盐酸普拉克索片剂的处方设计及质量评价

目的:通过对盐酸普拉克索片处方工艺研究的介绍,以期为国内企业研发该品种时提供有益的参考。方法:以淀粉、甘露醇为填充剂,以聚维酮K30为黏合剂,以微粉硅胶为助流剂,以硬脂酸镁为润滑剂,采用L₉(3⁴)正交设计优化各辅料的用量,以溶出度、含量均匀度为指标,进行本品的处方优化。结果:淀粉与甘露醇的用量为1:1,润湿剂为50%的乙醇溶液,黏合剂为10%的聚维酮K30,助流剂为1%的微粉硅胶,润滑剂为1%的硬脂酸镁,制备的片剂含量均匀度最佳,溶出度最接近原研处方。结论:制备的盐酸普拉克索片剂外观光洁,含量均匀度好,药物溶出行为达到了预期的目的。

Formulation design and quality evaluation of pramipexole hydrochloride tablets

OBJECTIVE Formulation of pramipexole dihydrochloride tablets was investigated to provide a rewarding reference for domestic enterprises in researching and developing pramipexole dihydrochloride tablets.METHODS Starch, mannitol were used as fillers, polyvidone K30 as binder, silica as glidant, magnesium stearate as lubricant. L₉(3⁴) orthogonal design was applied to optimize the amount of excipient; using dissolution and content uniformity as indicators to optimize formulation of pramipexole dihydrochloride tablets.RESULTS Dosage of starch and mannitol was determined to be 1:1, using 50% ethanol as moistening agent, 10% povidone K30 as adhesive, 1% aerosol as glidant, 1% magnesium stearate as the lubricant, the tablets were proved to have the best content uniformity, and dissolution of these tablets was the closest to that of the original formulation.CONCLUSION The prepared pramipexole dihydrochloride tablets have smooth appearance and satisfactory content uniformity. Drug dissolution behaviors have achieved the expected objective.