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Freeze-dried powder injection for treating hepatopathy

A freeze-dried powder injection and drying technology, applied in the field of medicine, can solve the problems of poor freeze-dried form and slow dissolution speed of powder injection

Active Publication Date: 2013-04-03
西安安健药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] However, when the present inventors prepared the freeze-dried powder injection of silybin dimetasuccinate sodium, they found that some undesirable disadvantages occurred in certain formula ratios, such as slow dissolution rate of the powder injection obtained and / or frozen powder injection. Poor dry form, etc.

Method used

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  • Freeze-dried powder injection for treating hepatopathy
  • Freeze-dried powder injection for treating hepatopathy
  • Freeze-dried powder injection for treating hepatopathy

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0073] Preparation example 1, powder injection of the present invention

[0074] formula:

[0075] Compound of formula I

75g，

Mannitol

50g，

[0076] pH regulator

to pH6.0,

Water for Injection

to 1000ml.

[0077] Preparation:

[0078] (1) Weigh the main drug and excipients of the prescribed amount, place them in a stainless steel bucket, add about 80% of the prescribed amount of water for injection to dissolve each component, and then add 0.2% (w / v) of Activated carbon, stirred for 30 minutes, decarbonized by filtration, and added water for injection to nearly the full amount of the prescription.

[0079] (2) Take a sample of the filtrate, measure the pH value, adjust it to the specified value with a pH regulator if necessary, and then add water for injection to the full amount of the prescription.

[0080] (3) The liquid medicine is first filtered with a 0.45um microporous membrane, and then filtered twice ...

preparation example 2

[0083] Preparation example 2, powder injection of the present invention

[0084] Except that the compound of formula I and mannitol were used in amounts of 53g and 27g, the others were the same as in Preparation Example 1.

preparation example 3

[0085] Preparation example 3, powder injection of the present invention

[0086] Except that the compound of formula I and mannitol are used in amounts of 50g and 100g respectively, the others are the same as in Preparation Example 1.

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Abstract

The invention provides a freeze-dried powder injection for treating hepatopathy. In particular, the freeze-dried powder injection comprises the following components: a formula-I compound, mannitol and optional pH regulating agent, wherein the weight ratio of the formula-I compound to an excipient is 1:0.2 to 1:0.5. The invention further relates to a preparation method of the freeze-dried powder injection. The freeze-dried powder injection provided by the invention has expected pharmaceutical advantages.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a freeze-dried powder injection which can be used for treating liver diseases, in particular to a freeze-dried powder injection containing a compound represented by formula I of the present invention. The freeze-dried powder injection of the present invention has expected good properties. Background technique [0002] In recent years, with the improvement of people's living standards and changes in dietary structure, the incidence of fatty liver in my country has approached the carrier rate of hepatitis B virus, and it is showing a clear upward trend. Among them, men aged 30 to 40 are the "main force" in the army of fatty liver patients, basically accounting for 1 / 4 of all fatty liver patients. It is estimated that the incidence of fatty liver is now about 30 times higher than that before the 1980s. It is reported that 15% of patients with fatty liver will develop cirrhosis, and...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/357A61K47/26A61P1/16
Inventor 傅卫国黄伟静曾韶辉王伟梅丹
Owner 西安安健药业有限公司
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