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Ranitidine hydrochloride composition tablet medicine for treating digestive system diseases

A technology for ranitidine hydrochloride and digestive system diseases, which is applied in the field of ranitidine hydrochloride composition tablets for the treatment of digestive system diseases, and can solve the problems of poor stability, easy deliquescence and discoloration of ranitidine hydrochloride, etc. Achieve the effects of improving stability, solving extremely deliquescence, and simple components

Inactive Publication Date: 2015-10-14
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 tablet 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 composition Simple, greatly reduces the occurrence of adverse reactions, and improves the stability, efficacy and bioavailability of tablet formulations

Method used

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  • Ranitidine hydrochloride composition tablet medicine for treating digestive system diseases
  • Ranitidine hydrochloride composition tablet medicine for treating digestive system diseases
  • Ranitidine hydrochloride composition tablet medicine for treating digestive system diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of ranitidine hydrochloride crystals

[0029] (1) Grind the crude ranitidine hydrochloride, pass through a 60-mesh sieve, then add it into deionized water whose volume is 8 times the weight of ranitidine hydrochloride, and stir at 130 rpm for 10 minutes;

[0030] (2) Add ethanol whose volume is 5 times the weight of ranitidine hydrochloride while stirring at 110 rpm, and raise the temperature to 35°C;

[0031] (3) After the solution is added, let it stand for 2 hours, and add dropwise a mixed solution of acetone and ether whose volume is 8 times the weight of ranitidine hydrochloride at 0°C under the condition of stirring at 165 rpm, the volume ratio of acetone and ether It is 3:1, and the uniform dropwise addition is completed within 2 hours;

[0032] (4) After the dropwise addition was completed, the temperature was lowered to -10°C, and stirring was continued at a stirring rate of 100 rpm for 2 h, and the crystals were precipitated after sta...

Embodiment 2

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

[0035] Prescription: in parts by weight as shown in Table 1

[0036] Table 1 The composition prescription of ranitidine hydrochloride

[0037]

[0038] Preparation:

[0039] (1) Processing of raw and auxiliary materials: pass ranitidine hydrochloride through an 80-mesh sieve with a vibrating sieving machine;

[0040] (2) Weighing: Weighing according to the prescription amount;

[0041] (3) Mixing: Add all the weighed raw and auxiliary materials into the three-dimensional motion mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 45 minutes;

[0042] (4) Tablet compression: Add the mixed granules into a high-speed tablet press, control the hardness to 8-12kgF, and the difference in tablet weight must meet the internal control standards;

[0043] (5) Packaging.

Embodiment 3

[0044] Example 3: Preparation of Ranitidine Hydrochloride Tablets:

[0045] Prescription: in parts by weight as shown in Table 2

[0046] Table 2 Prescription of ranitidine hydrochloride composition

[0047]

[0048] Preparation:

[0049] (1) Processing of raw and auxiliary materials: pass ranitidine hydrochloride through an 80-mesh sieve with a vibrating sieving machine;

[0050] (2) Weighing: Weighing according to the prescription amount;

[0051] (3) Mixing: Add all the weighed raw and auxiliary materials into the three-dimensional motion mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 45 minutes;

[0052] (4) Tablet compression: Add the mixed granules into a high-speed tablet press, control the hardness to 8-12kgF, and the difference in tablet weight must meet the internal control standards;

[0053] (5) Packaging.

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Abstract

The invention relates to a ranitidine hydrochloride composition tablet medicine for treating digestive system diseases and belongs to the technical field of medicines. The ranitidine hydrochloride composition is composed of ranitidine hydrochloride, calcium hydrogen phosphate, pregelatinized starch, aluminium-magnesium silicate and aerosol, wherein ranitidine hydrochloride is a new crystal form compound, and an X-ray powder differentiation pattern obtained through Cu-Kalpha radioactive measurement is shown as a Figure 1, so that the ranitidine hydrochloride adopted in the ranitidine hydrochloride composition tablet medicine is different from the ranitidine hydrochloride reported in the prior art. Experiments show that the tablet prepared from the ranitidine hydrochloride new crystal form compound can be used for solving the problem that ranitidine hydrochloride is extremely easy to deliquesce, high in possibility of moisture adsorption and colour change and poor in stability, and the composition is simple, so that adverse reactions are greatly reduced, and the stability, pharmaceutical effect and biological availability of a tablet preparation are improved.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a ranitidine hydrochloride composition tablet for treating diseases of the digestive system. 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 stron...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/341C07D307/52A61P1/04
Inventor 王贵宾
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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