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中药制剂是祖国医药学的重要组成部分。中药制剂的质量是保证药品质量和用药安全有效的重要环节。中药制剂的质量控制应包括鉴别、检查及含量测定三个主要项目。鉴别是确定某一药物真伪的定性试验。鉴别方法很多,如化学方法、显微鉴别及物理常数的测定方法等。目前化学方法应用较为广泛,其次是显微鉴别方法,中国药典(1977年版)一部收载了中药制剂365种,单味制剂95种,其中除个别用显微鉴别外,大部分采用化学鉴别法;复方制剂270种,其中只有部分是用化学鉴别,185种系采用显微鉴别。检查是控制制剂纯度,有害物质及控制生产工艺中存在问题的一项质控指标。
Chinese medicine preparations are an important part of the motherland’s medicine. The quality of Chinese medicine preparations is an important link to ensure the quality of medicines and the safe and effective use of medicines. The quality control of Chinese medicine preparations should include three major items of identification, inspection and content determination. Identification is a qualitative test to determine the authenticity of a drug. There are many methods for identification, such as chemical methods, microscopic identification, and methods for determining physical constants. At present, chemical methods are widely used, followed by microscopic identification methods. The Chinese Pharmacopoeia (1977 edition) included 365 kinds of Chinese medicine preparations and 95 kinds of single-flavor preparations in the first edition of the Chinese Pharmacopoeia (1977 edition). Among them, most of them use chemical identification in addition to microscopic identification. Method; 270 compound preparations, of which only some are chemically identified and 185 are microscopically identified. Inspection is a quality control indicator that controls the purity of the formulation, harmful substances, and problems in controlling the production process.