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Tiopronin freeze-dried powder injection

A technology of tiopronin and needle injection, which is applied in the field of hepatoprotective drug tiopronin and its freeze-dried powder injection and its preparation, can solve the problems of short validity period, poor stability of tiopronin, unsuitability, etc., and achieve convenient use , excellent curative effect and good stability

Inactive Publication Date: 2004-04-14
上海凯宝新谊(新乡)药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing injection is the aqueous solution of the tiopronin sodium salt of 2ml or 5ml concentration 5% in every 1 ampoule, because tiopronin has poor stability in water, oxidation reaction easily occurs, so the aqueous solution injection has the shortcoming of storage time, The short validity period of use affects the safe and effective use of the product
Powder injection preparation can solve the above problems, but because the melting point of tiopronin is low (96-99 ℃) and the stability of tiopronin is poor, so it is not suitable to adopt high temperature sterilization method to make sterile powder for injection.

Method used

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  • Tiopronin freeze-dried powder injection
  • Tiopronin freeze-dried powder injection
  • Tiopronin freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0220] Embodiment 1: preparation tiopronin freeze-dried powder injection

[0221] Tiopronin 100g

[0222] Dextran 40 50g

[0223] Water for injection 1000ml

[0224] A total of 1000 freeze-dried products were made

[0225] Preparation Process:

[0226] Preparation of liquid medicine:

[0227] Weigh the prescribed amount of raw materials for injection (the content of tiopronin must not be less than 98.5%, and the content of heavy metals must not exceed 15 parts per million), add sterile pyrogen-free distilled water to dissolve, and the concentration is 0.2g / ml. Then add the prescribed amount of 20% dextran 40 solution that has been sterilized and depyrogenated in advance and mix well. Add water to 1000ml, so that the content of tiopronin is 0.1g / ml, and the content of dextran 40 is 0.05 / ml;

[0228] Depyrogenation:

[0229] Add activated carbon for injection into the above liquid medicine (the amount of activated carbon is 0.3-0.5% of the weight of the tiopronin raw mate...

Embodiment 2

[0238] Embodiment 2: preparation tiopronin freeze-dried powder injection

[0239] Tiopronin 100g

[0240] Lactose 50g

[0241] Mannitol 50g

[0242] Water for injection 1000ml

[0243] A total of 1000 freeze-dried products were made

[0244] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

Embodiment 3

[0245] Embodiment 3: preparation tiopronin freeze-dried powder injection

[0246] Tiopronin 100g

[0247] Lactose 50g

[0248] Water for injection 1000ml

[0249] A total of 1000 freeze-dried products were made

[0250] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

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Abstract

The invention refers to a Tiopronin freeze-dried powder-form injection for treating chronic liver diseases. It comprises active Tiopronin compound 1-1000mg, like 50mg, 100mg or 200mg, and the receivable carrier of drug is selected from one or multiple of low-molecular dextran, mannite, cyclodextrin, soluble amylum, glucide, NaCl, benzoic acid, cellulose or water. It also refers to the making method including the steps of preparing medical liquid, eliminating heat source, sterilizing, canning and freeze-drying.

Description

technical field [0001] The invention relates to the field of medicines and preparations thereof. Specifically, the invention relates to a hepatoprotective medicine tiopronin and a freeze-dried powder injection thereof and a preparation method thereof. Background technique [0002] Tiopronin (English name: Tiopronin) is a metabolic improvement antidote, its molecular formula: C 5 h 9 NO 3 S, molecular weight: 163.20, structural formula as follows: [0003] [0004] It is mainly used for the improvement of liver function in chronic liver disease. Oral and aqueous injections of the product are currently on the market. Existing injection is the aqueous solution of the tiopronin sodium salt of 2ml or 5ml concentration 5% in every 1 ampoule, because tiopronin has poor stability in water, oxidation reaction easily occurs, so the aqueous solution injection has the shortcoming of storage time, The short validity period affects the safe and effective use ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/195A61P1/16
Inventor 穆来安杨波刘晨江邵长青宋祥林
Owner 上海凯宝新谊(新乡)药业有限公司
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