葛枳口腔崩解片的制备及质量评价

Study on preparation and quality evaluation of Gezhi oral disintegrating tablets

将口腔崩解片应用于葛枳解酒保肝药物,制备出一种新的解酒保肝产品——葛枳口腔崩解片,对缓解醉酒人群的脏器损伤、调节机体功能具有重要意义.以崩解时限为考察指标,采用单因素及正交试验确定崩解剂组成、崩解剂用量、填充剂组成及主药用量,确定葛枳口腔崩解片的最优处方.采用HPLC对葛枳口腔崩解片指标成分葛根素含量进行测定,并对葛根素溶出度进行评价.优选葛枳口腔崩解片最佳处方:主药浸膏6g、微晶纤维素(MCC)12.15g、低取代羟丙纤维素(L-HPC)1.35g、甘露醇5.58g、乳糖3.72g、柠檬酸0.3g、NaHCO30.3g、硬脂酸镁0.09g、阿斯巴甜0.21g,制成100片,所得葛枳口腔崩解片外观良好,崩解时间小于30s,葛根素在20min内基本溶出完全,符合要求.

In this study,oral disintegrating tablets were applied to Gezhi hangover and liverprotecting drugs,and a new hangover liver products——Gezhi oral disintegrating tablets,was prepared,which is of great significance for relieving organ damage and regulating body function in drunken people.With disintegration time as an index,the composition of disintegrant,dosage of disintegrant,the composition of filler and dosage of main drug were determined by single factor and orthogonal test,and the optimal prescription of Gezhi orally disintegrating tablets was determined.The content of puerarin in Gezhi oral disintegrating tablets was determined by HPLC,and the dissolution rate of puerarin was evaluated.The prescription of Gezhi oral disintegrating tablets was extract 6 g,microcrystalline cellulose(MCC)12.15 g,low-substituted hydroxypropyl cellulose(L-HPC)1.35 g,mannitol 5.58 g,lactose 3.72 g,citric acid 0.3 g,NaHCO30.3 g,magnesium stearate 0.09 g,aspartame 0.21 g and the 100 tablets were prepared.The Gezhi oral disintegrating tablets had good appearance and disintegration.The time was less than 30 s.Puerarin basically dissolves completely in 20 min.they’re meet the requirements.