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Manidipine hydrochloride solid dispersion, preparation and preparation method of above

A technology of manidipine hydrochloride and solid dispersion, which is applied in the field of manidipine hydrochloride solid dispersion and preparation and its preparation, can solve the problems of long duration of action, achieve high dissolution rate, facilitate storage and high bioavailability Effect

Active Publication Date: 2012-06-27
CHENGDU HENGRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] (1) The duration of action is longer

Method used

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  • Manidipine hydrochloride solid dispersion, preparation and preparation method of above
  • Manidipine hydrochloride solid dispersion, preparation and preparation method of above
  • Manidipine hydrochloride solid dispersion, preparation and preparation method of above

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A solid dispersion of manidipine hydrochloride is composed of manidipine hydrochloride and dispersion medium PEG6000, the weight ratio of manidipine hydrochloride to PEG6000 is 10:90, wherein the average molecular weight of PEG6000 is 5500-7000.

[0034] Preparation method of manidipine hydrochloride solid dispersion: heat PEG6000 to 60-80°C to become liquid, add manidipine hydrochloride under continuous stirring, stir and disperse for 30 minutes, quickly pour it on a metal panel to form a thin layer of solid, and place it immediately Quench cooling below -20°C for 1 hour, take out and pulverize through a 100-mesh sieve to obtain a solid dispersion of manidipine hydrochloride.

Embodiment 2

[0036] A solid dispersion of manidipine hydrochloride is composed of manidipine hydrochloride and dispersion medium PEG6000, the weight ratio of manidipine hydrochloride to PEG6000 is 25:75, wherein the average molecular weight of PEG6000 is 5500-7000.

[0037] Preparation method of manidipine hydrochloride solid dispersion: heat PEG6000 to 60-80°C to become liquid, add manidipine hydrochloride under continuous stirring, stir and disperse for 50 minutes, quickly pour it on a metal panel to form a thin layer of solid, and place it immediately Cool at -30°C for 0.5 hour, take out and pulverize through an 80-mesh sieve to obtain a solid dispersion of manidipine hydrochloride.

Embodiment 3

[0039] A solid dispersion of manidipine hydrochloride is composed of manidipine hydrochloride and dispersion medium PEG6000, the weight ratio of manidipine hydrochloride to PEG6000 is 40:60, and the average molecular weight of PEG6000 is 5500-7000.

[0040] Preparation method of manidipine hydrochloride solid dispersion: heat PEG6000 to 60-80°C to become liquid, add manidipine hydrochloride under continuous stirring, stir and disperse for 20 minutes, quickly pour it on a metal panel to form a thin layer of solid, and place it immediately Cool at -20°C for 2 hours, take out and pulverize through a 100-mesh sieve to obtain a solid dispersion of manidipine hydrochloride.

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Abstract

The invention discloses a manidipine hydrochloride solid dispersion, which comprises manidipine hydrochloride and a dispersing medium PEG6000, wherein a weight ratio of the manidipine hydrochloride to the PEG6000 is 10:90-40:60. The invention further discloses a manidipine hydrochloride solid dispersion preparation, which comprises the manidipine hydrochloride solid dispersion, lactose, microcrystalline cellulose, magnesium stearate, and PVPK30. The invention further discloses preparation methods for the solid dispersion and the solid dispersion preparation. According to the present invention, the manidipine hydrochloride is prepared into the manidipine hydrochloride solid dispersion to accelerate the drug release so as to provide an effective method, such that the dissolution of the manidipine hydrochloride can be improved, the bioavailability of the manidipine hydrochloride can be improved, the stability of the manidipine hydrochloride can be increased, and the drug is easily stored; the manidipine hydrochloride solid dispersion preparation prepared by using the manidipine hydrochloride solid dispersion has characteristics of high dissolution rate, high bioavailability, easy storage, and convenient large-scale application.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a manidipine hydrochloride solid dispersion and preparation and a preparation method thereof. Background technique [0002] Hypertension is one of the most common cardiovascular diseases in the world today. Current drug treatment of hypertension is based on the use of different drug classes, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) ), diuretics, β-receptor blockers and calcium channel blockers (also known as calcium antagonists), manidipine hydrochloride is the third generation of dihydropyridine calcium antagonists, which can inhibit the smooth muscle cell voltage-dependent The influx of calcium ions causes systemic vasodilation, thereby lowering blood pressure. Pharmacological and toxicological experiments have shown that manidipine hydrochloride has clear efficacy and less toxic side effects. [0003] Calcium ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/48A61K31/496A61K47/38A61P9/12
Inventor 马一明朱德其
Owner CHENGDU HENGRUI PHARMA
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