Abstract
A monolithic osmotic pump tablet (MOPT) of Traditional Chinese Medicine Compound Recipe (TCMCR) was successfully prepared and active components of Jingzhiguanxin prescription which has been widely used in China and Japan was selected as model drug. Analysis methods of maker compound in vitro of danshensu, paeoniflorin and safflor yellow A were built, and different methods were compared by f2 factors. The results showed that there were fine correlation among them. Finally UV method of safflor yellew A was chosen to determine the release of the drugs, which was fast, convenient, met the need of determination and could represent other methods. During the research, single factor influence selection was studied emphatically. It showed that there were significant influence between different varieties and quantity of osmotic promoting agents, different kind of retardants, different varieties and quantity of PEG (polyethylene glycol) and membrane weight. However, no significant influence existed between different quantity of retardants and SDS, different membrane orifices and methods of dissolution. Based on the single factor influence selection, an optimal formulation was decided, and three maker compounds of Jingzhiguanxin MOPT could isochronous release and at the same time they had good zero order release characteristics to 8 h. Paeoniflorin release in vivo was estimated by deconvolution, the results shown that there were a good in-vitro in-vivo correlation (r=0.9571).
