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Enoxaparin sodium injection and preparation process thereof

A technology for enoxaparin sodium and injection, which is applied in the field of enoxaparin sodium injection and its preparation, can solve problems such as the stability of enoxaparin sodium injection that cannot be well solved, and achieves improved stability and improved stability. Good, simple and applicable effect

Active Publication Date: 2014-09-03
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In view of the fact that the traditional technology cannot solve the stability problem of enoxaparin sodium injection well, the inventors have found a way to effectively solve the problems existing in the prior art through a large number of test screenings

Method used

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  • Enoxaparin sodium injection and preparation process thereof
  • Enoxaparin sodium injection and preparation process thereof
  • Enoxaparin sodium injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Prepare enoxaparin sodium injection according to the following formula:

[0030]

[0031] According to the above formula, first dissolve L-cysteine ​​in water for injection cooled to room temperature to obtain a solution of L-cysteine; quickly dissolve enoxaparin sodium and vitamin C in the above-mentioned L-cysteine In the solution, use 0.5mol / L NaOH to adjust the pH of the solution to 6.2, then filter it through a sterile filtration system, and aseptically fill it to obtain 5000 0.6ml / enoxaparin sodium injection injections .

Embodiment 2

[0033] Prepare enoxaparin sodium injection according to the following formula:

[0034]

[0035] According to the above formula, first dissolve L-cysteine ​​in water for injection cooled to room temperature to obtain a solution of L-cysteine; quickly dissolve enoxaparin sodium and vitamin C in the above-mentioned L-cysteine In the solution, use 0.5mol / L NaOH to adjust the pH of the solution to 6.2, then filter it through a sterile filtration system, and aseptically fill it to obtain 5000 0.6ml / enoxaparin sodium injection injections .

Embodiment 3

[0037] Prepare enoxaparin sodium injection according to the following formula:

[0038]

[0039] According to the above formula, first dissolve L-cysteine ​​in water for injection cooled to room temperature to obtain a solution of L-cysteine; quickly dissolve enoxaparin sodium and vitamin C in the above-mentioned L-cysteine In the solution, use 0.5mol / L NaOH to adjust the pH of the solution to 6.2, then filter it through a sterile filtration system, and aseptically fill it to obtain 5000 0.6ml / enoxaparin sodium injection injections .

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Abstract

The invention belongs to the pharmaceutic preparation field, and in particular relates to an enoxaparin sodium injection and a preparation process thereof. The processes of adding antioxygen of the assigned type and regulating the pH are applied to the preparation of the enoxaparin sodium injection. The injection is specifically prepared from enoxaparin sodium, vitamin C, L-cysteine and water for injection, the pH regulating agent is used for regulating the pH of the injection at 5.5-7.5. Compared with the prior art, the technical scheme provided by the invention is capable of greatly improving the stability of the enoxaparin sodium injection, the aspects that the color of the medicine liquor is darkened, the activity is reduced, and the pH of the medicine liquor is greatly reduced are obviously improved; and the process is simple and suitable for the large-scale industrial production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an enoxaparin sodium injection and a preparation process thereof. Background technique [0002] Enoxaparin sodium is a sodium salt of low-molecular-weight heparin. It is the sodium salt of aminodextran sulfate fragments obtained by alkali degradation of heparin extracted from pig small intestinal mucosa after benzyl esterification. It is a polysaccharide mixture with an average molecular weight of Around 4500 Daltons. It was approved by the FDA in 1933 and marketed in the United States. Its main mechanism of action is to inhibit the activity of factor Xa and factor IIa by binding to antithrombin and its complex. Venous thrombosis, prevention of deep venous thrombosis in patients undergoing abdominal surgery with thromboembolic complications, combined with aspirin to prevent arterial thrombosis in patients with unstable angina and no Q-wave myocardial infarc...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/727A61K47/22A61K47/18A61P7/02
Inventor 赵志全蒋新利冯中
Owner SHANDONG NEWTIME PHARMA
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