LIANG Jin-jie, WU Yan-hong, ZHANG Yan-mei, et al. Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(12): 253-258.
LIANG Jin-jie, WU Yan-hong, ZHANG Yan-mei, et al. Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations[J]. Chinese journal of experimental traditional medical formulae, 2014, 20(12): 253-258. DOI: 10.13422/j.cnki.syfjx.2014120253.
This paper aims to reveal the existing problems of the content determination of the stability study of traditional Chinese medicine(TCM) preparations and provide the reference for the quality control of the preparations
drug efficacy and the scientific stability study. Through searching the literature reports about the content determination of the stability study of TCM preparations since 2000
summarized the overview of stability of TCM preparations from the three aspects in the regulations of stability study
index component and the development trend of content determination method. And deeply analysis the existing problems of content determination of stability study
from the following three aspects: the index components selection
sample pretreatment and analytical methods
which can provide a reference for the stability study of TCM. At the same time
the editor noticed that R & D personnel focus on preparation process in the formulation standard preparation. In order to make the index components meet the standard
they make its enrichment by a variety of process and ignore the relationship between the index components and clinical effect
which greatly reduce the meaning of stability test. Therefore
in order to study on the effects material in TCM preparation
reduce the unsafe drug and improve study of content determination of stability study of TCM preparations
we need to absorb the advanced methods and techniques and carry out various aspects of theoretical study and experimental research on the basis of practice.