Ursodeoxycholic acid nano suspension and preparation method thereof

A technology of ursodeoxycholic acid and nanosuspension, which can be used in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve problems such as shelving, increase absorption opportunities, improve Dissolution, the effect of solving physical stability problems

Inactive Publication Date: 2012-05-30
THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

If it cannot be industrialized, it can only be shelved

Method used

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  • Ursodeoxycholic acid nano suspension and preparation method thereof
  • Ursodeoxycholic acid nano suspension and preparation method thereof
  • Ursodeoxycholic acid nano suspension and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Weigh 2 g of ursodeoxycholic acid raw material, 0.16 g of PVP K30 and 0.04 g of SDS, add 40 mL of double distilled water, stir well, ultrasonically emulsify with 8000 rpm probe for 2 min; The preparation conditions were 2 cycles at 200 bar, 2 cycles at 500 bar, and 20 cycles at 1500 bar to obtain a milky white nanosuspension with a measured particle size of 356 nm, PI 0.13, and zeta potential of -48 mv.

Embodiment 2

[0034] Weigh 2 g of ursodeoxycholic acid raw material, 0.16 g of PVP K30 and 0.04 g of SDS, add 40 mL of double distilled water, stir well, ultrasonically emulsify with 8000 rpm probe for 2 min; The preparation conditions were 2 cycles at 200 bar, 2 cycles at 500 bar, 2 cycles at 1000 bar, and 10 cycles at 1500 bar to obtain a milky white nanosuspension with a measured particle size of 380 nm, PI 0.15, and zeta potential of -45 mv.

Embodiment 3

[0036]Weigh 2 g of ursodeoxycholic acid raw material, 0.1 g of PVP K30 and 0.1 g of SDS, add 40 mL of double distilled water, stir well, ultrasonically emulsify with 8000 rpm probe for 2 min; The preparation conditions were 2 cycles at 200 bar, 2 cycles at 500 bar, and 20 cycles at 1500 bar to obtain a milky white nanosuspension with a measured particle size of 420 nm, PI 0.17, and zeta potential of -35 mv.

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Abstract

The invention discloses an ursodeoxycholic acid nano suspension and a preparation method thereof, relates to the field of pharmaceutical nano formulation, and particularly relates to an ursodeoxycholic acid nano suspension for curing cholestatic cirrhosis and dry powder thereof. The ursodeoxycholic acid nano suspension is characterized by adopting SDS and PVP K30 as surfactants and combining the SDS and the PVP K30 in a weight ratio of 1:1-1:3; and the ursodeoxycholic acid nano suspension has stable quality, with particle size of about 200-800nm. The invention also discloses a preparation method of the suspension.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a nano-suspension of ursodeoxycholic acid and its dry powder. The invention also discloses a preparation method thereof. Background technique [0002] Ursodeoxycholic acid (chemical name: 3a, 7β-dihydroxy-5β-cholestane-24-acid, molecular formula: C 24 h 40 o 4 ) is currently the only drug of choice approved by the FDA for various cholestatic liver diseases such as primary cholestatic cirrhosis and primary sclerosing cholangitis. There are many domestic manufacturers, but the clinical efficacy is not obvious. The bottleneck problem restricting its curative effect is mainly that ursodeoxycholic acid is a poorly soluble drug, and its dissolution is limited. If there is no dissolution, there will be no pharmacokinetic behavior such as absorption, and of course it will be ineffective or weak. [0003] At present, the commonly used pharmaceutical methods to improve the b...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K9/14A61K31/575A61K47/32A61K47/20A61P1/16
Inventor 袁海龙黄雪李仙义
Owner THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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