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Injection use-powder ampoule for inhibiting thrombocyte agglutination and its preparation method

A technology for platelet aggregation and injection, which is used in blood diseases, powder delivery, drug combination, etc. It can solve the problems of easy generation of insoluble particles, and achieve the effects of good stability, good stability and exact curative effect.

Active Publication Date: 2005-10-26
GRAND PHARM (CHINA) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In our opinion, the use of citrate buffered injections for IV administration has the following disadvantages: Citrate buffer is still a relatively easy substance to generate insoluble particles

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0011] Embodiment 1 Prescription freeze-dried powder for injection of the present invention

[0012] Specification: 5mg / bottle (calculated as anhydrous tirofiban), the same below

[0013] Tirofiban Hydrochloride 5.618g

[0014] Mannitol 100g

[0015] Water for injection to 2000ml

[0016] A total of 1000 powder needles were made

[0017] Preparation Process:

[0018] Preparation of liquid medicine:

[0019] Take tirofiban hydrochloride and selected pharmaceutically acceptable carrier by prescription quantity, add in 1950ml water for injection, and add water to nearly full amount; After adding water for injection to the prescribed amount, measure the intermediate content and should be 93.0%~107.0%, After passing the test, filter it with a 0.45um microporous membrane, check the clarity and pass it, then pack it into controlled antibiotic bottles, and hand it over to the freeze-drying group.

[0020] Freeze-dried:

[0021] First cool down for 1 hour...

Embodiment 2

[0022] Embodiment 2 Prescription injection of the present invention aseptic subpackage powder injection

[0023] Tirofiban Hydrochloride 5.618g

[0024] Mannitol 100g

[0025] A total of 1000 powder needles were made

[0026] Preparation Process:

[0027] Weigh tirofiban hydrochloride and selected pharmaceutically acceptable carrier according to the prescription quantity, add in 300ml alcohol solution and dissolve, ethanol: water is 95:5, under sterile conditions, filter with 0.45um microporous membrane, check clarity After passing the test, dry it; the content of the inspection intermediate should be 93.0% to 107.0%, and after passing the ethanol residue, pack it into a controlled antibiotic bottle and press the composite aluminum cover.

Embodiment 3

[0028] Example 3 Comparative injection containing citrate buffer

[0029] Tirofiban Hydrochloride 5.618g

[0030] Sodium chloride: 900g

[0031] Sodium citrate 54g

[0032] Citric acid 3.2g

[0033] A total of 1000 bottles of injection were made

[0034] Preparation Process:

[0035] Liquid preparation:

[0036] Weigh sodium chloride, citric acid and sodium citrate according to the prescription amount, add in 5000ml of newly prepared water for injection, stir until completely dissolved; weigh the active carbon of 0.3% solution amount, stir well, heat and boil for 15 minutes, after cooling, filter Remove activated carbon; accurately weigh tirofiban hydrochloride according to the prescription amount, completely dissolve it with water for injection, add it to the above sodium chloride solution, and add water for injection to nearly full amount; measure the pH at 5.5-6.5, add water for injection to the specified amount, Determination of intermediate content should be 93.0% t...

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PUM

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Abstract

A powder injection for suppressing the thrombocyte coagulation is proportionally prepared from tirofiban hydrochloride, the water for injection and the pharmacologically acceptable carrier chosen from lactose, mannitol, cane sugar, glucose, dextran, hydrolytic gelatin and sodium chloride through proportionally mixing, examining intermediate, adding water, filtering, loading in bottle and vacuum freeze drying.

Description

technical field [0001] The invention relates to a powder injection for inhibiting platelet aggregation and a preparation method thereof. Background technique [0002] Tirofiban hydrochloride (English name: Tirofiban hydrochloride, chemical name: (S)-N-(n-butylsulfonyl)-O-[4-(4-piperidinyl)butane]-L-tyrosine Hydrochloride monohydrate) is a salt compound of a platelet inhibitor. Tirofiban hydrochloride inhibits the binding of fibrinogen to platelets and inhibits platelet aggregation through the binding of fibrinogen receptor antagonists to glycoprotein (GP) IIb / IIIa fibrinogen receptor sites. The Chinese Patent Publication No. 1200676A of U.S. Mike Company has described the pharmaceutical composition of this compound, and this patent has described using citrate buffer to be superior to phosphate buffer, the citrate composition stability that contains tirofiban hydrochloride For more than 18 months, particles with a particle size greater than 50um can be seen in the solution ...

Claims

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Application Information

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IPC IPC(8): A61K31/445
Inventor 耿海明钱自强杨波周建明
Owner GRAND PHARM (CHINA) CO LTD
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