Aceclofenac in extended-released tablets and method of manufacturing the same

A technology for aceclofenac and sustained-release tablets, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and pill delivery, etc., can solve the problems of hematopoiesis, ulcers or perforations in the upper gastrointestinal tract, and no aceclofenac sustained-release has yet been seen. Reports on research and development of tablets, gastrointestinal irritation, etc.

Active Publication Date: 2008-01-23
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These varieties are more irritating to the gastrointestinal tract, and severe cases can cause upper gastrointestinal bleeding, ulcers or perforation, so the medication has to be discontinued
There is no report on the research and development of aceclofenac sustained-release tablets

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The prescription for each tablet is as follows:

[0036] Aceclofenac 200mg

[0037] Hydroxypropyl Methyl Cellulose (HPMC K4M) 86mg

[0038] 14% (W / V) PVP K-30 alcohol solution 50ml

[0039] Magnesium Stearate 3mg;

[0040] The preparation method is as follows:

[0041] Pass aceclofenac, HPMC K4M, respectively through a 100-mesh sieve, and mix well. Prepare soft material by wetting with 14% (w / v) PVPK30 alcohol solution, granulate with 16 mesh sieve, dry at 60-80°C, granulate with 20 mesh sieve, mix with magnesium stearate, and tablet.

[0042] The 24-hour cumulative release rate of the product of this embodiment is 71%.

Embodiment 2

[0044] The prescription for each tablet is as follows:

[0045] Aceclofenac 200mg

[0046] Hydroxypropyl Methyl Cellulose (HPMC E4M) 86mg

[0047] 14% (W / V) PVP K-30 alcohol solution 50ml

[0048] Magnesium Stearate 3mg;

[0049] The preparation method is as follows:

[0050] Pass aceclofenac, HPMC E4M, respectively through a 100-mesh sieve, and mix well. Prepare soft material by wetting with 14% (w / v) PVPK30 alcohol solution, granulate with 16 mesh sieve, dry at 60-80°C, granulate with 20 mesh sieve, mix with magnesium stearate, and tablet.

[0051] The 24-hour cumulative release rate of the product of this embodiment is 72%.

Embodiment 3

[0053] The prescription for each tablet is as follows:

[0054] Aceclofenac 200mg

[0055] Hydroxypropyl Methyl Cellulose (HPMC K4M) 86mg

[0056] Carbopol 934 P 3mg

[0057] 14% (W / V) PVP K-30 alcohol solution 50ml

[0058] Magnesium Stearate 3mg;

[0059] The preparation method is as follows:

[0060] Pass aceclofenac, HPMC K4M, and Carbopol 934 P through a 100-mesh sieve, and mix well. Prepare soft material by wetting with 14% (w / v) PVP K30 alcohol solution, granulate with 16 mesh sieve, dry at 60-80°C, granulate with 20 mesh sieve, mix with magnesium stearate, and tablet.

[0061] The 24-hour cumulative release rate of the product of this embodiment is 65%.

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Abstract

The invention relates to a drug sustained-release preparation and its preparation method, in particular to an aceclofenac sustained-release tablet and its preparation method, which comprises the following ingredients according to the weight percentage: aceclofenac of 60 to 95 per cent, skelecton retarder of 3 to 30 per cent, adhesive of 1 to 10 per cent and lubricant of 0.5 to 15 per cent. The hydroxypropylmethyl cellulose and carboxyvinyl polymer are adopted as optimized skelecton retarder. With such a technical proposal in the invention, the one aceclofenac sustained-release tablet can be taken a day to effectively reduce the fluctuation of blood drug level, prolong the maintenance duration of effective blood drug level and lower down the incitement to gastrointestinal tract. Besides, the invention also provides the preparation method of the aceclofenac sustained-release tablet.

Description

technical field [0001] The invention relates to a medicine sustained-release preparation and a preparation method thereof, in particular to an aceclofenac sustained-release tablet and a preparation method thereof. Background technique [0002] Aceclofenac (Aceclofenac) is a new type of oral potent non-steroidal anti-inflammatory drug that was first introduced to the market by Spanish Prodesfarma Company in 1992. As a non-steroidal anti-inflammatory drug, aceclofenac can exert a variety of pharmacological effects on the lesion site, providing favorable conditions for realizing its powerful anti-inflammatory, antipyretic and analgesic effects. Under normal circumstances, amino dextran and collagen in the extracellular matrix of cartilage tissue are in a dynamic balance. When the synthesis of aminoglucan is inhibited, this balance will be disrupted, and the synthesis of collagen will be affected, so there will be what is often called "inflammation" in the joints. Aceclofenac ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/24A61K31/222A61P29/00
Inventor 蒋晓萌黄金龙施存元
Owner ZHEJIANG JIANFENG PHARM CO LTD
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