Stable tartaric acid ifenprodil injection and method of preparing the same

A technology of ifendil tartrate and injection, which is applied in the directions of inactive medical preparations, pharmaceutical formulations, inorganic inactive ingredients, etc., to achieve the effects of reducing the risk of adverse reactions and reducing costs

Inactive Publication Date: 2009-01-21
重庆人本药物研发有限责任公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is challenging to develop this product into an injection on the basis of no relevant literature information, and to solve its stability problem

Method used

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  • Stable tartaric acid ifenprodil injection and method of preparing the same
  • Stable tartaric acid ifenprodil injection and method of preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Ifenprodil tartrate 5g,

[0026] Sodium sulfate 30g,

[0027] tartaric acid or sodium hydroxide to adjust pH6.7~7.2,

[0028] Water for injection 2000ml

[0029] a. According to the above formulation prescription, weigh 30g of sodium sulfate, add 2000mL of water for injection at 40°C to 80°C to dissolve.

[0030] b. Use tartaric acid or sodium hydroxide to adjust the pH of the solution to 6.7-7.2, add 5 g of ifenprodil tartrate, and dissolve.

[0031] c. Filter with a 0.8um microporous membrane, test the pH, clarity and content of the filtrate, and pack it into clean ampoules after passing the test, with a volume of not less than 2.15ml.

[0032] d. Seal the semi-finished product with nitrogen gas.

[0033] Sterilize in a 100°C water bath for 40 minutes and check for leaks.

Embodiment 2

[0035] Ifenprodil tartrate 20g,

[0036] Sodium sulfate 22g,

[0037] Hydrochloric acid or sodium hydroxide to adjust pH6.7~7.2,

[0038] Water for injection 2000ml

[0039] a. According to the above formulation prescription, weigh 22g of sodium sulfate, add 2000mL of water for injection at 40°C to 80°C to dissolve.

[0040] b. Use hydrochloric acid or sodium hydroxide to adjust the pH of the solution to 6.7-7.2, add 20 g of ifenprodil tartrate, and dissolve.

[0041] c. Filtrate with a 0.8um microporous membrane, check the pH, clarity and content of the filtrate, and pack it into clean ampoules after passing the test. The filling volume should not be less than 2.15ml.

[0042] d. The semi-finished product is obtained by fusing and sealing with argon gas.

[0043] Sterilize in a 100°C water bath for 40 minutes and check for leaks.

Embodiment 3

[0045] Ifenprodil tartrate 20g,

[0046] Sodium sulfate 139g,

[0047] tartaric acid or sodium hydroxide to adjust pH6.7~7.2,

[0048] Water for injection 10000ml

[0049] a. According to the above formulation prescription, weigh 139g of sodium sulfate, add 10000mL of water for injection at 40°C to 80°C to dissolve.

[0050] b. Use tartaric acid or sodium hydroxide to adjust the pH of the solution to 6.7-7.2, add 20 g of ifenprodil tartrate, and dissolve.

[0051] c. Filter with a 0.8um microporous membrane, test the pH, clarity and content of the filtrate, and pack it into clean ampoules after passing the test, with a volume of not less than 2.15ml.

[0052] d. Seal the semi-finished product with nitrogen gas.

[0053] Sterilize in a 100°C water bath for 40 minutes and check for leaks.

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PUM

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Abstract

The invention discloses a stable ifenprodil tartrate injection which contains ifenprodil tartrate, an osmotic pressure regulator, a pH regulator and water for injection. The invention also discloses a preparation method of the stable injection. The stable ifenprodil tartrate injection is obtained by controlling the range of the pH value of the solution and insulating oxygen, thus avoiding use of an antioxidant and possible adverse reactions thereof. Sterility tests, accelerated tests and long duration tests prove the stable ifenprodil tartrate injection.

Description

technical field [0001] The present invention relates to pharmaceutical preparation technology, more specifically, relate to a kind of stable ifenprodil tartrate injection and preparation method thereof Background technique [0002] Ifenprodil tartrate was first developed by the French company Sanofi-Synthelabo (US Patent No. 3,509,164, announced on April 28, 1970). Ifenprodil tartrate, chemical name: (1RS, 2RS)-2-(4-benzylpiperidinyl)-1-(4-hydroxyphenyl)-1-propanol-(2R,3R)-semitartaric acid Salt hemihydrate, its tablet and its preparation method have relevant patents and literature reports, but ifenprodil tartrate injection and its preparation method have no relevant patents and literature reports. The structure of ifenprodil tartrate contains phenolic hydroxyl groups, which can complex with heavy metal ions to form a color, and it is easy to oxidize when exposed to air. It is challenging to develop this product into an injection solution without relevant literature inform...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/445A61K9/08A61K47/02A61K47/12A61P25/04
Inventor 杜昌勇陈小勇王晓琳黄小林
Owner 重庆人本药物研发有限责任公司
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