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A kind of aspirin enteric-coated tablet and preparation process thereof

A technology for aspirin and enteric-coated tablets, applied in the field of pharmaceutical preparations, can solve the problems of lack of buffer and exhaust, irreversible damage of punching tools, involuntary movement, etc., to enhance compressibility and fluidity, improve production safety factor, and solve Flammable and explosive effects

Active Publication Date: 2017-01-04
SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The main defects of the existing 100mg aspirin enteric-coated tablets are as follows: First, some coated tablets in the stomach will leak, which will cause irritation to the stomach and damage to the gastric mucosa; if free salicylic acid in the enteric-coated tablets High content of salicylic acid will cause salicylic acid poisoning reaction, which is more common in patients with rheumatism treated by this product, manifested as headache, dizziness, tinnitus, deafness, nausea, vomiting, diarrhea, lethargy, mental disorder, sweating, deep and rapid breathing, Polydipsia, involuntary movement of hands and feet (more common in the elderly) and visual impairment; therefore, it is of great significance to reduce the content of free salicylic acid in aspirin enteric-coated tablets
[0005] The defects of the existing 100mg aspirin enteric-coated tablets preparation process are as follows: ①Wet granulation process, the water in the process will cause aspirin to be hydrolyzed to varying degrees, resulting in excessive salicylic acid content in aspirin enteric-coated tablets
②Powder direct compression process, although this process greatly reduces the process flow, but the powder direct compression has a high dependence on the tablet press, because the powder is directly compressed, the material has not been granulated, and there is no intermediate process of buffering and exhausting , Long-term use will cause different degrees of wear and tear on the equipment and irreversible damage to the punching tool, which will greatly reduce the service life of the equipment. Secondly, the instability of the equipment can easily lead to the difference in sheet weight exceeding the limit, and sticky The appearance and content of the aspirin tablet core are unqualified
③In the above two processes, the coating solution is prepared by organic dissolution, which has the potential risk of solvent residue exceeding the limit, and coating at high temperature, the organic solvent is flammable and explosive, and has a high risk

Method used

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  • A kind of aspirin enteric-coated tablet and preparation process thereof
  • A kind of aspirin enteric-coated tablet and preparation process thereof
  • A kind of aspirin enteric-coated tablet and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Calculated according to the weight of 1000 tablets, aspirin 100g, lactose 10.125g, microcrystalline cellulose 10.125g, 10% starch slurry 2.375g, talcum powder 7.5g; L30D-55 accounts for 8.75g, Ute NE30D accounted for 1.25g, triethyl citrate 1.25g, polysorbate-80 accounted for 0.625g, glyceryl monostearate 0.625g, and the solvent was water.

[0044] According to the above formula, (1) mix lactose and microcrystalline cellulose through a wet granulator, Ⅱ stirring Ⅰ shearing, a total of 2-5 minutes; (2) granulate with 10% starch slurry through a wet granulator, Ⅰ stirring Ⅱ Shearing, a total of 2-5 minutes, drying through a box-type drying oven or a fluidized granulation dryer at a drying temperature of 50-90°C; (3) Mixing blank granules and aspirin through a three-dimensional mixer or a column mixer, parameters: 500-800mA, 25-45 minutes; (4) Granulate the mixed granules through a dry granulator, parameters: pressure 3-6Kg, speed 500-900mA; (5) Mix and dry press throug...

Embodiment 2

[0047] Based on the weight of 1000 tablets, aspirin 100g, starch 20g, 2% hypromellose appropriate amount, talcum powder 0.615g; the proportion of enteric-coated layer by weight of solids is: uterine L100-55 accounted for 9.84g, triethyl citrate 1.476g, polysorbate-80 accounted for 0.369g, glyceryl monostearate 0.615, and the solvent was water.

[0048] According to the above formula, the process of the present invention is used for tablet compression and coating, and the release statistics are shown in the table below.

[0049]

Embodiment 3

[0051] Based on the weight of 100 tablets, aspirin 100g, starch 11.08g, lactose 7.38, pregelatinized starch 5.54g, 2% hypromellose appropriate amount; the proportion of enteric-coated layer by weight of solids is: Ute L100-55 accounts for 4.92g, Ute NE30D accounted for 2.952g, triethyl citrate 0.492g, polysorbate-80 accounted for 0.1968g, glyceryl monostearate 0.2952g, talc powder 0.984g, and the solvent was water.

[0052] According to the above formula, the process of the present invention is used for tablet compression and coating, and the release statistics are shown in the table below.

[0053]

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PUM

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Abstract

An aspirin enteric-coated tablet used in the technical field of pharmaceutical preparations and a preparation process thereof, the enteric-coated tablet consists of a tablet core and an enteric coating layer, the tablet core is composed of aspirin, a filler, a binder, and a flow aid Yes, the enteric coating layer is composed of enteric materials, plasticizers, anti-sticking agents, and water. The preparation process is to mix blank auxiliary materials, granulate and dry the mixed blank auxiliary materials to obtain auxiliary material granules, and mix aspirin Mix granules with auxiliary material granules to obtain intermediate granules by dry granulation, compress the intermediate granules, and coat the tablet cores obtained after tablet compression to obtain coated tablets. The slices are dried. The invention adopts water dispersion film coating to solve potential risks such as solvent residue and flammability and explosion caused by organic dissolution coating. The blank excipients are wet granulated to effectively solve the problem of stickiness caused by large batches and long-term compression. The difference between punch and tablet weight exceeds the limit.

Description

technical field [0001] The invention relates to an aspirin enteric-coated tablet and a preparation process thereof in the technical field of pharmaceutical preparations. Background technique [0002] Aspirin is an antipyretic and analgesic with a long history. So far, it has been used for a hundred years and has become one of the three classic drugs in the history of medicine. It is still the most widely used antipyretic, analgesic and anti-inflammatory in the world. It is also used as a standard preparation for comparing other drugs. In addition, it has an antithrombotic effect in the body, can inhibit the release reaction of platelets, and inhibit platelet aggregation. It is clinically used to prevent the onset of cardiovascular diseases. 100mg aspirin enteric-coated tablets have been rated as the first grade of myocardial infarction by SFDA in 2009 Protective medicine, original preparation (100mg biaspirin ) in the acid 2h leakage rate is 0, and in the pH 6.8 phosphate...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/32A61K31/616A61P7/02A61P29/00
Inventor 郭朗朱亚东陈铮李霄王慧颖王静
Owner SHENYANG NO 1 PHARMA FACTORY DONGBEI PHARMA GRP