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Tirofiban hydrochloride lyophilized powder injection and preparation method thereof

A technology for tirofiban and needle injection, which is applied in the field of tirofiban hydrochloride freeze-dried powder injection and preparation, and can solve the problems of undisclosed pH value and the like

Active Publication Date: 2010-06-30
鲁南新时代生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the pH value of the solution of tirofiban hydrochloride injection powder before lyophilization is not disclosed in the whole preparation process

Method used

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  • Tirofiban hydrochloride lyophilized powder injection and preparation method thereof
  • Tirofiban hydrochloride lyophilized powder injection and preparation method thereof
  • Tirofiban hydrochloride lyophilized powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] prescription

[0055] Tirofiban Hydrochloride 14.05g

[0056] Dextran-40 280.10g

[0057] Phosphoric acid appropriate amount

[0058]

[0059] Make 1000 pieces

[0060] Preparation method: Weigh the prescribed amount of tirofiban hydrochloride and dextran-40, add an appropriate amount of water for injection to dissolve, adjust the pH value of the solution to 2.5 with phosphoric acid, sterilize and filter with a 0.22 μm microporous membrane, and quantitatively fill it in sterile clean pencillin Put in a bottle, half stoppered with rubber, freeze-dried, vacuum-pressed, rolled aluminum cap, and packaged.

Embodiment 2

[0062] prescription

[0063] Tirofiban Hydrochloride 14.05g

[0064] Dextran-40 70.25g

[0065] Citric acid amount

[0066]

[0067] Make 1000 pieces

[0068] Preparation method: Weigh the prescribed amount of tirofiban hydrochloride and dextran-40, add an appropriate amount of water for injection to dissolve, adjust the pH value of the solution to 2.2 with citric acid, sterilize and filter with a 0.22 μm microporous membrane, quantitatively fill in sterile clean In vials, half stoppered with rubber, freeze-dried, vacuum-pressed, rolled aluminum caps, and packaged.

Embodiment 3

[0070] prescription

[0071] Tirofiban Hydrochloride 14.05g

[0072] Dextran-20 140.5g

[0073] Phosphoric acid appropriate amount

[0074]

[0075] Make 1000 pieces

[0076] Preparation method: Weigh the prescribed amount of tirofiban hydrochloride and dextran-20, add an appropriate amount of water for injection to dissolve, adjust the pH value of the solution to 2.3 with phosphoric acid, sterilize and filter with a 0.22 μm microporous membrane, and quantitatively fill it in sterile clean pencillin Put in a bottle, half stoppered with rubber, freeze-dried, vacuum-pressed, rolled aluminum cap, and packaged.

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PUM

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Abstract

The invention relates to a tirofiban hydrochloride lyophilized powder injection and a preparation method thereof, belonging to the field of western medicine preparation. The tirofiban hydrochloride lyophilized powder injection contains 1 part by weight of tirofiban hydrochloride and 0.5-100 parts by weight of dextran, and the pH value of solution before lyophilization is 1.8-2.6. Preferably, the weight ratio between the dextran and the tirofiban hydrochloride is 2:1-20:1. The tirofiban hydrochloride lyophilized powder injection has good composite dissolubility and stability as well as high safety.

Description

technical field [0001] The invention relates to a tirofiban hydrochloride freeze-dried powder injection and a preparation method, belonging to the field of western medicine preparations. Background technique [0002] Tirofiban is used for patients with unstable angina, non-Q wave myocardial infarction, and patients undergoing coronary angioplasty or intracoronary atherectomy. The currently marketed dosage form is isotonic sodium chloride. Regulators, citric acid buffer salts are concentrated solutions for injection and large infusions of pH regulators, which have disadvantages such as poor stability, unstable pH value, and insoluble particles in the solution during storage, which brings great harm to the patient's medication safety. hidden danger, and the volume and weight of the injection are relatively large, making transportation and storage inconvenient. In the production process of freeze-dried powder injection, the medicine is freeze-dried under low temperature and ne...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4465A61K47/36A61P9/10
Inventor 赵志全
Owner 鲁南新时代生物技术有限公司
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