光释光法筛查养阴清肺丸辐射情况研究  

Screening of Yangyin Qingfei pills radiation condition by optical luminescence method

作　　者：赵剑锋 陈安珍 王赵[3] ZHAO Jianfeng;CHEN Anzhen;WANG Zhao(China Pharmacopoeia Commission,Beijing 100061,China;Qingdao Institute for Food and Drug Control,Qingdao 266071,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]国家药典委员会,北京100061 [2]青岛市食品药品检验研究院,山东青岛266071 [3]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2022年第5期541-545,共5页Drug Standards of China

摘　　要：目的:筛查养阴清肺丸辐射情况,为中药辐射科学监管提供建议。方法:采用光释光法建立了养阴清肺丸辐射筛查方法,并对15家企业41批次养阴清肺丸进行辐射筛查研究。结果:15家企业均采用辐射方式进行灭菌,其中40批次样品存在辐射灭菌情况,占总抽样批次的97%。只有1家企业在生产工艺中明确灭菌方式为辐射杀菌。结论:建议药品监管部门以药品安全专项整治工作为契机,加强以药材原粉入药辐射杀菌监管,引导企业开展中药辐射灭菌质量研究,完善药品标准中生产工艺项下灭菌方式,保障公众用药安全。Objective:To screen the radiation situation of Yangyin Qingfei pills and providing suggestions for the scientific supervision of radiation of traditional Chinese medicine.Methods:The radiation screening method of Yangyin Qingfei pills was established by optical luminescence method,and the radiation screening research of 41 batches of Yangyin Qingfei pills from 15 enterprises was carried out.Results:All 15 companies used radiation for sterilization,of which 40 batches of samples had radiation sterilization,accounting for 97%of the total sampling batches.Only one company clearly defined the sterilization method as radiation sterilization in the production process.Conclusions:It is suggested that the drug regulatory authorities take the special rectification work on drug safety as an opportunity to strengthen the supervision of radiation sterilization of raw medicinal powders,guide enterprises to carry out research on the quality of radiation sterilization of traditional Chinese medicine,improve the sterilization method under the production process in the drug standard,and ensure the safety of public medication.

关 键 词：养阴清肺丸 光释光法 辐射灭菌 中国药典 国家药品评价性抽验 

分 类 号：R921.2[医药卫生—药学]