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Method for detecting compound lightyellow sophora root injection

A technology of Sophora flavescens injection and detection method, which is applied in the field of fingerprint detection, and can solve the problems of insufficient quality specificity of compound Sophora flavescens injection.

Active Publication Date: 2010-06-23
BEIJING ZHENDONG GUANGMING PHARMA RES INST +1
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  • Abstract
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  • Application Information

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Problems solved by technology

[0003] In the ministerial standard and other existing technologies, the detection method of compound matrine injection discloses the identification method of matrine and Baituling, and the content determination method of matrine, but these methods are not suitable for the detection of compound matrine injection. The specificity of the quality of the liquid is not strong enough, especially for an injection, there should be stricter testing methods to control the product quality, so it is urgent to improve the quality standard of the drug, improve the quality controllability, and ensure the safety of the drug

Method used

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  • Method for detecting compound lightyellow sophora root injection
  • Method for detecting compound lightyellow sophora root injection
  • Method for detecting compound lightyellow sophora root injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0150] Embodiment 1: compound matrine injection

[0151] Sophora flavescens 1400g Baituling 600g.

[0152] Grind the Erwei crude drug into coarse powder, mix it evenly, put it in a percolation tank, add 1% acetic acid equivalent to 5 times of the drug amount, and impregnate for 48 hours, then carry out percolation, collect the filtrate, and concentrate it under reduced pressure at 75°C to Appropriate amount, store in another container, add 5 times the amount of water for injection to the dregs, decoct twice, 1 hour each time, combine the filtrate, concentrate to an appropriate amount, let cool, centrifuge, combine the supernatant with the acid concentrate, adjust to 1000ml, Add ethanol to precipitate twice, first make the alcohol content of the solution reach 65%, let it stand overnight, centrifuge, and recover the ethanol from the supernatant under reduced pressure, concentrate to 500ml, add ethanol to make the alcohol content reach 90%, treat as above, add activated carbon f...

Embodiment 2

[0153] Embodiment 2: the fingerprint detection method of compound Kushen injection described in embodiment 1

[0154] According to high performance liquid chromatography ("Chinese Pharmacopoeia" 2005 edition an appendix VI D), in conjunction with fingerprint spectrum requirement determination:

[0155] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; linear gradient elution, 0min→A:B=100:0; 60min→A:B=60:40, mobile phase A is 0.01mol / L ammonium acetate aqueous solution, adjust pH value to 8.0 with concentrated ammonia water; mobile phase B is acetonitrile-0.1mol / L ammonium acetate aqueous solution=9:1; detection wavelength is 225nm; column temperature is room temperature; flow rate is 0.8 ml / min;

[0156] Preparation of reference substance solution: Accurately weigh oxymatrine reference substance, add methanol to make a solution containing 0.1mg per 1ml, and obtain it;

[0157] Preparation of the test solution: Accur...

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Abstract

The invention discloses a method named a chromatographic fingerprint method for detecting a compound lightyellow sophora root injection. The method comprises the following steps of: adopting a high-efficiency liquid phase chromatography to establish a fingerprint of the compound lightyellow sophora root injection, and applying the fingerprint to the quality control of an intermediate and a finished product of the compound lightyellow sophora root injection; and adopting 'traditional Chinese medicament fingerprint computer-assisted similarity evaluation software' issued by the Pharmacopoeia Commission to determine the fingerprint similarity threshold of the compound lightyellow sophora root injection to be not less than 0.90. Experiments prove that the method is accurate and reliable, and can embody the main components of the compound lightyellow sophora root injection and ensure the quality of the medicament to the utmost extent.

Description

field of invention [0001] The invention relates to a detection method of compound flavescens injection, in particular to a detection method of the fingerprint of compound flavescens injection. Background technique [0002] Compound Kushen Injection is a classic prescription recorded in Volume 14 of the Standards issued by the Ministry of Traditional Chinese Medicine, and the standard number is WS3-B-2752-97. Compound Sophora flavescens injection is composed of Sophora flavescens and Baituling. It has the effects of clearing away heat and dampness, cooling blood and detoxification, dispelling stagnation and relieving pain. It is used in anti-tumor, treatment of cancerous pain, hemostasis, improvement of immunity of tumor patients and improvement of quality of life, etc. significant effect. Due to the remarkable clinical efficacy, sales have continued to increase in recent years. [0003] In the ministerial standard and other existing technologies, the detection method of co...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/896A61K9/08A61P35/00A61P29/00A61P7/04A61P37/04G01N30/02G01N30/86
Inventor 王智民李安平菅晓勇胡红宇海丽娜李军红
Owner BEIJING ZHENDONG GUANGMING PHARMA RES INST
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