中药成方制剂中含乌头碱类中药制剂质量标准分析

Analysis on Quality Standards of Traditional Chinese Medicine Preparations Containing Aconitines among Traditional Chinese Medicines Drugs Preparation

目的:统计中药成方制剂中含乌头碱类中药如川乌、附子等含毒性中药制剂的质量标准内容,分析存在问题,提出修改建议。方法:查阅中药成方制剂中该类制剂的功能主治、鉴别、含量测定等具体内容,采用Excel 2003软件统计分析;收集标准修订资料,记录该类制剂的修订情况。结果:含乌头碱类成分的中药成方制剂共有309个,用于治疗风湿病、骨伤、经络肢体病及肾病等。制剂节下对有效成分含量测定的较多,但缺少对毒性中药成分的含量检测。结论:中药成方制剂颁布时间较早,建议对含毒性中药的制剂进行系统性研究,加强对毒性中药的特殊成分的控制,以严格制剂的安全性管理。

Objective：To summarize contents of quality standards of traditional Chinese medicine preparations with toxicity containing aconitines such as Radix aconiti and Radix aconiti lateralis preparata among traditional Chinese medicines preparations, analyze existing problems and propose suggestions for revision. Methods：Specific contents about these preparations were reviewed, including functions ,main indications, identification and assay. The software Excel 2003 was used for the statistical analysis. The data of revised standards were collected and the revision status about this kind of preparations was recorded. Results：There were 309 traditional Chinese medicines preparations containing aconitines for rheumatism, bone injury, meridian and body diseases, nephropathy and so on. Most assays of these medicines were for effective ingredients, however, assays for toxic Chinese medicinal ingredients were few. Conclusion：Standards of traditional Chinese medicines were published fairly early and some revisions need to be made. It is suggested a systematic research on preparations containing toxic Chinese medicinal materials be conducted and the control of special ingredients of toxic Chinese medicines be strengthened so as to ensure the preparation safety.