基于国家药品抽验的石淋通颗粒质量评价  

Quality Evaluation of Shilintong Granules Based on National Drug Sampling Inspection

作　　者：马杰 占丽琴 彭玲娜 邱婧 李瑞莲 Ma Jie;Zhan Liqin;Peng Lingna;Qiu Jing;Li Ruilian(Hunan Institute for Drug Control,Changsha 410001,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation)

机构地区：[1]湖南省药品检验研究院,长沙410001 [2]湖南省药品质量评价工程技术中心

出　　处：《中国药师》2021年第1期166-170,共5页China Pharmacist

摘　　要：目的:通过国家抽验工作,了解石淋通颗粒的质量现状并发现存在的质量问题,完善质量标准,为药品监管提供技术支持。方法:依据现行质量标准检验从全国范围内抽取的202批次石淋通颗粒样品,基于检验中发现的问题,从与药品真实性、安全性、有效性等方面进行探索性研究,建立多项检测方法全面分析其质量情况。结果:按法定标准检验合格率为98.5%;按探索性研究检验,合格率降为87.6%。结论:石淋通颗粒总体质量状况一般,部分生产企业可能存在对辅料、原药材把关不严,或者不足量投料等问题,不完善、专属性不强的质量标准亟待完善和提高。Objective: To analyze the overall quality status and related quality problems of Shilintong granules through national drug sampling inspection in order to improve the quality standard and provide technical support for drug supervision. Methods: According to the current quality standard,202 batches of Shiluitong granules from the whole country were tested. Moreover,based on the problems found in the tests,exploratory research was carried out in the aspects of authenticity,safety and effectiveness of the drug,and a number of detection methods were established to fully analyze the quality. Results: According to the legal standard,the qualified rate was 98.5%;according to the exploratory research,the qualified rate decreased to 87.6%. Conclusion: The overall quality of shiluitong granules is generally in general. Some manufacturers may have some problems,such as lax control of excipients and raw materials,or insufficient feeding. The imperfect and weak quality standards need to be improved.

关 键 词：石淋通颗粒 质量评价 国家药品抽验 

分 类 号：R927.1[医药卫生—药学]