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Industrial preparation method of ranitidine hydrochloride capsule

A technology of ranitidine hydrochloride and capsules, which is applied in the field of industrial preparation of ranitidine hydrochloride capsules, can solve the problems of unfavorable product stability, instability of ranitidine hydrochloride, long process cycle, etc., and achieve good bioavailability , Good drug dissolution rate, no discoloration effect

Active Publication Date: 2018-12-18
SUZHOU KELUN PHARMA RES CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the existing ranitidine capsule preparation process preparation method can not completely avoid the phenomenon of instability and moisture absorption of ranitidine hydrochloride in the capsule preparation process method
Adhesion to equipment is easy to occur during the granulation preparation process, and there are many processes and equipment involved, and the cycle of each process is long, which is not conducive to the stability of the product

Method used

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  • Industrial preparation method of ranitidine hydrochloride capsule
  • Industrial preparation method of ranitidine hydrochloride capsule
  • Industrial preparation method of ranitidine hydrochloride capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] The preparation of embodiment 1 ranitidine hydrochloride capsules of the present invention

[0067]

[0068] Preparation Process:

[0069] The ranitidine hydrochloride crude drug that takes prescription dosage is placed in fluidized bed, and the starch slurry solution of 3% concentration is sprayed in the fluidized bed with atomization form, atomization pressure 0.3MPa, spray speed 3g / kg / min, control the temperature of the material at 25-30°C, and granulate ranitidine hydrochloride; continue to dry the material with a fluidized bed until the moisture is less than 3%; pass the granule material through a 40-mesh sieve for granulation, and the particle size is uniform , white to light yellow. After adding supplementary materials such as carboxymethyl starch sodium, silicon dioxide and magnesium stearate in prescription dosage and mixing for 10 minutes, the ranitidine hydrochloride capsule product whose capsule content was 175 mg was prepared by filling.

Embodiment 2

[0070] The preparation of embodiment 2 ranitidine hydrochloride capsules of the present invention

[0071]

[0072] Preparation Process:

[0073] Weigh the ranitidine hydrochloride and starch of the prescribed amount and mix them in the fluidized bed and be in a fluidized state, spray water into it, the atomization pressure is 0.2MPa, the spray speed is 4g / kg / min, preheat and control The mixed material is granulated at a temperature of 30-35°C. After the mixed material is in good condition, the prepared granular material is dried until the moisture content is not higher than 3%; the granular material is passed through a 40-mesh screen for granulation, and the particle size is uniform. It is white to light yellow. After adding auxiliary materials such as croscarmellose sodium, talcum powder and magnesium stearate in prescription dosage and mixing for 15 minutes, the ranitidine hydrochloride capsule product whose capsule content was 210 mg was prepared by filling.

Embodiment 3

[0074] The preparation of embodiment 3 ranitidine hydrochloride capsules of the present invention

[0075]

[0076] Preparation Process:

[0077] The ranitidine hydrochloride crude drug and lactose that take prescription quantity are mixed in the fluidized bed, the povidone aqueous solution of 8% concentration is atomized and sprayed in the fluidized bed, atomization pressure 0.5MPa, spray speed 0.2g / kg / min, preheat and control the temperature of the material at 35-40°C before granulating, continue to dry the granular material in the fluidized bed until the moisture content is not higher than 3%; pass the granular material through a 40-mesh screen for granulation, The particle size is uniform, white to light yellow in color. After adding excipients such as low-substituted hydroxypropyl cellulose, silicon dioxide and magnesium stearate in the prescribed amount and mixing for 30 minutes, the ranitidine hydrochloride capsule product with a capsule content of 280 mg was prepa...

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Abstract

The invention relates to a preparation method of a ranitidine hydrochloride capsule. The ranitidine hydrochloride capsule mainly contains the following raw materials by weight percentage: 55-99% of ranitidine hydrochloride; 0-30% of a filler; 0%-10% of a binder; 0-5% of a disintegrant; and 0. 01-5% of a lubricant. The employed optimized prescription and process preparation method effectively improve the process robustness, controllability and feasibility; the production process of the ranitidine hydrochloride capsule is simplified, the production operation cycle is shortened, and the production efficiency is improved.

Description

technical field [0001] The invention relates to an industrial preparation method of ranitidine hydrochloride capsules, belonging to the field of preparation of pharmaceutical preparations. Background technique [0002] Ranitidine is a potent histamine H2 receptor antagonist, which can effectively inhibit the secretion of gastric acid stimulated by histamine, pentagastrin and carbamylcholine, and reduce the activity of gastric acid and gastric enzymes. The secretion of secretin and sex hormones was not affected. Oral absorption of ranitidine is fast, not affected by food and antacids, has a high curative effect on gastric and duodenal ulcers, has the characteristics of quick and long-acting, and has few side effects and is safe. [0003] Ranitidine, like cimetidine, is currently the most widely used drug for the treatment of ulcer disease. Developed by the British company Glaxo. It was synthesized by British Price in 1976, and its pharmacology was clarified by Bradshaw in ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/341A61P1/04
CPCA61K9/1611A61K9/1652A61K9/1682A61K31/341A61P1/04
Inventor 张欢张金龙危军吴灵静王琦王利春王晶翼
Owner SUZHOU KELUN PHARMA RES CO LTD
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