Tirofiban powder injection and its preparing method

A technology of rofiban powder and tirofiban, which is applied in the field of tirofiban powder injection, can solve the problems of poor physical stability of aqueous solution injection, difficult to maintain clarity, unstable pH value, etc. Stable properties and wide selection of effects

Inactive Publication Date: 2006-08-23
HUAZHONG UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Experiments have found that the aqueous solution injection of tirofiban has disadvantages such as poor physical stability, unstable pH value, and difficulty in maintaining clarity.
Moreover, solution injections are not convenient in transportation, storage and use, especially in cold regions and seasons.

Method used

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  • Tirofiban powder injection and its preparing method
  • Tirofiban powder injection and its preparing method
  • Tirofiban powder injection and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Preparation of tirofiban powder injection

[0061] 1. According to the technical scheme disclosed in document Tetrahedron (1993) 49 (26) 5767-76, take tyrosine and butanesulfonyl chloride as raw materials to synthesize tirofiban.

[0062] 2. Prepare raw materials according to the table:

[0063] Ingredient Amount

[0064] Tirofiban Hydrochloride 5.6g

[0065] Sodium dihydrogen phosphate 8.0g

[0066] Disodium hydrogen phosphate 20.4g

[0067] Mannitol 50g

[0068] Water for injection 1000ml

[0069] 3. Preparation process:

[0070] Take by weighing disodium hydrogen phosphate, sodium dihydrogen phosphate, mannitol of prescribed quantity, add 800ml of water for injection to dissolve, add appropriate amount of active carbon for needles, stir, filter, add tirofiban hydrochloride of prescribed quantity, use 0.1mol / LHCl and 0.1mol / LNaOH adjust the pH value to 5.0-7.0 and add water for injection to 1000ml. Sterilize the medicinal solution according to the aseptic ...

Embodiment 2

[0072] Preparation of tirofiban powder injection

[0073] 1. According to the technical scheme disclosed in document Tetrahedron (1993) 49 (26) 5767-76, take tyrosine and butanesulfonyl chloride as raw materials to synthesize tirofiban.

[0074] 2. Prepare the required raw materials according to the table below:

[0075] Ingredient Amount

[0076] Tirofiban Hydrochloride 14.0g

[0077] Sodium dihydrogen phosphate 8.0g

[0078] Disodium hydrogen phosphate 20.4g

[0079] Mannitol 50g

[0080] Water for injection 1000ml

[0081] 3. Preparation process:

[0082] The preparation method is the same as in Example 1 except that the amount of tirofiban hydrochloride added is different.

Embodiment 3

[0084] Preparation of tirofiban powder injection

[0085] 1. According to the technical scheme disclosed in document Tetrahedron (1993) 49 (26) 5767-76, take tyrosine and butanesulfonyl chloride as raw materials to synthesize tirofiban.

[0086] 2. Prepare raw materials according to the table:

[0087] Ingredient Amount

[0088] Tirofiban Hydrochloride 5.6g

[0089] Sodium dihydrogen phosphate 8.0g

[0090] Disodium hydrogen phosphate 20.4g

[0091] Sorbitol 50g

[0092] Water for injection 1000ml

[0093] 3. Preparation process:

[0094] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

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Abstract

The present invention relates to new preparation form of Tirofiban, especially Tirofiban powder for injection, as antiplatelet medicine and its preparation process. The powder for injection consists of Tirofiban as active component, freeze drying support agent and pH buffering agent. The present invention expands the administration range of Tirofiban and raises the clinical administration level of Tirofiban.

Description

technical field [0001] The invention provides a new preparation of tirofiban, in particular tirofiban powder injection. Background technique [0002] The rupture of atherosclerotic plaque in coronary arteries and subsequent platelet adhesion, aggregation, and thrombus formation are the main causes of coronary heart disease events. Platelet membrane glycoprotein GPIIb / IIIa receptors exist on the surface of platelet membranes and are expressed in large quantities when platelets are activated, which is the last pathway that causes platelet aggregation. Platelet membrane glycoprotein GPIIb / IIIa receptor antagonists produce antithrombotic effect by blocking the binding of platelet membrane glycoprotein GPIIb / IIIa receptors to coagulation factors. Tirofiban is a potent platelet membrane glycoprotein GPIIb / IIIa receptor antagonist, it selectively binds to the platelet glycoprotein GPIIb / IIIa receptor, occupies the binding site on it, and makes the platelet membrane Glycoprotein G...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4465A61K9/14A61P7/02A61P9/10
Inventor 项光亚胡婕
Owner HUAZHONG UNIV OF SCI & TECH
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