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Efonidipine hydrochloride-containing suspension and solid preparation thereof, and preparing method of suspension and solid preparation

A technology of efodipine hydrochloride and efodipine, which is applied in the field of medicine, can solve problems such as low safety, large environmental burden, and high quality requirements for personnel, and achieve low environmental burden, low requirements for equipment and personnel quality, and avoid The effect of using

Active Publication Date: 2015-09-09
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, commercially available preparations use organic solvent (ethanol and dichloromethane) volatilization method to prepare their solid dispersions to improve their oral bioavailability, but this process not only has high requirements on the hardware facilities and personnel quality of the factory, but also has a large environmental burden. The disadvantage is that it is difficult to produce in our country, and organic solvents are used in the production, which has low safety. At the same time, the residue of organic solvents must be strictly controlled

Method used

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  • Efonidipine hydrochloride-containing suspension and solid preparation thereof, and preparing method of suspension and solid preparation
  • Efonidipine hydrochloride-containing suspension and solid preparation thereof, and preparing method of suspension and solid preparation
  • Efonidipine hydrochloride-containing suspension and solid preparation thereof, and preparing method of suspension and solid preparation

Examples

Experimental program
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Embodiment 1

[0021] Embodiment 1 weighs 0.4g Polyoxyethylene-polyoxypropylene block copolymer （ F-68 ), 0.02g sodium lauryl sulfate , add 10mL of purified water to dissolve, weigh 2g of efodipine hydrochloride and add to the above solution, after the dispersion is uniform, transfer to a planetary ball mill for grinding to obtain a drug-containing suspension.

Embodiment 2

[0022] Embodiment 2 weighs 0.2g F68, 0.02g sodium lauryl sulfate and 0.3g L-arginine, add 10 Dissolve in mL of purified water, weigh 2 g of efodipine hydrochloride and add it to the above solution, disperse evenly, transfer it to a planetary ball mill for grinding, and obtain a drug-containing suspension.

Embodiment 3

[0023] Embodiment 3 takes by weighing Add 0.2g F68, 0.1g sodium lauryl sulfate and 0.45g L-arginine to 10 Dissolve in mL of purified water, weigh 2 g of efodipine hydrochloride and add it to the above solution, disperse evenly, transfer it to a planetary ball mill for grinding, and obtain a drug-containing suspension.

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Abstract

The invention relates to the medicine technical field, specifically relates to an efonidipine hydrochloride-containing suspension and a solid preparation thereof, and a preparing method of the suspension and the solid preparation, and in particular, relates to the cefonidipine hydrochloride-containing suspension and the solid preparation thereof, and the method for preparing the preparation through a wet medium grinding process. The suspension includes a drug, a stabilizer, lauryl sodium sulfate, a pH regulator and purified water, and particularly includes the following components by the weight percentage: 11.4%-33.0% of the drug, 0.86%-4.13% of the stabilizer, 0.08%-0.81% of lauryl sodium sulfate, 0.5%-5.0% of the pH regulator, and the balance water. The suspension can be further made into a spray dried powder, enteric coated granules and the like. The prescription is fast to dissolve, and the preparing process is simple, and adapts to industrial production.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a suspension containing eifdipine hydrochloride, a solid preparation thereof and a preparation method thereof. It specifically relates to a suspension containing efodipine hydrochloride and its solid preparation and a method for preparing the preparation through a wet medium grinding process. Background technique: [0002] Eifdipine hydrochloride (trade name: Landel) is a dual calcium channel blocker developed by Nissan Chemical Industry Co., Ltd. for the treatment of primary and renal hypertension and hypertension complicated with type 2 diabetes. The drug belongs to the BCSII class of drugs, that is, low solubility and high membrane permeability. At present, commercially available preparations use organic solvent (ethanol and dichloromethane) volatilization method to prepare their solid dispersions to improve their oral bioavailability, but this process not only has high req...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/675A61P9/12A61P3/10A61J3/00
Inventor 朴洪宇邹梅娟张雪竹候延婷卓秋琪王博崔福德
Owner SHENYANG PHARMA UNIVERSITY
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