Acetylsalicylic acid-phenacetin-caffeine sheet composition and preparation technology thereof

Abstract

The invention discloses an acetylsalicylic acid-phenacetin-caffeine sheet composition and a preparation technology thereof. The preparation technology comprises the following steps of 1, screening acetylsalicylic acid, phenacetin, caffeine, citric acid, microcrystalline cellulose, starch, sodium dodecyl sulfate, hydroxypropyl methylcellulose and polyvinylpyrrolidone K30 by a sieve of 80 meshes for next use, 2, by a fluidized drying granulator, preparing acetylsalicylic acid single-phase microsphere particles from the acetylsalicylic acid, a part of the starch and a part of the sodium dodecyl sulfate screened by the sieve of 80 meshes, 3, by the fluidized drying granulator, preparing phenacetin-caffeine mixed microsphere particles from the phenacetin, the caffeine, a part of the starch and a part of the sodium dodecyl sulfate screened by the sieve of 80 meshes, 4, uniformly mixing the acetylsalicylic acid single-phase microsphere particles, the phenacetin-caffeine mixed microsphere particles and the microcrystalline cellulose, and carrying out tabletting. The preparation technology improves stability of the drugs in the acetylsalicylic acid-phenacetin-caffeine sheet composition, reduces free salicylic acid content of the acetylsalicylic acid-phenacetin-caffeine sheet composition, and guarantees product quality stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical engineering, in particular to a composition of acetylsalicylic acid, phenacetin and caffeine tablets and a preparation process thereof. Background technique [0002] Acetylsalicylic acid, phenacetin and caffeine tablets are acetanilide antipyretic and analgesic drugs. By inhibiting cyclooxygenase, selectively inhibiting the synthesis of prostaglandins in the hypothalamic thermoregulation center, resulting in peripheral blood vessel dilation and sweating to achieve antipyretic effect, and its antipyretic effect is similar to that of aspirin; by inhibiting the synthesis of prostaglandins, etc. It is a peripheral analgesic, its effect is weaker than that of aspirin, and it is only effective for mild and moderate pain. The traditional preparation process of acetylsalicylic acid, phenacetin and caffeine tablets is wet granulation, that is, adding water to make wet granules, heating and drying the granule...

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Problems solved by technology

[0003] However, because free salicylic acid is not easy to meet the requirements of quality standards, free salicylic acid is prone to exceed the standard, and at the same time, production often cannot be carried out smoothly due to sticky punching and fragments during the process

Moreover, in the prescription of this variety, acetylsalicylic acid is unstable, and it is easy to hydrolyze to free salicylic acid when it encounters water, especially at high temperatures. After mixing, there will be a deep eutectic phenomenon. Although aspirin is granulated separately, and phenacetin and caffeine are mixed and granulated together, the aspirin granules made with conventional excipients are mixed with phenacetin After the mixed granules of caffeine and caffeine are mixed, sticky punching phenomenon will still occur during tablet compression, resulting in unqualified tablet appearance, and the friability of the product is often unqualified; the quality of the prepared compound aspirin tablets is unstable, and the product The friability of the product is not good, and the free salicylic acid exceeds the standard during storage, resulting in unqualified products

In the granules produced by the wet method, due to the existence of countless air pockets, the air is compressed when the punch is pressed down during tablet compression, but when the pressure is suddenly terminated, the compressed air expands and fragments are easily generated

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