E值法在卡马西平片溶出度过程分析中的误差探讨

Error analysis by using E value method to calculate the drug dissolution of Carbamazepine in fiber optic drug dissolution test

目的采用光纤传感溶出度过程分析技术(FODT)考察卡马西平片的溶出度并探讨采用E值法计算卡马西平片溶出度的误差来源。方法利用FODT选用不同规格探头(代表不同的光程),配制不同浓度的卡马西平对照品溶液,分别于测定波长处测定吸光度,计算由FODT获得的不同浓度溶液的E值,并与紫外分光光度计测定的相应百分吸光系数(E11c%m)比较,考察不同温度对卡马西平吸光度值的影响。结果温度对卡马西平的吸光度值影响不大,FODT采用E值法计算的卡马西平片溶出率与对照品法和紫外分光光度计E11c%m值法计算的卡马西平片的溶出率存在较大差异。FODT法测得的吸光度值随浓度增大而减小。结论药典中取样分析需经稀释再测定的品种,当采用FODT测定时,不能简单套用给定的吸收系数;药典中取样分析不经稀释可直接测定的仍可继续沿用药典给定的吸收系数进行计算。

Objective To investigate the drug dissolution of Carbamazepine tablets in fiber optic drug dissolution test（FODT） and discuss the source of error of calculating the drug dissolution of Carbamazepine tablets by using E value method.Methods Different probes in vary specifications were chosen which represented different optical paths and different reference solution in serial concentration were prepared which were measured in absorbance data in chosen wavelength then the E values of different solution in vary concentration were obtained in FODT,which were compared with the E1%1cm in ultraviolet ray（UV）.The affect of different temperature in drug dissolution of Carbamazepine tablets was also detected.Results There was little influence that can affect the drug dissolution of Carbamazepine tablets in different temperatures.The difference between the data for dissolution rate of Carbamazepine tablets in E value method in FODT and in reference substance comparison method were ignored,of which was also ineligible for the E1%1cm value method in UV.The absorbance data decreased with concentration increase.Conclusion The species which is required to be diluted before detection in Chinese Pharmacopoeia can＇t be treated normally in calculated the drug dissolution by using E value method in FODT while some other species of which the dilution omitted before detection is always fit for the calculation of the drug dissolution by given E value in Chinese Pharmacopoeia.