Stepronin powder injection and its preparing method

A technology of stilonine and powder injection, which is applied in the field of new dosage forms of stilonine, can solve the problems of low bioavailability, slow onset, slow absorption and distribution, etc., and achieve high bioavailability, fast distribution, and fast effect

Inactive Publication Date: 2006-08-23
HUAZHONG UNIV OF SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Due to the first-pass effect of the liver, the existing oral preparations have the dis

Method used

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  • Stepronin powder injection and its preparing method
  • Stepronin powder injection and its preparing method
  • Stepronin powder injection and its preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Preparation of steironine powder injection

[0061] 1. According to French Patent Fr 2483419, 04, the technical scheme disclosed by Dec1981 takes tiopronin as raw material to synthesize stironine;

[0062] 2. Prepare raw materials according to the following prescription:

[0063] Ingredient Amount

[0064] Steironine 200g

[0065] Mannitol 50g

[0066] Water for injection 2000ml

[0067] 3. Preparation process:

[0068] Take 200g of steironine and 50g of mannitol, add 1600ml of water for injection to dissolve, add an appropriate amount of activated carbon for needles, stir, filter, adjust the pH value to 2.0-4.0 with 0.1mol / L HCl and 0.1mol / L NaOH, add water for injection to 2000ml. Sterilize the medicinal liquid according to the aseptic operation method, filter it with a 0.22μ microporous membrane, send the filtrate sample to check the content of the semi-finished product, and then divide it into 1000 tubes according to the same amount, and pre-freeze the divide...

Embodiment 2

[0071] Preparation of steironine powder injection

[0072] Ingredient Amount

[0073] Steironine 200g

[0074] Sorbitol 50g

[0075] Add water for injection to 2000ml

[0076] A total of 1000 freeze-dried products were made

[0077] Preparation Process:

[0078] The preparation method is the same as in Example 1 except that the auxiliary materials added are different.

Embodiment 3

[0080] Steironine Sodium for Injection

[0081] Ingredient Amount

[0082] Steironine Sodium 216g

[0083] Mannitol 50g

[0084] Add water for injection to 2000ml

[0085] A total of 1000 freeze-dried products were made

[0086] Preparation Process:

[0087] The preparation method is the same as in Example 1 except that the raw materials added are different and the pH is adjusted at 7.0-9.0.

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Abstract

The present invention is new preparation form of Stepronin, especially Stepronin powder for injection, and its preparation process. The powder for injection consists of Stepronin or its metal salt or amino salt as active component and freeze drying support agent. Compared with available orally taken Stepronin preparation, the present invention has the advantages of high bioavailability, good medicine absorption, fast medicine dispersion, fast acting, etc. The present invention expands the administration range of Stepronin and raises the clinical administration level of Stepronin.

Description

technical field [0001] The invention provides a new dosage form of steironine, especially a powder injection. Background technique [0002] Stepronine (also known as: steppro acid, English name: stepronin), invented by Italy's Bolasco company, Italy's Mediolanun Farmaceuticls company produced and listed for the first time. Steironine is a metabolism-improving antidote that can improve liver function in chronic liver diseases. It is clinically used to treat acute and chronic liver diseases and liver poisoning. It also has a mucolytic effect and is used to relieve bronchospasm. [0003] Stilonine was first reported by Zanolo G et al. in Boll Clum Farm 1981 Jan: 120(1): 55-67. GaslandiM et al reported in Int J Clin Pharmacol Res 1988: 8(3): 223-225 the test of stiironine for mucolysis. [0004] Stilonine is a prodrug, which is hydrolyzed into 2-mercaptopropionylglycine (tiopronin) by hydrolase in vivo. Tiopronin is also a metabolic improving antidote and can also be used in ...

Claims

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Application Information

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IPC IPC(8): A61K31/381A61K9/14A61P1/16A61P11/00
Inventor 项光亚汤军
Owner HUAZHONG UNIV OF SCI & TECH
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