首页|2016年至2023年兵团中药材及饮片监督抽检结果分析

2016年至2023年兵团中药材及饮片监督抽检结果分析

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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、1 544 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。
Analysis of Supervised Spot-Check of Chinese Medicinal Materials and Decoction Pieces in the Corps from 2016 to 2023
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 1 544 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.

Chinese medicinal materialsdecoction piecessupervised spot-checkdrug regulation

吕秀华、张美玲、牛灿、赵伟丽、司晓萍

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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

中药材 饮片 监督抽检 药品监管

国家科技重大专项(民口)课题项目

2018ZX09735-005

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(20)