罗林云 杨燕梅 张建军 郑学东 史光伟 马真

[摘要]目的 分析我院不合格中药饮片退货原因，并采取相应的改进措施，保证临床用药的安全。方法 选取2016～2019年我院退货的197批次中药饮片作为研究对象，依据退货记录，运用Excel软件分析退货原因。结果 主要退货原因为：伪品和掺伪（9.1%）、染色（3.0%）、增重（10.2%）、提取药渣（1.0%）、熏硫（15.2%）、泛油（12.2%）、加工炮制不规范（27.9%）、地方标准品种混用（6.1%）、国家药典标准品种混用（7.1%）、其他（8.1%）。2016～2019年共招标12次，招标1591批次，退货197批次，退货率为12.4%。结论 我院不合格中药饮片退货原因主要有加工炮制不规范、熏硫、泛油等，针对以上主要退货原因，我院提出了4条改进措施，并严格落实执行，使我院中药饮片质量有了很大的提高。

[关键词]中药饮片;不合格;退货原因;质量标准;改进措施

[中图分类号] R942          [文献标识码] A          [文章編号] 1674-4721（2020）7（b）-0175-04

Analysis of the reasons for the return of unqualified Chinese medicine pieces and improved measures

LUO Lin-yun   YANG Yan-meiZHANG Jian-jun   ZHENG Xue-dong   SHI Guang-wei   MA Zhen

Jiuquan Traditional Chinese Medicine Hospital， Gansu Province， Jiuquan   735000， China

[Abstract] Objective To analyze the reasons for the return of unqualified Chinese medicine pieces in our hospital and take corresponding improved measures to ensure the safety of clinical medication. Methods A total of 197 batches of Chinese medicine pieces returned from 2016 to 2019 in our hospital were selected as the research objects. Based on the return records， Excel software was used to analyze the reasons for the return. Results The main reasons for the return were fakes and adulteration （9.1%）， dyeing （3.0%）， weight gain （10.2%）， extraction of drug residue （1.0%）， fumigation with sulfur （15.2%）， oil brimming （12.2%）， unqualified processing （27.9%）， mixed use of local standard varieties （6.1%）， mixed use of national pharmacopoeia standard varieties （7.1%）， and others （8.1%）. There were 12 tenders in total from 2016 to 2019 with 1591 batches， and 197 batches were returned accounting for 12.4%. Conclusion The reasons for the return of unqualified Chinese medicine pieces in our hospital mainly include unqualified processing， fumigation with sulfur， oil brimming， etc. Based on the above-mentioned main reasons for return， our hospital has put forward four improved measures and strictly implemented them， which has greatly improved the quality of Chinese medicine pieces in our hospital.

[Key words] Chinese medicine pieces; Unqualified; Reasons for return; Quality standards; Improved measures

中药是我国中医药发展的物质基础，对于治疗疾病和保障身体健康起着不可忽视的作用。中药饮片是中药材依据中医药理论和中药炮制方法加工炮制而成，是中成药的原料药，是可以直接用于中医临床的中药[1]。中药饮片质量直接关乎患者的临床治疗效果，间接反映医生开具处方的有效性及整个医院中药饮片的质量管理问题[2]。鉴于此，中药饮片必须符合药品安全可控和稳定有效等标准。目前由于各种原因，如野生资源濒危短缺、栽培种植技术不成熟、中药饮片标准不完整、鉴定难、监管难等，使中药饮片市场混乱，多种假劣中药饮片流入市场，严重危害了人们的身体健康[3-5]。……