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Preparation method of aspirin enteric microencapsulated capsule

A technology for aspirin and enteric-coated microparticles, which is applied in the field of preparation of aspirin enteric-coated microparticle capsules, can solve the problems of complex process, difficult to control aspirin degradation, etc., and achieves a technology with few process steps, which is beneficial for patients to swallow and easy to control process parameters. Effect

Inactive Publication Date: 2016-07-20
REGENEX PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention needs to compress the tablet first, and then wrap two layers of coating, the process is also relatively complicated, and it is difficult to control the degradation of aspirin

Method used

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  • Preparation method of aspirin enteric microencapsulated capsule
  • Preparation method of aspirin enteric microencapsulated capsule
  • Preparation method of aspirin enteric microencapsulated capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1: Aspirin enteric-coated microparticle capsules (according to 10000 capsules)

[0038]

[0039] (1) Material preparation: Weigh 20-100 mesh aspirin crystals, Eudragit® L30D-55, triethyl citrate and talcum powder according to the prescription, and set aside;

[0040] (2) Preparation of coating solution: Add triethyl citrate and talcum powder into purified water under stirring, mix homogeneously for 5-10 minutes, then add Eudragit? L30D-55, continue stirring for 30-60 minutes, 40 mesh Filter to obtain the coating liquid;

[0041] (3) Coating; put the aspirin crystals weighed in step (1) into the fluidized bed granulation coating machine, adjust the air intake frequency to 10-30HZ, the material temperature to 25-35°C, and the atomization pressure to 0.15-0.2Mpa, Add the coating solution in step (2) for coating, and the weight of the coating will increase by 30-70%, to obtain aspirin crystal enteric-coated particles;

[0042] (4) Capsule filling: Aspirin cryst...

Embodiment 2

[0043] Example 2: Aspirin enteric-coated microparticle capsules (according to 10000 capsules)

[0044]

[0045](1) Material preparation: Weigh 20-100 mesh aspirin crystals, Kollicoat® MAE30DP, triethyl citrate, glyceryl monostearate and Tween 80 according to the prescription, and set aside;

[0046] (2) Preparation of coating solution: Add Tween 80, glyceryl monostearate and triethyl citrate into 250g of hot purified water, mix well for 10 minutes, add the remaining purified water to glyceryl monostearate Stir in the emulsion to room temperature, then add to Kollicoat® MAE30DP, stir continuously for 30-60 minutes, filter through 40 mesh to obtain the coating solution;

[0047] (3) Coating; put the aspirin crystals obtained in step (1) into the fluidized bed granulation coating machine, adjust the air intake frequency to 10-30HZ, the material temperature to 25-35°C, the atomization pressure to 0.15-0.2Mpa, add The coating solution in step (2) is coated, and the weight of th...

Embodiment 3

[0049] Example 3: Aspirin enteric-coated microparticle capsules (according to 10000 capsules)

[0050] (1) Material preparation: Weigh 20-100 mesh aspirin crystals, Kollicoat® MAE100P, polyethylene glycol and talcum powder according to the prescription, and set aside;

[0051] (2) Preparation of coating solution: Slowly add Kollicoat®MAE100P to 600g of purified water under stirring, slowly add sodium hydroxide solution dropwise after stirring for 5-10 minutes, continue stirring for 30 minutes, add polyethylene glycol and talc powder into purified water , mix evenly for 5-10 minutes, then add Kollicoat® MAE100P water dispersion, stir continuously for 30-60 minutes, filter at 40 mesh to obtain the coating solution;

[0052] (3) Coating; put the aspirin crystals obtained in step (1) into the fluidized bed granulation coating machine, adjust the air intake frequency to 10-30HZ, the material temperature to 25-35°C, the atomization pressure to 0.15-0.2Mpa, add The coating solutio...

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Abstract

The invention relates to a preparation method of an aspirin enteric microencapsulated capsule. The method includes the steps of: (1) material preparation; (2) coating solution preparation; (3) coating; and (4) capsule filling. The preparation method provided by the invention employs an aspirin crystal raw material for direct coating, has the characteristics of few process steps, simplicity and practicability, easily controllable technological parameters, convenient operation, stable process, and strong reproducibility, also reduces the consumption of auxiliary materials, and is economical and efficient. The aspirin loading capacity is up to 75%, and the product size is effectively reduced, thus being conducive to swallowing by patients. At the same time, the problem of easy degradation of aspirin under hot and humid conditions is solved.

Description

technical field [0001] The invention relates to a preparation method of aspirin enteric-coated microparticle capsules, belonging to the field of pharmaceutical preparations. Background technique [0002] Aspirin belongs to non-steroidal antipyretic, analgesic and anti-inflammatory drugs, and has been used in clinical practice for hundreds of years. Over time, aspirin has gradually shifted from its original antipyretic, analgesic, and anti-inflammatory effects to its antithrombotic use. Aspirin inhibits the synthesis of thromboxane TXA2 (Thromboxane) by inhibiting the activity of cyclooxygenase (Cyclo-oxygenase) in platelets, so as to achieve the anticoagulant effect and avoid the occurrence of thrombus. [0003] The route of administration of aspirin is mainly oral, and the absorption rate is generally 80% to 100%. However, because aspirin has a certain irritation to the stomach, even if the dose is below 300mg, there is still an increased risk of gastric ulcer. Therefore,...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K9/50A61K31/616A61P29/00
Inventor 陈伟棠黄和意许烁陶艳汤丹彭贵子袁永玲左联卢智俊
Owner REGENEX PHARMA LTD
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