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Batifiban injection and its preparation

A technology of batifiban and injection, which is used in cyclic peptide components, blood diseases, extracellular fluid diseases, etc., can solve the problems of difficult preparation of preparations, achieve high bioavailability, avoid irritation, good stability and safety effect

Active Publication Date: 2016-03-30
BIO THERA SOLUTIONS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, although batifiban has been studied as an active ingredient of medicine, the solubility of batifiban is limited: it can only be easily dissolved in 0.1mol / L hydrochloric acid solution, and it can be dissolved in methanol, ethanol, ethyl acetate and 50% Slightly soluble in acetonitrile, almost insoluble in water, acetone, ether and 0.1mol / L sodium hydroxide solution, it is difficult to prepare a preparation suitable for pharmaceutical requirements according to conventional injection prescriptions

Method used

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  • Batifiban injection and its preparation
  • Batifiban injection and its preparation
  • Batifiban injection and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription

[0030] Specification: 10ml: 20mg

[0031] prescription:

[0032]

[0033] Take 52.5g of citric acid, dissolve it with 200ml of water for injection, add 20g of batifiban, stir to dissolve it, then adjust the pH value to 5.25 with 1mol / L sodium hydroxide solution; dilute to 10000ml with water for injection, coarse filter ; Filter with 0.22μm sterile filter membrane, ultrafiltration, inspection, 10.5ml per bottle, press stopper, add aluminum-plastic composite lid, outer packaging, inspection, and then get the product.

Embodiment 2

[0035] prescription

[0036] Specification: 100ml: 75mg

[0037] prescription:

[0038]

[0039] Take 525g of citric acid, dissolve it with 2000ml water for injection, add 75g batifiban, stir to dissolve it, then adjust the pH value to 5.35 with 1mol / L sodium hydroxide solution; then dilute to 100000ml with water for injection, and filter coarsely ; Filter with a 0.22μm sterile filter membrane, test, fill 100ml per bottle, press stopper, add aluminum-plastic composite cover, tie the cover, package, test, and then get the product.

Embodiment 3

[0041] prescription:

[0042]

[0043] Take 52.5g of citric acid, dissolve it with 200ml of water for injection, add 20g of batifiban, stir to dissolve it, then adjust the pH to 5.25 with 1mol / L sodium hydroxide solution, add 500g of mannitol, and dilute with water for injection To 10000ml, coarsely filter; filter with a sterile filter with a pore size of 0.22μm or less, and inspect. Each bottle is divided into 10.1-10.5ml, half-stopped, and placed in the freeze-drying box. Pay attention to the medicine bottles to be evenly distributed on the plate.

[0044] Pre-freezing: Set the plate temperature to -45°C, control the temperature of the medicine below -40°C, and keep it for 4-6 hours.

[0045] One-time drying: start vacuuming after the cold trap temperature drops below -40℃; when the vacuum is ≤10Pa, set the plate temperature to -20℃, turn on the vacuum alarm and electric heating, keep it for 8-10 hours; increase the plate temperature according to the temperature of the medicine , ...

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Abstract

The invention relates to Batifiban and a pharmaceutically acceptable injection thereof, and preparation and pharmaceutical application thereof. The result shows that the injection has good stability and safety in production and clinical application.

Description

Technical field [0001] The present invention relates to the field of injections for the treatment of thrombotic diseases, in particular to the field of injections containing batifiban as an effective ingredient for the treatment of thrombotic diseases. Background technique [0002] Coronary heart disease refers to insufficiency of blood supply and myocardial hypoxia caused by different degrees of obstruction of the coronary arteries. Coronary heart disease has always been the leading cause of death in Western countries, especially the United States. In the United States, approximately 1.55 million people get sick every year. However, cardiovascular morbidity and mortality in developing countries are increasing year by year. Percutaneous Coronary Intervention (PercutaneousCornonary Intervention, PCI) is one of the main effective treatments for coronary artery obstruction. However, during PCI or after PCI, acute coronary thrombosis and re-occlusion caused by platelet aggregation...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/12A61K9/08A61K9/10A61K9/14A61P7/02
Inventor 李胜峰
Owner BIO THERA SOLUTIONS LTD