维生素C口腔崩解片的处方筛选研究

Study on formulations screening of vitamin C orally disintegrating tablets

以崩解剂、发泡剂、填充剂、矫味剂等辅料的组成比例以及主药添加量为考察内容,以崩解时限、口感等为考察指标,对维生素C(Vc)口腔崩解片的处方进行了筛选。结果表明,Vc口腔崩解片的最佳处方为Vc 15 g,可压性淀粉12 g,甘露醇3 g,乳糖9 g,低取代羟丙基纤维素(L-HPC)0.96 g,微晶纤维素(MCC)3.84 g,交联聚乙烯吡咯烷酮(PVPP)4.8 g,柠檬酸0.8g,碳酸氢钠1 g,硬脂酸镁0.3 g,桔子香精0.45 g,阿斯巴甜0.75 g,粉末直接压片法制成200片.该处方制备的Vc口腔崩解片在30 s内崩解,制备工艺简单,口感适宜,主药Vc在30 min内释放完全.

Study on the composition and the ratio of disintegrants,vesicant,filler,corrigent and the amount of vitamin C to get the prescription about the vitamin C orally disintegrating tablets with the disintegration time and the tastes as the selection standard.The results showed that the best formulation of the vitamin C orally disintegrating tablets was 15 g vitamin C,12 g conpressible starch,3 g mannitol,9 g lactose,0.69 g low substituted hydroxypropyl cellulose（L-HPC）,3.84 g microcrystalline cellulose（MCC）,4.8 g crospolyvinylpyrrolidone（PVPP）,0. 8 g citric acid,1 g sodium bicarbonate,0.3 g magnesium stearate,0. 45 g orange flavor and 0. 75 g aspartame. The 200 pieces were produced by the direct powder compression.The orally disintegrating tablet scould be obtain the rapid disintegration time within 30 seconds and The process is simple,and the taste is suitable. Vitamin C was released completely in 30 minutes from the orally disintegrating tablets.