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Ranitidine hydrochloride composition dry suspension for treating gastric ulcer

A technology of ranitidine hydrochloride and dry suspension, applied in the field of medicine, can solve the problems of easy deliquescence, poor stability, discoloration and the like of ranitidine hydrochloride, so as to solve the problems of easy deliquescence, improve stability and simple components Effect

Inactive Publication Date: 2015-11-11
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention develops a new compound of ranitidine hydrochloride, and the dry suspension prepared by the new compound of ranitidine hydrochloride not only solves the problems of easy deliquescence, moisture absorption, discoloration and poor stability of ranitidine hydrochloride, but also The components are simple, which greatly reduces the occurrence of adverse reactions and improves the stability, efficacy and bioavailability of the dry suspension

Method used

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  • Ranitidine hydrochloride composition dry suspension for treating gastric ulcer
  • Ranitidine hydrochloride composition dry suspension for treating gastric ulcer
  • Ranitidine hydrochloride composition dry suspension for treating gastric ulcer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Preparation of ranitidine hydrochloride crystals

[0025] Get ranitidine hydrochloride crude drug, add in the mixed solvent A of water, ethanol, N-methylacetamide whose volume is 8 times of the weight of ranitidine hydrochloride at 30 ℃, water, ethanol, N-methylacetamide Volume ratio is 4:1:1, obtains solution; Apply the constant magnetic field that magnetic field strength is 1.0T then on the horizontal direction of the liquid surface of gained solution, and drop volume is radish hydrochloride in solution under the condition of this constant magnetic field. Acetone 8 times the weight of nitidine; after the dropwise addition, cool down to -10°C, let stand for 2 hours, filter, wash, and dry in vacuum to obtain the ranitidine hydrochloride crystals.

[0026] 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

[0027] Example 2: The preparation of ranitidine hydrochloride dry suspension:

[0028] Prescription: in parts by weight as shown in Table 1

[0029] Table 1 ranitidine hydrochloride composition prescription

[0030]

[0031] Preparation:

[0032] (1) Processing of raw and auxiliary materials: crush ranitidine hydrochloride through a 100-mesh sieve with a pulverizer;

[0033] (2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0034] (3) Total mixing: Add all the raw and auxiliary materials in the prescribed amount into the three-dimensional mixer, the mixing speed is 12r / min, and the mixer is turned on for 60 minutes;

[0035] (4) Packaging: Add the granules to the granule packaging machine for packaging, and control the difference in the amount of filling to meet the internal control standards.

Embodiment 3

[0036] Example 3: The preparation of ranitidine hydrochloride dry suspension:

[0037] Prescription: in parts by weight as shown in Table 2

[0038] Table 2 ranitidine hydrochloride composition prescription

[0039]

[0040] Preparation:

[0041] (1) Processing of raw and auxiliary materials: crush ranitidine hydrochloride through a 100-mesh sieve with a pulverizer;

[0042] (2) Weighing: Weigh each raw and auxiliary material according to the process prescription quantity;

[0043] (3) Total mixing: Add all the raw and auxiliary materials in the prescribed amount into the three-dimensional mixer, the mixing speed is 12r / min, and the mixer is turned on for 60 minutes;

[0044] (4) Packaging: Add the granules to the granule packaging machine for packaging, and control the difference in the amount of filling to meet the internal control standards.

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Abstract

The invention discloses a ranitidine hydrochloride composition dry suspension for treating gastric ulcer, and belongs to the technical field of medicine. A composition is composed of ranitidine hydrochloride, sucrose, sodium carboxymethylcellulose, sodium alginate, pectin, polyethylene glycol and stevioside; the ranitidine hydrochloride is a new crystal form compound, is measured with a Cu-Ka ray to obtain an X-ray powder diffraction pattern and is different from ranitidine hydrochloride reported by the prior art, wherein the X-ray powder diffraction pattern is as shown in figure 1. Experiments find that the dry suspension prepared with the ranitidine hydrochloride-new crystal form compound solves the problem that the ranitidine hydrochloride is extremely prone to being deliquesced, moisture is prone to being absorbed, color is prone to being changed, and the stability is poor, the components are simple, adverse reactions are greatly prevented from occurring, and the stability, medicine effects and bioavailability of the dry suspension are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a dry suspension of ranitidine hydrochloride composition for treating gastric 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/341C07D307/52A61K47/38A61P1/04
Inventor 刘学键
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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