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Process for granulating and coating diltiazem hydrochloride in diltiazem hydrochloride sustained release tablets

A technology of diltiazem hydrochloride and sustained-release tablets, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, cardiovascular system diseases, etc., can solve the problems of cumbersome coating process and material growth, and achieve guaranteed Eligibility, reduced growth, possible effects of reduced exposure

Active Publication Date: 2015-04-29
SHANGHAI SINE WANXIANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a granulation and coating process of diltiazem hydrochloride in diltiazem hydrochloride sustained-release tablets, in order to solve the problems of related substance growth and coating process cumbersome in the preparation process existing in the prior art

Method used

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  • Process for granulating and coating diltiazem hydrochloride in diltiazem hydrochloride sustained release tablets
  • Process for granulating and coating diltiazem hydrochloride in diltiazem hydrochloride sustained release tablets
  • Process for granulating and coating diltiazem hydrochloride in diltiazem hydrochloride sustained release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Each step of embodiment 1 is made up of following components:

[0056] (1) diltiazem hydrochloride solid dispersion:

[0057]

[0058] (2) Diltiazem hydrochloride granules:

[0059]

[0060] (3) Diltiazem hydrochloride granule swelling layer coating prescription:

[0061]

[0062] The specific preparation method is prepared according to the following steps:

[0063] step 1):

[0064] Step 101, co-dissolving diltiazem hydrochloride and the carrier material in the mixed solvent of absolute ethanol-dichloromethane according to the above-mentioned prescription amount according to the above-mentioned ratio, and configuring a mixed solution containing solvent-containing absolute ethanol-dichloromethane;

[0065] Step 102, evaporate the solvent from the mixture in the above step 101 in a 50°C water bath, and keep stirring until the mixture is thick, then transfer to a vacuum drying oven to dry for 24 hours, control the moisture content at 1-2%, take out After crushi...

Embodiment 2

[0076] The difference between embodiment 2 and embodiment 1 is to take the following components

[0077] (1) diltiazem hydrochloride solid dispersion:

[0078]

[0079] (2) Diltiazem hydrochloride granules:

[0080]

[0081] (3) Diltiazem hydrochloride granule swelling layer coating prescription:

[0082]

[0083] The preparation method was the same as in Example 1, and this batch of diltiazem hydrochloride sustained-release tablets J130102 was obtained. Example 3:

Embodiment 3

[0084] (2) diltiazem hydrochloride solid dispersion:

[0085]

[0086] Step 101, co-dissolving diltiazem hydrochloride and No. III acrylic resin carrier in the mixed solvent of absolute ethanol-dichloromethane according to the prescription amount according to the above ratio, and configuring a mixed solution containing solvent-containing absolute ethanol-dichloromethane;

[0087] Step 102, evaporate the solvent from the mixture in the above step 101 in a 50°C water bath, and keep stirring until the mixture is thick, then transfer to a vacuum drying oven to dry for 24 hours, control the moisture content at 1-2%, take out After crushing through 80 mesh, store in a desiccator.

[0088] (2) Diltiazem hydrochloride granules:

[0089]

[0090] Step 201, put the diltiazem hydrochloride solid dispersion powder prepared in step 1) step 102, crystal cellulose, hydroxypropyl methylcellulose K4M, ethyl cellulose, and colloidal silicon dioxide into a fluidized bed, Make the materia...

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Abstract

The invention discloses a process for granulating and coating diltiazem hydrochloride in diltiazem hydrochloride sustained release tablets. The process is characterized by comprising the following steps: by taking absolute ethyl alcohol as a solvent, preparing diltiazem hydrochloride solid dispersion, granulating, and performing one-step coating forming, thereby obtaining the diltiazem hydrochloride granules. According to the granulating and coating process, the solid dispersion is prepared by adopting an anhydrous process, increase of related substances is reduced, and the process flow is simplified.

Description

technical field [0001] The invention relates to the field of granulation coating technology, in particular to a granulation coating composition of diltiazem hydrochloride in diltiazem hydrochloride sustained-release tablets and a preparation process thereof. Background technique [0002] Diltiazem hydrochloride, the main ingredient and its chemical name are: cis-(+)-5-[(2-dimethylamino)ethyl]-2-(4-methoxyphenyl)-3-acetoxy-2 , 3-dihydro-1,5-benzothiazepine-4(5H)-one hydrochloride, this product can effectively dilate the epicardial and subendocardial coronary arteries, relieve spontaneous angina or Angina pectoris caused by ergometrine-induced coronary artery spasm; by slowing heart rate and lowering blood pressure, reducing myocardial oxygen demand, increasing exercise tolerance and relieving exertional angina. This product can relax vascular smooth muscle, reduce peripheral vascular resistance, and lower blood pressure; the degree of lowering blood pressure is related to th...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/554A61K47/32A61K47/36A61K47/38A61P9/10A61P9/06A61P9/12
Inventor 常艳玲董佳丽顾煜顾珽卢小玲王平郭晶晶
Owner SHANGHAI SINE WANXIANG PHARMA