清肺抑火片质量标准提升研究  

Improvement of the quality standard of Qingfei Yihuo tablets

作　　者：范秀春 徐维二 罗廷顺 董坤 缪明锦 FAN Xiu-chun;XU Wei-er;LUO Ting-shun;DONG Kun;MIAO Ming-jin(Drug Control Institute of Dali Bai Autonomous Prefecture,Dali Yunnan 671000)

机构地区：[1]大理白族自治州药品检验所,云南大理671000

出　　处：《中南药学》2024年第12期3361-3367,共7页Central South Pharmacy

基　　金：2022年云南省药品评价抽检计划项目(云药监办2022-07)。

摘　　要：目的 基于评价抽验工作,提升清肺抑火片质量标准,综合评价不同厂家的清肺抑火片质量。方法 建立大黄、栀子、黄芩、黄柏、苦参的TLC鉴别方法,采用HPLC法建立了35批清肺抑火片的特征图谱,同时采用PCA-X及OPLS-DA的分析方法对共有峰峰面积进行统计分析,筛选出清肺抑火片的关键质控成分并测定关键质控成分黄芩苷的含量。结果 建立的TLC鉴别方法快速、简便、准确易操作。清肺抑火片高效液相特征图谱共标定16个共有峰,并指认出12个已知成分。基于统计分析方法,初步发现不同厂家及不同批次间样品存在差异,并发现可能导致清肺抑火片质量微小差异的关键质控成分。HPLC法测得黄芩苷的含量为1.82~12.64 mg/片。结论 各厂家清肺抑火片质量存在差异,现行质量标准不够全面合理,不能完整评价清肺抑火片质量,建议提升质量标准,确保产品的质量和疗效的一致性。Objective To comprehensively evaluate the quality of Qingfei Yihuo tablets from different manufacturers by improving their quality standard based on the sampling and testing.Methods TLC identification method was established to dectect rhubarb,gardenia,scutellaria,phellodendri and sophora,and the feature chromatograph of 35 batches of Qingfei Yihuo tablets was established by HPLC.Meanwhile,the area of common peaks was analyzed by PCA-X and OPLS-DA.The quality control components of Qingfei Yihuo tablets were screened and the content of baicalin was determined.Results The TLC identification method for rhubarb,gardenia,scutellaria,phellodendron and sophora was rapid,simple,accurate and easy to operate.The HPLC of Qingfei Yihuo tablets identified 16 common peaks and 12 known components.Based on the statistical analysis method,the differences between different manufacturers and samples batches were preliminatively found.The key quality control components which for the slight difference in the quality of Qingfei Yihuo tablets were found.The content of baicalin by HPLC ranged 1.82~12.64 mg/tablet.Conclusion There are differences in the quality of Qingfei Yihuo tablets by different manufacturers.The existing quality standards need improvement to ensure the consistency of product quality and curative effect.

关 键 词：清肺抑火片 薄层鉴别 特征图谱 含量测定 质量评价 

分 类 号：R284.1[医药卫生—中药学]