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基于全流程控制的养阴清肺制剂产品优质性评价

劳永真 章军 赵桉熠 刘玉珍 王之光 刘安 刘艳

中国药物经济学2024,Vol.19Issue(7):97-102,107,7.
中国药物经济学2024,Vol.19Issue(7):97-102,107,7.DOI:10.12010/j.issn.1673-5846.2024.07.021

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

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

分类

医药卫生

引用本文复制引用

劳永真,章军,赵桉熠,刘玉珍,王之光,刘安,刘艳..基于全流程控制的养阴清肺制剂产品优质性评价[J].中国药物经济学,2024,19(7):97-102,107,7.

基金项目

中国中医科学院科技创新工程项目(CI2021A04405) (CI2021A04405)

中国药物经济学

1673-5846

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