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Tirofiban hydrochloride lyophilization powder injection

A technology of freeze-dried powder injection and tirofiban, which is applied in the field of medicine, can solve the problems of large volume and weight, low qualified rate of foreign matter, and inconvenient transportation, and achieve the effects of stable physical and chemical properties, simple preparation process, and convenient operation

Active Publication Date: 2012-04-25
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN200410061014.0 discloses an injection for inhibiting platelet aggregation and its preparation method. It consists of tirofiban hydrochloride, sodium chloride, and water. The above infusions all have large volume and weight, inconvenient transportation, easy damage, and visible foreign matter. Disadvantages of low rate
[0004] CN100367961C discloses tirofiban hydrochloride freeze-dried powder preparation and preparation method thereof, and lactose is excipient, and the sample prepared by this process has the following problems: 1. though visible foreign matter is better than excipient being mannitol and dextran, However, the problem of visible foreign matter has not been fundamentally solved. Experiments have proved that after reconstitution, there are still a few products with visible foreign matter that are unqualified, which brings certain hidden dangers to patients.
②The excipient used is lactose, but lactose does not currently have specifications for injection. As an excipient for injection, the dosage is large, and its safety has not been proven, posing a safety hazard
Since dextran is used to improve microcirculatory disorders caused by various shocks, prevent or eliminate intravascular red blood cell aggregation and thrombosis, and treat angina pectoris, acute myocardial infarction and other peripheral vascular diseases, etc., it has its own medicinal effect, so it is also unsafe. factor
[0006] CN101716148A discloses a freeze-dried powder injection of tirofiban hydrochloride, which adopts solid dispersion technology. Sodium, although safe and stable pharmaceutical preparations are obtained, solid dispersion technology undoubtedly increases the complexity of the production process
[0007] It is found by retrieval that there is no report about cysteine ​​hydrochloride as tirofiban hydrochloride freeze-drying excipient in the prior art

Method used

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  • Tirofiban hydrochloride lyophilization powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] The preparation of embodiment 1 tirofiban hydrochloride freeze-dried powder preparation

[0019] Tirofiban hydrochloride (calculated as tirofiban) 1 part

[0020] Cysteine ​​hydrochloride 0.5 part

[0021] Preparation Process:

[0022] (1) Take tirofiban hydrochloride and cysteine ​​hydrochloride of prescription quantity, add water for injection, stir to dissolve, then the medicinal solution is sterilized by filtration through a microporous membrane of 0.22 μm, and the filtrate is poured after passing the test. Packed in vials, then half stoppered, and put into a freeze-drying box.

[0023] (2) Turn on the freeze dryer to pre-freeze the product, reduce the temperature of the product to about -40°C at 2°C / min, and keep this temperature for 8 hours. After the product is completely frozen, turn on the condenser to reduce the temperature to -45°C Below ℃, start vacuuming for freeze-drying, and then gradually increase the temperature to -5°C to basically freeze-dry the mo...

Embodiment 2

[0025] The preparation of embodiment 2 tirofiban hydrochloride freeze-dried powder preparation

[0026] Tirofiban hydrochloride (calculated as tirofiban) 1 part

[0027] Cysteine ​​hydrochloride 2 parts

[0028] Preparation Process:

[0029] (1) Take tirofiban hydrochloride and cysteine ​​hydrochloride of prescription quantity, add water for injection, stir to dissolve, then the medicinal solution is sterilized by filtration through a microporous membrane of 0.22 μm, and the filtrate is poured after passing the test. Packed in vials, then half stoppered, and put into a freeze-drying box.

[0030] (2) Turn on the freeze dryer to pre-freeze the product, reduce the temperature of the product to about -40°C at 2°C / min, and keep this temperature for 8 hours. After the product is completely frozen, turn on the condenser to reduce the temperature to -45°C Below ℃, start vacuuming for freeze-drying, and then gradually increase the temperature to -5°C to basically freeze-dry the moi...

Embodiment 3

[0032] The preparation of embodiment 3 tirofiban hydrochloride freeze-dried powder preparation

[0033] Tirofiban hydrochloride (calculated as tirofiban) 1 part

[0034] Cysteine ​​hydrochloride 8 parts

[0035] Preparation Process:

[0036] (1) Take tirofiban hydrochloride and cysteine ​​hydrochloride of prescription quantity, add water for injection, stir to dissolve, then the medicinal solution is sterilized by filtration through a microporous membrane of 0.22 μm, and the filtrate is poured after passing the test. Packed in vials, then half stoppered, and put into a freeze-drying box.

[0037] (2) Turn on the freeze dryer to pre-freeze the product, reduce the temperature of the product to about -40°C at 2°C / min, and keep this temperature for 8 hours. After the product is completely frozen, turn on the condenser to reduce the temperature to -45°C Below ℃, start vacuuming for freeze-drying, and then gradually increase the temperature to -5°C to basically freeze-dry the moi...

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PUM

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Abstract

The invention relates to a tirofiban hydrochloride lyophilization powder injection. A lyophilization excipient which is used in the invention is cysteine hydrochloride, and the weight ratio of tirofiban hydrochloride (by free alkali) to cysteine hydrochloride is 1:0.25-8, preferably 1:0.5-4, and most preferably 1:1-2. The tirofiban hydrochloride lyophilization powder injection of the invention, which has the advantages of stable physical and chemical property and controllable quality, solves an unqualified phenomenon that there are foreign matters when tirofiban hydrochloride is redissolved.

Description

technical field [0001] The invention belongs to the technical field of medicine, in particular to a freeze-dried powder injection of tirofiban hydrochloride injection. Background technique [0002] Tirofiban (English name Tirofibon) is a non-titanium platelet glycoprotein GP II b / IIIa receptor antagonist, has anti-platelet aggregation effect, and its chemical name is: N-(n-butylsulfonyl) -O-[4-(4-piperidinyl)butyl]-L-tyrosine hydrochloride monohydrate. Tirofiban hydrochloride is used to treat patients with acute coronary syndrome (unstable angina or non-Q wave myocardial infarction), and is also suitable for patients with coronary ischemic syndrome undergoing coronary angioplasty or intracoronary atheroma block resection. Tirofiban hydrochloride can reduce the incidence of composite endpoint events of death, myocardial infarction, and refractory myocardial ischemia / revascularization. [0003] Most of the dosage forms of tirofiban hydrochloride listed at home and abroad ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4465A61K47/18A61P7/02A61P9/10
Inventor 赵志全郝贵周姜斌
Owner SHANDONG NEWTIME PHARMA
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