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Micro-pillet preparation of ranitidine

A technology of ranitidine and pellets, which is applied in the field of ranitidine-containing pellet preparations, can solve the problems of poor stability, instability, and low production efficiency, and achieve the effect of good stability and strong moisture resistance

Inactive Publication Date: 2004-02-04
TIANZE MEDICINE SCI & TECH DEV NANJING CITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because ranitidine hydrochloride is extremely deliquescent, it will become unstable after moisture absorption, the color will become darker, the content will decrease, and the drug effect will decrease
If an enterprise that uses powder to directly fill ranitidine capsules is not only difficult to control the difference in filling volume, but also has low production efficiency, it is also difficult to meet the humidity requirements of the operating environment. During production and sales, there may be rework and return of products due to moisture, so At present, most manufacturers make ranitidine into granules and then pack them into capsules, which improves its moisture absorption problem, but the improvement of its stability is still insufficient because the granules are not round; Granules, the color of the granules turns dark brown, the moisture resistance is not improved, resulting in poor stability and poor fluidity, so it is not suitable to use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1 ranitidine hydrochloride pellets and preparation method: ball core composition:

[0048] Ranitidine hydrochloride 168g (equivalent to ranitidine 150g)

[0049] Dry starch 58g

[0050] 3% PVP K30 Ethanol solution Appropriate amount of coating solution composition: 1) 8% gelatin aqueous solution 24ml

[0051] 2) 3% acrylic IV resin ethanol solution 240ml

[0052] 3) 110ml of 1% ethyl cellulose ethanol solution Preparation method:

[0053] Mix according to the prescription amount of pellet cores to make soft materials, sieve through 18 meshes to make wet granules, immediately put them into a coating pan, round them, and dry them at 40°C, then put them in a coating pan, and apply coating prescription 1, 2, 3 Spray onto the rolling ball core, coat and dry

Embodiment 2

[0054] Embodiment 2 ball core composition:

[0055]Ranitidine Hydrochloride 168g

[0056] Microcrystalline Cellulose 70g

[0057] 3% HPMC80% ethanol solution Appropriate coating formula:

[0058] 1% hypromellose 80% ethanol solution 190ml

[0059] 3% Acrylic No. IV Resin Ethanol Solution 240ml

[0060] The preparation method of 1% ethyl cellulose ethanol solution 110ml is the same as in Example 1, and then filled into 1000 empty capsules.

Embodiment 3

[0061] Embodiment 3 ball core composition:

[0062] Ranitidine Hydrochloride 168g

[0063] Lactose 62g

[0064] 85% ethanol solution Appropriate amount of coating formula:

[0065] 3% methylcellulose 63ml

[0066] 3% Acrylic No. IV Resin Ethanol Solution 240ml

[0067] The preparation method of 1% ethyl cellulose ethanol liquid 110ml is the same as in Example 1, and is packed into 1000 empty capsules to make micropill capsules.

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PUM

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Abstract

A ranitidine micropill is composed of core and coating layer prepared from 3 substances. It can be further made into capsule or tablet. Its advantages are low hydroscopicity, high stability and quick disintegration in stomach.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pellet preparation, a pellet preparation containing ranitidine. Background technique [0002] Ranitidine hydrochloride is non-imidazole H 2 - Receptor antagonist, can effectively control the secretion of gastric acid in the body, its effect is 5-10 times stronger than cimetidine; it has rapid absorption (1-2 hours after oral administration reaches the peak blood concentration), long-term action (lasting 12 hours) and adverse effects Reflecting the characteristics of few, it is widely used clinically to treat duodenal ulcer, reflux esophagitis and Zoller-Ellison syndrome. Because ranitidine hydrochloride is very easy to deliquescence, it will become unstable after moisture absorption, the color will become darker, the content will decrease, and the drug effect will decrease. If an enterprise that uses powder to directly fill ranitidine capsules is not only difficult ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/36A61K31/341A61P1/04
CPCA61K31/341A61K9/2077A61P1/04
Inventor 张钧寿管建立
Owner TIANZE MEDICINE SCI & TECH DEV NANJING CITY
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