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Preparation method of nicardipine hydrochloride injection

A technology for nicardipine hydrochloride and dipine injection, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., which can solve the problem of easy production of peroxides in medicinal liquids and lack of attention to stirring atmosphere , Injection quality decline and other issues, to achieve better decolorization effect, good decolorization effect, and safe finished product

Active Publication Date: 2022-08-02
回音必集团抚州制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the traditional process of nicardipine hydrochloride injection preparation, it is necessary to prepare the finished product through the steps of initial consideration-decolorization-fine filtration and disinfection of the prepared medicinal liquid. In the traditional decolorization step, activated carbon is usually used for decolorization, but activated carbon has no effect on nicardipine hydrochloride. The main drug of cardipine has extremely strong adsorption, which leads to serious loss of the main drug in the liquid medicine, which affects the quality, and at the same time it faces a long-term stirring process between the liquid medicine and activated carbon. The traditional process often does not pay attention to the stirring atmosphere, and the liquid is easy to The production of peroxides leads to a decrease in the quality of injections

Method used

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  • Preparation method of nicardipine hydrochloride injection
  • Preparation method of nicardipine hydrochloride injection
  • Preparation method of nicardipine hydrochloride injection

Examples

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Effect test

Embodiment 1

[0041] A preparation method of nicardipine hydrochloride injection, comprising the following steps:

[0042] S1. Material preparation: nicardipine hydrochloride with a volume fraction of 0.01%, an adjuvant mixture with a volume fraction of 2%, and the balance of water for injection;

[0043] S2. The adjuvant mixture is 10% of the solubilizer and the balance of the isotonicity regulator;

[0044] S3. after nicardipine hydrochloride and the adjuvant mixture are mixed, water for injection is added to obtain the first treatment solution;

[0045] S4. After the initial treatment of the first treatment solution, under a nitrogen atmosphere, add silica gel modified activated carbon with a total volume of 0.05% to the first treatment solution to stir and decolorize for 25 minutes, and then add silica gel modified activated carbon with a total volume of 0.05% for decolorization with stirring 30min, the second treatment solution was obtained after suction filtration, and the rotating s...

Embodiment 2

[0081] The difference between this embodiment and Embodiment 1 is:

[0082] In the present embodiment, the preparation method of nicardipine hydrochloride comprises the following steps:

[0083] After adding the crude nicardipine hydrochloride into methanol for 50 min of ultrasonic vibration, adding acid solution dropwise to adjust the pH value to 5, and then rotating at 50°C for 4 hours to obtain the first treatment material;

[0084] Add acetone to the first treatment material, cool down to -40°C, react for 1.5h until crystals are completely precipitated, filter out the solid, and dry under reduced pressure at 60°C for 13h to obtain nicardipine hydrochloride;

[0085] The ratio of crude nicardipine hydrochloride to methanol is 1:12;

[0086] The ratio of the first treatment material to acetone was 1:8.

Embodiment 3

[0088] The difference between this embodiment and Embodiment 1 is:

[0089] In the present embodiment, the preparation method of nicardipine hydrochloride comprises the following steps:

[0090] After adding the crude nicardipine hydrochloride into methanol for 50 min of ultrasonic vibration, adding acid solution dropwise to adjust the pH value to 5, and then rotating at 50°C for 4 hours to obtain the first treatment material;

[0091] Add acetone to the first treatment material, cool down to -40°C, react for 1.5h until crystals are completely precipitated, filter out the solid, and dry under reduced pressure at 60°C for 13h to obtain nicardipine hydrochloride;

[0092] The ratio of crude nicardipine hydrochloride to methanol is 1:14;

[0093] The ratio of the first treatment material to acetone was 1:6.

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Abstract

The invention discloses a preparation method of a nicardipine hydrochloride injection, which is characterized in that silica gel is loaded on activated carbon to modify the activated carbon to serve as a decolorizing agent, so that the problem of high absorptivity of a main drug of the nicardipine hydrochloride injection by using the activated carbon as the decolorizing agent in the traditional process is solved; meanwhile, the problem that the decolorizing effect is poor when single silica gel is used as a decolorizing agent is solved, the first treating fluid is subjected to decolorizing treatment under the protection condition of an inert atmosphere, the decolorizing effect is better, peroxide causing quality reduction of the injection is not prone to being generated, and the subsequent preservation effect of the injection is better.

Description

technical field [0001] The invention relates to the field of injection preparation, in particular to a preparation method of nicardipine hydrochloride injection. Background technique [0002] Nicardipine hydrochloride, alias: nolatentan hydrochloride, is a second-generation dihydropyridine calcium ion antagonist with high selectivity, low cardiotoxicity and good curative effect. Clinically, it is mainly used for the treatment of cardiovascular and cerebrovascular It is one of the first-choice antihypertensive drugs. [0003] In the traditional process for the preparation of nicardipine hydrochloride injection, the prepared medicinal liquid needs to be subjected to the steps of initial filtering-decolorization-fine filtration and disinfection to obtain the finished product. The main drug of cardipine has an extremely strong adsorption effect, which leads to serious loss of the main drug in the liquid, which affects the quality, and faces a long-term stirring process of the l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4422A61K47/02A61K47/26A61P9/00A61P9/08A61P9/12B01D15/08
CPCA61K31/4422A61K9/08A61K9/0019A61K47/26A61K47/02A61P9/12A61P9/00A61P9/08B01D15/08Y02A50/30
Inventor 冯明全陈妍徐忠辉袁清芳颜磊李淑芬万香玲
Owner 回音必集团抚州制药有限公司
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