Promethazine hydrochloride tablet and preparation method thereof
A promethazine hydrochloride tablet and a promethazine hydrochloride technology are applied in the directions of anti-inflammatory agents, pill delivery, pharmaceutical formulations, etc., which can solve the problem of uneven content uniformity of active ingredients, save dosage and cost, and achieve compressibility. Good, compliance-increasing effect
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Embodiment 1
[0017] (1) Preparation of solid dispersion carrier: Add 20 g of Poloxamer 407 and 85 g of PEG6000 into 60% (ml / ml) ethanol of 1 / 3 of the prescription amount, heat and stir until Poloxamer 407 and PEG6000 are completely dissolved That is, the auxiliary material solution is obtained;
[0018] Promethazine hydrochloride (dry, pure) 250g is dissolved in 60% (ml / ml) ethanol of recipe quantity 1 / 3 to obtain main drug solution; Gained adjuvant solution and main drug solution are mixed uniformly to obtain mixed solution; Gained mixing The solution is dried in vacuum until the water content is less than 1% (mass percentage);
[0019] (2) Preparation of tablet: pulverize the material obtained in step (1) to 100 mesh to obtain a solid dispersion powder; put the gained solid dispersion powder, starch 180g, and microcrystalline cellulose 360g into a granulator, and dry mix Evenly, add 60% (ml / ml) ethanol of the remaining 1 / 3 of the prescription amount as a binder, set the shearing knife f...
Embodiment 2
[0021] (1) Preparation of solid dispersion carrier, add poloxamer 407 25g and PEG6000 80g into 60% (ml / ml) ethanol of 1 / 3 of the prescription amount, heat and stir until poloxamer and PVPk30 are completely dissolved Yes, excipient solution;
[0022] Promethazine hydrochloride (dry, pure) 250g is dissolved in 60% (ml / ml) ethanol of recipe quantity 1 / 3 to obtain main drug solution; Gained adjuvant solution and main drug solution are mixed uniformly to obtain mixed solution; Gained mixing The solution is dried in vacuum until the water content is less than 1% (mass percentage);
[0023] (2) Preparation of tablet: pulverize the material obtained in step (1) to 120 mesh to obtain solid dispersion powder; put the gained solid dispersion powder, starch 180g, and microcrystalline cellulose 360g into a granulator, and dry mix Evenly, add 60% (ml / ml) ethanol of the remaining 1 / 3 of the prescription amount as a binder, set the frequency of the shearing knife as 30 Hz, and shear and gran...
Embodiment 1、2
[0034] Embodiment 1, 2, and the outward appearance of product in each comparative example, content uniformity are as shown in table 1 (check by Chinese Pharmacopoeia 2010 editions)
[0035] Table 1
[0036]
[0037] (Dissolution is tested according to the standards in Appendix XC of Part Two of the Chinese Pharmacopoeia 2010 Edition).
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