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Danhong injection quality control method

A quality control method, the technology of Danhong injection, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effect of simple method, avoiding one-sidedness and good reproducibility

Active Publication Date: 2012-09-26
ZHEJIANG UNIV +1
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When this method is used to evaluate the quantitative similarity of fingerprints, although the proportion of different components is considered, it is only in S F Significant effect at lower

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1: Danhong Injection Fingerprint Atlas Formulation

[0046] 1.1 Instruments and reagents

[0047] Agilent 1200 RRLC (including online vacuum degasser, high-pressure binary gradient pump, autosampler, column oven, diode array detector (DAD), chemstaion chromatography workstation); acetonitrile and formic acid are chromatographically pure; ultrapure water ; 15 batches of Danhong injection (Shandong Heze Buchang Pharmaceutical Co., Ltd., batch number (10mL): 101149, 101150, 110931, 110932, 110933, 110934, 110935, 110936, 101171, 101170, 101165, 101167, 101145, 101157, 10 ).

[0048] 1.2 Preparation of Danhong Injection Control Sample Solution

[0049] Precisely pipette 2 mL of Danhong injection, put it in a 10 mL volumetric bottle, dilute to the mark with acetonitrile-0.5% formic acid solution (50:50, v / v), shake well, and filter through a 0.45 μm microporous membrane , that is.

[0050] 1.3 Liquid chromatography conditions

[0051] Chromatographic conditio...

Embodiment 2

[0068] According to the method of Example 1, the difference is that the calculation of the correlation coefficient is used to evaluate the similarity of the fingerprints.

[0069] Compare the fingerprints of 15 batches of Danhong injection products to be tested with the established standard fingerprints, and calculate and identify the number of common peaks between the two. If the similarity is greater than 0.95, the injection is considered qualified; if the similarity is greater than 0.97, the injection is considered qualified. Liquid batches are stable and of good quality. It was found that for samples with a similarity > 0.990, the similarity obtained by the correlation coefficient algorithm was very close to the cosine value of the included angle, but the similarity values ​​calculated by the samples with a low similarity were significantly different. See Table 3.

[0070] table 3

[0071]

Embodiment 3

[0073] According to the method of embodiment 1, the difference is to calculate the ratio qualitative similarity, i.e. the comparison fingerprint do sample do calculate and The cosine of the included angle. If the similarity is greater than 0.95, the injection is considered qualified, and if the similarity is greater than 0.97, the batch of injection is considered to be stable and of good quality. See Table 4 for the results.

[0074] Table 4

[0075]

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Abstract

The invention relates to a Danhong injection quality control method. According to the method, an efficient liquid chromatography is used for measuring fingerprint spectrums of Danhong injection products to be measured, and in addition, three kinds of algorithms including the included angle cosine algorithm, the relative coefficient algorithm and the ratio qualitative algorithm are adopted for calculating the qualitative similarity of fingerprint spectrums of the Danhong injection; and the P value and the M value are calculated, and the qualitative similarity of the fingerprint spectrums of the Danhong injection is obtained. Meanwhile, a content measuring method of eight effective ingredients of the Danhong injection is built. Finally, a high performance liquid chromatography (HPLC) is used for measuring, the conditions that the sodium danshensu and protocatechualdehyde content is greater than 350mug / mL, the qualitative similarity is greater than 0.95, the quantitative similarity P is between 0.80 and 1.20, and the M is between 0.90 and 1.10 are used as quality control standards for controlling the Danhong injection quality. The fingerprint spectrum qualitative and quantitative discrimination is combined with the multi-index quantitative analysis, and the reliability and the safety of the Danhong injection quality are further ensured.

Description

technical field [0001] The invention relates to a method for controlling the quality of Danhong injection, a traditional Chinese medicine compound preparation. Specifically, the quality of Danhong injection is controlled by a method of fingerprinting combined with high-performance liquid chromatography (HPLC) multi-index component content determination. Background technique [0002] Danhong injection is a traditional Chinese medicine injection made from two medicinal materials of Danshen and safflower through extraction, concentration, alcohol precipitation, water precipitation, and preparation. It is mainly used to treat cardiovascular and cerebrovascular diseases such as angina pectoris, myocardial infarction, and atherosclerosis. disease. It has the effects of quick onset and good curative effect, and has been widely used in clinical practice. However, due to factors such as uneven quality of raw medicinal materials and fluctuations in working conditions, product batches...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/86
Inventor 吴永江刘雪松吴增增杨凯丁海樱金叶万新民苏晓涛刘象银陆世海王臣臣王振华
Owner ZHEJIANG UNIV
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