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Method for measuring contents of multiple components in Shenxiong glucose injection

A technology of Shenxiong glucose and a determination method is applied in the field of quality control of traditional Chinese medicine preparations, which can solve problems such as difficulty in comprehensively reflecting the characteristics of chemical components of preparations, and achieve the effect of improving the level of quality control.

Active Publication Date: 2012-08-01
GUIZHOU JINGFENG INJECTION
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Problems solved by technology

The current quality standard of Shenxiong Glucose Injection (WS-10001-(HD-1136)-2002) content determination items only carry out quantitative control of Danshensu and Ligustrazine Hydrochloride, which is difficult to fully reflect the chemical composition characteristics of the preparation

Method used

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  • Method for measuring contents of multiple components in Shenxiong glucose injection
  • Method for measuring contents of multiple components in Shenxiong glucose injection
  • Method for measuring contents of multiple components in Shenxiong glucose injection

Examples

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Embodiment 1

[0076] Example 1: Determination of the six chemical components of Danshensu Sodium, Ligustrazine Hydrochloride, Protocatechualdehyde, Rosmarinic Acid, Salvianolic Acid B and Salvianolic Acid A in Shenxiong Glucose Injection by HPLC

[0077] 1. Chromatographic conditions and system suitability test

[0078] Instrument: ultrafast liquid chromatography system (UFLC, Shimadzu, including binary gradient pump, vacuum degasser, autosampler, column oven, diode array detector, Lcsolution workstation);

[0079] Column: Diamonsil C 18 Chromatographic column (4.6mm×250mm, 5μm);

[0080] Mobile phase: A is acetonitrile, B is 0.05% H 3 PO 4 , carry out gradient elution according to the regulations in Table 1;

[0081] Flow rate: 1mL / min;

[0082] Column temperature: 40°C;

[0083] Detection wavelength: 220nm;

[0084] Injection volume: 10 μL.

[0085] Table 1 Mobile phase gradient elution table

[0086]

[0087]

[0088] 2. Preparation of reference substance solution Accurate...

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Abstract

The invention belongs to the technical field of quality control of Chinese materia medica preparations, and provides a method for measuring contents of multiple components in Shenxiong glucose injection. According to the invention, the HPLC (high performance liquid chromatography) is adopted to measure contents of six compounds, namely tanshinol, ligustrazine hydrochloride, protocatechuic acid, rosmarinic acid, danshinolic acid B and danshinolic acid A, in the Shenxiong glucose injection under the same chromatographic condition. Compared with the present simple content measurement method for a single component, the method provided by the invention is better in integrity, characteristics and stability, can comprehensively reflect the interior quality of the preparations, and provides test base for further improving the quality control level of the Shenxiong glucose injection and ensuring the quality stability of the products.

Description

technical field [0001] The invention relates to a multi-component content determination method of Shenxiong glucose injection, which belongs to the technical field of quality control of traditional Chinese medicine preparations. Background technique [0002] Shenxiong glucose injection is composed of Salvia miltiorrhiza and ligustrazine hydrochloride, which has anti-platelet aggregation and coronary artery expansion effects, and is clinically used for the treatment of occlusive cerebrovascular disease and other ischemic vascular diseases. The current quality standard of Shenxiong Glucose Injection (WS-10001-(HD-1136)-2002) content determination items only quantitatively control Danshensu and Ligustrazine Hydrochloride, which is difficult to fully reflect the chemical composition characteristics of the preparation. With the improvement of my country's drug production quality control level and the increasing emphasis on injection safety, efficacy, and quality control, the Stat...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 叶湘武郑林王永林兰燕宇
Owner GUIZHOU JINGFENG INJECTION
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