第四章复方丹参脉冲片的制备及其体外评价-中国实验方剂学杂志.docVIP

复方丹参脉冲片处方因素对其体外释放度的影响 孙婷婷1，张国松，潘德城，张 尧，杨世林,3，罗晓健,3* (1.葫芦岛市食品药品监督管理局，辽宁 葫芦岛 125000 2．江西中医学院，江西 南昌 330006， .中药固体制剂制造技术国家工程研究中心，江西 南昌 330006；) [摘要] 目的：研究复方丹参脉冲片的处方因素对制剂体外释放度的影响，确定最佳的片芯和包衣处方。方法：以丹参总酚酸、人参皂苷Rg1、冰片的释放度为指标，考察片芯中崩解剂和填充剂的种类与用量，以及包衣处方中增塑剂和致孔剂的种类与用量对复方丹参脉冲片体外释放度的影响。结果：片芯处方中崩解剂选用低取代羟丙基纤维素（L-HPC）,填充剂为微晶纤维素（MCC），粘合剂为聚维酮（PVP）乙醇溶液；包衣处方中选用乙基纤维素（EC）为主要包衣材料，增塑剂为枸橼酸三乙酯（TEC），致孔剂为乳糖。按最佳处方制备的样品指标成分释放曲线可用Weibull分布函数模型拟合。结论：确定的复方丹参脉冲片处方制剂能达到很好的体外脉冲释药效果，为复方丹参脉冲片的进一步研究奠定了基础。 关键词：复方丹参脉冲片；脉冲释药；处方因素；总酚酸；人参皂苷Rg1；冰片[中图分类号] R283.6 [文献标识码]A [文章编号]1005-9903（2011）10- The Effect of Formulation Factors of Fufang Danshen Pulsed Tablets on Release Behavior in Vitro SUN Ting-ting1, ZHANG Guo-song3, PAN De-cheng2, Zhang Yao3 , YANG Shi-lin3, LUO Xiao-jian2,3 (1.Huludao Food and Drug Administration，，，China;．Jiang Xi University of Traditional Chinese Medicine，Nanchang，330006，China; ．National Pharmaceutical Engineering Center for Solid Preparation in Chinese Herbal Medicine,Nanchang ,330006,China ) [Abstract] Objective: To study the effect of formulation factors of Fufang Danshen pulsed tablets on release behavior in vitro, and to determine the best tablet core formulation and the coating formulation. Method: Three constituents of Fufang, total phenolic acids, ginsenoside Rg1 and borneol were taken as the index to study the effect of different types and usage amount of disintegrants, diluents, adhesives on release behavior in tablet core formulation. The same study was carried out on the effect of plasticizers and pore-forming agent in the coating formulation. Results: Low-substituted hydroxypropylcellulose (L-HPC) was selected as disintegrants, meanwhile microcrystalline cellulose (MCC) was as diluent with PVP ethanol solution as adhesive in tablet core formulation. Ethyl cellulose (EC) was employed as the main coating materials. And triethyl citrate (TEC) and lactose were chosen as plasticizers and pore-forming agent in the coating formulation respectively. Release curves of ind