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Methane sulfonic acid pradaxa pellet and preparation method

A technology for dabigatran etexilate mesylate and gatran etexilate pellets, applied in the field of medicine, can solve the problems of wet dabigatran etexilate mesylate raw material, large increase in substance, reduced curative effect, etc. Stable and reliable, fast drug application, good film-forming effect

Active Publication Date: 2017-05-31
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] There is a problem in the existing dabigatran etexilate mesylate capsules that has not been well resolved, that is, the raw material of dabigatran etexilate mesylate is wet and unstable, the related substances increase greatly, and the curative effect decreases

Method used

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  • Methane sulfonic acid pradaxa pellet and preparation method
  • Methane sulfonic acid pradaxa pellet and preparation method
  • Methane sulfonic acid pradaxa pellet and preparation method

Examples

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Embodiment 1

[0054] This embodiment provides a kind of dabigatran etexilate mesylate pellets and preparation method. Dabigatran etexilate mesylate pellet structure schematic diagram of the present invention is as figure 1 shown.

[0055] The structure of dabigatran etexilate mesylate pellets comprises a pellet core, an isolation layer wrapped in the outer layer of the pellet core, and a drug-containing layer wrapped in the outer layer of the isolation layer; wherein the pellet core contains glycine and hypromellose; the isolation layer Contains hypromellose phthalate and talc; drug-containing layer contains dabigatran etexilate mesylate, methyl methacrylate and talc;

[0056] Ball core contains 30% glycine and 5% hypromellose; barrier layer contains 15% hypromellose phthalate and 5% talc; drug-containing layer contains 30% dabigatran mesylate ester, 5% methyl methacrylate and 10% talc.

[0057] The present invention also provides a kind of preparation method of above-mentioned dabigatra...

Embodiment 2

[0065] This embodiment provides a kind of dabigatran etexilate mesylate pellets and preparation method. Dabigatran etexilate mesylate pellet structure schematic diagram of the present invention is as figure 1 shown.

[0066] The structure of dabigatran etexilate mesylate pellets comprises a pellet core, an isolation layer wrapped in the outer layer of the pellet core, and a drug-containing layer wrapped in the outer layer of the isolation layer; wherein the pellet core contains glycine and hypromellose; the isolation layer Contains hypromellose phthalate and talc; drug-containing layer contains dabigatran etexilate mesylate, methyl methacrylate and talc;

[0067] Ball core contains 30% glycine and 1% hypromellose; barrier layer contains 5% hypromellose phthalate and 5% talc; drug-containing layer contains 49% dabigatran mesylate ester, 5% methyl methacrylate and 5% talc.

[0068] The present invention also provides a kind of preparation method of above-mentioned dabigatran ...

Embodiment 3

[0076] This embodiment provides a kind of dabigatran etexilate mesylate pellets and preparation method. Dabigatran etexilate mesylate pellet structure schematic diagram of the present invention is as figure 1 shown.

[0077] The structure of dabigatran etexilate mesylate pellets comprises a pellet core, an isolation layer wrapped in the outer layer of the pellet core, and a drug-containing layer wrapped in the outer layer of the isolation layer; wherein the pellet core contains glycine and hypromellose; the isolation layer Contains hypromellose phthalate and talc; drug-containing layer contains dabigatran etexilate mesylate, methyl methacrylate and talc;

[0078] Ball core contains 32% glycine and 3% hypromellose; barrier layer contains 12% hypromellose phthalate and 8% talc; drug-containing layer contains 32% dabigatran mesylate ester, 7% methyl methacrylate and 6% talc.

[0079] The present invention also provides a kind of preparation method of above-mentioned dabigatran...

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Abstract

The invention discloses a methane sulfonic acid pradaxa pellet and a preparation method and belongs to the technical field of medicals. The structure of the pellet comprises a pellet core, an isolating layer and a drug-containing layer, wherein the isolating layer is wrapped on the outer layer of the pellet core; the drug-containing layer is wrapped on the outer layer of the isolating layer; glycine and hydroxypropyl methylcellulose are contained in the pellet core; hydroxypropyl methylcellulose phthalic ester and talcum powder are contained in the isolating layer; methane sulfonic acid pradaxa, methyl methacrylate and talcum powder are contained in the drug-containing layer. The surface of the isolating layer of the pellet prepared according to the invention is round and smooth; no so-called satellite particle exists; the completeness of the isolating layer is not influenced, so that the active ingredients and the glycine can be effectively isolated in space and the stability of the active ingredients of the preparation in a storage process can be guaranteed. The methane sulfonic acid pradaxa pellet prepared according to the invention has the effects of preventing and treating cerebral ischemia and systemic embolism diseases.

Description

technical field [0001] The invention relates to dabigatran etexilate mesylate pellets and a preparation method, belonging to the technical field of medicine. Background technique [0002] With the aging of the population and the increase in the incidence of cardiovascular diseases, the current anticoagulant gold standard drugs can no longer adapt and meet these needs. It is an inevitable trend that successively improved new drugs are approved for marketing, so it is expected that the market structure of anticoagulant drugs will change. [0003] What needs to be pointed out is that anticoagulation and antiplatelet therapy are different. Aspirin, clopidogrel, etc. are antiplatelet therapy, not anticoagulation. Both anticoagulation and antiplatelet therapy are antithrombotic treatments, but their specific mechanisms of action are different. In addition, anticoagulation therapy is generally stronger than antiplatelet therapy. [0004] First, platelets play a very important rol...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K9/16A61K47/38A61K47/18A61K47/14A61K47/02A61K31/4439A61P7/02A61P9/10
CPCA61K9/1611A61K9/1617A61K9/1652A61K9/167A61K31/4439
Inventor 袁淑杰李郑武孙照英张珊珊户巧芬曹翊婕高晶李金花丁辉王立东赵华南王晓颖关录凡韩志福刘勇
Owner 哈药集团股份有限公司
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