头孢泊肟酯片体外溶出曲线研究  

Study on Dissolution Curves of Cefpodoxime Proxetil Tablets in vitro

作　　者：张聪 程婵婵 郝洁 姚路路 卞梦芹 周冰 李焕娟 周德刚 ZHANG Cong;CHENG Chan-chan;HAO Jie;YAO Lu-lu;BIAN Meng-qin;ZHOU Bing;LI Huan-juan;ZHOU De-gang(Luoyang Huizhong Animal Medicine Co.,Ltd.,Luoyang,Henan 471000,China)

机构地区：[1]洛阳惠中兽药有限公司,河南洛阳471000

出　　处：《中国兽药杂志》2023年第2期47-52,共6页Chinese Journal of Veterinary Drug

摘　　要：建立头孢泊肟酯片溶出度测定方法,通过比较自制头孢泊肟酯片与参比制剂的溶出曲线,评价两种制剂体外溶出行为是否一致。测定自制制剂及参比制剂在盐酸溶液(pH=1.5)、甘氨酸-氯化钠-盐酸溶液(pH=3.0)、醋酸盐缓冲液(pH=4.0)、磷酸盐缓冲液(pH=6.8)的溶出曲线,并通过计算相似因子(f_(2))评价溶出曲线的相似性。在4种溶出介质中,3批自制制剂与参比制剂溶出曲线均相似。本研究建立的溶出试验方法能有效控制自制头孢泊肟酯片的质量,自制制剂与参比制剂体外溶出行为基本一致。A dissolution test assay for cefpodoxime proxetil tablets was established to evaluate the consistency of in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets and reference preparations by comparing the dissolution curves of the two preparations.The dissolution curves of self-developed preparations and reference preparations in hydrochloric acid solution(pH=1.5),glycine-sodium chloride-hydrochloric acid solution(pH=3.0),acetate buffer(pH=4.0)and phosphate buffer(pH=6.8)were determined and the similarity of dissolution curves was evaluated by calculating similarity factor(f_(2)).Results show that the dissolution curves of three batches of self-developed preparations and reference preparations were similar in all four dissolution media.In conclusion,the dissolution test method established in this study can effectively control the quality of self-developed cefpodoxime proxetil tablets.The in vitro dissolution behaviors of self-developed cefpodoxime proxetil tablets were basically consistent with that of reference preparations.

关 键 词：头孢泊肟酯片 参比制剂 溶出曲线 一致性评价 

分 类 号：S859.796[农业科学—临床兽医学]