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A kind of benidipine hydrochloride solid preparation and preparation method thereof

A technology of benidipine hydrochloride and dipine solid, applied in the field of medicine, can solve the problems of inhibiting bone anabolism and the like

Inactive Publication Date: 2011-12-07
张兆勇
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is known that low or intermittently high concentrations of parathyroid hormone in the blood can promote bone anabolism, but when the concentration of parathyroid hormone in the blood increases for a long time, it will inhibit bone anabolism

Method used

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  • A kind of benidipine hydrochloride solid preparation and preparation method thereof
  • A kind of benidipine hydrochloride solid preparation and preparation method thereof
  • A kind of benidipine hydrochloride solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] 1. Preparation of benidipine hydrochloride solid dispersion

[0027] Weigh 30 grams of polyethylene glycol 4000 in a beaker, heat and melt in a water bath; 6 grams of benidipine hydrochloride are dissolved in 30 ml of hot absolute ethanol and then added to the molten polyethylene glycol 4000, stir and mix, continue to stir until no The water and ethanol are evaporated, rapidly cooled, and pulverized to obtain the solid dispersion powder of the drug.

[0028] 2. Preparation of capsules of benidipine hydrochloride dispersion

[0029] Use the above benidipine hydrochloride dispersion powder to obtain capsules according to the following prescription and preparation method.

[0030]

[0031] Mix benidipine hydrochloride dispersion powder, mannitol, lactose, sodium lauryl sulfate, and sodium carboxymethyl starch evenly, and granulate the mixture under the spraying of povidone K30 ethanol solution, and dry the granules Add magnesium stearate and mix evenly, and fill in ca...

Embodiment 2

[0033] 1. Preparation of benidipine hydrochloride solid dispersion

[0034] Weigh 100 grams of polyethylene glycol 6000 in a beaker, heat and melt in a water bath; add 4 grams of benidipine hydrochloride into the melted polyethylene glycol 6000, stir until the drug is dissolved, cool rapidly, and pulverize to obtain the solid dispersion of the drug body powder.

[0035] 2. Preparation of capsules of benidipine hydrochloride dispersion

[0036] Use the above benidipine hydrochloride dispersion powder to obtain capsules according to the following prescription and preparation method.

[0037]

[0038] Mix benidipine hydrochloride dispersion powder, mannitol, microcrystalline cellulose, sodium lauryl sulfate, and sodium carboxymethyl starch evenly, and granulate the mixture under the spraying of povidone K30 ethanol solution, and wait for After the granules are dried, magnesium stearate is added, mixed evenly, and filled into capsules. Each capsule contains 140mg of granules...

Embodiment 3

[0040] 1. Preparation of benidipine hydrochloride solid dispersion

[0041] Weigh 80 grams of polyvinylpyrrolidone K30 and 20 grams of benidipine hydrochloride in a beaker, add 400ml of absolute ethanol to dissolve them, keep the temperature, stir and mix, continue to stir until the ethanol is evaporated, quickly cool, crush, and obtain the drug solid dispersion powder.

[0042] 2. Preparation of capsules of benidipine hydrochloride dispersion

[0043] Use the above benidipine hydrochloride dispersion powder to obtain capsules according to the following prescription and preparation method.

[0044]

[0045]

[0046] Mix benidipine hydrochloride dispersion powder, lactose, corn starch, poloxamer 188, and carboxymethyl starch sodium evenly, and granulate the mixture under the spraying of povidone K30 ethanol solution. After the granules are dried Then add magnesium stearate, mix well, and fill in capsules. Each capsule contains 140mg of granules.

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Abstract

The invention provides a benidipine hydrochloride solid preparation and a preparation method thereof. The benidipine hydrochloride solid preparation of the present invention consists of benidipine hydrochloride, a solid dispersion carrier and functional auxiliary materials. In the preparation, the highly dispersed benidipine hydrochloride has the characteristics of rapid dissolution and rapid absorption. The preparation process of the benidipine hydrochloride solid preparation of the present invention is: (1) adding benidipine hydrochloride to the molten solid dispersion carrier after being dissolved in a suitable organic solvent, or directly adding benidipine hydrochloride to the molten solid Stir in the dispersion carrier until the drug is dissolved, continue to maintain the molten state, stir until the organic solvent is evaporated, then rapidly cool, and pulverize; or dissolve benidipine hydrochloride and the solid dispersion carrier in a suitable organic solvent, and then evaporate the organic solvent, Pulverize; (2) The above-mentioned drug dispersion powder and functional auxiliary materials are prepared into granules through a certain granulation method, and the obtained granules are directly packaged as granules, and filled in capsules as capsules, and the obtained granules can also be compressed into tablets.

Description

technical field [0001] The invention relates to the technical field of medicine, and relates to a solid preparation of benidipine hydrochloride and a preparation method thereof. The highly dispersed benidipine hydrochloride in the preparation can be rapidly dissolved and inhaled into the body. Background technique [0002] Benidipine hydrochloride is a new type of dihydropyridine calcium ion antagonist. It binds to dihydropyridine receptors that block cell membrane potential-dependent calcium ion channels, preventing calcium ions from flowing into cells and dilating blood vessels. Benidipine hydrochloride is widely used as a therapeutic drug for hypertension, renal hypertension, angina pectoris, etc. because of its safety and effectiveness. [0003] In the process of treating essential hypertension, calcium antagonists, as a class of core drugs, play a very important role, especially for elderly patients with essential hypertension. Studies have shown that osteoporosis is a...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61P9/12A61P19/10A61P9/10
Inventor 张震陈建明
Owner 张兆勇
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