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Pharmaceutical ranitidine hydrochloride composition for treating digestive diseases

A technology for ranitidine hydrochloride and digestive diseases, which is applied in the field of drug ranitidine hydrochloride composition for treating digestive diseases, can solve problems such as drug safety impact, toxic and side effects, and achieves low content of insoluble particles and stable Good performance and low impurity content

Inactive Publication Date: 2016-01-13
杨献美
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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 incompatibility of the excipients and the main drug, impurities in the excipients, etc. will have an impact on the safety of the drug.

Method used

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  • Pharmaceutical ranitidine hydrochloride composition for treating digestive diseases
  • Pharmaceutical ranitidine hydrochloride composition for treating digestive diseases
  • Pharmaceutical ranitidine hydrochloride composition for treating digestive diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of ranitidine hydrochloride crystals

[0025] 1) Prepare mixed solution A by mixing N-methylpyrrolidone and water at a volume ratio of 1:5;

[0026] 2) Take the ranitidine hydrochloride raw material, add the mixed solution A prepared in step 1), wherein the ratio of the volume of the mixed solution A to the mass of ranitidine hydrochloride is 15ml:1g, heat to 35°C, After stirring to dissolve all the solution, add 0.1% g / ml activated carbon to decolorize and filter to obtain a clear solution;

[0027] 3) Prepare mixed solution B with acetone and ethylene glycol at a volume ratio of 4:1.5;

[0028] 4) At room temperature, add mixed solution B to the clear solution obtained in step 2) under an ultrasonic field with a power of 0.6KW, where the amount of mixed solution B added is 6 times the volume of mixed solution A, and turn off the ultrasonic field after adding , cooled to -10°C, allowed to stand for 2 hours, crystals were precipitated, and dri...

Embodiment 2

[0030] Example 2: Preparation of ranitidine hydrochloride composition

[0031] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.01 part by weight of arginine.

[0032] The preparation method is:

[0033] (1) Weigh ranitidine hydrochloride crystals and arginine in proportion and mix them thoroughly;

[0034] (2) Dispense into sterilized vials and stopper them.

Embodiment 3

[0035] Example 3: Preparation of ranitidine hydrochloride composition

[0036] The composition is: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.02 part by weight of arginine.

[0037] The preparation method is:

[0038] (1) Weigh ranitidine hydrochloride crystals and arginine in proportion and mix them thoroughly;

[0039] (2) Dispense into sterilized vials and stopper them.

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PUM

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Abstract

The invention discloses a pharmaceutical ranitidine hydrochloride composition for treating digestive diseases and belongs to the technical field of medicine. The composition is composed of ranitidine hydrochloride and arginine. The ranitidine hydrochloride is crystal, and an X-ray powder diffraction pattern of the crystal obtained by measurement using Cu-KAlpha ray is shown in 1. The novel crystal form of the ranitidine hydrochloride provided by the invention is different from crystal form structures of the prior art, testing shows that this novel-crystal form compound has high purity, good fluidity, good stability and low impurity content, rarely damps and is safe and reliable to clinically apply, powder injection prepared using the novel-crystal form compound is good in stability, is highly stable after being compatible with a solvent, has very low content of dissolvable particles and is very 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 digestive diseases. 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...

Claims

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Application Information

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IPC IPC(8): A61K31/341A61K47/18A61P1/04C07D307/52
Inventor 杨献美
Owner 杨献美
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