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Medicine, namely, ranitidine hydrochloride composition capsule, for treating digestive system disease

A technology for ranitidine hydrochloride and digestive system diseases, applied in the field of ranitidine hydrochloride composition capsules for the treatment of digestive system diseases, can solve the problems of discoloration, easy deliquescence of ranitidine hydrochloride, poor stability, etc., and achieve Improve stability, solve the effect of easy deliquescence and simple components

Inactive Publication Date: 2015-09-02
苗怡文
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention has developed a new compound of ranitidine hydrochloride. Compared with the ranitidine hydrochloride capsules of the prior art, the capsule prepared by the new ranitidine hydrochloride compound not only solves the problem that ranitidine hydrochloride is easily deliquescent , moisture absorption, discoloration, and poor stability, and the components are simple, which greatly reduces the occurrence of adverse reactions and improves the stability, efficacy, and bioavailability of capsule preparations

Method used

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  • Medicine, namely, ranitidine hydrochloride composition capsule, for treating digestive system disease
  • Medicine, namely, ranitidine hydrochloride composition capsule, for treating digestive system disease
  • Medicine, namely, ranitidine hydrochloride composition capsule, for treating digestive system disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1: Preparation of ranitidine hydrochloride crystals

[0030] (1) Add ranitidine hydrochloride solid into the mixed solvent of methanol, 2-methyltetrahydrofuran and acetonitrile, the volume of the mixed solvent is 10 times of the weight of ranitidine hydrochloride, the volume of methanol, 2-methyltetrahydrofuran and acetonitrile The volume ratio is 8:3.5:1.5;

[0031] (2) Control the temperature at 35-45°C, add a mixed solvent of acetone and ethyl acetate to the solution obtained in step (1), the volume of the mixed solvent is 9 times the weight of ranitidine hydrochloride, acetone and The volume ratio of ethyl acetate is 4:1.5;

[0032] (3) After adding a mixed solvent of acetone and ethyl acetate, cool down to -10-°C at a rate of 12°C / min, stand at -10-°C for 3 hours, precipitate crystals, filter, wash the filter cake with acetone, vacuum After drying, ranitidine hydrochloride compound is obtained.

[0033] The X-ray powder diffraction figure that the prep...

Embodiment 2

[0034] Example 2: Preparation of Ranitidine Hydrochloride Capsules:

[0035] Prescription: in parts by weight, 1.5 parts of the ranitidine hydrochloride compound prepared in Example 1, and 0.04 part of talcum powder.

[0036] 1) Raw material processing: sieve ranitidine hydrochloride with a vibrating sieving machine;

[0037] 2) Weighing: Weigh the raw and auxiliary materials according to the prescription;

[0038] 3) Mixing: Add the weighed raw and auxiliary materials into the mixer, set the operating frequency of the motor, and start the mixer to mix for 50 minutes;

[0039] 4) Filling by automatic capsule filling machine, the difference in filling volume must meet the national standard;

[0040] 5) Packaging.

Embodiment 3

[0041] Example 3: Preparation of Ranitidine Hydrochloride Capsules:

[0042] Prescription: in parts by weight, 1.5 parts of the ranitidine hydrochloride compound prepared in Example 1, and 0.05 part of talcum powder.

[0043] 1) Raw material processing: sieve ranitidine hydrochloride with a vibrating sieving machine;

[0044] 2) Weighing: Weigh the raw and auxiliary materials according to the prescription;

[0045] 3) Mixing: Add the weighed raw and auxiliary materials into the mixer, set the operating frequency of the motor, and start the mixer to mix for 50 minutes;

[0046] 4) Filling by automatic capsule filling machine, the difference in filling volume must meet the national standard;

[0047] 5) Packaging.

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Abstract

The invention discloses a medicine, namely, a ranitidine hydrochloride composition capsule, for treating a digestive system disease, and belongs to the technical field of medicines. The composition capsule is prepared from ranitidine hydrochloride and talcum powder. Ranitidine hydrochloride is a new crystal type compound, an X-ray powder diffraction diagram obtained by adopting Cu-K alpha ray measurement is as shown in the Figure1, and ranitidine hydrochloride is different from ranitidine hydrochloride reported in the prior art. Tests prove that as compared with the ranitidine hydrochloride capsule in the prior art, the capsule prepared from the new crystal type ranitidine hydrochloride compound not only solves the problems that ranitidine hydrochloride has high possibility of deliquescing, absorbing moisture and changing color as well as poor stability, but also has the advantages that the component is simple, the adverse reaction is reduced greatly, and the stability, the medicine effect and the bioavailability of the capsule preparation are improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a ranitidine hydrochloride composition capsule for treating digestive system 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 th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/341A61K9/48C07D307/52A61P1/04
Inventor 李清华
Owner 苗怡文
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