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卫生部药政管理局颁布《中药新药研究指南(药效学、药理学、毒理学)》(简称《指南》),《新药审批办法(有关中药部分的修订和补充规定)》(简称《方法》)是中药新药研究的规范性文献。在药理学部分明确规定:中药新药药效学试验必须设置阳性药物对照组,阴性对照组(正常及模型动物对照组,必要时应设溶媒对照组),受试药物组。笔者在试验
The Bureau of Pharmacy of the Ministry of Health promulgated the “Guidelines for the Study of New Chinese Medicines (Pharmacodynamics, Pharmacology, Toxicology)” (referred to as the “Guide”) and the “Approval Methods for New Drugs (Revision and Supplementary Provisions for the Part of Traditional Chinese Medicine)” (referred to as “Methods”). ")) is a normative document for the study of new Chinese medicines. In the pharmacology section, it is stipulated that the pharmacodynamics test of new Chinese medicines must include a positive drug control group, a negative control group (a normal and model animal control group, if necessary, a vehicle control group), and a test drug group. The author is experimenting