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期 刊 ：中国中药杂志 2006年 31卷 05期 页码：380.

关键词：复方丹参口腔速溶片；正交设计；综合评分法；制备工艺；

Keywords:Fufang Danshen, immediate release tablet, orthogonal design process, colligationscore,

摘 要 ：目的:优化复方丹参口腔速溶片处方,制备中药口服速释固体制剂。方法:以颗粒的流动性、片剂的崩解时间、片剂的硬度和片剂中有效成分的溶出速度为指标,采用正交设计综合评分法优化干法制粒制备复方丹参口腔速溶片的处方和制备工艺。结果:优化所得处方为微晶纤维素40%,羧甲基淀粉钠10%,糊精约15%。以此处方制备的复方丹参口腔速溶片在崩解时间不超过3 min,硬度为4.5 kg,有效成分的溶出速度参数T50为5 min。结论:优化所得处方合理稳定,复方丹参口腔速溶片具有明显的速释特征。

Abstract:Objective: To optimize the formulation of immediate release tablet.Method: The immediate release tablet was prepared by using dry granules.The preparation was optimized by using orthogonal design which took the flow property of granules,the hardness,the disintegrating time and the dissolution rate of the tablet as indices.Result: the optimized formulation contained 40% microcrystalline cellulose,10% sodium carboxymethyl starch and 15% dextrin.The hardness disintegrating time and T_(50)of the tablet were 4.5 kg,3 min,5 min respectively.Conclusion: It is successful to prepare on immediate release tablet using the optimized formula above.

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