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目的:分析中药注射剂入选《国家基本药物目录·基层医疗卫生机构配备使用部分》(2009版)存在的问题。方法:以丹参注射液为例,通过分析其成分(包括水溶性成分、脂溶性成分、其它类型化合物、无机元素、蛋白质、鞣质、多糖、挥发油等)、不良反应、质量标准,探讨中药注射剂入选《国家基本药物目录·基层医疗卫生机构配备使用部分》(2009版)存在的问题。结果与结论:中药注射剂的成分复杂、质量标准可控性差,亟待药学工作者进一步研究;安全性很难保证,再评价、研究、整顿工作势在必行。
OBJECTIVE: To analyze the existing problems of Chinese medicine injections into the “Part of National Essential Medicines Catalog, Primary Health Care Equipments” (2009 edition). Methods: Salvia miltiorrhiza injection was taken as an example to study the effects of traditional Chinese medicine injection (injection) on its components (including water-soluble components, fat-soluble components, other types of compounds, inorganic elements, proteins, tannins, polysaccharides, volatile oils, etc.) Entered the “National Essential Drug List, primary health care institutions equipped with the use of” (2009 version) problems. RESULTS AND CONCLUSION: The composition of traditional Chinese medicine injection is complex and quality controllability is poor. It is urgent for further study by pharmacologists. It is difficult to ensure the safety of re-evaluation, research and rectification work.