Aspirin enteric-coated tablet and preparation technology thereof

Abstract

The invention disclose an aspirin enteric-coated tablet applied in the technical field of medicine preparations and a preparation technology thereof. The enteric-coated tablet comprises a tablet core and an enteric coating layer. The tablet core comprises aspirin, a filling agent, an adhesive and a glidant. The enteric coating layer comprises an enteric material, a plasticizer, an antiadherent and water. The preparation technology includes mixing blank accessories, granulating the mixed blank accessories and drying to obtain accessory particles, mixing the aspirin and the accessory particles to obtain a totally-mixed particles; subjecting the totally-mixed particles to dry granulation to obtain intermediate particles, tabletting the intermediate particles, coating the tablet core obtained after tabletting to prepare the enteric-coated tablet, and drying the enteric-coated tablet in air. According to the tablet and the preparation technology, aqueous dispersion film is adopted for coating, thus solving latent risks of solvent residue and capability of being flammable and combustible which are produced by coating dissolution by organic solvents. The blank accessories are granulated in a wet method, thus overcoming sticky punch and tablet weight difference over-limit which are caused by tabletting in large batches and for a long time.

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...

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

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