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Medicinal ranitidine hydrochloride composition for treating peptic ulcer

A technology for ranitidine hydrochloride and peptic ulcer, which is applied in the field of medicine, can solve the problems of easy deliquescence of ranitidine hydrochloride, decreased drug efficacy, darker color, etc., and achieves low content of insoluble particles, good stability, good fluidity

Inactive Publication Date: 2015-12-02
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Ranitidine hydrochloride is extremely deliquescent, causing instability after moisture absorption, darkening the color, decreasing the content, and decreasing the efficacy

Method used

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  • Medicinal ranitidine hydrochloride composition for treating peptic ulcer
  • Medicinal ranitidine hydrochloride composition for treating peptic ulcer
  • Medicinal ranitidine hydrochloride composition for treating peptic ulcer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Preparation of ranitidine hydrochloride crystals

[0022] Dissolve the solid ranitidine hydrochloride in a propanol solution whose volume is 8 times the weight of ranitidine hydrochloride at 35°C; first add 1,6-hexanediol whose total volume is 13 times the weight of ranitidine hydrochloride , a mixed solvent of ethyl acetate, the volume ratio of 1,6-hexanediol and ethyl acetate is 3.5:1.5, stir while adding, control the temperature at 35°C, and grow crystals for 1.5 hours; then add the total volume of hydrochloric acid Methyl acetone that is 6 times the weight of ranitidine, after growing the crystal for 2 hours, cool down to -10°C at a speed of 8°C / hour, then maintain the stirring speed at 90 rpm to stir and crystallize, and grow the crystal for 4 hours; filter , dried under reduced pressure to obtain ranitidine hydrochloride crystalline compound.

[0023] The X-ray powder diffraction figure that the prepared ranitidine hydrochloride crystal uses Cu-Kα ra...

Embodiment 2

[0024] Example 2: Preparation of ranitidine hydrochloride composition

[0025] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.03 part by weight of sodium dihydrogen phosphate.

[0026] The preparation method is:

[0027] (1) Weigh ranitidine hydrochloride crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0028] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0029] Example 3: Preparation of ranitidine hydrochloride composition

[0030] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.04 part by weight of sodium dihydrogen phosphate.

[0031] The preparation method is:

[0032] (1) Weigh ranitidine hydrochloride crystals and sodium dihydrogen phosphate in proportion, and mix them thoroughly;

[0033] (2) Dispense into sterilized vials and stopper them.

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Abstract

The invention relates to a medicinal ranitidine hydrochloride composition for treating peptic ulcer. The composition comprises ranitidine hydrochloride and sodium dihydrogen phosphate. The ranitidine hydrochloride is a new crystal compound, the X-ray powder diffraction diagram, obtained by using Cu-K alpha rays for measuring, of the ranitidine hydrochloride is shown in figure 1, and the crystal structure of the pantoprazole sodium is different from that of ranitidine hydrochloride in the prior art. Experiments show that the new crystal compound is high in purity, good in flowability, good in stability, low in impurity content, less prone to moisture absorption and safe and reliable in clinical application; powder injection prepared by the new crystal compound is good in stability, good in stability after being combined with solvent, extremely low in insoluble particle content and quite suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug ranitidine hydrochloride composition for treating peptic ulcer. Background technique [0002] Ranitidine, like cimetidine, is currently the most widely used drug for the treatment of ulcer disease. Developed by the British Glaxo (glaxo) company. It was synthesized by British Price in 1976, and its pharmacology was clarified by Bradshaw in 1979. In 1980, Berstad reported that it was effective for duodenal ulcer. Apps in hundreds of countries. my country was produced by Shanghai Sixth Pharmaceutical Factory in 1985. [0003] Ranitidine is a selective H2 receptor antagonist, which can effectively inhibit the gastric acid secretion caused by histamine, pentagastrin and food stimulation, reduce the activity of gastric acid and gastric enzymes, but has no effect on gastrin and The secretion of sex hormones was not affected. The effect is 5-8 times stronger than that of cimet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/341C07D307/52A61P1/04
Inventor 朱爱菊
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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