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Method for measuring content of ginsenoside in Aidi preparation

A technology of ginsenosides and determination methods, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of not being able to effectively control the quality of Aidi injection preparations, absorption peaks of impurities, and affecting the clinical efficacy of preparations, etc.

Inactive Publication Date: 2009-12-30
GUIZHOU YIBAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, with the development of society, the requirements for the quality control of medicines are getting higher and higher, and the demand for finding a fast, convenient and controllable detection method is becoming more and more urgent. The inventors have found through research that the quality of the existing Aidi preparations In the control standard, the ultraviolet spectrophotometric method used for the determination of ginsenosides in ginseng is not accurate, has low resolution, has impurity absorption peaks, and has an impact on the experimental results; at the same time, the active ingredients in ginseng in the original method Saponin Re is counted, but with the progress of research, it is known that active ingredients in ginseng include ginsenosides Rg1, Re and Rb1, etc.
Therefore, the analysis and determination of ginseng content determination by the original method are not accurate and detailed enough, so the existing quality control methods cannot effectively control the quality of Aidi injection preparations, which will affect the clinical efficacy of the preparations

Method used

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  • Method for measuring content of ginsenoside in Aidi preparation
  • Method for measuring content of ginsenoside in Aidi preparation
  • Method for measuring content of ginsenoside in Aidi preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Content determination:

[0084] Ginsenoside Re

[0085] Measure according to Chinese Pharmacopoeia 2005 edition an appendix VI D high performance liquid chromatography:

[0086] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A and water as mobile phase B, perform gradient elution in the following table, and the detection wavelength is 203nm. The number of theoretical plates calculated based on the peak of ginsenoside Rg1 should not be less than 6000;

[0087]

[0088] Preparation of reference substance solution: Accurately weigh ginsenoside Rg1 reference substance, ginsenoside Re reference substance, and ginsenoside Rb1 reference substance, add methanol to make a mixed solution containing 0.1 mg per 1 mL, and shake well to obtain the reference substance solution;

[0089] Preparation of the test solution: Accurately measure 25ml of this preparation, extract 4 times with water-...

Embodiment 2

[0092] Ginsenoside Re

[0093] Measure according to Chinese Pharmacopoeia 2005 edition an appendix VI D high performance liquid chromatography:

[0094] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A and water as mobile phase B, perform gradient elution in the following table, and the detection wavelength is 203nm. The number of theoretical plates calculated based on the peak of ginsenoside Rg1 should not be less than 6000;

[0095]

[0096] Preparation of reference substance solution: Accurately weigh ginsenoside Rg1 reference substance, ginsenoside Re reference substance, and ginsenoside Rb1 reference substance, add methanol to make a mixed solution containing 0.2 mg per 1 mL, and shake well to obtain the reference substance solution;

[0097] Preparation of the test solution: Accurately measure 50ml of this preparation, extract 5 times with water-saturated n-butanol, respectively...

Embodiment 3

[0100] Measure according to Chinese Pharmacopoeia 2005 edition an appendix VI D high performance liquid chromatography:

[0101] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler; use acetonitrile as mobile phase A and water as mobile phase B, perform gradient elution in the following table, and the detection wavelength is 203nm. The number of theoretical plates calculated based on the peak of ginsenoside Rg1 should not be less than 6000;

[0102]

[0103] Preparation of reference substance solution: Accurately weigh ginsenoside Rg1 reference substance, ginsenoside Re reference substance, and ginsenoside Rb1 reference substance, add methanol to make a mixed solution containing 0.4 mg per 1 mL, and shake well to obtain the reference substance solution;

[0104] Preparation of the test solution: Accurately measure 100ml of this preparation, extract 6 times with water-saturated n-butanol, respectively 25mL, 25mL, 20mL, 20mL,...

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Abstract

The invention provides a method for measuring content of ginsenoside in Aidi preparation, which is to measure the content of the effective component, namely the ginsenoside Rg1, Re and Rb1 contained in ginseing in the preparation by taking ginsenoside Rg1, Re and Rb1 comparison products as contrast. Compared with the prior art, the method adopts the high performance liquid chromatography for gradient elusion of two kinds of mobile phases, improves the method for measuring the content of the ginseng, has high precision, good repeatability, good stability, high recovery rate and accurate and reliable measurement result, improves the quality control standard of the Aidi preparation, and can effectively control product quality so as to ensure clinical efficacy of the Aidi preparation.

Description

Technical field: [0001] The invention relates to a method for determining the content of ginsenosides in Aidi preparations, belonging to the technical field of quality control of medicines. Background technique: [0002] Cancer is a large class of diseases that seriously threaten human health. Aidi's injection preparations are mainly composed of mylabris, ginseng, astragalus and eleuthero, which have the functions of clearing away heat and detoxifying, eliminating blood stasis and dispelling stagnation. It is mainly used for primary liver cancer, lung cancer, Rectal cancer, malignant lymphoma, gynecological malignancy and other diseases. Among them, "Aidi Injection" is published in the 20th volume of the standard issued by the Ministry of Traditional Chinese Medicine. However, with the development of society, the requirements for the quality control of medicines are getting higher and higher, and the demand for finding a fast, convenient and controllable detection method is...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 窦啟玲林瑶朱亭潘杨义
Owner GUIZHOU YIBAI PHARMA CO LTD
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