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中药制剂质量标准是保证药品质量和用药安全有效的重要一环。历代经典著作均有大量记载。至宋《太平惠民和剂局方》进入了标准规格化阶段,不少感官检查方法迄今仍在沿用。建国卅多年来,中药制剂质量标准不论在理化鉴别、显微鉴定、定量分析等方面都有了迅速的发展。本文介绍了中药制剂质量标准的历史情况及近年来工作的进展,对今后如何适应中药事业的发展,进一步提高中药制剂质量标准提出了看法。
The quality standards of traditional Chinese medicine preparations are an important part of ensuring the quality and safety of medicines. Historical classics have a large number of records. The Song Dynasty “Taiping Huimin Harmony Bureau” entered the standardization stage, and many sensory inspection methods are still in use. For many years, the quality standards of Chinese medicine preparations have been rapidly developed in terms of physical and chemical identification, microscopic identification, and quantitative analysis. This article describes the history of the quality standards of traditional Chinese medicine preparations and the progress of work in recent years, and proposes opinions on how to adapt to the development of traditional Chinese medicine and further improve the quality standards of traditional Chinese medicine preparations.