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A kind of lacidipine silica gel adsorption solid dispersion and its preparation

A technology of solid dispersion and lacidipine, which is applied in the field of medicine, can solve the problems of complicated operation and the use of a large amount of organic solvents, and achieves the effects of good economy, simple and easy operation and good stability in the preparation process.

Inactive Publication Date: 2016-08-31
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, both methods have the disadvantages of cumbersome operation and the use of a large amount of organic solvents and additives
At the same time, there is no literature so far to compare the in vitro dissolution rate and in vivo bioavailability of self-made solubilizing preparations and commercially available Lexiping Tablets.

Method used

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  • A kind of lacidipine silica gel adsorption solid dispersion and its preparation
  • A kind of lacidipine silica gel adsorption solid dispersion and its preparation
  • A kind of lacidipine silica gel adsorption solid dispersion and its preparation

Examples

Experimental program
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Effect test

example 1

[0033] Example 1: Grinding the lacidipine crude drug, passing through a 100-mesh sieve for subsequent use. The mass ratio of lacidipine to silica gel is 1:1. Weigh 0.5 g of lacidipine and 0.5 g of silica gel, mix them evenly and put them into a special filter paper bag, and place the filter paper bag containing the medicine in the reactor. Raise the temperature of the system to 40°C, and introduce CO 2 , until the pressure reaches 20MPa. After maintaining the system under this condition for 2 hours, open the vent valve to make the CO in the system 2 When the pressure reaches normal pressure, the drug in the reaction vessel is taken out to obtain the lacidipine silica gel adsorption solid dispersion. Take by weighing an appropriate amount of sample (containing about 4 mg of lacidipine) and pack it into a hard capsule shell, and the dissolution rate of the medicine determined by the following dissolution rate determination method is 8.92%.

example 2

[0034] Example 2: Grinding the lacidipine crude drug, passing through a 100-mesh sieve for subsequent use. The mass ratio of lacidipine to silica gel is 1:3. Weigh 0.5g of lacidipine and 1.5g of silica gel, mix well and put them into a special filter paper bag. The preparation process is the same as Example 1. The dissolution rate of the drug measured by the dissolution determination method described below is 16.26%.

example 3

[0035] Example 3: Grinding the lacidipine crude drug, passing through a 100-mesh sieve for subsequent use. The mass ratio of lacidipine to silica gel is 1:5. Weigh 0.5g of lacidipine and 2.5g of silica gel, mix well and put them into a special filter paper bag. The preparation process is the same as Example 1. Measure the dissolution rate of medicine according to the dissolution rate determination method described below to be 34.26%.

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Abstract

The invention discloses a lacidipine silica gel adsorption solid dispersion and a preparation method thereof. The method uses hydrophilic gas phase silica as a carrier and adopts supercritical fluid (SFC) technology to prepare the lacidipine silica gel adsorption solid dispersion. The method effectively increases the water dissolubility of lacidipine and improves the oral bioavailability of lacidipine. The preparation method does not use any organic solvent, overcomes the drug safety problem caused from organic solvent residues, is simple and easy to operate, and has low cost and good economical efficiency.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a lacidipine silica gel adsorption solid dispersion and a preparation method thereof. Background technique [0002] Lacidipine is a new type of long-acting dihydropyridine calcium channel blocker, its chemical name is (E)-4-[2-[3-(carboxy tert-butyl)-3-oxo-1- Propyl]phenyl]-1,4-dihydro-2,6-dimethyl-3,5-pyridine-diethyl carboxylate, the structural formula is as follows. Lacidipine is highly selective, acting on smooth muscle calcium channels, mainly expanding peripheral arteries, reducing peripheral resistance, and has a strong and lasting antihypertensive effect. It has no significant effect on the cardiac conduction system and myocardial systolic function. And can improve the diastolic function of the damaged hypertrophic left ventricle, and anti-atherosclerosis. It is relatively safe for elderly patients with coronary heart disease, heart failure, renal insuffic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/04A61K31/4422A61P9/12A61P9/10
Inventor 张天虹耿雅杰刘晓红孙进孙英华何仲贵
Owner SHENYANG PHARMA UNIVERSITY
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