Ranitidine hydrochloride combination for inhibiting generation of gastric acid

A technology of ranitidine hydrochloride and composition, which is applied in the field of drug ranitidine hydrochloride composition for inhibiting the production of gastric acid, which can solve the problems of toxic side effects and drug safety impact, and achieve good stability and low content of insoluble particles , good fluidity effect

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

More and more studies have shown that the toxic and side effects of the excipients themselves, the incompatibilit...

Method used

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  • Ranitidine hydrochloride combination for inhibiting generation of gastric acid
  • Ranitidine hydrochloride combination for inhibiting generation of gastric acid
  • Ranitidine hydrochloride combination for inhibiting generation of gastric acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: the preparation of ranitidine hydrochloride crystal

[0026] (1) Grind the crude ranitidine hydrochloride, pass through an 80-mesh sieve, then add it into ethanol whose volume is 5 times the weight of ranitidine hydrochloride, and stir at 130 rpm for 10 minutes;

[0027] (2) Add propanol with a volume 6 times the weight of ranitidine hydrochloride under stirring at 145 rpm, and raise the temperature to 40°C;

[0028] (3) After adding the solution, let it stand for 2 hours, and add dropwise a mixed solution of 2-pentanone and carbon tetrachloride whose volume is 10 times the weight of ranitidine hydrochloride at 10°C under the condition of stirring at 180 rpm , The volume ratio of 2-pentanone and carbon tetrachloride is 4:1, and the uniform dropwise addition is completed within 2 hours;

[0029] (4) After the dropwise addition was completed, the temperature was lowered to -10°C, and stirring was continued for 3 hours at a stirring rate of 85 rpm, and the c...

Embodiment 2

[0031] Embodiment 2: the preparation of ranitidine hydrochloride composition

[0032] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared in Example 1 of the present invention, and 0.4 part by weight of sodium chloride.

[0033] The preparation method is:

[0034] (1) Weigh ranitidine hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0035] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0036] Embodiment 3: the preparation of ranitidine hydrochloride composition

[0037] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared in Example 1 of the present invention, and 0.5 part by weight of sodium chloride.

[0038] The preparation method is:

[0039] (1) Weigh ranitidine hydrochloride crystals and sodium chloride in proportion and mix them thoroughly;

[0040] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention discloses a ranitidine hydrochloride combination for inhibiting generation of gastric acid and belongs to the technical field of medicine. The ranitidine hydrochloride combination is composed of ranitidine hydrochloride and sodium chloride, ranitidine hydrochloride is a crystal, and X-ray powder diffraction pattern acquired by using Cu-K alpha ray for measuring is shown as a Figure 1. New crystal form of ranitidine hydrochloride is difference from crystal form structure in the prior art; experiments verify that a compound with the new crystal form is high in purity, fluidity and stability, low in impurity content, less prone to moisture absorption and safe and reliable in clinical application; a powder injection prepared by utilizing the compound is high 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 inhibiting gastric acid production. 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 ...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/341C07D307/52A61P1/04
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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