The Development Of TPsustained-release Tablet And In Vivo-in Vitro Correlation

The paper discussed the thinking and the pathway of the manufacture of sustained-release form based on a optical activity-TP as model drug by using the principles of biophamaceutics and pharmacokinetics. The thesis adopted HPMC as the basic matrix material, pregelatinized starch as compression aids, magnesium stearate as lubricant.The TP sustained-release tablet was prepared which could release twelve hours continuously in vitro.The basic prescription and preparation technology was initially defined by the study about formulation screening and technology optimizing ,based on the pharmacy rule as indicator and the stability maintaining of optical activity as premiss.Dissolution rate is an important factor of influencing internal quality of tablet. The determination method was initially set up for the dissolution rate of the TP sustained-release tablet. And the various factors were studied,which influence the TP release of TP sustained-release tablet.Orthogonal project was employed to screen the prescriptions which based on the study of mono-factor experiment. Verification experiments about the dissolution rate of optimized prescription were done . The results showed that the dissolution rate of TP among the TP sustained-release tablets at 2h,6h,10h was 15~35%,40~60%,>75% respectively.The f2 similar factor analysis explained that the recur capability of TP sustained-releasetablets releasing was good and the craft was stable.The quality study of the TP sustained-release tablet was done.The main components included that the identification methods were set up,the HPLC method was established for the content determination of the TP in the TP sustained-release tablet by the comparison of UV method and HPLC method, and the TP sustained-release tablet examining method of the correlated material was founded. The studing results according to items of the quality evaluating showed that evaluating method was reasonable and the quality of the TP sustained-release tablet was under the control. The release law of the TP sustained-release tablet was studied, the Ritger-Peppas equation describes the law,and the n,the releasing parameter,equaling to 0.7439(0.45