静态法与动态法测定药物水中溶解度的探讨

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1、静态法与动态法测定药物水中溶解度的探讨作者：袁飞，何琳，丁沐淦，龙晓英，李志棠，梁静敏，林小玲【摘要】目的比较采用静态法与动态法对药物水中平衡溶解度测定结果的影响。方法静态法：超声1h、25℃水浴恒温24h，25℃气浴振荡24h，25℃水浴恒温放置7d及16d;动态法：超声1h、25℃气浴振荡24h，25℃气浴振荡24h，25℃水浴搅拌24h，分别测定布洛芬、盐酸小檗碱、葛根素、对乙酰氨基酚在水中的溶解度。结果25℃条件下采用静态法及动态法测得药物在水中的平衡溶解度如下：布洛芬为0.067~0.078mg/mL(RSD11.94%~22.18%)和0.063~0.078mg/

2、mL(RSD3.2%~7.8%);盐酸小檗碱为7.072~8.230mg/mL(RSD3.4%~14.5%)和7.654~9.771mg/mL(RSD2.2%~5.0%)，葛根素为7.305~9.479mg/mL(RSD7.5%~14.5%)和6.057~8.046mg/mL(RSD2.5%~6.8%);对乙酰氨基酚为8.708~9.771mg/mL(RSD3.2%~13.6%)和8.965~10.932mg/mL(RSD1.5%~6.6%)。结论4种药物在水中的平衡溶解度以动态法重现性较好，其中采用水浴搅拌24h测得的结果重现性最好，最低RSD值为1.5%;而采用超声与恒温

3、气浴振荡结合法，除溶解度特别小的药物造成误差较大外，基本能满足大部分药物溶解度测定的要求(RSD<2.5%)，而且，相对于水浴搅拌，该法处理样品量大，可广泛应用。【关键词】静态法;动态法;平衡溶解度12　Abstract:ObjectiveTocomparetheeffectofstationarymethodanddynamicmethodontheresultsofdrugs′equilibriumsolubilityinwater.MethodsThesolubilityofibuprofen,berberine,puerarinandparacetamolinw

4、aterweredeterminedbystationarymethod,i.e.,ultrasound1h,thenstayinwaterbath24hat25℃oroscillatedinairbath24hat25℃,thenstay7dand16datthesametemperature;andbydynamicmethod,i.e.,oscillatedinairbath24hat25℃,ultrasound1handthenoscillatedinairbath24hat25℃,oragitatedinwaterbar24hat25℃,respectively.R

5、esultsThesolubilityofibuprofen,berberine,puerarinandparacetamolbystationaryanddynamicmethodwere0.067~0.078mg/mL(RSD=11.94%~22.18%)and0.063~0.078mg/mL(RSD=3.2%~7.8%),7.072~8.230mg/mL(RSD=34%~14.50%)and7.654~9.771mg/mL(RSD=2.2%~5.0%),7.305~9.479mg/mL(RSD=75%~14.50%)and6.057~8.046mg/mL(RSD=2

6、.5%~6.8%),8.708~9.771mg/mL(RSD=32%~13.6%)and8.965~10.932mg/mL(RSD=1.5%~6.6%),respectively.ConclusionThesolubilitydataoffourdrugsinwaterexhibitsgoodreproducibilitybydynamicmethod,especiallywithagitatinginwaterbar24handthelowestRSDis1.5%.TheRSDofcombinationofultrasoundand12oscillationofairba

7、thislessthan2.5%,whichsatisfiestherequirementofdeterminingmostdrugs′solubility,exceptthedrug′ssolubilityisverylow.Moreover,comparedwithagitationinwater,itcandealwithmasssampleswithcombinationofultrasoundandoscillationofairbath,whichcanbewidelyused.　　Keyw