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Screening,Preparation,Characterization and Solubility of Polymorphic Forms of ethinyl estradiol

Chinese Journal of Structural Chemistry 2017年第6期36卷 949-957页

作者：徐娟王慧萍李鹏宁丽峰 National Research Institute for Family Planning

ethinyl estradiol（EE） as a contraceptive,（17α）-19-nopregna-1,3,5-（10）-trien-20-yne-3,17-diol（formula： C（20）H（24）O2, molecular weight： 296.4, CAS number： 57-63-6）, is known to have different pseudo-polymorphic forms. Some EE polymorphs have been synthesized by means of physical or chemical methods, characterized by X-ray powder diffraction（XRPD）, thermogravimetric（TG）, differential scanning calorimetry（DSC） and IR spectra. Dissolution profile was tested by high performance liquid chromatography（HPLC）. Meanwhile, the crystal structure of the new EE solvate（formamide） was characterized by single-crystal X-ray structure analysis（SXRD）. The results confirmed that EE existed polymorphism. Five crystal forms of EE were presented and two of them were reported firstly. Furthermore, five polymorphs＇ dissolution curves were drawn and they could be identified by several analysis methods. Our study on polymorphs of EE could provide a variety of crystal material composition, preparation methods and solubility.

关键词： ethinyl estradiol polymorphism useful characterization methods dissolutionprofiles96

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Antifertility Effects of Orally Administration of Low Dose Gossypol Acetic Acid Combined with Methyltestosterone Plus ethinyl estradiol on Male Rat

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Journal of Reproduction and Contraception 2008年第4期19卷 201-210页

作者： Zhanjun YANG Wei-san YE Lan WANG Yan GUO She-pu XUE Department of Human Anatomy BaoTou Medical College Science and Technology University Inner Mongolia Baotou 014010 China Department of Histology and Embryology School of Basic Medicine Peking Union Medical College & Chinese Academy of Medical Sciences Beijing 100005 China

Objective To investigate the feasibility and optimal regimen of orally administration of low dose gossypol acetic acid （GA） combined with methyltestosterone （MT） plus ethinyl estradiol （EE） for contraception in males.Methods Wistar male rats were randomly assigned into four groups, 20 in each group. Animals in group A or B were administered daily with 1% methyl cellulose or GA （12 mg/kg） suspended in 1% methyl cellulose, respectively. Rats in group C or D took firstly GA 12 mg/kg＋MT 20 mg/kg＋EE 0.1 mg/kg or MT 20 mg/kg＋EE 0.1 mg/kg, in asuspension with 1% methyl cellulose, via gastric intubation. After the infertilities were initiated（6 weeks for group C, 8 weeks for group D）, GA was served alone while MT＋EE were withdrawn in rats of groups C and D. The treatment was ceased after 18 weeks and some males from group C were permitted to recover. Fertility testing, 10 males per group, was served for determining infertility or restoration of fertility in treated rats. Examinations of histology and biochemistry in treated rats were used to examine the morphologic influences on sperm, testis, epididymides and viscera, and biochemical changes in blood. The growth and development of F1 generation of the rats would also be tested in a series of behavioral tests.Results Ten rats from group C were infertile at week 6 after treatment, and the fulfilled infertility was maintained with low-dose GA （12 mg/kg） only daily. Six weeks after cessation of treatment, all of treated males recovered their fertility. However, 8 of 10 rats from group D were in sterility at 6th week of treatment and all at 8th week of treatment, but the infertility could not be kept with the similar dose GA alone later on. Moreover, no adverse effects were found in our present experiments.Conclusion Administration of oral low dose GA combined with MT and EE as loading dose could successfully induce infertility in short term, whereafter the efficacy could completely be maintained by similar low dose of

关键词： gossypol methyltestosterone ethinyl estradiol antifertility effect rats

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