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Medicinal ranitidine hydrochloride composition capsule for treating gastric ulcer

A technology of ranitidine hydrochloride and a composition, which is applied in the field of drug ranitidine hydrochloride composition capsules for treating gastric ulcer, can solve the problems of poor stability, easy oxidation of products, difficult filling, etc., and achieves the improvement of stability. Effect

Inactive Publication Date: 2015-09-16
苗怡文
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The patent uses 50-90% ethanol solution as a wetting agent to produce soft and loose granules. After granulation, more than 80% of the granules become powder, resulting in poor fluidity and difficult filling. Moreover, the patent uses wet granulation, raw materials Ranitidine hydrochloride is easy to absorb moisture and deliquesce, causing discoloration and affecting product quality
[0007] Therefore, be necessary to develop a kind of ranitidine hydrochloride new compound, fundamentally solve ranitidine hydrochloride meeting wet, heat, unstable air, the product is easily oxidized, easy to absorb moisture and change color, problems such as poor stability, this hydrochloric acid The new crystal form compound of ranitidine is used in capsules, which improves the stability, efficacy and bioavailability of capsules

Method used

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  • Medicinal ranitidine hydrochloride composition capsule for treating gastric ulcer
  • Medicinal ranitidine hydrochloride composition capsule for treating gastric ulcer
  • Medicinal ranitidine hydrochloride composition capsule for treating gastric ulcer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Preparation of ranitidine hydrochloride crystals

[0031] (1) Prepare methanol and N,N-dimethylformamide as a mixed solvent, and the volume ratio of methanol and N,N-dimethylformamide is 2.5:1;

[0032] (2) Take the ranitidine hydrochloride raw material, dissolve it in the mixed solvent of methanol and N,N-dimethylformamide whose volume is 8 times the weight of ranitidine hydrochloride in step (1), and stir until all Dissolving to obtain ranitidine hydrochloride solution;

[0033] (3) At a temperature of 8°C and a stirring speed of 240r / min, add the ranitidine hydrochloride solution in step (2) into 80% ethanol whose volume is 10 times the weight of ranitidine hydrochloride, and mix to form Cool the suspension to -5°C at a rate of 15°C / min;

[0034] (4) Carry out suction filtration, wash the filter cake with 95% ethanol, and then vacuum-dry the filter cake at 35°C to obtain a crystalline powder, which is the ranitidine hydrochloride compound.

[0035] Th...

Embodiment 2

[0036] Example 2: Preparation of Ranitidine Hydrochloride Capsules:

[0037] Prescription: in parts by weight as shown in Table 1

[0038] Table 1 The composition prescription of ranitidine hydrochloride

[0039]

[0040] 1) Processing of raw and auxiliary materials: pass ranitidine hydrochloride and anhydrous lactose through a 60-mesh sieve with a vibrating sieving machine;

[0041] 2) Weighing: Weigh the raw and auxiliary materials according to the prescription;

[0042] 3) Mixing: Add the weighed raw and auxiliary materials into the mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 50 minutes;

[0043] 4) Filling by automatic capsule filling machine, the difference in filling volume must meet the national standard;

[0044] 5) Packaging.

Embodiment 3

[0045] Example 3: Preparation of Ranitidine Hydrochloride Capsules:

[0046] Prescription: in parts by weight as shown in Table 2

[0047] Table 2 Prescription of ranitidine hydrochloride composition

[0048]

[0049] 1) Processing of raw and auxiliary materials: pass ranitidine hydrochloride and anhydrous lactose through a 60-mesh sieve with a vibrating sieving machine;

[0050] 2) Weighing: Weigh the raw and auxiliary materials according to the prescription;

[0051] 3) Mixing: Add the weighed raw and auxiliary materials into the mixer, set the motor operating frequency to 200r / min, and start the mixer to mix for 50 minutes;

[0052] 4) Filling by automatic capsule filling machine, the difference in filling volume must meet the national standard;

[0053] 5) Packaging.

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Abstract

The invention discloses a medicinal ranitidine hydrochloride composition capsule for treating gastric ulcer and belongs to the technical field of medicines. The capsule is composed of ranitidine hydrochloride, lactose anhydrous, cross-linking sodium carboxymethylcellulose, silica and talcum powder. The ranitidine hydrochloride is a novel crystal compound. The X-ray powder diffraction diagram obtained through measurement of Cu-Kalpha rays is as shown in the Figure 1. The ranitidine hydrochloride is different from ranitidine hydrochloride reported in the prior art. Experiments find that compared with a ranitidine hydrochloride capsule in the prior art, the capsule prepared by the ranitidine hydrochloride as the novel crystal compound solves the problems that ranitidine hydrochloride is prone to deliquescing, absorbing moisture and changing colors and has the poor stability, and the stability, medicine effect and bioavailability of the capsule are improved.

Description

technical field [0001] The invention belongs to the technical field of medicines and relates to a ranitidine hydrochloride composition capsule 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 that of c...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/341C07D307/52A61P1/04
Inventor 苗怡文
Owner 苗怡文
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