[关键词]
[摘要]
中药新药复方制剂质量标准【鉴别】项设置薄层色谱(thin layer chromatography,TLC)鉴别的目的既是检验制剂是否按规定的处方药味投料,也是反映制剂的整体质量特征进行真伪鉴别。在此基础上,提出中药新药复方制剂质量标准【鉴别】项TLC研究可按“整体鉴别”的新模式开展,并对TLC“整体鉴别”的思路、方法等提出建议,对TLC的处方药味鉴别与制剂整体鉴别进行了对比分析。TLC整体鉴别具有以下优势或特点:可充分利用样品展开后的斑点信息,可提高结果判断的准确性,鉴别试验次数相对较少。TLC“整体鉴别”为中药新药复方制剂质量标准【鉴别】项研究提供了可反映中药制剂整体质量特征的新模式。
[Key word]
[Abstract]
The purpose of thin layer chromatography (TLC) identification in the specification of compound preparation of new traditional Chinese medicine (TCM) is to test whether the batch charging is according to the recipe, as well as to reflect the overall quality characteristics of the products for authenticity identification. Based on this, it is proposed that the TLC study on specification of TCM compound preparation can be carried out according to the novel model of “holistic identification”. The ideas and methods of TLC “holistic identification” are put forward, and the comparison and analysis of prescription medicines identification and holistic identification are carried out. The holistic identification method has the following advantages or characteristics: It can make full use of the spot information, increase the accuracy of the results, and decrease the number of identification tests. TLC “holistic identification” provides a novel model for the study of specification of TCM compound preparations, which can reflect the overall quality characteristics of TCM compound preparations.
[中图分类号]
R283.69;R288.4
[基金项目]