尼群地平口服定时释药片的成型工艺考察  

Study on molding process of time-controlled release tablets of nitrendipine

作　　者：周秋贵[1] 杨亚军[1] 彭才圣[1] 刘兵[2] 

机构地区：[1]井冈山大学医学院药学系,江西吉安343000 [2]井冈山大学附属医院药剂科,江西吉安343000

出　　处：《中国医院药学杂志》2008年第3期200-203,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研究尼群地平口服定时释药片的成型工艺。方法:以崩解时间为指标筛选片芯处方、工艺。应用薄膜包衣技术,采用羟丙基甲基纤维素(HPMC)为成膜材料,巴西棕榈蜡和蜂蜡混合物为阻滞剂制备尼群地平口服定时释药片,并考察巴西棕榈蜡和蜂蜡混合物用量、比例、片芯增重量、不同pH溶出介质和转篮转速对定时释药的影响。结果:经过筛选确定片芯处方为每片含尼群地平10mg,微晶纤维素(MCC)81mg,低取代羟丙基纤维素(L-HPC)9mg,硬脂酸镁0.5%;包衣混悬液处方为5%HPMC,3.5%巴西棕榈蜡,1.5%蜂蜡,0.5%PEG4000,0.5%吐温-80,89%水。结论:巴西棕榈蜡和蜂蜡混合物用量与比例,包衣层厚度,是影响定时释药的主要因素。巴西棕榈蜡和蜂蜡混合物用量越多,释药时滞越长;混合物总量不变,蜂蜡用量增大,释药时滞变长;包衣层厚度越厚,释药时滞变长。OBJECTIVE To study the molding process of time-controlled release tablets of nitrendipine. METHODS Disintegrating test was used for the selection of the formulation of the tablet core and processing method. The tablets were prepared with hypromellose as the film material, the mixture of Carnauba wax and bees wax as retarder. The composition of the retarder, and the drug release profiles were studied. RESULTS The selected formulation of the each tablet core was nitrendipine 10 nag, MCC81 rag, L-HPC 9 rng, magnesium stearate 0. 5%; the coating liquid was composed of HPMC （5%）, Carnauba wax （3. 5%） ,beeswax （1.5%） ,PEG 4000（0. 5%） ,Tween-80（0. 5%） ,and water （89%）. CONCLUSION The ratio of the mixture of Beeswax and Carnaubawax, and the thickness of the coating influence the drug release,the more of the mixture used,the longer the retarded releasing time. Other factors resulting in longer retarded releasing are the quantity of the beeswax, and the thickness of the coating.

关 键 词：尼群地平 定时释药 成型工艺 薄膜包衣 

分 类 号：R972.4[医药卫生—药品]