| Objectives: The purpose of the research is according to the formulation of Premarin, which produced by America, to study new conjugated estrogen sustained release tablets in little dosage. This project include 3 important sections, the screening of optimizing prescriptions and the study of producing process,examming the stability of newpreparation and studying the CE's activity in vitro. Methods: (l)According to the physical and chemical properties of raw material and excipients, in terms of the prescription of 0.625mg/tablet, control the release characteristic of the preparation through film coating and study the processing parameter to select the better coating process using dissolution rates as the index to select the better prescriptions and producing process through the stress'test and compared with control samples abroad. (2)Accelerating test and Long-term test was studied according to Chinese Pharmacopeia (Edition 2000), the indexes were the color, content, dissolution rate, related substances.(3)Test the in vitro activity of CE with the molecular biology technique. Results:(1)After the stress'testing,both of the apperance and content did not take obvious change in optimizing prescription.(2)Establish the better thickness range of film coating;the dissolution behavior of CE sustained released tablets tested goodness of fitting with control samples abroad and followed the Weibull's equation.(3)The indexes did not take obvious change in 6 months. (4)Compared with estrodiol,CE has a good biological activity in vitro. Conclusions: (l)Verify experiment made it known that the betterprescription is reasonable and stable.(2) The quality control method is stable and has a good repeatability and can be used to control the quality of the compound tablets. (3)The CE sustained released tablets were stable under the different test conditions for 6 months.(4)Tested by molecular biology technique ,the biological activity in vitro of CE was good. |
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