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Frozen powder injection of tiopronin

A technology for tiopronin and freeze-dried powder injection, which is applied in the field of new tiopronin freeze-dried powder injection and its preparation, and can solve the problems of thermal instability, limitation, poor stability and the like

Inactive Publication Date: 2005-02-23
江西欧氏药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Tiopronin is a white crystalline powder, easily soluble in water, and extremely unstable in water, so it is directly prepared into water injections with poor stability. The melting point of this product is 96-99°C, and it is also unstable to heat. The above properties Limits the possibility of directly making tiopronin into injections
[0004] Chinese patent CN 1404827 "tiopronin preparation" discloses a freeze-dried powder injection of tiopronin and a drug carrier, which solves the disadvantages that tiopronin has poor thermal stability and should not be made into sterile powder for injection by high temperature sterilization, but The main drug carrier used in this patent is low-molecular-weight dextran 40, which is currently on the market in China

Method used

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Examples

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Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1. Preparation of Tiopronin Glycine freeze-dried powder injection

[0034] prescription:

[0035] Tiopronin 100g

[0036] Glycine 40g

[0037] Water for injection 1000ml

[0038] Preparation process: weigh 100 grams of tiopronin (content 98.6%), add 200 ml of water for injection to dissolve, weigh 40 g of glycine, add 100 ml of water for injection to dissolve, mix the above two solutions, stir, and make up the remaining water.

[0039] Under 0.1MPa pressure, filter with 0.22μm microporous membrane, fill, freeze-dry, and seal.

Embodiment 2

[0040] Embodiment two, preparation Tiopronin glycine freeze-dried powder injection

[0041] Tiopronin 100g

[0042] Glycine 50g

[0043] Water for injection 1000ml

[0044] Preparation process: weigh 100 grams of tiopronin (content 98.6%), add 200 ml of water for injection to dissolve, weigh 50 g of glycine, add 100 ml of water for injection to dissolve, mix the above two solutions, stir, and make up the remaining water.

[0045] Under 0.1MPa pressure, filter with 0.22μm microporous membrane, fill, freeze-dry, and seal.

Embodiment 3

[0046] Embodiment three, preparation Tiopronin glycine freeze-dried powder injection

[0047] Tiopronin 100g

[0048] Glycine 100g

[0049] Water for injection 1000ml

[0050] Preparation process: weigh 100 grams of tiopronin (content 98.6%), add 200 ml of water for injection to dissolve, weigh 100 g of glycine, add 100 ml of water for injection to dissolve, mix the above two solutions, stir, and make up the remaining water.

[0051] Under 0.1MPa pressure, filter with 0.22μm microporous membrane, fill, freeze-dry, and seal.

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PUM

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Abstract

A freeze-dried powder injection of tiopronin is prepared from tiopronin and the excipient chosen from amino acid, the salt of amino acid, and phosphate through proportionally and respectively dissolving them in the water for injecting, mixing, stirring, sterilizing, pouring in containers and freeze drying.

Description

technical field [0001] The invention relates to a novel tiopronin freeze-dried powder injection and a preparation method thereof. Background technique [0002] Tiopronin N-(2-mercaptopropionyl)-glycine can activate metabolic enzymes, improve protein metabolism, promote liver function repair, and can integrate with toxic substances that hinder the activity of HS-enzyme, and has a detoxification effect. In addition, this product has a significant inhibitory effect on cellular immunity, and has a certain preventive effect on liver fibrosis. [0003] Tiopronin is a white crystalline powder, easily soluble in water, and extremely unstable in water. Therefore, it has poor stability when it is directly prepared into a water injection. The melting point of this product is 96-99 °C, and it is also unstable to heat. The above properties The possibility of directly preparing tiopronin for injection is limited. [0004] Chinese patent CN 1404827 "Tiopronin preparation" discloses a fre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/198A61P1/16
Inventor 赵凯苑洪忠侯建平赵孝先
Owner 江西欧氏药业有限责任公司
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