules as examples in the optional dosage forms of the above-mentioned Chinese medicine compound to further illustrate the preparation of a Qingfei Paidu Decoction and a Qingfei Paidu Granule method.
  • a Qingfei Paidu Granule preparation method includes the following steps:
  • Decoction Weigh various Chinese medicinal materials according to the above-mentioned Chinese medicine compound, first take the raw gypsum, add water to decoct, then add the remaining 20 Chinese medicinal materials, and then add water to decoct to obtain a decoction liquid;
  • the Chinese medicinal materials used are Chinese medicinal pieces.
  • the present invention provides the application of the traditional Chinese medicine compound in the preparation of drugs with the efficacy of clearing lungs and detoxification, especially in the preparation of drugs for the treatment of pneumonia caused by novel coronavirus infection.
  • the present invention further provides the use of the traditional Chinese medicine compound as a medicine for treating pneumonia caused by virus infection.
  • the present invention provides the application of the traditional Chinese medicine compound in the preparation of medicines for the treatment of pneumonia caused by viral infections.
  • the present invention provides the application of the Chinese medicine compound (and the aforementioned Qingfei Paidu Decoction or the aforementioned Qingfei Paidu Granules) in the treatment of viral pneumonia, especially in the treatment of infection caused by the new coronavirus 2019-nCoV Application in pneumonia.
  • the method of use of the traditional Chinese medicine compound is: decocting in water, one pair a day, twice in the morning and evening (forty minutes after a meal), and taking it warmly. If possible, take half a bowl of rice soup after each pair of medicines, and up to one bowl for those with dry tongue and body fluid deficiency. Three pairs of a course of treatment. It is recommended that patients take a full course of treatment according to the original prescription, and take a second course of treatment if symptoms improve but not cured. If the patient has special conditions or other underlying diseases, the second course of treatment can be modified according to the actual situation, and the drug will be discontinued if the symptoms disappear.
  • the raw materials of Chinese medicinal materials involved in the present invention are all common commercially available products, and the operations involved are routine operations in the field unless otherwise specified.
  • the present invention combines the disease symptoms of the "new coronavirus pneumonia” this time, and believes that pneumonia infected by the new coronavirus (2019-nCoV) belongs to the category of "cold disease” in traditional Chinese medicine, and damp pathogens prevail.
  • the main disease is in the lungs, followed by the surface guard, spleen and stomach; the main cause is the combination of Fuzao and dampness and cold.
  • the main pathogenesis is the dampness and coldness of the epidemic virus and the congestion of Fuzao, leading to blockage of the Qi machine and abnormal movements.
  • the present invention provides the aforementioned Chinese medicine compound, which utilizes a variety of Chinese medicines to optimize fusion and co-administer the treatment. Judging from the current treatment of diagnosed patients of different ages in many provinces and places, the curative effect is definite. Related clinical observation and research are ongoing.
  • the Chinese medicine compound (Qingfei Paidu Decoction) provided by the present invention is used in the emergency scientific research project of the State Administration of Traditional Chinese Medicine "Clinical Screening Study of Effective Chinese Medicine Compounds for Preventing and Treating New Coronavirus Pneumonia", and is currently being carried out in conjunction with clinical treatment Clinical observation work and related research are continuing to advance.
  • This prescription is suitable for light, common, and heavy patients. It can also be used reasonably in combination with the actual conditions of the patients in the treatment of critically ill patients, and has good social benefits.
  • This example is used to illustrate Qingfei Paidu Decoction (water decoction) and its preparation method.
  • the dosage of raw gypsum is adjusted within the above dosage range according to whether the patient has a fever. If the patient does not have a fever, the dosage of the raw gypsum should be small, and if the patient has a fever or strong heat, the dosage of the raw gypsum should be increased.
  • This example is used to illustrate Qingfei Paidu Granules and the preparation method thereof.
  • Decoction Weigh each Chinese medicinal material according to the above-mentioned Chinese medicine compound, first take the raw gypsum, add water to decoc, then add the remaining 20 Chinese medicinal materials, and then add water to decoc to obtain the decoction liquid;
  • the Qingfei Paidu granules prepared in this embodiment have a better industrial production prospect, are conducive to storage and transportation, and are easy to achieve a wider range of popularization and application.
  • the Qingfei Paidu Decoction was prepared by the preparation method described in Example 1. In a pair of medicine, each Chinese medicinal material was weighed at 1 g per part by weight.
  • the Qingfei Paidu Decoction was prepared by the preparation method described in Example 1. In a pair of medicine, each Chinese medicinal material was weighed at 1 g per part by weight.
  • This experimental example uses the Qingfei Paidu Granules prepared in Example 5 to conduct a drug safety test to prove the safety of the traditional Chinese medicine compound of the present invention.
  • the acute toxicity of Qingfei Paidu Granules administered to mice was evaluated. Observe the death of the animal after the test substance is given, and determine its maximum tolerable dose; and continuously observe the toxicity symptoms and their degree, and the time when the toxicity appears and disappear within 14 days, so as to provide references for other safety evaluation tests and clinical trials.
  • ICR mice weighing 18-21g were randomly divided into 7 groups according to fasting weight: the control group and Qingfei Paidu Granules 104.5, 122.9, 144.6, 170.1, 20.2, 235.5g crude drug/kg 6 dose groups, each Group of 20 animals, half male and half male. After fasting for about 15 hours, each administration group was given intragastrically once with a volume of 40mL/kg, and the control group was given intragastrically with equal volume of purified water once a day. After administration, the observation was continued for 14 days, on the 15th day. After fasting, the surviving animals were subjected to necropsy.
  • mice were weighed on the 1, 2, 3, 5, 7, 10, and 14 days after the administration, and the mice were fasted after the observation period on the 14th day, and the surviving animals were subjected to necropsy as above.
  • Qingfei Paidu Granules were administered to animals at a dose of 104.5, 122.9, 144.6, 170.1, 200.2, 235.5g crude drug/kg, once a day, and the main toxic reactions that could be observed were diarrhea and abnormal activity (including reduction of spontaneous activity). Or increase, lying still, etc.), startle reflex, tremor and acute death.
  • the Chinese medicine compound with the functions of clearing lungs and detoxification disclosed in the present invention with reference to Zhang Zhongjing's "Treatise on Febrile and Miscellaneous Diseases" in the Han Dynasty classic of Chinese medicine, consists of Mahuang Almond Gancao Gypsum Decoction (referred to as Maxing Shigan Decoction, Treatise on Febrile Diseases 63) and Xiao Chaihu Decoction (Treatise on Febrile Diseases) Lun 96), Wuling San (Shanghan Lun 71), Shegan Mahuang Decoction (Golden Chamber Synopsis. Lung wilt, Lung carbuncle, Cough, Cough, Shangqi disease, pulse treatment seventh). The treatment has obvious effect on the symptoms of the new type of coronavirus pneumonia COVID-19.

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Abstract

一种具有清肺排毒功能的中药复方，由如下重量份的中药材制成：麻黄8-10份、炙甘草5-8份、杏仁8-10份、生石膏15-30份、桂枝8-10份、泽泻8-10份、猪苓8-10份、白术8-10份、茯苓15份、柴胡15-18份、黄芩5-8份、姜半夏8-10份、生姜8-10份、紫菀8-10份、冬花8-10份、射干8-10份、细辛5-8份、山药10-14份、枳实5-8份、陈皮5-8份、藿香8-10份，所述中药复方对新型冠状病毒感染而出现的肺炎症状具有显著的治疗效果。

Description

一种具有清肺排毒功能的中药复方及其应用 技术领域
本发明涉及中药组合物，具体地说，涉及一种具有清肺排毒功能的中药复方。
背景技术
病毒性肺炎(Viral pneumonia)是上呼吸道感染病毒后，向下蔓延至下呼吸道，直至支气管、肺部的炎症，以流行性感冒病毒感染最常见。
然而，2020年1月12日被世界卫生组织正式命名为2019-nCoV的2019新型冠状病毒，是在人体中发现的冠状病毒新毒株。该病毒症状一般为发热、乏力、干咳、逐渐出现呼吸困难等病毒性肺炎症状，严重者表现为急性呼吸窘迫综合征，脓毒症休克，以及难以纠正的代谢性酸中毒和凝血功能障碍。该病毒已确认存在人传人现象，潜伏期具有传染性，所致疾病没有特效的治疗方法。
截至本申请的申请日前，已于多个国家发现新型变异新冠病毒，但目前所开发的新冠病毒疫苗对变异新冠病毒的有效性尚未得到确认。因此，研究开发能够有效治疗新冠病毒肺炎的药物具有极大的必要性。
发明内容
为了解决现有技术中存在的问题，本发明的目的是提供一种具有清肺排毒功能的中药复方及其应用，以实现对病毒性肺炎的治疗，尤其是为2019新型冠状病毒及其变异病毒所导致的病毒性肺炎提供有效的治疗方案。
为了实现本发明目的，本发明的技术方案如下：
第一方面，本发明提供一种具有清肺排毒功能的中药复方，其原料包括如下重量份的中药材：
麻黄8-10份、炙甘草5-8份、杏仁8-10份、生石膏15-30份、桂枝8-10份、泽泻8-10份、猪苓8-10份、白术8-10份、茯苓15份、柴胡15-18份、黄芩5-8份、姜半夏8-10份、生姜8-10份、紫苑8-10份、冬花8-10份、射干8-10份、细辛5-8份、山药10-14份、枳实5-8份、陈皮5-8份、藿香8-10份。
本发明所述中药复方的组方，参考中医经典著作汉代张仲景《伤寒杂病论》，由麻黄杏仁甘草石膏汤(简称麻杏石甘汤，伤寒论63)、小柴胡汤(伤寒论96)、五苓散(伤寒论71)、射干麻黄汤(金匮要略.肺萎肺痈咳嗽上气病脉证治第七)加减化裁而成。方中的山药、枳实、陈皮和藿香，是针对本次新型冠状病毒感染的肺炎临床症状加减。
其中，麻杏石甘汤宣肺透邪；五苓散化湿祛浊，通利三焦，湿走小便，使得湿气从毛孔与小便尽除；小柴胡汤梳理少阳枢机；射干麻黄汤解表化饮下气止咳；藿香、枳实、陈皮调理脾胃气机，芳香行气化浊，使得胸腹部浊气排除而呼吸顺畅；更有山药补益脾肾，扶助正气。全方共奏祛湿化浊，清肺透邪、调和气机之效。
作为优选，所述中药复方的原料包括如下重量份的中药材：麻黄9份、炙甘草6份、杏仁9份、生石膏15-30份、桂枝9份、泽泻9份、猪苓9份、白术9份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜9份、紫苑9份、冬花9份、射干9份、细辛6份、山药12份、枳实6份、陈皮6份、藿香9份。
其中，生石膏的用量多少可依据患者是否发烧进行调整，如果患者不发烧则生石膏的用量要小，如果患者发烧或壮热则加大生石膏的用量。
进一步地，所述中药复方的剂型可选为水煎剂(汤剂)、颗粒剂、膏剂、丸剂、散剂、丹剂或片剂，但并不局限于此。
以上剂型的具体制备方法可采用本领域常规的制备方法进行，优选采用水煎剂和颗粒剂发挥药物疗效。
因此第二方面，本发明在上述中药复方的可选剂型中，以水煎剂(汤剂)和颗粒剂为例，进一步说明一种清肺排毒汤剂和一种清肺排毒颗粒剂的制备方法。
具体为，一种清肺排毒汤(水煎剂)，按照本发明所述的中药复方称取各味中药材，将其中的生石膏先加水煎煮，再将其余中药材投入合并煎煮，获得煎煮液，即得清肺排毒汤。
具体为，一种清肺排毒颗粒剂，其制备方法包括如下步骤：
(1)煎煮：按照上述中药复方称取各味中药材，先取其中的生石膏，加 水煎煮，再加入其余二十味中药材，再加水煎煮，得到煎煮液；
(2)浓缩：将所得煎煮液滤过，浓缩得到水提浓缩膏；
(3)制粒成型：以水提浓缩膏为原料，加入甜菊糖苷及适量糊精，一步制粒，即得清肺排毒颗粒剂。
作为优选，在制备以上具体药剂时，所采用的中药材为中药饮片。
第三方面，本发明提供了所述中药复方在制备具有清肺排毒药效的药物中的应用，尤其是在制备治疗新型冠状病毒感染的肺炎的药物中的应用。
本发明进一步提供了所述中药复方在作为治疗由病毒感染导致的肺炎的药物中的用途。
换言之，本发明提供了所述中药复方在制备治疗由病毒感染导致的肺炎的药物中的应用。
进一步地，本发明提供了所述中药复方(以及前述清肺排毒汤剂或前述清肺排毒颗粒剂)在治疗病毒性肺炎方面的应用，尤其是在治疗由新型冠状病毒2019-nCoV感染引起的肺炎方面的应用。
经客观实验证实，本发明所述中药复方对新型冠状病毒2019-nCoV感染引发的肺炎具有良好的治疗效果。
作为推荐，所述中药复方的使用方法为：水煎服，一天一副，早晚两次(饭后四十分钟)，温服。如有条件，每副药服用后服大米汤半碗，舌干津液亏虚者可多服至一碗。三副一个疗程。建议患者须按原方服满一个疗程，若症状好转而未痊愈则服用第二个疗程。若患者有特殊情况或其他基础病，第二疗程可以根据实际情况修改处方，症状消失则停药。
另外，服用此方前若有便秘现象，须加服防风通圣丸，大便通利后停服丸药。
本发明涉及到的中药材原料均为普通市售产品，涉及到的操作如无特殊说明均为本领域常规操作。
在符合本领域常识的基础上，上述各优选条件，可以相互组合，得到具体实施方式。
本发明的有益效果在于：
本发明结合本次“新型冠状病毒肺炎”的疫病症状表现，认为新型冠状病毒(2019-nCoV)感染的肺炎属于中医“寒疫”范畴，且湿邪为盛。主要病位在肺，其次病位在表卫、脾胃；主要病因为伏燥和湿寒邪气夹杂。主要病机为疫毒湿寒与伏燥搏结，导致气机痹阻，升降失常。
本发明据此提供了前述中药复方，利用多种中药优化融合，共同施治。从目前多省多地不同年龄层次的确诊患者救治情况看，疗效确切。相关临床观察研究持续进行中。
本发明所提供的中药复方(清肺排毒汤)为国家中医药管理局应急科研专项“中医药防治新型冠状病毒感染的肺炎有效中药复方临床筛选研究”所使用中药复方，目前正结合临床救治开展临床观察工作，相关研究正持续推进。该方适用于轻型、普通型、重型患者，在危重型患者救治中也可结合患者实际情况合理使用，具有良好的社会效益。
具体实施方式
下面将结合实施例对本发明的优选实施方式进行详细说明。需要理解的是以下实施例的给出仅是为了起到说明的目的，并不是用于对本发明的范围进行限制。本领域的技术人员在不背离本发明的宗旨和精神的情况下，可以对本发明进行各种修改和替换。
下述实施例中所使用的实验方法如无特殊说明，均为常规方法。
下述实施例中所用的材料、试剂等，如无特殊说明，均可从商业途径得到。
实施例1
本实施例用于说明清肺排毒汤(水煎剂)及其制备方法。
一、原料(以重量份计)：
麻黄9份、炙甘草6份、杏仁9份、生石膏15-30份、桂枝9份、泽泻9份、猪苓9份、白术9份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜9份、紫苑9份、冬花9份、射干9份、细辛6份、山药12份、枳实6份、陈皮6份、藿香9份。
其中，生石膏的用量依据患者是否发烧在上述用量范围内进行调整，如果患者不发烧则生石膏的用量要小，如果患者发烧或壮热则加大生石膏的用量。
二、制备方法
按照上述重量配比称取中药材(中药饮片)，先将生石膏置于水中煎煮，再将其他中药材(中药饮片)投入合并煎煮。
煎煮完成后，即得清肺排毒汤。
实施例2
本实施例与实施例1的区别在于：
原料(以重量份计)：
麻黄8份、炙甘草7份、杏仁10份、生石膏15-30份、桂枝8份、泽泻10份、猪苓10份、白术8份、茯苓14份、柴胡15份、黄芩7份、姜半夏10份、生姜8份、紫苑10份、冬花8份、射干10份、细辛5份、山药13份、枳实5份、陈皮7份、藿香10份。
实施例3
本实施例与实施例1的区别在于：
原料(以重量份计)：
麻黄10份、炙甘草6份、杏仁8份、生石膏15-30份、桂枝10份、泽泻8份、猪苓8份、白术10份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜9份、紫苑8份、冬花9份、射干10份、细辛6份、山药12份、枳实6份、陈皮5份、藿香8份。
实施例4
本实施例与实施例1的区别在于：
原料(以重量份计)：
麻黄9份、炙甘草6份、杏仁10份、生石膏15-30份、桂枝9份、泽泻9份、猪苓10份、白术10份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜8份、紫苑9份、冬花10份、射干9份、细辛6份、山药12份、枳实5份、陈皮6 份、藿香9份。
实施例5
本实施例用于说明清肺排毒颗粒剂及其制备方法。
一、原料(以重量份计)：
麻黄9份、炙甘草6份、杏仁9份、生石膏15-30份、桂枝9份、泽泻9份、猪苓9份、白术9份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜9份、紫苑9份、冬花9份、射干9份、细辛6份、山药12份、枳实6份、陈皮6份、藿香9份。
二、制备方法
(1)煎煮：按照上述中药复方称取各味中药材，先取其中的生石膏，加水煎煮，再加入其余二十味中药材，再加水煎煮，得到煎煮液；
(2)浓缩：将所得煎煮液滤过，浓缩得到水提浓缩膏；
(3)制粒成型：以水提浓缩膏为原料，加入甜菊糖苷及适量糊精，一步制粒，即得清肺排毒颗粒剂。
本实施例所制备的清肺排毒颗粒剂，相对于前述水煎剂，具有更好的工业化生产前景，利于保存与运输，易实现更大范围的推广应用。
实验例1 本发明所述中药复方对新冠肺炎的治疗效果
对新型冠状病毒感染的肺炎确诊病例给予清肺排毒汤进行治疗。
以实施例1记载的制备方法制备所述清肺排毒汤，一副药中，各中药材以每重量份为1g进行称取。
水煎服，一天一副，早晚两次(饭后四十分钟)，温服；三副一个疗程。如有条件，每副药服用后服大米汤半碗，舌干津液亏虚者可多服至一碗。
截至2020年12月1日，利用本发明所述中药复方制备的清肺排毒汤已在中国12个省54个城市60个医院共计1137名新型冠状病毒感染的肺炎确诊病例使用，通过对乏力、发烧、咳嗽、咽痛、纳差以及影像学等症状变化情况进行综合观察，数据显示：
1137名患者服药后，总有效率约为96.66％。其中，1099名患者服药后症状改善或消失，核酸检测转阴并痊愈出院，约占总观察病例的96.66％，另38 名患者病情未得到改善，约占总观察病例的3.34％。
实验例2 本发明所述中药复方对非新冠病毒引起的肺炎的治疗效果
对非新型冠状病毒感染(新冠病毒检测阴性)的其他病毒性肺炎病例给予清肺排毒汤进行治疗。
以实施例1记载的制备方法制备所述清肺排毒汤，一副药中，各中药材以每重量份为1g进行称取。
水煎服，一天一副，早晚两次(饭后四十分钟)，温服；三副一个疗程。如有条件，每副药服用后服大米汤半碗，舌干津液亏虚者可多服至一碗。
截至到2020年3月11日，利用本发明所述中药复方制备的清肺排毒汤在2个省2个城市2个医院(陕西省传染病医院及哈尔滨市传染病院)共62名住院的病毒性肺炎(非新冠肺炎)病例使用，通过对乏力、发烧、咳嗽、咽痛、纳差以及影像学等症状变化情况进行综合观察，数据显示：
59名患者服药后有效，总有效率约为95.16％。其中，59例患者服药后症状改善或消失，约占总观察病例的95.16％，另3名患者服药后仍有咳嗽、乏力等症状，但最终均痊愈出院，约占总观察病例的4.84％。
说明本发明所述中药复方对病毒性肺炎具有良好的治疗效果。
实验例3 药物安全性试验
本实验例利用实施例5制备的清肺排毒颗粒剂，进行药物安全性试验，以证明本发明所述中药复方的安全性。
1、试验目的：
进行小鼠经口给予清肺排毒颗粒剂的急性毒性评价。观察给予受试物后动物的死亡情况，测定其最大耐受量；并连续观察14天内的毒性症状及其程度，毒性出现和消失的时间，为其它安全性评价试验和临床试验提供参考。
2、试验方法：
140只ICR小鼠，体重18-21g，按禁食体重随机分为7组：对照组和清肺排毒颗粒剂104.5、122.9、144.6、170.1、200.2、235.5g生药/kg 6个剂量组，每组20只，雌雄各半。禁食约15h后，各给药组均灌胃给药1次，给药体积40mL/kg，对照组1次/日灌胃等体积纯净水，给药后连续观察14天，于第15天禁食后对 存活动物进行剖检。
给药后即刻观察动物是否出现毒性反应，毒性症状及其程度，毒性出现和消失的时间，记录不良反应情况，对死亡动物进行大体剖检，包括动物皮毛、眼、耳、口、鼻、生殖孔、肛门及其黏膜的观察，主要的组织器官包括心、肝、脾、肺、肾、胸腺、肾上腺、气管、食管、脑、睾丸、附睾、子宫、卵巢等的观察。并于给药后第1、2、3、5、7、10、14天称量小鼠体重和饲料量，第14天观察期结束后禁食，对存活动物同上进行剖检。
3、试验结果：
清肺排毒颗粒剂以104.5、122.9、144.6、170.1、200.2、235.5g生药/kg剂量，1次/日灌胃给予动物，可观察到的主要毒性反应为腹泻、活动异常(包括自发活动的减少或增加、静卧等)、惊跳反射、震颤和急性死亡。
144.6g生药/kg及以上剂量组在给药后出现动物死亡，122.9g生药/kg及以下剂量组未出现动物死亡，动物死亡均在药后24h内发生，死亡高峰在药后120-370min内。上述6个剂量组动物的死亡率分别为0％、0％、5％、15％、10％和15％。
除急性死亡外，其它肉眼可见的不良反应主要表现为腹泻、活动异常和惊跳反射；144.6、170.1、200.2、235.5g生药/kg剂量组均有上述指征不同程度的改变，发生率分别为65％、75％、90％和70％，发生在药后10min-410min内，均在24h内恢复；122.9g生药/kg剂量组仅表现为软便/腹泻，在给药后70-370min内发生，在40-310min内恢复，发生率为30％。104.5g生药/kg剂量组未见肉眼可见的不良反应。此后直至观察期14天结束，动物的一般情况、活动、步态、呼吸、进食、饮水、二便、皮毛等均未见异常。
与对照组相比，给药后14天内，清肺排毒颗粒剂雄性动物170.1、200.2g生药/kg剂量组、雌性动物144.6、170.1、200.2、235.5g生药/kg剂量组在药后D1体重较对照组明显降低；雌性动物170.1、200.2、235.5g生药/kg剂量组摄食量D1亦较对照组明显降低；给药后D2至观察期14天结束，各剂量组在各时间点体重和摄食量与对照组比较均未见明显的统计学差异。
14天后所有存活动物进行剖检，未发现有明显的大体病理改变。
4、试验结论：
清肺排毒颗粒剂不同剂量以给药体积40mL/kg，1次经口灌胃给予小鼠，肉眼可见的不良反应主要表现为腹泻、活动异常(包括自发活动的减少或增加、静卧等)、惊跳反射、震颤和急性死亡，动物不良反应均在药后24h内发生，所有存活动物于给药后第二天恢复。其最大耐受剂量为122.9g生药/kg，为临床最大使用剂量(196g生药/人)的44倍；最大无毒反应剂量为104.5g生药/kg，为临床最大使用剂量的37倍。
虽然，上文中已经用一般性说明及具体实施方案对本发明作了详尽的描述，但在本发明基础上，可以对之作一些修改或改进，这对本领域技术人员而言是显而易见的。因此，在不偏离本发明精神的基础上所做的这些修改或改进，均属于本发明要求保护的范围。
工业实用性
本发明公开的具有清肺排毒功能的中药复方，参考中医经典著作汉代张仲景《伤寒杂病论》，由麻黄杏仁甘草石膏汤(简称麻杏石甘汤，伤寒论63)、小柴胡汤(伤寒论96)、五苓散(伤寒论71)、射干麻黄汤(金匮要略.肺萎肺痈咳嗽上气病脉证治第七)加减化裁而成，利用多种中药优化融合，共同施治，对新型冠状病毒肺炎COVID-19的症状具有明显疗效。

Claims (10)

  1. 一种具有清肺排毒功能的中药复方，其特征在于，由如下重量份的中药材制成：
    麻黄8-10份、炙甘草5-8份、杏仁8-10份、生石膏15-30份、桂枝8-10份、泽泻8-10份、猪苓8-10份、白术8-10份、茯苓15份、柴胡15-18份、黄芩5-8份、姜半夏8-10份、生姜8-10份、紫苑8-10份、冬花8-10份、射干8-10份、细辛5-8份、山药10-14份、枳实5-8份、陈皮5-8份、藿香8-10份。
  2. 根据权利要求1所述的中药复方，其特征在于，所述中药材的重量份为：
    麻黄9份、炙甘草6份、杏仁9份、生石膏15-30份、桂枝9份、泽泻9份、猪苓9份、白术9份、茯苓15份、柴胡16份、黄芩6份、姜半夏9份、生姜9份、紫苑9份、冬花9份、射干9份、细辛6份、山药12份、枳实6份、陈皮6份、藿香9份。
  3. 根据权利要求1或2所述的中药复方，其特征在于，所述中药复方的剂型为水煎剂、颗粒剂、膏剂、丸剂、散剂、丹剂或片剂。
  4. 一种清肺排毒汤剂，其特征在于，按照权利要求1或2所述的中药复方称取各味中药材，将其中的生石膏先加水煎煮，再将其余中药材投入合并煎煮，获得煎煮液，即得。
  5. 一种清肺排毒颗粒剂，其特征在于，其制备方法包括如下步骤：
    (1)煎煮：按照权利要求1或2所述的中药复方称取各味中药材，先取其中的生石膏，加水煎煮，再加入其余二十味中药材，再加水煎煮，得到煎煮液；
    (2)浓缩：将所得煎煮液滤过，浓缩得到水提浓缩膏；
    (3)制粒成型：以水提浓缩膏为原料，加入甜菊糖苷及适量糊精，一步制粒，即得清肺排毒颗粒剂。
  6. 权利要求1-3任一项所述的中药复方在制备具有清肺排毒药效的药物 中的应用。
  7. 权利要求1-3任一项所述的中药复方在制备治疗新型冠状病毒感染的肺炎的药物中的应用。
  8. 权利要求1～3任一项所述的中药复方在作为治疗由病毒感染导致的肺炎的药物中的用途。
  9. 权利要求1～3任一项所述的中药复方在制备治疗由病毒感染导致的肺炎的药物中的应用。
  10. 权利要求1～3任一项所述的中药复方，或权利要求4所述的清肺排毒汤剂，或权利要求5所述的清肺排毒颗粒剂在治疗病毒性肺炎方面的应用。
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