自制与进口盐酸左西替利嗪片溶出度比较  

Comparison of Dissolutions between Self-Made and Imported Levocetirizine Hydrochoride Tablets

作　　者：李莺[1] 吴燕[1] 刘丽平[1] 郭双艳[1] 

机构地区：[1]中国人民解放军空军总医院,北京100142

出　　处：《中国药业》2012年第21期8-9,共2页China Pharmaceuticals

摘　　要：目的评价自制与进口盐酸左西替利嗪片体外溶出行为的相似性。方法依据2010年版《中华人民共和国药典(二部)》标准和参照日本《医疗用药品品质情报集》中的溶出度试验条件,采用紫外分光光度法,分别以水、0.1 mol/L的盐酸、pH=4.0的醋酸盐缓冲液、pH=6.8的磷酸盐缓冲液为溶出介质进行测定,溶出方法为桨法,转速为50 r/min,并通过f2相似因子法评价自制与进口盐酸左西替利嗪片溶出曲线的相似性。结果 3个批号的自制片在不同溶出介质中30 min溶出度均大于90%,与进口片的相似因子大于50%。结论自制片与进口片的溶出曲线相似,提示该试验药品处方合理,生产工艺稳定可靠。Objective To observe the similarity of dissolubility in vitro between self-made and imported Levocetirizine Hydrochoride Tablets. Methods The UV spectrophotometric method was adopted to determine the dissolubility according to the criteria of the Chinese Pharmacopoeia （edition 20100） and referring to the dissolution test conditions in Japan＇s Medical Drugs Quality Information Set. Water, 0. 1 mol/L hydrochloric acid, pH =4.0 acetate buffer and pH =6.8 phosphate buffer were separately used as the dissolution media and the paddle dissolving method was adopted with the rotational speed of 50 r/min. The similarity of dissolution curve was evaluated by f2 similarity factor method. Results The 30 min dissolution rate in different dissolution media for three batch numbers of self-made tablets was over 90% and the similarity factor to the imported tablets was above 50%. Conclusion The dissolution curve of self-made and imported Levocetirizine Hydrochoride Tablets is similar, which prompts that this test preparation has the rational prescription and the production technology is stable and reliable.

关 键 词：盐酸左西替利嗪片 溶出度 紫外分光光度法 f2相似因子法 

分 类 号：R927.1[医药卫生—药学] R976