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Pharmaceutical composition for treating steatohepatitis and preparation method of pharmaceutical composition

A steatohepatitis and composition technology, which is applied in the field of pharmaceutical preparations, can solve the problems of elimination of candidate drugs for solubilization requirements, and achieve the effects of avoiding drug degradation reactions, improving dissolution rate, and avoiding dust pollution

Active Publication Date: 2021-08-20
GANNEX PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this case, drug candidates with clear efficacy but unable to meet solubilization requirements are often eliminated in early development stages due to dissolution limitations

Method used

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  • Pharmaceutical composition for treating steatohepatitis and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating steatohepatitis and preparation method of pharmaceutical composition
  • Pharmaceutical composition for treating steatohepatitis and preparation method of pharmaceutical composition

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Prescription composition:

[0047] Table 1. The composition of the prescription of embodiment 1

[0048]

[0049]

[0050] Preparation Process:

[0051] 1. Prepare a blank matrix: add polyethylene glycol, poloxamer 188, and anhydrous citric acid in sequence in order of melting point from low to high at a temperature 5-15°C higher than the melting temperature of the carrier;

[0052] 2. Remove air bubbles: stand still, ultrasonic or negative pressure to remove air bubbles;

[0053] 3. Add the compound shown in formula (I): Add the compound drug substance shown in formula (I) under stirring state, continue to stir to make it completely melt in the matrix;

[0054] 4. Capsule filling: Transfer the prepared melted content to the preheated insulation barrel of the capsule filling machine, turn on the stirring function, and pour the melted content into the gelatin hard capsule with the preset filling parameters (control the average The difference in filling capacity ...

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Abstract

The invention provides a pharmaceutical composition for treating steatohepatitis and a preparation method of the pharmaceutical composition. The pharmaceutical composition comprises the following components in parts by weight: (a) 1 part of a compound shown in a formula (I); (b) 16-600 parts of a meltable dispersion carrier, wherein the meltable dispersion carrier comprises poloxamer and polyethylene glycol, and the weight ratio of the poloxamer to the polyethylene glycol is 1:(0.5-27); and (c) 0.2-100 parts of non-volatile weak acid. The pharmaceutical composition is beneficial to greatly improving the in-vitro dissolution rate of the compound shown in the formula (I), and meanwhile, the stability of the compound shown in the formula (I) can be ensured due to mild preparation conditions.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition for treating steatohepatitis and a preparation method thereof. Background technique [0002] Compound shown in formula (I) (molecular formula is C 28 h 32 ClO 5 P, molecular weight 514.98, CAS registration number 852948-13-1) is a novel oral thyroid hormone β receptor agonist (THR-beta agonist), which regulates downstream CYP7A and SREBP- The expression of genes such as 1c can effectively promote the decomposition of fatty acids and stimulate the biogenesis of mitochondria, reduce the level of low-density lipoprotein and triglyceride, thereby reducing lipotoxicity and improving liver function, reducing liver fat. Drug candidates for alcoholic steatohepatitis (NASH). [0003] [0004] The compound represented by the formula (I) is a poorly soluble drug with strong fat solubility. As a result of measuring its equilibrium so...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/10A61K47/12A61K31/665A61P1/16
CPCA61K9/4825A61K9/4816A61K9/4858A61K9/4866A61K31/665A61P1/16A61K47/10A61K47/26A61K31/661A61K9/146A61K9/4833A61K9/4875
Inventor 吴劲梓柴旭煜
Owner GANNEX PHARM CO LTD
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