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

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Problems solved by technology

This invention needs to compress the tablet first, and then wrap two layers of coating, the pr

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
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Example Embodiment

[0037] Example 1: Aspirin enteric-coated microcapsules (10,000 capsules)

[0038]

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

[0040] (2) Preparation of coating solution: add triethyl citrate and talc into purified water under stirring, and mix uniformly for 5-10 minutes, then add to Eudragit® L30D-55, stir continuously for 30-60 minutes, 40 mesh Filtration to get the coating liquid;

[0041] (3) Coating; add the aspirin crystals weighed in step (1) into the fluidized bed granulation coating machine, adjust the air inlet frequency to 10 to 30 Hz, the material temperature to 25 to 35 °C, and the atomization pressure to 0.15 to 0.2 Mpa. adding the coating solution of step (2) for coating, and the coating weight is increased by 30-70% to obtain aspirin crystal enteric particles;

[0042] (4) Filling capsules: Fill the aspirin crystal enteric-...

Example Embodiment

[0043] Example 2: Aspirin enteric-coated microcapsules (10,000 capsules)

[0044]

[0045](1) Preparation of materials: Weigh 20-100 mesh aspirin crystals, Kollicoat® MAE30DP, triethyl citrate, glyceryl monostearate and Tween 80 according to the prescribed amount, for use;

[0046] (2) Preparation of coating solution: Add Tween 80, glycerol monostearate and triethyl citrate to 250g of hot purified water, homogenize and mix for 10 minutes, and add the remaining purified water to glycerol monostearate The emulsion is stirred to room temperature, then added to Kollicoat® MAE30DP, stirred continuously for 30-60 min, and filtered through 40 mesh to obtain the coating solution;

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

Example Embodiment

[0049] Example 3: Aspirin enteric-coated microcapsules (10,000 capsules)

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

[0051] (2) Preparation of coating solution: slowly add Kollicoat® MAE100P into 600g of purified water under stirring state, slowly add sodium hydroxide solution dropwise after stirring for 5-10min, stir continuously for 30min, add polyethylene glycol and talc powder to purified water , homogeneously mixed for 5-10min, then added to Kollicoat® MAE100P water dispersion, stirred continuously for 30-60min, and filtered through 40 mesh to obtain the coating liquid;

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

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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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