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口服避孕片2号(复方醋酸甲地孕酮片)每片含醋酸甲地孕酮1.0mg,炔雌醇0.035mg。对本片中炔雌醇的测定,目前尚缺乏满意的方法。中国药典对本片的测定,仅规定了甲地孕酮一项。我们参考Kober反应的基本原理,找到一种适用于测定本片中炔雌醇的荧光分光光度法。炔雌醇荧光产物的激发峰为468nm,荧光峰为490hm。荧光强度稳定,专一性好。其它成分与赋形剂並无干扰。用本法测得炔雌醇的线性范围为0～3.15μg/ml,糖衣片平均回收率100.1±1.2(S. D)%,变异系数1.20%,纸型片平均回收率100.9±1.45(S. D)%,变异系数1.44%。测定步骤如下:取糖衣片8片研细(或纸型片8片剪碎),用0.1N NaOH转移至100ml容量瓶中並加至刻度,时时振摇放置半小时,用双层滤纸过滤,弃去初滤液,收集续滤液。精密吸取续滤液2ml,置一10ml棕色容量瓶中。另吸取一份0.28μg/
Oral contraceptive tablets 2 (compound megesterone acetate tablets) each containing megesterone acetate 1.0mg, ethinyl estradiol 0.035mg. The determination of ethinylestradiol in this film, the current lack of satisfactory method. Chinese Pharmacopoeia determination of the film, only provides a megesterone. We refer to the Kober reaction principle, find a suitable for the determination of ethinylestradiol fluorescence spectrophotometry. Ethinyl estradiol fluorescent product excitation peak 468nm, fluorescence peak 490hm. Fluorescence intensity is stable, specificity is good. Other ingredients and excipients do not interfere. The linear range of ethynylestradiol was 0 ~ 3.15μg / ml, the average recovery of sugar-coated tablets was 100.1 ± 1.2 (SD%), the coefficient of variation was 1.20%. The average recovery of paper tablets was 100.9 ± 1.45 (S. D)%, coefficient of variation 1.44%. The determination steps are as follows: take sugar-coated tablets 8 fine grinding (or paper pieces 8 cut), with 0.1N NaOH transferred to 100ml volumetric flask and added to the mark, shaking for half an hour from time to time, with double filter paper, discard Go to the filtrate, collect the filtrate. Precision drawing continued filtrate 2ml, set a 10ml brown volumetric flask. Another draw a 0.28μg /