2016年至2023年兵团中药材及饮片监督抽检结果分析  

Analysis of Supervised Spot-Check of Chinese Medicinal Materials and Decoction Pieces in the Corps from 2016 to 2023

作　　者：吕秀华 张美玲 牛灿 赵伟丽 司晓萍 LYU Xiuhua;ZHANG Meiling;NIU Can;ZHAO Weili;SI Xiaoping(Drug Control Institute of Shihezi,The Eighth Division of Xinjiang Production and Construction Corps,Shihezi,Xinjiang,China 832000)

机构地区：[1]新疆生产建设兵团第八师石河子市药品检验所,新疆石河子832000

出　　处：《中国药业》2024年第20期26-29,共4页China Pharmaceuticals

基　　金：国家科技重大专项(民口)课题项目[2018ZX09735-005]。

摘　　要：目的促进中药材及饮片质量提升。方法对2016年至2023年在新疆生产建设兵团(简称兵团)辖区14个师(市)开展的中药材及饮片监督抽检结果进行汇总分析,梳理不合格的品种及项目,分析不合格原因,并提出相应质量控制措施及监管建议。结果共抽检中药材及饮片227个品种、1544批,其中不合格95批(6.15%),涉及39个品种,8个检验项目;2017年不合格率最高(26.60%),之后总体呈下降趋势。以性状不合格率最高(56.84%),杂质、过氧化值最低(均为1.05%)。性状不合格原因包括贮存养护不当、掺伪等;含量测定不合格原因包括混用入药品种、混用入药部位等;浸出物及灰分不合格原因包括样品中掺杂非药用部位、人为掺入泥沙等;非法染色可能为添加金胺O等化学染色剂。结论兵团2017年至2023年中药材及饮片质量整体较好且稳定。基层监管部门应强化源头管理,加强源头监管,持续完善中药材及饮片的检验标准,扩大补充检验方法并推广运用,重视药品监督抽检工作,重点突出科学监管等,以加速我国药品抽检制度体系科学化进程。Objective To improve the quality of Chinese medicinal materials and decoction pieces.Methods The data of supervised spot-check of Chinese medicinal materials and decoction pieces conducted in 14 divisions(cities)of Xinjiang Production and Construction Corps(referred to as the Corps)from 2016 to 2023 were summarized and analyzed.The unqualified varieties and items were sorted out,the relevant reasons were analyzed,and the corresponding quality control measures and regulatory suggestions were proposed.Results A total of 227 varieties and 1544 batches of Chinese medicinal materials and decoction pieces were sampled,of which 95 batches(6.15%)were unqualified,involving 39 varieties and eight inspection items;the unqualified rate was the highest in 2017(26.60%),and that decreased generally since that time.The unqualified rate of characters was the highest(56.84%),while that of impurity and peroxide values was the lowest(1.05%).The reasons for the unqualified characters included improper storage and maintenance,adulteration,etc.The reasons for unqualified content determination included mixed use of medicinal varieties,mixed use of medicinal parts,etc.The reasons for the unqualified extract and ash included the inclusion of non-medicinal parts in the samples and the artificial addition of mud and sand.Illegal dyeing might be induced by the addition of chemical dyes such as auramine O.Conclusion The overall quality of Chinese medicinal materials and decoction pieces in the Corps is good and stable from 2017 to 2023.The grassroots regulatory departments should strengthen the source management and supervision,continuously improve the inspection standards for Chinese medicinal materials and decoction pieces,expand the supplementary inspection methods and promote their application,pay attention to the supervised spot-check of drugs,and highlight the scientific supervision to promote the scientific development of China′s drug spot-check system.

关 键 词：中药材 饮片 监督抽检 药品监管 

分 类 号：R95[医药卫生—药学]