《广东省医疗机构制剂规范》中的中药制剂质量标准的分析与探讨
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篇名: 《广东省医疗机构制剂规范》中的中药制剂质量标准的分析与探讨
TITLE:
摘要: 目的:为完善医疗机构的中药制剂质量标准修订,促进医疗机构中药质量标准提高提供参考。方法:对《广东省医疗机构制剂规范》中的中药制剂质量标准进行梳理,总结其存在的主要问题并提出改进建议。结果与结论:《广东省医疗机构制剂规范》收载中药制剂品种897个,现行(2017年版)质量标准虽较首版(1985年版)已有较大的提高,但在制剂的整体质量控制、指标性成分量化控制、项目专属性、药材的源头控制、非《中国药典》收载药材的控制和同方系列品种质量标准等方面仍存在问题。建议在兼顾先进性和适用性的前提下,加强对中药医院制剂的整体的质量控制及地方药材、毒性药材的质量控制,适当更新专属性好、重现性强的检测方法,加强对生产工艺关键参数的控制,以充分提高医疗机构中药制剂的质量标准,促进医疗机构提供安全、有效、质量可控的制剂产品。
ABSTRACT: OBJECTIVE: To provide reference for perfecting the quality standard revision of TCM preparations in medical institutions, and improving the quality standard of TCM preparations in medical institutions. METHODS: By sorting out the quality standards of TCM preparations in Guangdong provincial medical institution preparation specification, this paper summarized the main problems and put forward suggestions for improvement. RESULTS & CONCLUSIONS: There are 897 kinds of TCM preparations included in the Guangdong provincial medical institution preparation specification. The recent quality standards (2017 edition) have been greatly improved compared with those of the first edition (1985 edition); however, there are still some problems in the overall quality control of preparations, quantitative control of indicative components, project specificity, source control of medicinal materials, control of medicinal materials not included in the Chinese Pharmacopoeia and quality standards of the same series of varieties. It is suggested that on the premise of considering both advancement and applicability, the quality control of the whole, local and toxic preparations of TCM hospitals should be strengthened, the detection methods with good specificity and reproducibility should be properly updated, the control of key parameters of production process should be strengthened, the quality standard of TCM preparations in medical institutions should be fully improved, so as to provide the products with safe, effective and controllable in quality products in medical institutions.
期刊: 2019年第30卷第15期
作者: 刘潇潇,隆颖,戴忠,李华,马双成,罗卓雅
AUTHORS: LIU Xiaoxiao,LONG Ying,DAI Zhong,LI Hua,MA Shuangcheng,LUO Zhuoya
关键字: 《广东省医疗机构制剂规范》;中药制剂;医疗机构;质量标准;问题与建议
KEYWORDS: Guangdong provincial medical institution preparation specification; TCM preparations; Medical institution; Quality standard; Problems and suggestions
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