冬凌草甲素环糊精包合物口腔崩解片的制备工艺及质量研究  

Preparation and Quality Study of Oridonin Hydroxypropyl-β-cyclodextrin Inclusion Complexes Orally Disintegrating Tablets

作　　者：万蒞 王莉[2] WAN Li1, WANG Li2(1. Dept. of Pharmacy, Hubei Provincial Maternal and Child Healthcare Hospital, Hubei Wuhan 430070, China; 2. Dept. of Stomatology, Affiliated Tianyou Hospital of Wuhan University of Science and Technology, Hubei Wuhan 430064, Chin)

机构地区：[1]湖北省妇幼保健院药剂科,湖北武汉430070 [2]武汉科技大学附属天佑医院口腔科,湖北武汉430064

出　　处：《中国医院用药评价与分析》2018年第3期384-387,共4页Evaluation and Analysis of Drug-use in Hospitals of China

摘　　要：目的:探讨冬凌草甲素包合物口腔崩解片的制备工艺和质量。方法:采用沉淀法制备冬凌草甲素包合物;以体外崩解时间和10 min体外溶出度为考察指标,采用正交设计法优选辅料微晶纤维素、羧甲基淀粉钠和甘露醇的用量;测定冬凌草甲素包合物口腔崩解片的崩解时间和溶出度。结果:冬凌草甲素包合物包封率和载药量分别为75.53%、35.03%;冬凌草甲素包合物口腔崩解片辅料用量的最佳工艺为:微晶纤维素90 mg,羧甲基淀粉钠48 mg,甘露醇25 mg;在该工艺下,冬凌草甲素包合物口腔崩解片的崩解时间<1 min,累积溶出度在2 min即达到98.2%,面向由于普通片剂。结论:辅料微晶纤维素、羧甲基淀粉钠和甘露醇可用于冬凌草甲素包合物口腔崩解片的制备,且其质量符合要求。OBJECTIVE： To probe into the preparation and quality study of oridonin hydroxypropyl-β-cyclodextrin inclusion complexes Orally disintegrating tablets. METHODS： Precipitation method was adopted to prepare oridonin inclusion complexes. The disintegration time in vitro and dissolution of 10 min in vitro were set as determination indicators,orthogonal design method was used to optimize consumption amount of microcrystalline cellulose,sodium carboxymethyl starch and mannitol; and then the disintegration time and dissolution rate of oridonin inclusion complexes were inspected.RESULTS： The encapsulation efficiency and drug loading capacity of oridonin inclusion complexes were respectively75. 53% and 35. 03%. The optimized technology were as follows： microcrystalline cellulose 90 mg,sodium carboxymethyl starch 48 mg and mannitol 25 mg; under the above conditions,the disintegration time was 1 min and the dissolution rate up to 98. 2% within 2 min; compared with ordinary tablets,it had significant difference. CONCLUSIONS： Microcrystalline cellulose,sodium carboxymethyl starch and mannitol can be used for preparation of oridonin hydroxypropyl-β-cyclodextrin inclusion complexes Orally disintegrating tablets,and accords with the standard of quality.

关 键 词：冬凌草甲素 羟丙基-Β-环糊精包合物 崩解剂 口腔崩解片 

分 类 号：R94[医药卫生—药剂学]