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目的:通过了解12种中药注射液质量检查的现状,为进一步提高中药注射剂的用药安全,减少不良反应发生率提供参考建议。方法:12种中药注射液的检验报告单中相关项目与2010年版《中国药典》第一部中注射剂质量检查项目进行对照,对说明书中标明的成分进行归类分析。结果:部分中药注射液未能严格按照《中国药典》规定的项目进行有关物质的检查。结论:建议将蛋白质、鞣质、树脂、草酸盐及K+等有关物质作为法定检查内容,并针对临床上不良反应发生情况,实时调整专项检查规定,控制中药质量,减少不良反应发生率。
OBJECTIVE: To provide reference for further improving the medication safety of traditional Chinese medicine injection and reducing the incidence of adverse reactions by understanding the status quo of quality inspection of 12 kinds of traditional Chinese medicine injection. Methods: The related items in the test reports of 12 kinds of Chinese traditional medicine injections were compared with the quality inspection items of injection in the first edition of “Chinese Pharmacopoeia” in 2010 edition, and the components indicated in the manual were classified and analyzed. Results: Some traditional Chinese medicine injection failed to carry out the related substances inspection in strict accordance with the items stipulated in “Chinese Pharmacopoeia”. Conclusion: It is suggested that the related substances such as protein, tannin, resin, oxalate and K + should be statutory examination contents. In view of the occurrence of clinical adverse reactions, the special inspection rules should be adjusted in real time to control the quality of Chinese medicine and reduce the incidence of adverse reactions.