中国药房2017，Vol.28Issue(34)：4860-4863,4.DOI:10.6039/j.issn.1001-0408.2017.34.28
卡前列甲酯-羟丙基-β-环糊精包合物舌下片的制备及质量评价
Preparation and Quality Evaluation of Carboprost Methyl-hydroxypropyl-β-cyclodextrin Clathrate Sublin-gual Tablets
摘要
Abstract
OBJECTIVE:To prepare the Carboprost methyl-hydroxypropyl-β-cyclodextrin (HP-β-CD) clathrate sublingual tab-lets,and conduct quality evaluation. METHODS:Wet granulation method was used to prepare Carboprost methyl-HP-β-CD clath-rate sublingual tablets. Using the appearance,calving time,wetting time and main drug content as investigation indexes,mass ratio of mannitol-lactose,povidone volume fraction and amount of low-substituted hydroxypropylcellulose(L-HPC)as factors,orthogo-nal test was used to screen the formulation. The calving time,wetting time,main drug content,content uniformity,dissolution de-gree of sublingual tablets with optimal formulation were evaluated. RESULTS:The optimal formulation was as follow as 78.82 mg of carboprost methyl-HP-β-CD clathrate (containing carboprost methyl 1 mg),100 mg of mannitol-lactose (mass ratio of 9:1) mixed powder,appropriate amount of 2% povidone solution,30 mg of L-HPC,and 1 mg of magnesium stearate. The calving time of prepared 3 batches of sublingual tablets was(25.30±3.21)-(26.53±2.69)s;wetting time was(64.65±8.07)-(65.54±7.21)s;main drug content was (96.13 ± 0.43)%-(97.06 ± 0.82)%;content uniformity was 5.95-7.68;the cumulative dissolution degree within 10 min was more than 50%,and it can completely dissolute within 30 min. CONCLUSIONS:Carboprost methyl- HP-β-CD clathrate sublingual tablets,which are up to requirements,are prepared successfully.关键词
卡前列甲酯/羟丙基-β-环糊精/包合物/舌下片/正交试验/质量评价Key words
Carboprost methyl/Hydroxypropyl-β-cyclodextrin/Clathrate/Sublingual tablets/Orthogonal test/Quality evalua-tion分类
医药卫生引用本文复制引用
何瑶,阮一,李卓恒,王丽娟,李峥..卡前列甲酯-羟丙基-β-环糊精包合物舌下片的制备及质量评价[J].中国药房,2017,28(34):4860-4863,4.基金项目
重庆市卫生和计划生育委员会医学科研计划项目(No.20142078) （No.20142078）
