Ranitidine hydrochloride composition for treating gastric diseases

The technology of ranitidine hydrochloride and the composition is applied in the field of the drug ranitidine hydrochloride composition for treating gastric diseases, and can solve the problems of the ranitidine hydrochloride being easily deliquescent, the efficacy of the drug being decreased, the color becoming darker, and the like, and achieving Low content of insoluble particles, good stability and good fluidity

Inactive Publication Date: 2015-11-18
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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  • Ranitidine hydrochloride composition for treating gastric diseases
  • Ranitidine hydrochloride composition for treating gastric diseases
  • Ranitidine hydrochloride composition for treating gastric diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1: Preparation of ranitidine hydrochloride crystals

[0022] Prepare a saturated isopropanol solution of ranitidine hydrochloride crude product at 35°C, then add isoamyl alcohol whose volume is 11 times the volume of the saturated isopropanol solution, stir evenly, and stir while cooling down at a cooling rate of 8°C / hour , the stirring speed is 110 rev / min, and the mixed solvent of acetone and dimethyl sulfoxide whose volume is 4 times the volume of isoamyl alcohol is added simultaneously, the volume ratio of acetone and dimethyl sulfoxide is 1:4, and the temperature is lowered to -5 After ℃, the stirring was stopped, and the crystal was grown for 4 hours, filtered, and 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 ray measurement to obtain is as follows figure 1 shown.

Embodiment 2

[0024] Example 2: Preparation of ranitidine hydrochloride composition

[0025] The composition comprises: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.1 part by weight of anhydrous sodium carbonate.

[0026] The preparation method is:

[0027] (1) Weigh ranitidine hydrochloride crystals and anhydrous sodium carbonate 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 comprises: 1 part by weight of ranitidine hydrochloride crystal prepared by the present invention, and 0.15 part by weight of anhydrous sodium carbonate.

[0031] The preparation method is:

[0032] (1) Weigh ranitidine hydrochloride crystals and anhydrous sodium carbonate in proportion and mix them thoroughly;

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

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PUM

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Abstract

The invention relates to a ranitidine hydrochloride composition for treating gastric diseases, belonging to the technical field of medicines. The composition comprises ranitidine hydrochloride and anhydrous sodium carbonate, wherein ranitidine hydrochloride is a crystal. An X-ray powder diffraction pattern obtained through measurement by using a Cu-Kalpha ray is shown in a drawing 1 in the specification. A new crystal form of ranitidine hydrochloride provided by the invention is different from the crystal structure of the prior art. Through experimental verification, the compound in the new crystal form has high purity, good flowability and stability and low impurity content, has low possibility of moisture absorption and is safe and reliable to apply clinically. Powder injections prepared by utilizing the compound in the new crystal form have good stability after undergoing compatibility with solvents, have low content of insoluble particles and are very suitable to apply clinically.

Description

Technical field [0001] The invention is a pharmaceutical technology field involving a reinopine composition that treats gastric disease. Background technique [0002] Like Simiidine is the most widely used drug at present.Developed by the British Glaxo Company.In 1976, it was synthesized by the British Price, and in 1979, Bradshaw clarified its pharmacology.Application of hundreds of countries.my country was produced by Shanghai Sixth Pharmaceutical Factory in 1985. [0003] Renitidine is a selective H2 receptor antagonist, which can effectively inhibit gastric acid secretion caused by histamine, five peptides gastricin and food stimulation, and reduce the activity of gastric acid and gastases.The secretion of sex hormones has no effect.The effect is 5-8 times stronger than Simi Ding, which has high efficacy on gastric and duodenal ulcers. It has the characteristics of rapid and long-term effects. The side effects are small and safe.30-90 minutes after a single oral 80mg, the ave...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/00A61K31/341A61K9/14C07D307/52A61P1/04
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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