雌二醇控释贴片的含量测定及体外释放度试验  

Determination of Content and the Controlled Release of Estradiol in Transdermal Delivery Patches

作　　者：刘放[1] 王俏[1] 叶金翠[1] 陈国神[1] 

机构地区：[1]浙江省医学科学院药物研究所

出　　处：《药物分析杂志》1999年第1期24-27,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的：测定雌二醇控释贴片的含量和体外释放度。方法：采用反相高效液相色谱法，用ＳｐｅｒｉｓｏｒｂＣ１８柱，以甲醇水（７５∶２５）为流动相，检测波长２８０ｎｍ，用ＦＤＡ桨法溶出装置，测定不同批号雌二醇控释贴片１６８ｈ的累积释放量。结果：雌二醇在５０～８００μｇ·ｍＬ－１（ｒ＝０９９９６）浓度范围内呈线性关系，平均加样回收率为９８８９％（ｎ＝５），日内和日间ＲＳＤ分别为１９％（ｎ＝５）和２５％（ｎ＝５）；３批供试品２４、７２、１２０和１６８ｈ的平均释放度分别为２８％、５５％、７０％和８４％。结论：方法简便，快速，准确，重现性好，可作为雌二醇控释贴片的质量控制方法。Objective:To make an assay of estradiol in estradiol controlled release patches.Methods:A RPHPLC method was reported Spherisorb C 18 column with a mobile phase of methanol and water(75∶25)UV,detection at 280 nm.Controlled release procedure using the FDA paddle method was developed for determining the vitro release profile of different patch of estradiol transdermal delivery system (E 2TDS)in 168 hours.Results:The standard curves for estradiol was liner in the range 5 0～80 0 μg·mL -1 ( r =0 9996).The average recovery rate of estradiol is 98 89%( n =5).The precision within-day RSD is 1 9%( n =5)and betweenday RSD is 2 5%( n =5).The accumlative rate was 28%,55%,70%and 84% in 24,72,120 and 168 hours.Conclusion :The method is convenient,rapid,accurate and precise.

关 键 词：雌二醇 控释贴片 释放度 含量测定 HPLC 

分 类 号：R977.12[医药卫生—药品] R927.2[医药卫生—药学]