基于山东省药品抽检的北柴胡配方颗粒质量分析与研究  

Quality Analysis and Research on Bupleurum Chinense Formula Granules Based on Drug Sampling Inspection in Shandong Province

作　　者：毕天琛 曲智雅 郭衍珩 杨国宁 赵丹彤 BI Tian-chen;QU Zhi-ya;GUO Yan-heng;YANG Guo-ning;ZHAO Dan-tong(Heze Institute for Food and Drug Control,Heze 274000,China;Heze Medical College,Heze 274000,China)

机构地区：[1]菏泽市食品药品检验检测研究院,山东菏泽274000 [2]菏泽医学专科学校,山东菏泽274000

出　　处：《食品与药品》2024年第6期553-557,共5页Food and Drug

基　　金：山东省药品监督管理局2022年山东省药品风险监测工作项目(局函〔2022〕147号)。

摘　　要：目的基于山东省药品抽检工作,对全省北柴胡配方颗粒质量状况进行综合考察与分析。方法对抽样的54批样品按法定标准检验,并进行探索性研究,以全面评价北柴胡配方颗粒质量现状。结果按法定标准检验合格率为100%;按探索性研究方法检验合格率为90.7%,5批样品不合格原因主要是柴胡皂苷总量低于拟定限度。探索性研究发现部分批次样品存在重金属污染的风险;部分批次样品可能存在原料质量差、未按处方投料等问题。结论建议企业加强原料控制,同时优化工艺,严把质量关,从而更好地保障药品安全性与有效性。Objective To evaluate the quality of Bupleurum Chinese Formula Granules based on drug sampling inspection in Shandong province.Methods A total of 54 batches of samples were tested according to the statutory standard combined with exploratory research,in order to comprehensively evaluate the quality status of Bupleurum Chinese Formula Granules.Results The qualified rate was 100%determined according to the statutory standard,however,the qualified rate determined according to methods of the exploratory research was 90.7%.The main reason for the failure of 5 batches of samples was that the total amount of saikosaponin was lower than the proposed limit.Exploratory research found that some batches of samples had the risk of heavy metal pollution.Some batches of samples may have problems such as poor quality of raw materials and incorrect feeding.Conclusion It is suggested that enterprises should strengthen the control of raw materials,optimize the process and strictly control the quality,so as to better ensure the safety and effectiveness of the drug products.

关 键 词：北柴胡配方颗粒 法定标准 探索性研究 柴胡皂苷 质量分析 

分 类 号：R927[医药卫生—药学]