Study On The Quality Of Medroxyprogesterone Acetate In Conjugation Estrogens And Medroxyprogesterone Acetate Tablets

Objective: The purpose of the research is according to the formulation of Prempro,which produced by America Pfizer,to study compound tablet of Conjugated Estrogen and Medroxyprogesterone Acetate-With a small dose of double speed tablet release function.The main research object of this study is Medroxyprogesterone acetate in compound preparation,To provided the reference of research on consistency evaluations,in virto analysis methods of Medroxyprogesterone acetate were established,and the quality of Medroxyprogesterone acetate in the test and reference product were studied.Methods:(1)To investigate the morphology,particle size distribution,hygroscopicity,angle of repose,equilibrium solubility,the oil-water partition coefficient,the stability of Medroxyprogesterone acetate API with the SEM and Malvern Mastersizer etc.(2)In vitro analysis methods of MPA were established.HPLC was used to determine the Medroxyprogesterone acetate content,its content uniformity and dissolution degrees in tablets and Prempro.(3)To investigate the tablet weight variation,hardness friability of test product with the hardness tester,friability tester etc..(4)Using Similarity factor method to compared release profiles of Conjugated estrogens in the Conjugated Estrogens Tablets and the reference product which in the water.Results:(1)Medroxyprogesterone acetate API was suitable for the oral solid test product due to its particle size distributed uniform,fluidity was well,not having hygroscopicity and relative critical humidity,added sodium dodecyl sulfate increased its solubility high hydrophobic,.(2)The method of vitro analysis of Medroxyprogesterone acetate in Conjugated esrtogens and Medroxyprogesterone acetate tablets was accurate and well reprofucible,which can controled the test product quality effectively.The content,content uniformity and dissolution of Medroxyprogesterone acetate in the three batches of Conjugated esrtogens and Medroxyprogesterone acetate tablets showed no significant difference between the Prempro.(3)the weight difference,hardness and brittleness of Conjugated esrtogens and Medroxyprogesterone acetate tablets were all in accordance with the requirements.(4)Conjugated esrtogens and Medroxyprogesterone acetate tablets has the similar release rate curve to that of Conjugated esrtogens in test product in water,with f2 factor: 54.Conclusion:(1)Medroxyprogesterone acetate API is suitable as the raw material of oral solid preparation,and light shall be avoided during production,storage and transport;(2)The quality standard is feasible,the quality of Medroxyprogesterone acetate in the preparation is stable and controllable,and its quality is not less than that of the reference preparation;(3)The comparison of release rate of Conjugated esrtogens tablets and Conjugated esrtogens in test product in water demonstrates that both are consistent in vitro dissolution behavior.