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Ibuprofen sustained-release pellet capsule and preparation method thereof

A technology of sustained-release pellets and capsules, which is applied in the field of ibuprofen sustained-release pellets and capsules and its preparation, can solve the problems of anti-sticking performance, fluidity, brittleness of pellets, adverse effects of pellets, etc., and achieve excellent Bead performance, the effect of less content of related substances

Active Publication Date: 2019-10-11
西安圣雪沙药物开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] However, the readjustment of each excipient may lead to changes in the anti-sticking properties, fluidity, and brittleness of the pellets, and the adjustment of excipients may also cause adverse effects between different parts of the pellets
Thereby, when solving the impurity problem of ibuprofen ethyl ester, how to solve the technical problem of anti-sticking performance, fluidity and friability of the pellets is the problem that the ibuprofen pellets sustained-release preparation exists

Method used

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  • Ibuprofen sustained-release pellet capsule and preparation method thereof
  • Ibuprofen sustained-release pellet capsule and preparation method thereof
  • Ibuprofen sustained-release pellet capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Ibuprofen Sustained Release Pellet Capsules, Prescription:

[0037] Ball core:

[0038] Starch 5g

[0039] Mannitol 20g

[0040] Calcium sulfate 5g;

[0041] Drug layer:

[0042]

[0043] Coating layer:

[0044]

[0045] Preparation:

[0046] (1) Weigh the prescribed amount of starch, mannitol and calcium sulfate and mix them evenly, put them in a multi-functional pill making machine, use water as a wetting agent, and dry while spraying to make the fine powder aggregate into pellets or fine particles, stop Spraying, drying for 4 hours, sieving the pellets and fine particles as mother pellets;

[0047] (2) Weigh an appropriate amount of 80% ethanol, add povidone K30 and histidine while stirring, and continue stirring for 45 minutes after adding, so that it is completely dispersed into a 2% ethanol solution (W / V), as a bonding agent agent, spare;

[0048](3) Take the main drug of the prescription amount, pass through a 30-mesh sieve, and put it in the powder...

Embodiment 2

[0055] Ibuprofen Sustained Release Pellet Capsules, Prescription:

[0056] Ball core:

[0057] Starch 5g

[0058] Mannitol 23g

[0059] Calcium sulfate 2g;

[0060] Drug layer:

[0061]

[0062] Coating layer:

[0063]

[0064] Preparation:

[0065] (1) Weigh the prescribed amount of starch, mannitol and calcium sulfate and mix them evenly, put them in a multi-functional pill making machine, use water as a wetting agent, and dry while spraying to make the fine powder aggregate into pellets or fine particles, stop Spraying, drying for 4 hours, sieving the pellets and fine particles as mother pellets;

[0066] (2) Weigh an appropriate amount of 80% ethanol, add povidone K30 and histidine while stirring, and continue stirring for 45 minutes after the addition, so that it is completely dispersed into a 3% ethanol solution (W / V) as a bonding agent. agent, spare;

[0067] (3) Take the main drug of the prescription amount, pass through a 30-mesh sieve, and put it in the...

Embodiment 3

[0074] Ibuprofen Sustained Release Pellet Capsules, Prescription:

[0075] Ball core:

[0076] Starch 5g

[0077] Mannitol 15g

[0078] Calcium sulfate 7g;

[0079] Drug layer:

[0080]

[0081] Coating layer:

[0082]

[0083] Preparation:

[0084] (1) Weigh the prescribed amount of starch, mannitol and calcium sulfate and mix them evenly, put them in a multi-functional pill making machine, use water as a wetting agent, and dry while spraying to make the fine powder aggregate into pellets or fine particles, stop Spraying, drying for 4 hours, sieving the pellets and fine particles as mother pellets;

[0085] (2) Weigh an appropriate amount of 80% ethanol, add povidone K30 and histidine while stirring, and continue stirring for 45 minutes after the addition, so that it is completely dispersed into a 5% ethanol solution (W / V) as a bonding agent. agent, spare;

[0086] (3) Take the main drug of the prescription amount, pass through a 30-mesh sieve, and put it in the...

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Abstract

The invention relates to an ibuprofen sustained-release pellet capsule and a preparation method thereof. The ibuprofen sustained-release pellet capsule is composed of a blank pellet core, a drug layerand a coating layer; the drug layer is composed of ibuprofen, histidine and a binder, and the content of the impurity ibuprofen ethyl ester is 0-0.03%. The pellet capsule not only can reduce the generation of ibuprofen impurities, but also has excellent damp-proof and anti-sticking properties.

Description

technical field [0001] The invention relates to an ibuprofen sustained-release preparation, in particular to an ibuprofen sustained-release pellet capsule and a preparation method thereof. Background technique [0002] Ibuprofen is a white crystalline powder, easily soluble in ethanol, acetone, chloroform or ether, almost insoluble in water, and easily soluble in sodium hydroxide or sodium carbonate test solution. The mechanism of action of ibuprofen is to inhibit the synthesis of prostaglandins related to inflammation. It is absorbed rapidly after oral administration, and the bioavailability is 80%. The drug concentration in the blood reaches a peak in one hour, and the plasma half-life is about 2 hours, and it is 2.4 hours for the elderly. Due to the short half-life, in order to reduce the number of times of taking the medicine, ibuprofen is made into a slow-release preparation. [0003] At present, the sustained-release preparation of ibuprofen is mainly prepared into su...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/62A61K47/26A61K47/18A61K47/38A61K47/10A61K31/192A61P29/00
CPCA61K9/5015A61K9/5031A61K9/5047A61K9/5078A61K31/192A61K47/26A61P29/00
Inventor 王涛
Owner 西安圣雪沙药物开发有限公司
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