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
劳永真 1章军 2赵桉熠 2刘玉珍 3王之光 3刘安 2刘艳2
作者信息
- 1. 中国中医科学院中药研究所,北京 100700;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
- 2. 中国中医科学院中药研究所,北京 100700
- 3. 中华全国工商业联合会医药业商会,北京 100101
- 折叠
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.
Abstract
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Key words
Yangyin Qingfei preparations/High-quality evaluation/Chinese patent medicine/High-quality Standard/Consistency引用本文复制引用
基金项目
中国中医科学院科技创新工程项目(CI2021A04405)
出版年
2024
国家科技期刊平台
NSTL
万方数据