中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
4期
450-456
,共7页
刘小鸣%吴瑞环%张振凌%沈莎莎%梁君
劉小鳴%吳瑞環%張振凌%瀋莎莎%樑君
류소명%오서배%장진릉%침사사%량군
中药制剂%乌头碱%质量标准%川乌%草乌%附子%药物安全管理
中藥製劑%烏頭堿%質量標準%川烏%草烏%附子%藥物安全管理
중약제제%오두감%질량표준%천오%초오%부자%약물안전관리
traditional Chinese Medicine preparations%aconitine%quality standards%Radix aconiti%Radix aconiti kusnezofifi%Radix aconiti lateralis preparata%drug safety management
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。
目的:統計中藥成方製劑中含烏頭堿類中藥如川烏、附子等含毒性中藥製劑的質量標準內容,分析存在問題,提齣脩改建議。方法:查閱中藥成方製劑中該類製劑的功能主治、鑒彆、含量測定等具體內容,採用Excel 2003軟件統計分析;收集標準脩訂資料,記錄該類製劑的脩訂情況。結果:含烏頭堿類成分的中藥成方製劑共有309箇,用于治療風濕病、骨傷、經絡肢體病及腎病等。製劑節下對有效成分含量測定的較多,但缺少對毒性中藥成分的含量檢測。結論:中藥成方製劑頒佈時間較早,建議對含毒性中藥的製劑進行繫統性研究,加彊對毒性中藥的特殊成分的控製,以嚴格製劑的安全性管理。
목적:통계중약성방제제중함오두감류중약여천오、부자등함독성중약제제적질량표준내용,분석존재문제,제출수개건의。방법:사열중약성방제제중해류제제적공능주치、감별、함량측정등구체내용,채용Excel 2003연건통계분석;수집표준수정자료,기록해류제제적수정정황。결과:함오두감류성분적중약성방제제공유309개,용우치료풍습병、골상、경락지체병급신병등。제제절하대유효성분함량측정적교다,단결소대독성중약성분적함량검측。결론:중약성방제제반포시간교조,건의대함독성중약적제제진행계통성연구,가강대독성중약적특수성분적공제,이엄격제제적안전성관리。
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.