Preparation process of bivalirudin for injection

A bivalirudin and preparation technology technology, applied in the field of pharmaceutical preparations, can solve the problems of bivalirudin precipitation and dispensing time, etc., and achieve the effects of shortening the dispensing time, reducing microbial load, and reducing related substances

Pending Publication Date: 2020-06-12
HAINAN SHUANGCHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of this, the present invention proposes a preparation process of bivalirudin for injection to solve the problems of bivalirudin precipitation and long liquid preparation time in the liquid preparation process

Method used

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  • Preparation process of bivalirudin for injection
  • Preparation process of bivalirudin for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A preparation process of bivalirudin for injection, comprising the following steps:

[0026] (1) Take 1.25 kg of mannitol, dissolve it in 28.5 L of water for injection, stir to dissolve, then add 2.5 kg of bivalirudin (in dry form), and stir to dissolve to obtain a mixed solution of bivalirudin and mannitol;

[0027] (2) Bivalirudin mannitol mixed solution and 0.5mol / L sodium hydroxide solution are simultaneously pumped into the liquid mixing tank through different pipelines, stirred and mixed, and the flow rate of the bivalirudin mannitol mixed solution is: 720ml / min, the flow rate of the sodium hydroxide solution is 240ml / min, that is, the flow ratio of the two is 3:1, keep stirring, the stirring rate is 300rpm~400rpm, adjust the pH value of the solution to 5.0~6.0, add water for injection to 50L, to obtain bivalirudin intermediate solution for injection; the temperature of the whole solution is 10℃~20℃;

[0028] (3) The bivalirudin intermediate solution for injectio...

Embodiment 2

[0030] A preparation process of bivalirudin for injection, comprising the following steps:

[0031] (1) Take 1.25kg of mannitol, dissolve it in 19L of water for injection, stir to dissolve, then add 2.5kg of bivalirudin (in dry form), stir to dissolve, and obtain a mixed solution of bivalirudin and mannitol;

[0032] (2) Bivalirudin mannitol mixed solution and 0.25mol / L sodium hydroxide solution are pumped into the liquid mixing tank through different pipelines simultaneously, stirred and mixed, and the flow rate of described bivalirudin mannitol mixed solution is: 600ml / min, the flow rate of the sodium hydroxide solution is 600ml / min, that is, the flow ratio of the two is 1:1, keep stirring, the stirring rate is 150rpm-200rpm, adjust the pH value of the solution to 5.0-6.0, add water for injection to 50L, to obtain the bivalirudin intermediate solution for injection; the whole dosing temperature is 5°C to 10°C;

[0033] (3) The bivalirudin intermediate solution for injection...

Embodiment 3

[0035] A preparation process of bivalirudin for injection, comprising the following steps:

[0036] (1) Take 1.25 kg of mannitol, dissolve it in 28.5 L of water for injection, stir to dissolve, then add 2.5 kg of bivalirudin (in dry form), and stir to dissolve to obtain a mixed solution of bivalirudin and mannitol;

[0037] (2) Bivalirudin mannitol mixed solution and 1.5mol / L sodium hydroxide solution are pumped into the liquid mixing tank through different pipelines simultaneously, stirred and mixed, and the flow rate of described bivalirudin mannitol mixed solution is: 900ml / min, the flow rate of the sodium hydroxide solution is 100ml / min, that is, the flow ratio of the two is 9:1, keep stirring, the stirring rate is 400rpm-500rpm, adjust the pH value of the solution to 5.0-6.0, add water for injection to 50L, to obtain the bivalirudin intermediate solution for injection; the whole dosing temperature is 20°C to 25°C;

[0038] (3) The bivalirudin intermediate solution for in...

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Abstract

The invention provides a preparation process of bivalirudin for injection, and the process comprises the following steps: (1) dissolving bivalirudin and mannitol with water for injection to obtain a bivalirudin and mannitol mixed solution; (2) adding the bivalirudin mannitol mixed solution and a sodium hydroxide solution into one same container according to a certain flow ratio of the bivalirudinmannitol mixed solution to the sodium hydroxide solution being (1-9): 1 for stirring and mixing, adjusting the pH value of the solution to 5.0-6.0, and supplementing water to the total amount of the prepared solution so as to obtain a bivalirudin intermediate solution for injection; and (3) subjecting the bivalirudin intermediate solution for injection to sterilization, filtration, filling, semi-plugging, freeze-drying, plug pressing and capping so as to obtain a bivalirudin freeze-dried powder injection for injection. When the bivalirudin for injection is prepared by adopting the method, no bivalirudin is separated out in the liquid preparation process, the liquid preparation time is short, the microbial load of an intermediate solution is remarkably reduced, and the prepared bivalirudinfinished product for injection contains few related substances.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation process of bivalirudin for injection. Background technique [0002] Bivalirudin is a polypeptide composed of 20 amino acids with the molecular formula C 98 h 138 N 24 o 33 , the molecular weight is 2180.33. Bivalirudin directly inhibits the action of thrombin by binding to the catalyst site and the anion export site of the circulation and thrombin clot. Thrombin is a serine protease that plays an important role in the process of thrombus formation. It can decompose hemogenous fibrinogen into fibrin monomers, activate active factor X III into factor X IIIa, and make fibrin become covalent Cross-linking structure, so as to achieve the purpose of stabilizing thrombus. Thrombin is also capable of activating factor V and factor V III, which further promotes thrombin generation, activates platelets, and stimulates their aggregation and granule release. Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/02A61K38/58A61P7/02
CPCA61K9/0019A61K9/19A61K38/58A61K47/02A61K47/26A61P7/02
Inventor 艾一祥李建明王建丹汪翔
Owner HAINAN SHUANGCHENG PHARMA
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