Preparation method of ranitidine hydrochloride tablets

A technology of ranitidine hydrochloride tablets and ranitidine hydrochloride, which is applied to medical preparations with no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., which can solve the problem of low production efficiency and moisture absorption of tablet cores and other problems to achieve the effect of avoiding the drying process, solving moisture absorption, improving product quality and production efficiency

Inactive Publication Date: 2019-05-03
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a preparation method of ranitidine hydrochloride tablets, which solves the problems of moisture absorption of the tablet core, degradation of the bulk drug affected by heat and humidity, and low production efficiency, and the process is simple and easy to prepare. Implementation, suitable for large-scale production

Method used

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  • Preparation method of ranitidine hydrochloride tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] The prescription composition of every 10,000 ranitidine hydrochloride tablets is: ranitidine hydrochloride 1674g, PH101 type microcrystalline cellulose 700g, pharmaceutical direct pressure anhydrous calcium hydrogen phosphate 500g, magnesium stearate 20g, silicon dioxide 20g.

[0022] Preparation:

[0023] (1) First, add ranitidine hydrochloride, microcrystalline cellulose and anhydrous calcium hydrogen phosphate into the mixer, set the mixer speed to 8 rpm, and mix for 20 minutes;

[0024] (2) Then add the prescribed amount of magnesium stearate and silicon dioxide into the mixer, set the mixer speed to 8rpm, mix for 5min and then compress the tablet, and the hardness of the tablet is controlled at 100-120N, to obtain dynamite hydrochloride Nitidine tablets.

Embodiment 2

[0026] The prescription composition of every 10,000 ranitidine hydrochloride tablets is: ranitidine hydrochloride 1674g, PH102 type microcrystalline cellulose 800g, pharmaceutical direct pressure anhydrous calcium hydrogen phosphate 600g, magnesium stearate 30g, silicon dioxide 30g.

[0027] Preparation:

[0028] (1) First, add ranitidine hydrochloride, microcrystalline cellulose and anhydrous calcium hydrogen phosphate into the mixer, set the mixer speed to 8 rpm, and mix for 20 minutes;

[0029] (2) Then add the prescribed amount of magnesium stearate and silicon dioxide into the mixer, set the mixer speed to 8rpm, mix for 5min and then compress the tablet, and the hardness of the tablet is controlled at 100-120N, to obtain dynamite hydrochloride Nitidine tablets.

Embodiment 3

[0031] The prescription composition of every 10,000 ranitidine hydrochloride tablets is: ranitidine hydrochloride 1674g, PH101 type microcrystalline cellulose 300g, PH102 type microcrystalline cellulose 300g, PH200 type microcrystalline cellulose 300g, pharmaceutical direct pressure type Anhydrous calcium hydrogen phosphate 900g, magnesium stearate 40g, silicon dioxide 40g.

[0032] Preparation:

[0033] (1) First, add ranitidine hydrochloride, microcrystalline cellulose and anhydrous calcium hydrogen phosphate into the mixer, set the mixer speed to 8 rpm, and mix for 20 minutes;

[0034] (2) Then add the prescribed amount of magnesium stearate and silicon dioxide into the mixer, set the mixer speed to 8rpm, mix for 5min and then compress the tablet, and the hardness of the tablet is controlled at 100-120N, to obtain dynamite hydrochloride Nitidine tablets.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation method of ranitidine hydrochloride tablets. The method selects auxiliary materials which are suitable for direct tabletting and have moisture-proof function, such as microcrystalline cellulose, anhydrous calcium hydrogen phosphate, magnesium stearate and silicon dioxide, adopts adirect tabletting process at the same time, solves the problem of moisture absorption of the tablet core, avoids the drying process of particles after wet granulation, and improves product quality and production efficiency. The process is simple, easy to implement, and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a preparation method of ranitidine hydrochloride tablets. Background technique [0002] Ranitidine hydrochloride is used to treat stomach ulcers, gastroesophageal reflux disease, and hyperacidity. Ranitidine hydrochloride is a moisture-sensitive drug, which is easily hydrolyzed when exposed to humidity and / or high temperature, which brings great challenges to formulation development. The development of tablets containing moisture-sensitive drugs will be affected by the coating process. Effects of high temperature and high humidity. Therefore, it is very important to include excipients in the tablet core composition to prevent moisture absorption or degradation of the drug. [0003] The stability of moisture-sensitive pharmaceuticals can be improved by different techniques. As moisture in the air can be absorbed by the product, the humidity in the production ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/341A61K47/38A61P1/04
Inventor 苗得足黄京山李伟陈德仁
Owner REYOUNG PHARMA
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