Diltiazem hydrochloride tablet and preparation method thereof

A technology of diltiazem hydrochloride tablets and diltiazem, which can be applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of easy residual organic solvents, low production efficiency and dissolution rate. It can reduce the frequency of taking medication, improve the output rate, and simplify the production process.

Inactive Publication Date: 2019-11-19
XINHUA PHARMA GAOMI CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Existing diltiazem hydrochloride Tablets use organic solvents as binders, and organic solvents are likely to remain in the finished product, resulting in low dissolution rates; or coating is required, resulting in low production efficiency

Method used

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  • Diltiazem hydrochloride tablet and preparation method thereof
  • Diltiazem hydrochloride tablet and preparation method thereof
  • Diltiazem hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] This embodiment provides a kind of diltiazem hydrochloride tablets, the diltiazem hydrochloride Tablets are prepared from the following raw materials comprising by weight:

[0036] diltiazem hydrochloride 15%; filler 50%; polyethylene glycol 6000 10%; hydrogenated castor oil 10%; microcrystalline cellulose 10%, and the filler is calcium hydrogen phosphate.

[0037] diltiazem hydrochloride The preparation method of sheet, comprises the following steps:

[0038] (1) diltiazem hydrochloride , filler, polyethylene glycol, hydrogenated castor oil and microcrystalline cellulose are mixed and then melted, granulated and sieved to form a granulated semi-finished product, cooled for later use;

[0039] (2) compress the semi-finished product obtained in step (1), or mix the semi-finished product with a lubricant and then compress the tablet to obtain the diltiazem hydrochloride piece.

Embodiment 2

[0041] This embodiment provides a kind of diltiazem hydrochloride tablets, the diltiazem hydrochloride Tablets are prepared from the following raw materials comprising by weight:

[0042] diltiazem hydrochloride 15%; filler 44.6%; polyethylene glycol 4000 5%; hydrogenated castor oil 30%; microcrystalline cellulose 5%, the filler is lactose, lubricant 0.4%, and the lubricant is talcum powder.

[0043] diltiazem hydrochloride The preparation method of sheet, comprises the following steps:

[0044] (1) diltiazem hydrochloride , filler, polyethylene glycol, hydrogenated castor oil and microcrystalline cellulose are mixed and put into a mixing granulator to melt and granulate, and pass through a 18-mesh sieve to form a granular semi-finished product, which is cooled by natural cooling for standby;

[0045] (2) Tablet the semi-finished product obtained in step (1), or use a high-speed mixer to mix the semi-finished product and lubricant, and then compress the tablet to obt...

Embodiment 3

[0047] This embodiment provides a kind of diltiazem hydrochloride tablets, the diltiazem hydrochloride Tablets are prepared from the following raw materials comprising by weight:

[0048] diltiazem hydrochloride 15%; filler 59%; polyethylene glycol 6000 is 10%; hydrogenated castor oil 10%; microcrystalline cellulose 5%, the filler is calcium carbonate, lubricant 1%, and the lubricant is talcum powder , magnesium stearate and stearic acid, the weight ratio of described talcum powder, magnesium stearate and stearic acid 4:2:3.

[0049] diltiazem hydrochloride The preparation method of sheet, comprises the following steps:

[0050] (1) diltiazem hydrochloride , filler, polyethylene glycol, hydrogenated castor oil and microcrystalline cellulose are mixed and put into a mixing granulator to melt and granulate, pass through a 18-mesh sieve to form a granulated semi-finished product, and use natural air in a hot air circulation oven or cold wind to cool down, spare;

[00...

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Abstract

The invention relates to a diltiazem hydrochloride tablet. The diltiazem hydrochloride tablet is prepared by the following steps: taking diltiazem hydrochloride, a filling agent, polyethylene glycol,hydrogenated castor oil, microcrystalline cellulose and the like as raw materials, performing melting and pelletizing, and performing tabletting so as to obtain the diltiazem hydrochloride tablet. Theinvention has the beneficial effects that the diltiazem hydrochloride tablet is molten and pelletized, water or an organic solvent does not need to be added to serve as an adhesive, no residue of theorganic solvent exists, and the prepared particle does not need a drying step; the microcrystalline cellulose in the raw materials is matched with the hydrogenated castor oil to achieve a synergisticeffect, a skeleton is formed by virtue of melting and pelletizing, the hydrogenated castor oil is promoted to well achieve a skeleton slow-release effect, a slow-release purpose of the diltiazem hydrochloride is achieved, and drug action time is prolonged.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to diltiazem hydrochloride Tablets and methods for their preparation. Background technique [0002] diltiazem hydrochloride The chemical name of the tablet is: cis-(+)-5-[(2-dimethylamino)ethyl]-2-(4-methoxyphenyl)-3-acetoxy-2,3-dihydro -1,5-Phenylpropylthiazepine -4(5H)-one hydrochloride. Indications are angina pectoris; mild and moderate hypertension. It is a calcium ion channel blocker. It acts on the calcium ion channels in the smooth muscle of the myocardium, coronary vessels, peripheral blood vessels, and atrioventricular nodes to inhibit the transmembrane influx of calcium ions from the outside to the inside of the cell and reduce the intracellular calcium flow. ion concentrations, but did not alter serum calcium concentrations. Relieve and prevent the contraction of myocardium and vascular smooth muscle cells, expand coronary arteries and periphe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/44A61K47/10A61K31/554A61P9/12A61P9/10A61P9/06
CPCA61K9/2013A61K9/2031A61K9/2054A61K9/2095A61K31/554A61P9/06A61P9/10A61P9/12
Inventor 朱玉竹郭永军王晓燕朱岩岩高明才
Owner XINHUA PHARMA GAOMI CO LTD
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