中药制剂质量标准十年来的进展与瞻望

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近十年在中药制剂质量标准方面,全国许多单位在理化常数测定、定性鉴别、定量分析等方面作了研讨,正在突破“膏丹丸散神仙难辨”的局面。用数据说明质量情况,逐步向中药制剂质量标准化、科学化迈进。《中国药典》1977年版编订工作起了组织和推动作用,全国动员了大批力量参与起草和实验工作,使得过去很少有人问津的中药制剂内部质量标准,成了众矢之的,群起而攻。中药单味药的分析本身就存在很多难题,因此中药复方制剂的检测则更为困难,但我国广大科研人员在参考资料甚少的条件下,闯出一条有自己特色的路来,作出了应有的贡献。回顾七十年代以来的工作加以概括,将会增强我们继续前进的信心。兹就数方面归纳如下: In the past ten years, in terms of quality standards for traditional Chinese medicine preparations, many units across the country have conducted discussions on the determination of physicochemical constants, qualitative identification, and quantitative analysis, and are breaking through the situation in which “Gold Dan Maru San San is difficult to discern”. Using data to explain the quality of the situation, gradually move toward quality standardization and scientific development of traditional Chinese medicine preparations. The compilation of the 1977 edition of the Chinese Pharmacopoeia has played an important role in organizing and promoting the work. The country has mobilized a large number of forces to participate in drafting and experimental work, making the internal quality standards of traditional Chinese medicine preparations that few people have been interested in in the past, and it has become the target of public criticism. There are many problems in the analysis of single-taste medicines of Chinese medicines. Therefore, the detection of traditional Chinese medicine compound preparations is even more difficult. However, under the condition that the reference materials are scarce, the majority of scientific research personnel in China have come up with a path with their own characteristics and made a Some contributions. Looking back at the work since the 1970s and summarizing it will increase our confidence in moving forward. Several aspects are summarized as follows:
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