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Method for rapidly and quantitatively evaluating quality stability of traditional Chinese medicine injection

A quantitative evaluation and injection technology, applied in the measurement of color/spectral properties, etc., can solve the problems that cannot be confirmed theoretically, and achieve the effect of fast quantitative evaluation of stability

Active Publication Date: 2018-05-22
石药银湖制药有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Whether there will be an isosbestic point phenomenon in complex samples, especially complex samples of traditional Chinese medicine injection solutions, has not been reported, and its existence cannot be theoretically confirmed.

Method used

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  • Method for rapidly and quantitatively evaluating quality stability of traditional Chinese medicine injection
  • Method for rapidly and quantitatively evaluating quality stability of traditional Chinese medicine injection
  • Method for rapidly and quantitatively evaluating quality stability of traditional Chinese medicine injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Example 1 Changes in the isosbestic point and area under the curve of Qingkailing injection.

[0057] Take 10ml of Qingkailing injection (batch number 1003272) purchased in the market, take a sample of 1.0ml for later use (recorded as standard sample Q0), add the remaining injection into a 15ml capped centrifuge tube, close the cap tightly and place it in a 60°C water bath for constant temperature . After 1, 2, 3, 4, and 8 weeks, 1.0 ml samples were taken at fixed time points (the samples were respectively marked as Q1, Q2, Q3, Q4, and Q8). After the sample is taken, it is sealed and stored at -20°C. After the sample is taken, the absorption spectrum detection is performed, and the fingerprint detection is performed in parallel to verify from the side (reference literature: Wang Zhihong, Zhao Xuyuan, Yao Jincheng. Qingkailing injection fingerprint HPLC study of the spectrum. Chinese Journal of Traditional Chinese Medicine 2008; 26:868-70).

[0058] Absorption spectrum...

Embodiment 2

[0067] Example 2 Changes in isosbestic point and area under the curve of Shuanghuanglian injection.

[0068]Take 10ml of Shuanghuanglian injection (batch number 20100324) purchased in the market, sample 1.0ml for later use (denoted as standard sample S0), add the remaining injection into a 15ml capped centrifuge tube, close the cap tightly and place it in a 60°C water bath for constant temperature. After 1, 2, 3, 4, and 8 weeks, 1.0 ml samples were taken at fixed time points (the samples were respectively marked as S1, S2, S3, S4, and S8). After the sample is taken, it is sealed and stored at -20°C. After the sample is taken, the absorption spectrum is detected, and the fingerprint is detected in parallel to verify from the side (reference literature: Li Fang, Jiang Wenhong, Liu Lijuan, Zhong Zhaoqing. Injection Establishment of fingerprints of Shuanghuanglian (lyophilized) and its application in quality control. Chinese Patent Medicine 2007;29:1196-8).

[0069] Absorption sp...

Embodiment 3

[0080] Example 3 Changes in the isosbestic point and area under the curve of Danshen injection.

[0081] Take 10ml of Danshen injection (batch number 1005104) purchased in the market, sample 1.0ml for later use (denoted as standard sample D0), add the remaining injection into a 15ml capped centrifuge tube, close the cap tightly and place it in a water bath at 60°C for constant temperature. After 1, 2, 3, 4, and 8 weeks, 1.0 ml samples were taken at fixed time points (the samples were respectively marked as D1, D2, D3, D4, and D8). After the sample is taken, it is sealed and stored at -20°C. After the sample is taken, the absorption spectrum detection is carried out, and the fingerprint detection is performed in parallel to verify from the side (reference literature: Xu Man, Liu Aihua, Cui Yajun, Zhang Jinlan, Guo Dean. Comparative study on Chromatographic Fingerprint of Salvia Miltiorrhiza in Xiangdan Injection produced by different manufacturers. Chinese Natural Medicine 2007...

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Abstract

The invention relates to a method for rapidly and quantitatively evaluating the quality stability of traditional Chinese medicine injection, and belongs to the technical fields of pharmacy and traditional Chinese medicine evaluation. The method comprises the following steps: firstly, diluting a traditional Chinese medicine injection solution by a certain number of times, and setting a standard absorption curve of the traditional Chinese medicine injection; secondly, determining an isoabsorptive point of the absorption curve of the traditional Chinese medicine injection at the dilution times according to a stability experiment; thirdly, computing the areas under the absorption curve in front of and in rear of the isoabsorptive point; fourthly, further determining the reference values of theareas under the absorption curve in front of and in rear of the isoabsorptive point and / or the reference value of the ratio of the areas under the absorption curve in front of and in rear of the isoabsorptive point according to an acceptable active substance change degree; fifthly, performing stability change judgment according to the fact that whether the areas under the absorption curve in front of and in rear of the isoabsorptive point and / or the ratio of the areas under the absorption curve in front of and in rear of the isoabsorptive point exceeds a range after a standard is determined.

Description

technical field [0001] The invention relates to a rapid quantitative evaluation method, in particular to a rapid quantitative evaluation method for the quality stability of traditional Chinese medicine injections, and belongs to the technical fields of pharmaceutical technology and traditional Chinese medicine evaluation. Background technique [0002] Traditional Chinese medicine injection is a unique preparation in my country, which was born in the 1940s. After more than half a century of development, traditional Chinese medicine injections have developed from the earliest Bupleurum injection to the current 132 listed varieties. The unique curative effect of traditional Chinese medicine injection has been recognized by the medical circle and society, but safety problems also occur from time to time. According to the complexity of the substances contained, traditional Chinese medicine injections can be divided into: 1) active monomer or quasi-monomer traditional Chinese med...

Claims

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Application Information

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IPC IPC(8): G01N21/31
CPCG01N21/31
Inventor 李月狄彩霞段为刚王振国吴美谕康月菊云宇阴华吕小满郭良张祎
Owner 石药银湖制药有限公司
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