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Tirofiban hydrochloride freeze-dried powder injecta and preparing method

A technology of tirofiban and needle injection, which is applied in the field of pharmaceutical preparations and its preparation, can solve the problems of solution-insoluble particles, inconvenient transportation, large volume, and heavy weight, and achieve easy storage and transportation, reduced transportation costs, and obvious economic benefits Effect

Active Publication Date: 2006-03-08
SHENYANG XINMA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the tirofiban hydrochloride injections listed at home and abroad all have the disadvantages of large volume and weight, inconvenient transportation and easy damage.
Moreover, the injections on the market are all liquid preparations, which need to undergo final high-temperature sterilization, which has a certain impact on the stability of the active ingredient. During storage, the active ingredient is not as stable as the solid form, and insoluble particles are easily produced in the solution. bring security risks
Freeze-dried powder injection can overcome the above defects, but so far there is no report on the listing of tirofiban hydrochloride freeze-dried powder injection

Method used

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  • Tirofiban hydrochloride freeze-dried powder injecta and preparing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription

[0024] Tirofiban hydrochloride monohydrate 5.62g

[0025] 200g lactose

[0026] Made into 1000

[0027] Take prescription amount of lactose, add 1600ml water for injection, stir to dissolve, add 0.1% (g / ml) activated carbon for needles, stir at 50℃ for 30 minutes, filter and decarbonize, add prescription amount of tirofiban hydrochloride, stir Dissolve, add water for injection to 2000ml, adjust the pH of the solution to 2.5 with hydrochloric acid or sodium hydroxide, sterile precision filtration with 0.22μm microporous membrane, determine the content of semi-finished products, quantitatively fill in vials, stopper, freeze Dry, sterile full stopper, pressed aluminum plastic cover, packaged.

[0028] Inspection: 1. Visible foreign body: According to the method of Appendix IX H of the Chinese Pharmacopoeia 2005 Edition, it meets the requirements.

[0029] 2. Insoluble particles: According to the method of Appendix IX C of the Chinese Pha...

Embodiment 2

[0031] prescription

[0032] Tirofiban hydrochloride monohydrate 5.62g

[0033] Lactose 75g

[0034] Made into 1000

[0035] Take prescription amount of lactose, add 1200ml water for injection, stir to dissolve, add 0.01% (g / ml) activated carbon for needles, stir at 25℃ for 60 minutes, filter and decarbonize, add prescription amount of tirofiban hydrochloride, stir Dissolve, add water for injection to 1500ml, adjust the pH of the solution with hydrochloric acid to 2, 0.22μm microporous filter membrane aseptically and finely filter, determine the content of semi-finished products, quantitatively fill in vials, stopper, freeze-dry, sterile Fully press stopper, press aluminum and plastic cover, ready to pack.

[0036] Inspection: 1. Visible foreign body: According to the method of Appendix IX H of the Chinese Pharmacopoeia 2005 Edition, it meets the requirements.

[0037] 2. Insoluble particles: According to the method of Appendix IX C of the Chinese Pharmaco...

Embodiment 3

[0039] prescription

[0040] Tirofiban hydrochloride monohydrate 5.62g

[0041] 800g lactose

[0042] Made into 1000

[0043] Take prescription amount of lactose, add 3200ml water for injection, stir to dissolve, add 0.5% (g / ml) activated carbon for needles, stir at 100°C for 10 minutes, filter and decarbonize, add prescription amount of tirofiban hydrochloride, stir Dissolve, add injection water to 4000ml, adjust the pH of the solution to 3 with sodium hydroxide, aseptically filter with 0.22μm microporous membrane, determine the content of semi-finished products, quantitatively fill in vials, stopper, freeze-dry, Sterile full stopper, pressed aluminum plastic cover, packaged.

[0044] Inspection: 1. Visible foreign body: According to the method of Appendix IX H of the Chinese Pharmacopoeia 2005 Edition, it meets the requirements.

[0045] 2. Insoluble particles: According to the method of Appendix IX C of the Chinese Pharmacopoeia 2005 edition, it meets t...

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Abstract

The preparation method of tirofiban hydrochloride freeze-dried powder injection preparation includes the following steps: using 30-1200g of lactose, adding water for injection, dissolving, adding active carbon, stirring for 10-60 min at 25-100deg.C, filtering and removing carbon, adding 5.62g of tirofiban hydrochloride monohydrate, stirring, adding water for injection to 1500-4000ml, regulating pH value of solution to 2-3, sterile filtering, filling, freeze-drying, squeezing cap and packaging, etc.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to an antiplatelet agglutinant tirofiban hydrochloride freeze-dried powder injection and a preparation method thereof. Background technique: [0002] Tirofiban (English name: Tirofiban) is a non-peptide platelet glycoprotein GP IIb / IIIa receptor antagonist, which has the effect of anti-platelet aggregation. Its chemical name is N-(butylsulfonyl)-O-[4-(4-piperidinyl)butyl]-L-tyrosine, and its hydrochloride monohydrate is generally used in pharmacy. [0003] Tirofiban hydrochloride is used to treat patients with acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction), and it is also suitable for coronary angioplasty or intracoronary atheroma in patients with coronary ischemic syndrome Mass resection, tirofiban hydrochloride can reduce the incidence of death, myocardial infarction, refractory myocardial ischemia / revascularization composi...

Claims

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Application Information

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IPC IPC(8): A61K31/4465A61K9/19A61P7/02A61P9/10
Inventor 闫志刚黄牧童姚俊平张曦赜
Owner SHENYANG XINMA PHARMA
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