中成药均一化投料研究策略

Research strategy for homogenization feeding of Chinese patent medicines

中成药是中医药产业的重要组成部分,也是中医药现代化的重要标志。目前,中成药制剂批间质量稳定性问题成为制约中药产业高质量发展的关键因素之一,投料饮片质量不均一是影响该问题的直接因素。该文就提高中成药投料饮片质量的均一性问题,提出了均一化投料研究方案。分别从均一化对象及前处理、均一化投料操作规程、均一化评价指标的选择、均一化投料算法、均一化投料工艺等方面进行系统阐述,依据关键质控指标作为均一化目标,探讨均一化投料工艺及其质量分析,形成中成药均一化投料示范性工艺策略,以期为推进中成药制剂批间质量一致性研究提供科学依据。

Chinese patent medicine constitutes a vital segment of the traditional Chinese medicine(TCM)industry and stands as a significant emblem of TCM modernization.At present,the quality stability between batches of Chinese patent medicine preparations has become a pivotal factor directly restricting the high-quality development of the TCM industry.Consequently,addressing the homogeneity of Chinese patent medicines,this paper proposes a research scheme of homogenization feeding.It systematically elaborates on the object and pretreatment of homogenization,operational procedures of homogenization feeding,selection of homogenization evaluation indices,homogenization feeding algorithm,and homogenization feeding process.With the key quality control indicators as the homogenization target,the homogenization feeding process and its quality analysis were discussed.Finally,a demonstration strategy for homogenization feeding of Chinese patent medicine was formed,providing the scientific basis for advancing the research of quality consistency across batches of Chinese patent medicine preparations.