The Study On Preparation Of Compound Conjugated Estrogens Tablets

Objectives: The purpose of the research is according to the formulation of Premelle, which produced by America Wyeth, to study compound conjugated estrogens tablets, which contain a formulation of medroxyprogesterone acetate that is immediately released and conjugated estrogens that are slowly released over several hours. Methods: 1) To develop a HPLC method for the determination of medroxyprogesterone acetate (MPA) and conjugated estrogens (CE). 2) CE sustained-release core tablets with Eudragit used as film material was obtained by pan coating method, using the dissolution of CE as index, study sustained-release film thickness in the effects on the CE behavior of compound tablets; MPA and Opadry II is suspended in the coating preparation, then the rapid-release coating film which contains medroxyprogesterone acetate is made by applying the suspension to a sustained-release core tablet of CE , using the content of MPA in rapid-release coating film as index, study increased weight percentage of core tablets in the effects on the MPA content of compound tablets. 3) The dissolution behavior and MPA content uniformity of compound conjugated estrogens tablets were compared with control samples abroad, to select the better coating process. 4) Accelerating test and Long-term test was studied, the indexes were the color, content, content uniformity, dissolution rate. 5) To study the rudiment pharmacodynamics of compound conjugated estrogens tablets when compared with Premelle. Results: 1) The method of compound conjugated estrogens tablets is accurate and well reproducible, which can control...