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Sustained release preparation of licardipine hydrochloride and its preparing process

A technology of nicardipine hydrochloride and nicardipine hydrochloride, which is applied in the direction of medical formula, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of low yield and high price, and achieve good The effect of slow release effect

Inactive Publication Date: 2007-08-08
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The preparation of nicardipine hydrochloride sustained-release pellets by applying drug powder to the blank core can obtain pellets with regular appearance and easy coating, but the production process requires expensive fluidized bed powder coating equipment. Strictly managed intermediate process control must be carried out, and the yield rate of production is not high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0044] The preparation process of stomach-soluble pellets is the same as the above-mentioned preparation process of enteric-coated pellets, adopting extrusion-spheronization technology, and using water as a wetting agent. The process parameters are also the same as those for the preparation of enteric-coated pellets.

[0045] According to the Chinese Pharmacopoeia edition in 2005 two appendices XD the first method is measured the drug release of this nicardipine hydrochloride gastric dissolving pellet. The release medium is 900ml of hydrochloric acid of 0.1mol / L, the rotating speed is 150r / min, and samples are taken and analyzed at 0.25, 0.5, 1, and 2 hours. The results show that the stomach-soluble pellets have 80% drug release in 0.25 hours, and the drug release reaches more than 95% in 1 hour.

[0046] The preparation is prepared by mixing stomach-coated pellets and enteric-coated pellets at a ratio of 1:0.5 to 5 and then filling them in capsules, wherein the preparation m...

Embodiment 1

[0047] Embodiment 1: the preparation of nicardipine hydrochloride stomach-soluble pellets

[0048] prescription

[0049] Name of main drug and excipients

weight / g)

Nicardipine Hydrochloride

20

microcrystalline cellulose

20

lactose

130

Sodium carboxymethyl starch

18

Polyvinylpyrrolidone K-30

12

purified water

80

[0050] Preparation Process

[0051] Wetting agent was prepared by dissolving 12 g of polyvinylpyrrolidone K-30 in 80 ml of purified water. Fully mix 20 g of nicardipine hydrochloride, 130 g of lactose, 20 g of microcrystalline cellulose, and 12 g of sodium carboxymethyl starch, and pass through a 60-mesh sieve. Add the wetting agent to the mixed dry powder and stir at high speed for 5 minutes to obtain a soft material. Extrude the soft material through a 1.0mm mesh, and process it on a spheronizer for 10 minutes at a speed of 500 rpm. The obtained wet ...

Embodiment 2

[0052] Embodiment 2: the preparation of nicardipine hydrochloride stomach-soluble pellets

[0053] prescription

[0054] Name of main drug and excipients

weight / g)

Nicardipine Hydrochloride

20

microcrystalline cellulose

33

Mannitol

130

Low-substituted hydroxypropyl cellulose

15

Polyvinylpyrrolidone K-30

12

purified water

80

[0055] Preparation Process

[0056] The preparation process is the same as in Example 1, except that lactose is replaced by mannitol, and sodium carboxymethyl starch is replaced by low-substituted hydroxypropyl cellulose. The yield is 88%.

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Abstract

The invention relates to a method for preparing Licardipine Hydrochloride slow-release agent, which can be used to treat hypertension, coronary disease or the like. The inventive slow-release agent is formed by quick-release stomach-soluble micro drop and slow-release enteric-soluble micro drop at 1:0.5-5 ratios in the hollow capsule. The inventive capsule has slow-release effect in 12 hours. The slow-release enteric-soluble micro drop comprises Licardipine Hydrochloride, medical macromolecule materials, drug release adjusting agent and some medical finding. The micro drops are prepared by extruding-rolling technique. The invention can quickly approach the blood drug density to treatment object and hold the density stably, with low side effect.

Description

technical field [0001] Specifically, the invention relates to a sustained-release preparation of nicardipine hydrochloride for treating essential hypertension, coronary heart disease and various types of angina pectoris, and relates to the technical field of pharmaceutical preparations. Background technique [0002] Hypertension is an important risk factor for cardiovascular and cerebrovascular diseases. In people of any age and gender, the risk of cardiovascular and cerebrovascular diseases is positively correlated with elevated blood pressure. Therefore, prevention and treatment of high blood pressure should be strengthened to reduce the incidence and mortality of cardiovascular and cerebrovascular diseases. Elderly hypertensive patients have more target organ damage, and are often accompanied by coronary heart disease, angina pectoris, and renal insufficiency. Therefore, many countries have carried out clinical research on drugs for diseases such as hypertension, angina ...

Claims

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Application Information

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IPC IPC(8): A61K31/4422A61K9/16A61K9/52A61K47/38A61K47/32A61J3/00A61P9/12
Inventor 孙柏旺姜新东杜琳张美苏戴建方刘付英钱燕燕丁利军
Owner SOUTHEAST UNIV
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