释药吸液避孕膜稳定性与体外释放度研究

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1、志2010年第8期总第179释药吸液避孕膜稳定性与体外释放度研究李荣秀韩玉英胡振华范国荣高羽赵慧芬摘要目的：考察新研制释药吸液避孕膜的稳定性，体外释放度和体、内外溶化时限。方法：稳定性试验在40℃±1℃、相对湿度75％±5％的恒温恒湿培养箱内和室温自然条件下放置样品，使用高效液相色谱法(HPLC)，在设定的时间测定样品中壬苯醇醚一9(NP一9)含量；分别将释药吸液避孕膜放人37℃±0．5℃水浴中及女性阴道内测定体外释放度并观察体内外溶化时限，在不同的时间点采样，采用HPLC测定释放介质中NP一9累积释放量。结果：在设定的时问内，样品中NP一9含量无明显变化，稳定性良好。药

2、膜中NP一9累积释放量随着时间的延长而增加，0rain及80min时累积释放率分别为28．93％、98．10％。释药吸液避孕膜在妇女阴道内溶化时限为8～12h，在体外溶化时限平均为61．48±0．16min。结论：释药吸液避孕膜具有良好的稳定性，可在室温条件下存放24个月。释药吸液避孕膜中N一9体外释放量随着时间的延长而增加。体内、外溶化时间不一致的特性，表明释药吸液避孕膜溶化速度可能与液体量有关，这一特点可使药膜在遇到精液时迅速释放出N一9，以提高杀精效果。关键词释药吸液避孕膜壬苯醇醚一9稳定性释放度高效液相色谱法doi：10．3969／j．issn．1004—8189

3、．2010．08StudyonstabilityandreleaserateofreleasedrugimbibitioncontraceptivemembranesLiRongxiu，HanYuying，Zhenhua，eta1．HebeiResearchInstituteforFamilyPlanning，Sh~azhuang050071AbstractObjective：Toinvestigatethestabilityandthereleaserateofthenewreleasedrugimbibitioncon—traceptivemembranesinvit

4、roanditsdissolutiontimeinvivoandinvitro．Methods：Thesampleswerere—tainedintheconstanthumidityincubatorwiththe(40±1)℃oftemperatureand(75±5)％ofrelativehu—midity．Thecontentsofnonoxinol一9(N一9)weremeasuredbyhighperformanceliquidchromatography(HPLC)atthetargettime．Thereleasedrugimbibitioncontrac

5、eptivemembraneswereputinthe(37±0．5)℃waterbathandinterposedinthevaginaofthewomenrespectively，thenthereleaserateanditsdissolu—tiontimeweredeterminednvivoandinvitro．ThecumulativereleaseamountsofN一9inthereleasemedi—umatdifferenttimeweremeasured．Results：TherewerenosignificantdifferencesintheN一

6、9contentsatthetargettime；thestabilitywasgoodaswel1．ThecumulativereleaseofN一9inthereleasemediumsraisedastimeincreased．with28．93％and98．10％ofthecumulativepercentagesat0，80minrespectively．Onaverage，thedissolutiontimeofthereleasedrugimbibitioncontraceptivemembranewasbetween8and12houminthevagin

7、aofthewomen．anditsdissolutiontimewas(61．48±0．16)minutesnvitro．Conclu．sion：Thereleasedrugimbibitioncontraceptivemembraneshavewellstabilityandmaybepreservedatthe收稿日期：2010—02—22roomtemperaturefor24months．Thedifferentpropertyofthedissolutiontimeinvitroandinvivoindicates