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用于测定共轭雌激素产品生物等效性的稳态尿排泄方法。

Steady-state urinary excretion method for determining bioequivalence of conjugated estrogen products.

作者信息

Johnson R N, Masserano R P, Kho B T, Adams W P

出版信息

J Pharm Sci. 1978 Sep;67(9):1218-24. doi: 10.1002/jps.2600670908.

DOI:10.1002/jps.2600670908
PMID:211222
Abstract

The steady-state excretion of conjugated estrogens in the urine of postmenopausal women dosed with conjugated estrogens tablets was studied using a modification of a previously published method. The procedure was used to quantitate the estrogens both before and during conjugated estrogens replacement therapy. The method, which is relatively specific, involves enzyme hydrolysis of urine samples a number of classical extraction and purification steps, and analysis of the silylated estrogens on a 2.7-m, 1.7% diethylene glycol succinate column using flame-ionization detection. The results indicate that steady-state urinary estrogen excretion levels were obtained within 17 days of dosing. Furthermore, the urinary estrogen excretion profile was significantly different from the composition of the estrogens in the dosage form.

摘要

采用对先前发表方法的一种改进,研究了服用结合雌激素片的绝经后妇女尿液中结合雌激素的稳态排泄情况。该程序用于在结合雌激素替代治疗之前和期间对雌激素进行定量。该方法相对特异,包括对尿液样本进行酶水解、一系列经典的提取和纯化步骤,以及使用火焰离子化检测在2.7米、1.7%二乙二醇琥珀酸酯柱上对硅烷化雌激素进行分析。结果表明,给药后17天内可获得稳态尿雌激素排泄水平。此外,尿雌激素排泄谱与剂型中雌激素的组成有显著差异。

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Steady-state urinary excretion method for determining bioequivalence of conjugated estrogen products.用于测定共轭雌激素产品生物等效性的稳态尿排泄方法。
J Pharm Sci. 1978 Sep;67(9):1218-24. doi: 10.1002/jps.2600670908.
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