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Method for detecting content of bromo-succinimide and succinimide in sodium ozagrel raw material medicine

The technology of bromosuccinimide and succinimide is applied in the field of medicine, and can solve the problems of instability, residue of N-bromosuccinimide, affecting the quality of sodium ozagrel injection, and the like, Achieving the effect of ensuring quality and good quality

Inactive Publication Date: 2018-01-30
浙江科瑞医药科技有限公司
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Problems solved by technology

[0005] Due to the addition of N-bromosuccinimide in the above synthesis process, the product ozagrel contains two impurities, bromosuccinimide and succinimide. If it cannot be effectively removed, it will remain in the intermediate imidazolium methyl cinnamate, which will affect the quality of the raw material drug and drug Ozagrel Sodium Injection
However, on the one hand, due to the extreme instability of N-bromosuccinimide, the detection error is relatively large; on the other hand, there is no Ozagrel / Ozagrel sodium obtained by the above-mentioned synthesis process in the art. Methods for Bromosuccinimide and Succinimide Impurities in APIs

Method used

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  • Method for detecting content of bromo-succinimide and succinimide in sodium ozagrel raw material medicine
  • Method for detecting content of bromo-succinimide and succinimide in sodium ozagrel raw material medicine
  • Method for detecting content of bromo-succinimide and succinimide in sodium ozagrel raw material medicine

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Embodiment 1

[0028] A method for detecting content of bromosuccinimide and succinimide in ozagrel sodium crude drug, the specific steps are as follows:

[0029] (1) Get the sodium ozagrel sample to be measured, add 0.05mol / L hydrochloric acid aqueous solution to dissolve and dilute to make a solution containing about 1mg sodium ozagrel sample in every 1ml, as need testing solution;

[0030] (2) get succinimide standard substance, dissolve and dilute with 0.05mol / L hydrochloric acid aqueous solution and make the solution that contains about 1 μ g succinimide standard substance in every 1ml, as reference substance solution;

[0031] (3) Utilize high-performance liquid chromatography to detect succinimide in the test solution; wherein, adopt CAPCELLPAK C18 AQ (250mm × 4.6mm, 5 μm) chromatographic column; mobile phase A is 0.02mol / L dihydrogen phosphate Potassium (use 10% potassium hydroxide to adjust the pH value to 6.5), the mobile phase B is methanol, perform linear gradient elution in the ...

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Abstract

The invention discloses a method for detecting content of bromo-succinimide and succinimide in sodium ozagrel raw material medicine. The method comprises: taking a to-be-detected sodium ozagrel sample, and after adding aqueous solution of hydrochloric acid to dissolve, obtaining test solution; detecting succinimide in the test solution by utilizing a high-performance liquid chromatography technology, and obtaining total content of the bromo-succinimide and the succinimide in the sodium ozagrel raw material medicine. According to the method disclosed by the invention, by using the hydrochloricacid as a solvent, firstly the bromo-succinimide in the to-be-detected sodium ozagrel sample is totally converted into the succinimide, and then detection is carried out by adopting the liquid chromatography technology with specific parameter conditions, so that the total content of the bromo-succinimide and the succinimide in the sodium ozagrel raw material medicine can be effectively and accurately detected, the theoretical basis is provided for identification of impurities in the sodium ozagrel raw material medicine, and quality of the sodium ozagrel raw material medicine and downstream medicine are ensured.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a method for detecting the contents of bromosuccinimide and succinimide in ozagrel sodium crude drug. Background technique [0002] Sodium ozagrel, whose chemical name is trans-3-[4-(1H-imidazole-1-methyl)phenyl]-2-sodium acrylate, was established in 1989 by Japan Ono Pharmaceutical Co., Ltd. The first thromboxane synthase inhibitor to be marketed under the trade name Cataclot; it blocks prostaglandin (PGH 2 ) generates thromboxane (TXA 2 ), promote platelet-derived PGH 2 Turn to endothelial cells, which synthesize PGI 2 , thus improving the TXA 2 PGI 2 abnormal balance. Ozagrel sodium has the effect of inhibiting platelet aggregation and dilating blood vessels. Clinically, Ozagrena is mainly used for the treatment of acute thrombotic cerebral infarction and the movement disorder associated with cerebral infarction. [0003] At present, there are many synthetic processe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 斯卫东程绍红王强张春景
Owner 浙江科瑞医药科技有限公司
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