Ranitidine hydrochloride controlled-release dry suspension and preparation method thereof

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...

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

Images