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Tirofiban hydrochloride injecta and preparation method thereof

A technology of tirofiban and injection, applied in the direction of medical preparations with non-active ingredients, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problem of increasing the amount of insoluble particles

Inactive Publication Date: 2012-07-25
武汉同源药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] We conducted experiments according to the above-mentioned patents, and the experiments proved that adding pH buffer solution to Tirofiban Hydrochloride Injection is not the best method. After the solution is placed, insoluble particles are still produced continuously, and the amount of insoluble particles increases as time goes by.

Method used

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  • Tirofiban hydrochloride injecta and preparation method thereof
  • Tirofiban hydrochloride injecta and preparation method thereof
  • Tirofiban hydrochloride injecta and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1: prepare tirofiban hydrochloride injection (specification 100ml: 5mg)

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] (1) Add 80L of water for injection at 70-80°C to the concentrated preparation tank, add 890 grams of sodium chloride and 6 grams of L-arginine, stir to dissolve, add 80 grams of activated carbon for needles, stir well, and let stand for 30 minutes. Filtration and decarbonization, the filtrate enters the dilute distribution tank;

[0040] (2) Take 100ml of water for injection at 70-80°C, add 5 grams of tirofiban hydrochloride, stir to dissolve, add to the dilute tank filtrate, and stir well;

[0041] (3) Add water for injection to the full amount, stir well, slowly add hydrochloric acid while stirring, adjust the pH value to 5.5-6.5, measure the main drug content and osmotic pressure of the semi-finished product;

[0042] (4) Fine filtration: Fine filtration with 0.45 μm and 0.22 μm microporous membranes respectiv...

Embodiment 2

[0046] Embodiment 2: prepare tirofiban hydrochloride injection (specification 50ml: 12.5mg)

[0047] prescription:

[0048]

[0049] Preparation Process:

[0050] (1) Add 80L of water for injection at 70-80°C to the concentrated preparation tank, add 890 grams of sodium chloride and 13 grams of L-arginine, stir to dissolve, add 80 grams of activated carbon for needles, stir well, and let stand for 30 minutes. Filtration and decarbonization, the filtrate enters the dilute distribution tank;

[0051] (2) Take 500ml of water for injection at 70-80°C, add 25 grams of tirofiban hydrochloride, stir to dissolve, add to the dilute tank filtrate, and stir well;

[0052] (3) Add water for injection to the full amount, stir well, slowly add hydrochloric acid while stirring, adjust the pH value to 5.5-6.5, measure the main drug content and osmotic pressure of the semi-finished product;

[0053] (4) Fine filtration: Fine filtration with 0.45 μm and 0.22 μm microporous membranes respe...

Embodiment 3

[0057] Embodiment 3: preparation tirofiban hydrochloride injection (specification 250ml: 12.5mg)

[0058] prescription:

[0059]

[0060] Preparation Process:

[0061] (1) Add 400L of water for injection at 70-80°C to the concentrated preparation tank, add 4450 grams of sodium chloride and 25 grams of L-arginine, stir to dissolve, add 400 grams of activated carbon for needles, stir well, and let stand for 30 minutes. Filtration and decarbonization, the filtrate enters the dilute distribution tank;

[0062] (2) Take 500ml of water for injection at 70-80°C, add 25 grams of tirofiban hydrochloride, stir to dissolve, add to the dilute tank filtrate, and stir well;

[0063] (3) Add water for injection to the full amount, stir well, slowly add hydrochloric acid while stirring, adjust the pH value to 5.5-6.5, measure the main drug content and osmotic pressure of the semi-finished product;

[0064] (4) Fine filtration: Fine filtration with 0.45 μm and 0.22 μm microporous membran...

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Abstract

The invention provides a tirofiban hydrochloride injecta and a preparation method thereof. L-arginine is added into an injecta formula, and compared with a formula in which a pH (Potential Of Hydrogen) buffer solution is used as an accessory and a formula provided with arginine aspirin, insoluble particles of the tirofiban hydrochloride injecta are reduced in the formula with the L-arginine, and particularly, after the standing of the solution, the quantity of the insoluble particles is basically not increased as time goes on, so that the tirofiban hydrochloride injecta is ensured to be safe and effective.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to tirofiban hydrochloride injection and a preparation method thereof Background technique [0002] Tirofiban hydrochloride (N-n-butylsulfonyl-O-4-(4'-piperidinyl) butyl-L-tyrosine hydrochloride monohydrate), the structural formula is as follows: [0003] [0004] Tirofiban hydrochloride is a reversible non-peptide platelet GP IIb / IIIa receptor antagonist developed by Merck Company of the United States. It was first launched in the United States in May 1998 and is currently available in Switzerland, Germany, the United Kingdom, and the Netherlands , listed in China and other countries. [0005] Tirofiban hydrochloride is suitable for patients with unstable angina or non-Q wave myocardial infarction to prevent cardiac ischemic events, and it is also suitable for coronary angioplasty or intracoronary plaque resection in patients with coronary ischemic syndrome , to prev...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4465A61K47/16A61P9/10
Inventor 黄毅黄层霄彭俊张宇玄熊昕
Owner 武汉同源药业有限公司
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