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中药注射剂的规范使用严格质控研究
引用本文:姚风华,周国斌,樊贺明.中药注射剂的规范使用严格质控研究[J].中外健康文摘,2007(10).
作者姓名:姚风华  周国斌  樊贺明
作者单位:吉林省四平市中医医院药剂科 四平市136001(姚风华,周国斌),吉林省四平市中心医院药剂科 四平市136000(樊贺明)
摘    要:目的:规范使用严格质控中药注射剂。方法制定严格标准,应用创新工艺,完善临床用法,构筑安全屏障,提高致敏试验的灵敏度,找出致敏原,重视质量标准研究是核心;重视中药注射剂再评价,临床合理用药是保障。结果与结论生产单位除加强对药品"严格质控"外,还直加强过敏性实验和配伍的研究及对上市后药品的再评价工作,以提高药品的安全性,达到"安全、有效、可控"的要求,减少ADR发生,保障广大患者用药安全,提高患者用药依从性及治疗效果。

关 键 词:中药注射剂  规范使用  严格质控  应用对策

esearch on the Standardized Use and Strict Quality Control for TOMs injections
YAO Fenghua ZHOU Guobin.esearch on the Standardized Use and Strict Quality Control for TOMs injections[J].World Health Digest Medical Monthly,2007(10).
Authors:YAO Fenghua ZHOU Guobin
Abstract:OBJECTIVE:To standardly use and strictly control the traditional Chinese medicine (TCMs) injections.METHODS:The key way to approach to the purpose above are to make restrictive standards,applicate the innovocative technologies,perfect the clinical usages,increase the sensitivity of sensitization tests and find out the allergens,and to address the quality standard researches,while the ensurance are to reevaluation of TCMs injections and to medicate in clinical rationally.RESULTS:Besides the strict quality control,manufacturers should control the TCMs injections strictly,and strength the researches into the anaphylactic experiments and compatibilities as well as the reevaluation of listed drugs, in order to improve their safety,meet the"safe,efficient,controllable"requirements,reduce the ADR emergency,to guarantee the medication safety,and to prompt the medication compliableness and therapeutic effects.
Keywords:TCMS injections  standard use  strict quality control  application countermeasures  
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