Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations

LIANG Jin-jie; WU Yan-hong; ZHANG Yan-mei; LUO Yu; LIU Jing; ZHU Sheng-shan; HUANG Juan-ping; CAI Yan-qu

doi:10.13422/j.cnki.syfjx.2014120253

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Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations

更新时间：2024-01-04

- Analysis on Problem of Content Determination of Stability of Traditional Chinese Medicine Preparations
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 20, Issue 12, Pages: 253-258(2014)
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- DOI：10.13422/j.cnki.syfjx.2014120253
  CLC： R286.0
- Published：2014
- 稿件说明：
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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：

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.

摘要

本文旨在揭示中药制剂稳定性研究中含量测定存在的问题，为控制制剂质量、保证药物疗效、科学进行稳定性研究提供参考。通过检索2000年以来国内有关中药制剂稳定性含量测定研究的文献报道，对其内容进行分类总结。并从稳定性研究法规、含量测定指标成分以及测定方法发展趋势三方面综述了中药制剂稳定性研究的概况，从指标成分的选择、样品前处理、仪器分析方法等方面对制剂稳定性研究中含量测定的存在问题进行深入分析，可为中药制剂稳定性研究提供参考。目前制剂标准的制定偏重于制剂工艺，为了指标成分达标，通过各种工艺使其富集，造成了考核指标与临床疗效脱节的现象，使稳定性考察意义大大降低。所以，开展中药制剂的药效物质研究，减少用药的不安全性，完善中药制剂稳定性含量测定研究，需要在不断实践的基础上，吸收先进的方法与技术手段，进行多方面的理论探讨和实验研究，以控制中药制剂的质量。

Abstract

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.

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