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Manidipine hydrochloride composition and preparation method thereof

A technology of manidipine hydrochloride and its composition, which is applied in the field of manidipine hydrochloride composition and its preparation, can solve the problems of low oral bioavailability, etc., and achieve the effects of improving oral bioavailability, low cost, and simple preparation method

Active Publication Date: 2014-12-24
嘉善县魏塘资产管理有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Manidipine hydrochloride has a good antihypertensive effect, but its oral bioavailability is very low due to poor solubility in water

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Dissolve 0.1 g of proline in 100 mL of ethanol, then add 0.1 g of sodium stearyl fumarate to obtain a dispersion of the auxiliary material; dissolve 0.1 g of manidipine hydrochloride with 50 mL of ethanol to obtain a dispersion of the drug; Mix evenly with the drug dispersion, recover ethanol under vacuum at 40°C, and dry at 40°C for 6 hours to obtain the product.

Embodiment 2

[0014] Dissolve 0.1 g of proline in 100 mL of ethanol, then add 0.1 g of sodium stearyl fumarate to obtain a dispersion of the auxiliary material; dissolve 0.1 g of manidipine hydrochloride with 20 mL of ethanol to obtain a dispersion of the drug; Mix evenly with the drug dispersion, recover ethanol under vacuum at 40°C, and freeze-dry to obtain the product.

Embodiment 3

[0016] Dissolve 0.1 g of proline in 200 mL of ethanol, then add 0.1 g of sodium stearyl fumarate to obtain a dispersion of the auxiliary material; dissolve 0.1 g of manidipine hydrochloride with 100 mL of ethanol to obtain a dispersion of the drug; Mix evenly with the drug dispersion, recover ethanol under vacuum at 30°C, and freeze-dry to obtain the product.

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PUM

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Abstract

The invention provides a manidipine hydrochloride composition with high orally-taken bioavailability and a preparation method for the manidipine hydrochloride composition. The manidipine hydrochloride composition is characterized by comprising manidipine hydrochloride, sodium stearyl fumarate and proline, wherein the mass ratio of manidipine hydrochloride to sodium stearyl fumarate to proline is preferably 1:1:1. The preparation method for the manidipine hydrochloride composition comprises the following steps: dissolving proline with ethanol, and adding sodium stearyl fumarate to obtain auxiliary material dispersion liquid; dissolving manidipine hydrochloride with ethanol to obtain medicine dispersion liquid; uniformly mixing the auxiliary material dispersion liquid and the medicine dispersion liquid, recycling ethanol, and performing drying to obtain the manidipine hydrochloride composition.

Description

technical field [0001] The invention relates to a manidipine hydrochloride composition and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Manidipine hydrochloride has a good antihypertensive effect, but its oral bioavailability is very low due to poor solubility in water. Contents of the invention [0003] The object of the present invention is to provide a manidipine hydrochloride composition with higher oral bioavailability and a preparation method thereof. [0004] For the purpose of the above invention, the present invention provides the following technical solutions: [0005] Manidipine hydrochloride composition of the present invention is characterized in that containing manidipine hydrochloride, sodium stearyl fumarate and proline; The mass ratio of manidipine hydrochloride, sodium stearyl fumarate and proline is preferably 1:1:1. [0006] The method for manidipine hydrochloride composition of the present...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K47/22A61K47/12A61P9/12
Inventor 罗瑞雪
Owner 嘉善县魏塘资产管理有限公司
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