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Pharmaceutical composition for treating liver disease

A composition and drug technology, applied in the field of medicine, can solve problems such as content loss and poor product stability

Inactive Publication Date: 2012-04-11
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 inventors prepared the freeze-dried powder injection of silibinin disuccinate sodium, they found that some undesirable disadvantages occurred in certain pH environments, such as loss of content and / or stability of the final product during the preparation process. Poor sex

Method used

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  • Pharmaceutical composition for treating liver disease
  • Pharmaceutical composition for treating liver disease
  • Pharmaceutical composition for treating liver disease

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0071] Preparation example 1, powder injection of the present invention

[0072] formula:

[0073] Compound of formula I

75g，

Mannitol

50g，

pH regulator

to pH6.0,

Water for Injection

to 1000ml.

[0074] Preparation:

[0075] (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.

[0076] (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.

[0077] (3) The liquid medicine is first filtered with a 0.45um microporous membrane, and then filtered twice with a 0.22um mic...

preparation example 2

[0080] Preparation example 2, powder injection of the present invention

[0081] formula:

[0082] Compound of formula I

[0083] Preparation method: refer to Preparation Example 1.

preparation example 3

[0084] Preparation example 3, powder injection of the present invention

[0085] formula:

[0086] Compound of formula I

[0087] Preparation method: refer to Preparation Example 1.

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PUM

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Abstract

The invention provides a pharmaceutical composition for treating liver disease. Specifically, the pharmaceutical composition comprises a compound shown in the formula I and pharmaceutically acceptable excipients. The pharmaceutical composition is prepared into a solution by using water, wherein each 1ml of the solution contains 20mg of the compound shown in the formula I, the solution is measured according to the method in the appendix VI H of 2005 'China Pharmacopoeia'(II), and the pH value of the solution is 5.2-6.8. The invention also relates to a preparation method of the pharmaceutical composition. The pharmaceutical composition provided by the invention has pharmaceutical advantages.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating liver diseases, in particular to a pharmaceutical composition containing the compound represented by formula I of the present invention. The pharmaceutical composition of the present invention has desirable 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 3% of patients with fat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/357A61K9/19A61P1/16A61P31/12
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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