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Method for auxiliary identification of flunarizine hydrochloride original research medicine prescription composition

A flunarizine hydrochloride and auxiliary identification technology, which is applied in the field of medicine, can solve the problems of analysis, unfavorable original drugs, and increased difficulty in the development of generic drugs, etc., and achieve the effect of easy implementation and simple operation

Active Publication Date: 2022-07-01
北京阳光诺和药物研究股份有限公司
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the existing mass spectrometry, high performance liquid and other detection methods can only understand the composition and content of some excipients in the prescription of the original research drug, and cannot comprehensively and effectively analyze the composition of the prescription of the original research drug, which is not conducive to the comprehensive analysis of the original research drug. The development of generic drugs increases the difficulty

Method used

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  • Method for auxiliary identification of flunarizine hydrochloride original research medicine prescription composition
  • Method for auxiliary identification of flunarizine hydrochloride original research medicine prescription composition
  • Method for auxiliary identification of flunarizine hydrochloride original research medicine prescription composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0050] Flunarizine hydrochloride 170830 and 170820 used in the following examples are self-made products of our company;

[0051] The original research drug of flunarizine hydrochloride is the product of Xi'an Janssen Pharmaceutical Co., Ltd.

[0052] The instrument used was a HF-ExR610 Raman spectrometer.

[0053] batch number 170830 170820 Flunarizine hydrochloride 5.9 5.9 lactose 122.7 132.7 corn starch 20 10 talcum powder 9 9 silica 0.4 0.4 Magnesium stearate 2 2 total 160 160

[0054] The raw and auxiliary materials in the table are directly mixed, and then filled in the 4# red-gray capsule shell.

[0055] Example

[0056] 1. Sample direct test

[0057] After connecting the instrument, start the test and preheat for 0.5h.

[0058] For powder samples, take out a small amount of powder with a spatula and place it on a clean sample table, gently flatten it with a clean glass slide, focus the laser on the samp...

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Abstract

The invention provides a method for auxiliary identification of flunarizine hydrochloride original research medicine prescription composition. Whether the sample is the flunarizine hydrochloride original research medicine or not is judged by measuring the Raman spectrum information of the sample, operation is easy, and implementation is easy.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a method for assisting in identifying the composition of the original research drug prescription of flunarizine hydrochloride. Background technique [0002] Flunarizine hydrochloride is a calcium channel blocker, which can prevent cell damage caused by intracellular pathological calcium overload caused by ischemia and other reasons. It is suitable for cerebral arteriosclerosis, cerebral thrombosis, cerebral embolism, cerebral circulation disorder caused by hypertension, cerebral hemorrhage, cerebral circulation disorder caused by arachnoid, cerebral hemorrhage, etc. [0003] Flunarizine hydrochloride capsules were developed in 1968 by Johnson & Johnson Pharmaceuticals in the United States, and are only available in some countries in Europe, Asia and South America. They were first listed in 1977 under the trade name Sibelium. Because the original drug was launched relatively e...

Claims

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Application Information

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IPC IPC(8): G01N21/65
CPCG01N21/65
Inventor 谌宗永刘宇晶罗桓白靳飞童元峰
Owner 北京阳光诺和药物研究股份有限公司
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