Method for quantitatively detecting saponin components in Radix Ginseng Rubra and Radix Ophiopogonis injection

A quantitative detection method, the technology of Shenmai injection, is applied in the direction of measuring devices, material separation, and analysis of materials, which can solve the problems of difficulty in comprehensive quality control, large differences in component content, and low specificity. The effect of stable solution, good reproducibility, and relatively short analysis time

Inactive Publication Date: 2015-06-17
HEBEI SHINEWAY PHARMA
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  • Abstract
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  • Claims
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Problems solved by technology

[0003] The current implementation standard of Shenmai Injection (National Drug Standard WS 3 -B-3428-98-2010) stipulates the qualitative identification of ginsenosides Rb1, Rg1, Re, and the quantitative determination of total saponins and ginsenosides Rb1, Rg1, Re, wherein the total saponins are determined by colorimetry, which is not specific
In view of the complex composition of Shenmai Injection and the large difference in the content of various components, the quantitative determination of saponins in Shenmai Injection only measures a few kinds of ginsenosides, so it is difficult to fully control its quality

Method used

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  • Method for quantitatively detecting saponin components in Radix Ginseng Rubra and Radix Ophiopogonis injection
  • Method for quantitatively detecting saponin components in Radix Ginseng Rubra and Radix Ophiopogonis injection
  • Method for quantitatively detecting saponin components in Radix Ginseng Rubra and Radix Ophiopogonis injection

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Embodiment 1

[0030] 1. Instruments and reagents

[0031] Agilent Series 1200 high performance liquid chromatograph, including autosampler, binary pump, column thermostat, online degassing device and DAD detector.

[0032]Acetonitrile is a product of Merck Reagent Company; Methanol is analytically pure, a product of Sinopharm Group Co., Ltd.; water is Robust double-distilled water; reference substances ginsenosides Rg1, Re, Rf, Rh1, Rg2, Rb1, Rc, Rb2, Rb3, Rd , Rg3 were purchased from China National Institute for the Control of Pharmaceutical and Biological Products; Shenmai Injection was provided by Hebei Shineway Pharmaceutical Co., Ltd.

[0033] 2. Methods and results

[0034] (1) Chromatographic conditions

[0035] Column: C 18 Analytical column (250mm×4.6mm, 5μm); mobile phase: acetonitrile as mobile phase A, water as mobile phase B, and gradient elution as shown in the table below; flow rate: 1mL / min; column temperature: 30°C; UV detection device; detection wavelength 203nm.

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Abstract

The invention provides a method for quantitatively detecting saponin components in a Radix Ginseng Rubra and Radix Ophiopogonis injection. High performance liquid phase chromatography is adopted to simultaneously determine ginsenoside Rb1, Re and Rg1 and the content of at least one of the following saponin compounds: ginsenoside Rg1, Re, Rf, Rh1, Rg2, Rb1, Rc, Rb2, Rb3, Rd and Rg3. The method comprises the following steps: preparing a mixed solution reference substance solution, preparing a tested substance solution, setting liquid phase determination conditions, and sampling the above sample, wherein the chromatographic conditions of liquid phase determination conditions comprise an octadecyl silane bonded silica gel column, acetonitrile-water as a mobile phase to carry out gradient elution and an ultraviolet detector for detection. The method has the characteristics of good specificity, few interference, high sensitivity, good precision, good reappearance, stable tested substance solution, accurate determination, fastness, accuracy and short analysis time.

Description

technical field [0001] The invention relates to a quantitative determination method for saponin components in Shenmai injection, belonging to the field of drug analysis. Background technique [0002] Shenmai Injection is a compound preparation made from red ginseng and Radix Ophiopogon japonicus. It has clear curative effect in the adjuvant treatment of cardiovascular diseases and tumors, and has been widely used clinically. Shenmai injection contains saponins, flavonoids, sugar compounds and other active ingredients, wherein ginsenosides include protopanaxadiol type saponins (ginsenosides Rb1, Rb2, Rc, Rd), protopanaxatriol type saponins (ginsenosides Re, Rg1, Rf), oleanolic acid type ginsenosides (ginsenoside Ro) and others (ginsenosides Rg2, Rh1, Rh2, Rg3, Rg5, Rg6, Rs4-Rs7, Rk1-Rk3) D is a representative saponin in Ophiopogon japonicus. [0003] The current implementation standard of Shenmai Injection (National Drug Standard WS 3 -B-3428-98-2010) stipulates the quali...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 杨琴孙胜斌郝鹏彬姜国志陈钟李振江
Owner HEBEI SHINEWAY PHARMA
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