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Brucea javanica oil emulsion injection liquid quality control method

A quality control method and technology of bruceus brucei oil emulsion, which are applied to measurement devices, instruments, scientific instruments and other directions, can solve problems such as cumbersome steps, inaccurate results, etc., achieve high extraction rate, less mobile phase components, and increase peak area. The effect of ratio

Inactive Publication Date: 2015-07-15
李宏 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problems of inaccurate results and cumbersome steps in the quality control of Brucea javanica oil emulsion injection in the prior art, the embodiment of the present invention provides a quality control method for Brucea javanica oil emulsion injection

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0051] According to the preparation method of the above-mentioned test solution and the determined chromatographic conditions, the fingerprints of 19 batches of Brucea javanica oil emulsion injection were measured, and according to different production batch numbers, 10 batches of samples were selected to generate Brucea javanica oil emulsion injection. Liquid Standard Fingerprint

[0052] Determination of Fingerprint Samples of Brucea Brucea Oil Emulsion Injection

[0053] Using the standard fingerprints as a comparison, the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine 2.0 provided by the National Pharmacopoeia was used to measure the similarity of fingerprints of 19 batches of samples. The result is that 95% of the samples have a similarity greater than 0.998, and 100% of the samples have a similarity greater than 0.99.

[0054] Determination of trioleic acid ester content

[0055] The HPLC-ELSD method was used to simultaneo...

experiment example 1

[0057] Experimental Example 1: Fingerprint, determined with reference to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2010 Edition).

[0058] Chromatographic conditions and system suitability test

[0059] Octadecylsilane bonded silica gel is used as filler; acetonitrile / dichloromethane mixed solution (acetonitrile:dichloromethane is 60-70:40-30, preferably 65:35) is used as mobile phase; the flow rate is per minute 0.3-0.8ml, preferably 0.5ml; column temperature 30-40°C, preferably 35°C; evaporative light scattering detector; analysis time 40-130 minutes, preferably 65 minutes. The number of theoretical plates should be no less than 5000 based on the trioleate peak, and the resolution of peak No. 2 and peak No. 3 corresponding to the standard fingerprint in the test sample should be above 1.5.

[0060] Preparation of reference solution

[0061] Take 1,2-dilinoleic acid-3-oleic acid glyceride, 1,2-dioleic acid-3-linoleic acid glyceride and g...

Embodiment 2

[0182] Embodiment 2: content determination (triglyceride is example)

[0183] Determine according to high performance liquid chromatography (Appendix VI D of Chinese Pharmacopoeia 2010 edition).

[0184] The chromatographic conditions and system suitability test are the same as under [Fingerprint].

[0185] The preparation of the reference solution is the same as that of the reference solution I under [Fingerprint].

[0186] The preparation of the test solution is the same as under [Fingerprint].

[0187] Assay

[0188] Precisely draw 5 μl and 10 μl of the reference substance solution and 5-10 μl of the test solution, inject it into the liquid chromatograph, measure its spectrum, and calculate it with the logarithmic equation of the external standard two-point method.

[0189] LgA=aLg(NC)+b

[0190]

[0191] In the formula:

[0192] A is the peak area

[0193] N is the injection volume, μl;

[0194] C is concentration, mg / ml;

[0195] V is the sampling volume, ml; ...

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Abstract

The invention provides a brucea javanica oil emulsion injection liquid quality control method including the following steps: a methanol / dichloromethane solution containing 1,2-dilinoleic acid-3-glyceryl oleate, 1,2-dilinoleic acid-3-glyceryl linoleate and glycerol trioleate is used as a reference substance solution I; a methanol / dichloromethane solution containing brucea javanica oil is used as a reference substance solution II; a methanol / dichloromethane solution containing brucea javanica oil emulsion injection liquid is used as a sample solution; and liquid chromatography graphs of the reference substance solution I, the reference substance solution II and the sample solution are respectively measured. According to the method, both the content and fingerprint can be measured by the same method, the method is quantitative and qualitative, and a rapid, simple and accurate and multi-angle brucea javanica oil emulsion injection liquid quality control method is provided.

Description

technical field [0001] The invention relates to a quality control method for javanica javanica oil emulsion injection. Background technique [0002] The quality standard of Brucea javanica oil emulsion injection is recorded in the fourteenth volume of the Ministry of Health's drug standard for traditional Chinese medicine preparations, the standard number: WS3-B-2739-97, the content of this standard is determined by titration method to measure the total acid content, the method is backward, And can not truly reflect the composition of Brucea javanica oil. [0003] Also have a lot of bibliographical reports to adopt gas chromatography to measure the content of oleic acid or linoleic acid, but the specificity of this method is not good at first, as 85% are triglycerides in Brucea javanica oil, and oleic acid is transformed after its hydrolysis in the body , and the free fatty acid content is low, mainly fatty acid glycerides in the combined form; secondly, in the process of g...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 麻军法李海鹏岳昌林李宏
Owner 李宏
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