Studies On Tea Polyphenols Sustained-release Tablet

The paper discussed the thinking and the pathway of the manufacture of Chinese Materia Medica sustained-release tablet based on TP(tea polyphenols) as model drug by using the principles of pharmaceutics.The quality study of the TP sustained-release tablet was done. We had not only determined the tea polyphenols content of TP and its preparation by colorimetry according the quality standard (WS3-B-3380-98 ) for xin nao jian capsule(tea polyphenols capsule),but also determined the main component EGCG content of TP and its preparation by HPLC. Cumulative release percent in sustained-release tablet of TP was attained by HPLC for determining the contents of EGCG.During the prescription and technical study, First we had done some research on the interaction of drug and excipients to screen out fit excipients. Second,choose direct compression procedure to manufacture the sustained-release tablet after the compare of wet granule, dry granule and direct compression procedure. Three, the factors influencing drug release such as the content and properties of matrix components was studied. The release rate depends on the content of CMC-Na and Carbopol. Orthogonal project was employed to get the optimal prescriptions which based on the study of mono-factor experiment. At last,coated the tablet by Eudragit solution to avoid been moisture and oxidant. The dissolution profiles of TP sustained-release tablet conform to Higuchi formula.The influence factors study showed that high temperature and light have not obvious effect on the TP sustained-release tablet but the humidity has some effect on the appearance and realese rate of TP sustained-release tablet. The result gave a clue that the TP sustained-release tablet should be packed in moistureproof material and preserved under dry enviroment.