The Development Of TFH Sustained-released Capsule

The paper, which adopted available part of Chinese traditional medicine TFH as drug model, discussed the idea and method for the research of sustained-release capsule by the instruction of biopharmaceutics and pharmacokinetics theory. The subject adopted HPMC as the basic matrix material, lactose as filler to prepare TFH sustained-release capsule, which could release 12h continuously in vitro. The paper studied the factors which influenced the release of TFH sustained-release capsule, optimized the TFH sustained-release capsule prescription by uniformity design method, got the related equation which expressed the influence of the HPMC, lactose and adhesives concentration. The equation indicates that HPMC block the release of TFH but lactose and adhesives concentration did not significantly influent drug release in a certain range. The release velocity could be adjusted by altering the ratio of HPMC, and the charge of capsules could be adjusted by controlling the amount of lactose. The three capsule samples were produced by the optimized prescription. The f₂ factor analysis showed that the reproducibility of release rate of the three samples was stable.Guided by modern Chinese traditional preparations quality control themry, the quality standard of TFH sustained-release capsule was established in order to comprehensively control the quality of TFH sustained-release capsule. Thedetermination method of total flavone in TFH material and TFH sustained-release capsule was set up by UV, and TFH principle and the determination method of Quer and Isor content in TFH sustained-release capsule was set up by RP-HPLC, and both of the two methods were evaluated; on the base of the content determination of several samples of preparations, considered contemporary Chinese traditional preparations quality standards, the content controlling standard fitted for this preparation, which was safe, available and feasible, was formulated, so that the quality of product content was comprehensively controlled, from preparation material to end product. Suitable release medium was adopted to observe the release rate in vitro TFH sustained-release capsule; release rate in vitro of several samples was observed through release rate determination method selected, and after referring to Ch.P.(II)'controlled-release preparation instruct principle'and fully considering the particularity of Chinese traditional preparations, release rate standard of this preparation was formulated.Referred to appendix of Ch.P.2000. (Il)'drug stability experiment instruct principle', chief inspect item of quality standard draft of TFH sustained-release capsule initially recommended was regarded as index, then the stability of TFH sustained-release capsule was initially studied.The release law of TFH sustained-release capsule was studied initially, the Ritger-Pepper equation describes the law better, release parameter n=0.7439, 0.45