Nisoldipine capsule and preparation method thereof

A technology of dipine capsules and nisoldipine, applied in the field of medicine, can solve the problems of complex preparation process, low dissolution rate, poor absorption, etc., and achieve the effects of stable drug release, small difference in tablet weight, and high dissolution rate

Inactive Publication Date: 2015-12-23
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These dosage forms often have defects such as low dissolution rate, poor absorption, and low bioavailability
At present, the prescription and preparation process of the chip-packed and three-layer tablets used in Nisoldipine sustained-release tablets are relatively complicated.
[0004] Patent CN101269046A discloses a nisoldipine sustained-release dripping pill and its preparation method, but it may have the problems of inconvenient taking and low bioavailability
Patent CN102406608B discloses a nisoldipine liposome solid preparation, which can improve bioavailability, but the auxiliary materials used are expensive and the preparation process is relatively complicated
Patent CN103006620A discloses a nisoldipine patch, which is composed of a backing layer, a drug-containing polymer layer and an anti-adhesive layer. It also has the problem of complex preparation process and low production capacity during industrialization

Method used

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  • Nisoldipine capsule and preparation method thereof
  • Nisoldipine capsule and preparation method thereof
  • Nisoldipine capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0033] Nisoldipine, filler, sodium lauryl sulfate and magnesium stearate were pulverized through a 60-mesh sieve; 400 g of nisoldipine, 8800 g of filler and 120 g of sodium lauryl sulfate were weighed and mixed. Weigh 50 g of povidone and add absolute ethanol to prepare a 6% solution as a binder. Nisoldipine, mannitol and sodium lauryl sulfate are added to a wet granulator, and the povidone solution is used as a binder to make soft materials, and granulated with a 20-mesh screen. Dry using a fluidized granulation dryer. The granules were sized with a 20-mesh sieve in a swing granulator, and 9370 g of the granules and 64 g of magnesium stearate were added to the mixer and mixed for 10 minutes. Capsule filling with capsule filling machine.

[0034] See Table 1 for the types and amounts of fillers used in Examples 1-6 and related performance indicators.

[0035] As can be seen from the data in Table 1, Example 3 has the best performance.

[0036] The kind and consumption of t...

Embodiment 7-9

[0039] Nisoldipine, filler, sodium lauryl sulfate and magnesium stearate were pulverized through a 60-mesh sieve; 400 g of nisoldipine, 8800 g of sorbitol and a solubilizer were weighed, and mixed evenly. Weigh 50 g of povidone and add absolute ethanol to prepare a 6% solution as a binder. Nisoldipine, mannitol and solubilizer are added to the wet granulator, and the povidone solution is used as a binder to make soft materials, and granulated with a 20-mesh screen. Dry using a fluidized granulation dryer. The granules were sized with a 20-mesh sieve in a swing granulator, and 9370 g of the granules and 64 g of magnesium stearate were added to the mixer and mixed for 10 minutes. Capsule filling with capsule filling machine.

Embodiment 10

[0047] Nisoldipine, fillers, sodium lauryl sulfate and magnesium stearate were pulverized through a 60-mesh sieve; 400 g of nisoldipine, 8800 g of sorbitol and 120 g of sodium lauryl sulfate were weighed and mixed. Add nisoldipine, mannitol and solubilizer to a wet granulator, add a soft material made of a binder, and granulate with a 20-mesh sieve. Dry using a fluidized granulation dryer. The granules were sized with a 20-mesh sieve in a swing granulator, and 9370 g of the granules and 64 g of magnesium stearate were added to the mixer and mixed for 10 minutes. Capsule filling with capsule filling machine.

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Abstract

The invention belongs to the technical field of medicines, and concretely relates to a nisoldipine capsule and a preparation method thereof. The nisoldipine capsule is prepared from the following raw materials in parts by weight: 3.2-4.8 parts of nisoldipine, 44-132 parts of a filler, 0.25-0.75 parts of an adhesive, 6-18 parts of a solubilizer, and 0.4-1.2 parts of a lubricant. The technology is simple and easy to enforce, and the prepared nisoldipine capsule is steady for medicine release and high in medicine dissolution rate.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a nisoldipine capsule and a preparation method thereof. Background technique [0002] Nisoldipine is a dihydropyridine calcium antagonist, which has a specific blocking effect on calcium channels in smooth muscle and cardiac muscle, and can dilate peripheral blood vessels and reduce resistance. Clinical studies have shown that while nisoldipine causes a drop in blood pressure, it has no significant effect on the respiratory and central nervous systems, and long-term treatment does not produce tolerance. However, the drug has significant gastrointestinal and hepatic effects, and its oral bioavailability is less than 5%. [0003] Nisoldipine medication currently on the market includes ordinary tablets, capsules and sustained-release tablets. These dosage forms often have defects such as low dissolution rate, poor absorption, and low bioavailability. However, the pre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4422A61K47/34A61K47/20A61K47/12A61K47/10A61P9/12
Inventor 赵玉山黄京山李伟杨金成邵伟
Owner REYOUNG PHARMA
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