A kind of roxatidine hydrochloride acetate pellets and preparation method thereof

A technology of roxatidine hydrochloride acetate and rosatidine hydrochloride, applied in the field of rosatidine hydrochloride acetate pellets and preparation thereof, can solve the problems of poor stability of rosatidine hydrochloride acetate and the like

Active Publication Date: 2021-07-23
山东康美乐医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the problem of poor stability of roxatidine hydrochloride acetate, the invention provides a kind of roxatidine hydrochloride acetate pellets, which have sustained-release effect, and in addition, hydroxymethyl cellulose is added into the pellets And hydroxyapatite, the combination of the two has the effect of stabilizing roxatidine hydrochloride acetate and its crystal form, can effectively protect roxatidine hydrochloride acetate, avoid external damage to it, and improve the roxatidine hydrochloride acetate. Stability of Butylacetate

Method used

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  • A kind of roxatidine hydrochloride acetate pellets and preparation method thereof
  • A kind of roxatidine hydrochloride acetate pellets and preparation method thereof
  • A kind of roxatidine hydrochloride acetate pellets and preparation method thereof

Examples

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Effect test

Embodiment 1

[0033] The roxatidine hydrochloride acetate pellets of the present invention are composed of a drug-loaded pellet core, an isolation layer and a slow-release layer, and the components contained in each layer and the contents of each component are as shown in prescription 1.

[0034]

[0035] The pellet preparation method is as follows:

[0036] 1. Mix roxatidine acetate hydrochloride, epoxy-modified cornstarch and refined sucrose in deionized water according to the content shown in prescription 1, stir evenly, and add the hydroxymethyl group shown in prescription 1 at 30°C Cellulose and hydroxyapatite, after stirring for 20 minutes, observe the state of the solution, it is colloidal, then add the microcrystalline cellulose with the content shown in prescription 1, and make spherical pellets by extrusion and spheronization, the extrusion speed is 30r / min, spheronization The speed is 700r / min, the spheronization time is 2.5min, and it is dried to obtain the drug-loaded pellet...

Embodiment 2

[0040] The roxatidine hydrochloride acetate pellets of the present invention are composed of a drug-loaded pellet core, an isolation layer and a slow-release layer, the components contained in each layer and the content of each component are as shown in prescription 2, and the preparation method of the pellets is the same as in Example 1.

[0041]

Embodiment 3

[0043] The roxatidine hydrochloride acetate pellets of the present invention are composed of a drug-loaded pellet core, an isolation layer and a slow-release layer, the components contained in each layer and the content of each component are as shown in prescription 3, and the preparation method of the pellets is the same as in Example 1.

[0044]

[0045]

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Abstract

The invention discloses a roxatidine hydrochloride acetate pellet and a preparation method thereof. The pellet is composed of a drug-carrying pellet core, an isolation layer and a sustained-release layer, wherein the drug-carrying pellet core comprises roxatidine hydrochloride acetate, hydroxyl Methyl cellulose, hydroxyapatite, other pharmaceutical excipients. In the present invention, hydroxymethyl cellulose and hydroxyapatite are added to the core of the drug-loaded pill, which can effectively protect the roxatidine hydrochloride from external damage, improve its stability, and obtain the optical properties and crystal purity of the pellet. improve.

Description

technical field [0001] The invention relates to roxatidine acetate hydrochloride pellets and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Roxatidine acetate hydrochloride was developed by Japan Zang Pharmaceutical Co., Ltd. (now renamed Asuka Pharmaceutical), and its specifications include 37.5mg / 75mg sustained-release capsules, 75mg roxatidine hydrochloride acetate for injection and 20% sustained-release fine granules. At present, roxatidine has been marketed in 9 countries including South Korea, Germany, France, Sweden, Switzerland, and Italy. The technical information about roxatidine hydrochloride acetate sustained-release capsules has not been fully disclosed yet. [0003] Roxatidine hydrochloride acetate can be used for gastric ulcer, duodenal ulcer, anastomotic ulcer, Zollinger-Ellison syndrome, reflux esophagitis, premedication before anesthesia, and can improve gastric mucosal lesions (e...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K47/38A61K47/02A61K31/4453A61P1/04
CPCA61K9/5005A61K9/5089A61K31/4453A61K47/02A61K47/38A61P1/04
Inventor 时耿青路艳红王学斌耿凤娈
Owner 山东康美乐医药科技有限公司
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