Ranitidine hydrochloride releasing-controlling dry suspension and preparing method thereof

A technology of ranitidine hydrochloride and dry suspension is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, which can solve the problem of small adverse reactions, inability to achieve controlled release effects, technical difficulties, etc.

Active Publication Date: 2016-04-20
JIANGSU SUNAN PHARMA IND CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Although controlled-release preparations, especially controlled-release dry suspensions, have more advantages than ordinary sustained-release preparations and have received great attention from pharmacists and clinicians, the prior art only has the sustained-release preparation of ranitidine hydrochloride, It can only achieve the sustained release effect in vitro and in vivo, but cannot achieve the controlled release effect to make the drug release in the body more stable and the adverse reactions smaller. There is no controlled release preparation of ranitidine hydrochloride, let alone the controlled release of ranitidine hydrochloride dry suspension
Applicants believe that this is at least in part because certain physical properties of ranitidine hydrochloride are unfavorable for the preparation of conventional controlled release dry suspensions, and therefore the preparation of controlled release dry suspensions of ranitidine hydrochloride is of great importance. It is technically difficult for those skilled in the art

Method used

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  • Ranitidine hydrochloride releasing-controlling dry suspension and preparing method thereof
  • Ranitidine hydrochloride releasing-controlling dry suspension and preparing method thereof
  • Ranitidine hydrochloride releasing-controlling dry suspension and preparing method thereof

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preparation example Construction

[0029] 1. Preparation of Drug Resin

[0030] An appropriate amount of deionized water is added to the cation exchange resin, the drug is added under stirring and mixed evenly, and samples are taken regularly to measure the concentration of the drug in the solution. When the drug concentration no longer changes with time, the equilibrium is reached, the unbound drug on the surface of the resin is washed away with deionized water, and the drug-loaded resin is obtained by drying at 40°C-60°C.

[0031] 2. Impregnation of drug resin

[0032] Take an appropriate amount of drug-loaded resin, add it to 20% PEG4000 aqueous solution, stir for 0.5 hour, dry and sieve to obtain impregnated drug resin.

[0033] 3. Preparation of Drug Resin Microcapsules

[0034] Using bottom-spray fluidized bed equipment, put 150g of impregnated drug resin of 180-200μm into the fluidization chamber, use a spray gun with a nozzle diameter of 1mm, adjust the air volume so that the particles are in an ideal...

Embodiment 1

[0041]

Embodiment 2

[0043]

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PUM

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Abstract

The invention discloses a ranitidine hydrochloride releasing-controlling dry suspension and a preparing method thereof. The ranitidine hydrochloride releasing-controlling dry suspension comprises ranitidine hydrochloride and polymers which can be accepted in the pharmacy and comprises, by weight, 10%-90% of ranitidine hydrochloride, 10%-90% of auxiliary materials and the balance other auxiliary materials. The auxiliary materials with the releasing controlling effect are one or more of positive ion exchange resin, methylcellulose, ethyl cellulose, acrylic resin and hydroxypropyl methylcellulose. Compared with an immediate-release preparation, the releasing-controlling preparation can keep the effective blood concentration within 24 hours, curative effects are improved, toxic and side effects are small, taking and carrying are convenient, and the taking times are reduced. Compared with a sustained-release preparation, the releasing-controlling preparation can keep the more stable blood concentration within 24 hours, curative effects are improved, and toxic and side effects are small. According to the ranitidine hydrochloride releasing-controlling dry suspension, dosing only needs to be carried out once in one day; the releasing-controlling preparation is used for treating benign gastric ulcer and duodenal ulcer in clinic.

Description

technical field [0001] The invention relates to ranitidine hydrochloride controlled-release dry suspension for treating benign gastric ulcer and duodenal ulcer and a preparation method thereof. Background technique [0002] Ranitidine hydrochloride is N'-methyl-N-[2-[[[5-[(dimethylamino)methyl]-2-furyl]-methyl]thio]ethyl]-2- Nitro-1,1-ethylenediamine hydrochloride. This product is off-white or light yellow crystalline powder; it has a peculiar smell; the taste is slightly bitter and astringent; it is easy to deliquescence, and the color becomes dark after absorbing moisture. t 1 / 2 About 2-3h. Soluble in water or methanol, slightly soluble in ethanol. A potent, long-acting H 2 - Receptor antagonist, the effect is 5-8 times stronger than cimetidine, and its action time is longer than the latter. One dose can inhibit gastric acid secretion for 12 hours, and can effectively inhibit gastric acid secretion caused by basal gastric acid and gastrin stimulation , Reduce the act...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/341A61K47/38A61K47/32A61P1/04
CPCA61K9/0002A61K9/146A61K31/341
Inventor 何燕俞洋刘宏飞张艳
Owner JIANGSU SUNAN PHARMA IND CO LTD
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