基于全流程控制的养阴清肺制剂产品优质性评价  

High Quality Evaluation of Yangyin Qingfei Preparation Products Based on Whole Process Control

作　　者：劳永真 章军[1] 赵桉熠 刘玉珍 王之光 刘安[1] 刘艳[1] LAO Yong-Zhen;ZHANG Jun;ZHAO An-Yi;LIU Yu-Zhen;WANG Zhi-Guang;LIU An;LIU Yan(Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;National Engineering Technology Research Center for Gelatin-based Traditional Chinese Medicine,Dong'e Ejiao Co.Ltd.,Liaocheng 252200,China;Pharmaceutical Chamber of Commerce,All China National Industry and Commerce Association Federation,Beijing100101,China)

机构地区：[1]中国中医科学院中药研究所,北京100700 [2]东阿阿胶股份有限公司,国家胶类中药工程技术研究中心,山东聊城252200 [3]中华全国工商业联合会医药业商会,北京100101

出　　处：《中国药物经济学》2024年第7期97-102,107,共7页China Journal of Pharmaceutical Economics

基　　金：中国中医科学院科技创新工程项目(CI2021A04405)。

摘　　要：目的中成药优质性评价是中成药质量评价方式的延伸,应用相应标准对养阴清肺制剂进行质量评价,揭示其质量优劣性。方法本研究采用“以质量为核心的中成药优质评价标准”,基于全流程控制从原料选材、生产过程、质量控制、上市后研究,依据企业提供的材料和实验室研究数据进行评分,采用赋分形式对3种养阴清肺剂型产品进行全生产周期质量评估,分析各阶段质量控制情况,依据得分相对质量常数划分等级。结果参与优质评价的3种养阴清肺制剂被划分为两个等级,养阴清肺糖浆为相对优质的一等品,养阴清肺颗粒、养阴清肺膏为三等品。结论本文的研究方法能够揭示3种养阴清肺制剂产品的关键环节质量差异,最终实现产品质量优劣分级。Objective The high quality evaluation of Chinese patent medicine is an extension of the quality evaluation method of Chinese patent medicine,which applies corresponding standards to evaluate the quality of Yangyin Qingfei preparation and reveal its quality advantages and disadvantages.Methods In this study,the "high-quality evaluation criteria with the quality as core for Chinese patent medicine" was used,based on the whole process control from raw material selection,production process,quality control and post-marketing research items,scoring based on the materials provided by the companies and laboratory research data,and the three Yangyin Qingfei Preparation products were evaluated for quality throughout the production cycle in the form of assigned scores,analyzed for quality control at each stage,and graded based on the score relative quality constants.Results The three kinds of Yangyin Qingfei preparation products participating in the quality evaluation were divided into two grades.The Yangyin Qingfei syrup was the first grade of relative high quality,Yangyin Qingfei granules and Yangyin Qingfei ointment were the third grade.Conclusion The research methods in this paper can reveal the quality differences of the key links of the three kinds of Yangyin Qingfei preparations,and finally realize the classification of product quality.

关 键 词：养阴清肺制剂 优质性评价 中成药 优质标准 一致性 

分 类 号：R28[医药卫生—中药学]