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Ranitidine pharmaceutical composition and preparation method thereof

A technology of ranitidine and ranitidine hydrochloride, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations of non-active ingredients, and can solve the problems of inability to meet drug release requirements, large gaps in bioavailability, and long-term stability of drugs Poor drug resistance and other problems, to achieve the effect of ensuring bioavailability, good stability, and improving drug safety

Active Publication Date: 2018-02-23
武汉九州钰民医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN101032479A discloses a pharmaceutical preparation of ranitidine, but after testing, the long-term stability of the drug is poor and cannot meet the release requirements of the drug
CN104971053A discloses a ranitidine tablet, but the release effect of this patent is not good, and the bioavailability is far from that of the reference preparation

Method used

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  • Ranitidine pharmaceutical composition and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1 (specification 150mg)

[0022] Preparation prescription:

[0023] Ranitidine Hydrochloride 150mg

[0024] Lactose 90mg

[0025] Polyethylene glycol 30mg

[0026] Benzoic acid 24.9mg

[0027] Magnesium stearate 5.1mg

[0028] Preparation Process:

[0029] 1. Put ranitidine hydrochloride in a grinder and grind for about 30 minutes to obtain ranitidine hydrochloride powder with a particle size of 20 μm.

[0030] 2. Mix ranitidine hydrochloride powder and lactose evenly, add polyethylene glycol and benzoic acid, make a soft material with 5% PVP (50% ethanol aqueous solution), pass through a 20-mesh sieve for granulation, and dry at 50°C for 1 hour.

[0031] 3. Add magnesium stearate to the dried granules, sieve the granules with 20 mesh, and press into tablets (pressure 3.0Kg / cm 2 ).

Embodiment 2

[0032] Embodiment 2 (specification 150mg)

[0033] Preparation prescription:

[0034] Ranitidine Hydrochloride 150mg

[0035] Lactose 60mg

[0036] Polyethylene glycol 60mg

[0037] Benzoic acid 24.9mg

[0038] Magnesium stearate 5.1mg

[0039] Preparation Process:

[0040] With embodiment 1, difference is that charging amount is different.

Embodiment 3

[0041] Embodiment 3 (specification 150mg)

[0042] Preparation prescription:

[0043] Ranitidine Hydrochloride 150mg

[0044] Lactose 80mg

[0045] Polyethylene glycol 40mg

[0046] Benzoic acid 24.9mg

[0047] Magnesium stearate 5.1mg

[0048] Preparation Process:

[0049] With embodiment 1, difference is that charging amount is different.

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Abstract

The invention relates to a ranitidine pharmaceutical composition and a preparation method of the ranitidine pharmaceutical composition. The ranitidine pharmaceutical composition comprises ranitidine hydrochloride, an excipient, a stabilizer and a lubricant. The composition is excellent in preparation stability and release behavior, is quite suitable for clinical application, and improves the safety of drug use for a patient.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of ranitidine and a preparation method thereof. Background technique [0002] Peptic ulcer (peptic ulcer, PU) is a chronic disease that easily recurs. Due to the increasing pace of modern life and work pressure, as well as the abuse of corticosteroids, the incidence of PU is increasing. The incidence of digestive system in the world accounts for 10% to 12% of human beings, and the incidence of digestive system in cities and towns in my country is about 11.43%, which is basically similar to many developed countries in Europe and America. At present, there is no effective method to completely cure it, which has become one of the key topics in the field of medical research. Current therapeutic drugs mainly include antacids, anticholinergics, histamine H2 receptor antagonists, proton pump H+, K+-ATPase inhibitors, pepsin inhibitors, gastrin re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/341A61K47/12A61K47/26A61P1/04
CPCA61K31/341A61K47/12A61K47/26
Inventor 许勇范昭泽于静黄璐
Owner 武汉九州钰民医药科技有限公司
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