Rivaroxaban gastric retention tablets and preparation method thereof

A technology for rivaroxaban and gastric retention, which is applied in the field of medicine, can solve difficult problems, and achieve the effects of small side effects, stable retention effect, and simple preparation method

Active Publication Date: 2019-04-12
中润药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Therefore, it is still difficult to prepare rivaroxaban into gastric retention tablets that are not affected by food. At present, there is no relevant research on rivaroxaban gastric retention tablets at home and abroad.

Method used

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  • Rivaroxaban gastric retention tablets and preparation method thereof
  • Rivaroxaban gastric retention tablets and preparation method thereof
  • Rivaroxaban gastric retention tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045]

[0046]The preparation method of rivaroxaban gastric retention tablet comprises the steps:

[0047] 1) Mix 15 parts of micronized rifaxaban, 22.5 parts of carrageenan (50% by weight) and 34.8 parts of hydroxypropylmethylcellulose with an appropriate amount of water, extrude and granulate, and then granulate at 50°C Bake for 2 hours to obtain drug-containing granules;

[0048] 2) Dry mix the above-mentioned drug-containing granules, 22.5 parts of carrageenan, 5 parts of sodium bicarbonate and 0.2 part of micropowder silica gel evenly, and then use a high-speed tablet press to compress tablets to obtain tablet cores. The hardness of the tablet cores is controlled by the tablet press to 50~70N;

[0049] 3) Take Opadry (85F120028) and add purified water, stir and dissolve to prepare a gastric-soluble coating solution with a mass percentage of 10%, and use a high-efficiency coating machine to evenly spray the gastric-soluble coating solution on the tablet core until Th...

Embodiment 2

[0051]

[0052] The preparation method of the rivaroxaban gastric retention tablet in Example 2 is the same as that in Example 1, except that the prescription of the Rivaroxaban gastric retention tablet is the prescription in Example 2.

Embodiment 3

[0054]

[0055] The preparation method of the rivaroxaban gastric retention tablet in Example 3 is the same as that in Example 1, except that the prescription of the Rivaroxaban gastric retention tablet is the prescription in Example 3.

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Abstract

The invention discloses rivaroxaban gastric retention tablets and a preparation method thereof. Each of the gastric retention tablets comprises a tablet core and a periphery layer, wherein the tabletcore comprises the following components of rivaroxaban, carrageenin, hydroxypropyl methylcellulose, a gas-forming agent and a lubricant. The rivaroxaban gastric retention tablets can rapidly swell inthe stimulated gastric juice environment, can maintain the minimum diameter to be 19mm or above for 4h, cannot be easily removed along with gastric contents, cannot be influenced by eating or foods, besides, can also guarantee sufficient dissolving out of the rivaroxaban in the stomach, and besides, is also favorable for sufficient absorption of medicines by proximal small intestines, so that theeffect of high biological availability is achieved. In the preparation process, the carrageenin is added twice, so that the prepared rivaroxaban gastric retention tablets can rapidly swell in the gastric juice environment, and besides, the situation that the gastric retention tablets maintain in a certain diameter range within a long time can also be guaranteed; and therefore, the effect of gastric retention is achieved. The preparation method is simple, and the condition is controllable.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a rivaroxaban gastric retention tablet and a preparation method thereof. Background technique [0002] Atrial fibrillation (AF) is one of the most common heart rhythm disorders. Survey data show that the prevalence of atrial fibrillation among residents aged 30 to 85 in my country is 0.77%. Thromboembolic complications are the leading cause of death and disability in AF, with stroke being the most common manifestation. Atrial fibrillation is an independent risk factor for stroke. Suffering from atrial fibrillation can increase the risk of stroke by 5 times. The mortality rate, disability rate and recurrence rate of stroke caused by atrial fibrillation are high, which brings serious economic burden to patients and society. A large number of clinical studies have confirmed that anticoagulant therapy plays an important role in the prevention of atrial fibrillation stroke, and rat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/36A61K31/5377A61P9/06
CPCA61K9/0065A61K9/205A61K9/28A61K31/5377A61P9/06
Inventor 魏林华朱少璇何清龙勇易德平张传宝
Owner 中润药业有限公司
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