水合氯醛β-环糊精包合物干糖浆剂的制备与质量控制  

Preparation and Quality Control of Chloral Hydrate β-cyclodextrins Inclusion Complex Dry Syrup

作　　者：杜倩[1,2] 吴铭[1,3] 倪璐卿[1] 丁芬[1] 范先鹏[1] 胡玲玲[1] 

机构地区：[1]徐州医学院,江苏徐州221004 [2]徐州医学院新药与临床应用实验室,江苏徐州221004 [3]徐州医学院附属医院,江苏徐州221004

出　　处：《中国药房》2012年第25期2365-2366,共2页China Pharmacy

摘　　要：目的:制备水合氯醛β-环糊精包合物干糖浆剂并建立测定该制剂中水合氯醛含量的气相色谱法。方法:采用饱和水溶液法制备水合氯醛β-环糊精包合物,湿法制粒法制备干糖浆剂;采用气相色谱内标(正己烷)法测定制剂中水合氯醛含量,色谱柱为Rtx-1毛细管柱,氢离子火焰检测器温度为250℃,进样口温度为200℃。结果:所制制剂为白色颗粒,其鉴别和检查等符合相关规定;水合氯醛检测浓度线性范围为2.5～25mg.mL-1(r=0.9990),回收率为99.24%,RSD=1.14%(n=6)。结论:制剂制备方法简单、可行。建立的含量测定方法简便、灵敏、专属性强、重复性好,可用于该制剂的质量控制。OBJECTIVE：To prepare Chloral hydrate β-cyclodextrins inclusion complex（CCI） dry syrup and to establish GC method for the content determination of chloral hydrate.METHODS：Chloral hydrate β-cyclodextrins inclusion complex were prepared by staturated solution method and dry syrup was prepared with wet granulation;GC was used to determine the content of chloral hydrate in the preparation.The condition of GC：the analytical column was Rtx-1 capillary column with an FID detector.The injector temperature was 200 ℃.The detector temperature was set at 250 ℃.RESULTS：Prepared dry syrup was white granule,which was in line with the requirements of related identification and examination.The linear range of chloral hydrate was 2.5～25 mg·mL-1（r=0.999 0） with average recovery of 99.24%（RSD=1.14%,n=6）.CONCLUSION：The preparation method is simple and feasible.The determination method is simple,sensitive,specific and reproducible,and can be used for quality control of it.

关 键 词：水合氯醛 Β-环糊精包合物 干糖浆剂 制备 气相色谱法 质量控制 

分 类 号：R943[医药卫生—药剂学] R971.3[医药卫生—药学]