Study On The Different Dosage Forms Compound Danshen Sustained-Release Preparations And The In Vitro Release

Objective The compound Danshen sustained-release preparations of different dosage forms were developed and theirs in vitro release was studied to obtained the optimal technology parameters of the prescription.Method①Through single factor test, the tangential spray method of wan mei coating machine and orthogonal design test with turntable frequency, fans frequency, the rotary speed of peristaltic pump and drying temperature as factors were applied to prepare blank pellets and to select the optimal technology parameters of the blank pellets;②The blank pellets were used as parent nucleus, spray coating method from the end and orthogonal design test with atomization pressure, fans frequency, turntable frequency, the rotary speed of peristaltic pump and materials temperature as factors were applied to prepare drug-loaded pellets and to select the optimal technology parameters of the drug-loaded pellets; then spray coating method from the end was applied to coat the drug-loaded pellets.③The compound Danshen sustained-release tablets were prepared by choosing different hyperviscosity hypromellose (HPMC) and the optimal technology parameters of the compound Danshen sustained-release tablets was selected with the cumulative release in vitro of salvianolic acid B as the evaluation index .④The compound Danshen sustained-release tablets and the film clothing pellets were prepared with the optimal technology parameters respectively , and the release behavior in vitro of their active compnents was studied to select the optimal dosage forms structure of compound Danshen sustained-release preparation. Results①The blank pellets were suitable for preparing the compound Danshen sustained-release pellet , which were prepared according to optimal technology parameters of the blank pellets: pharmaceutical additives 4 was used as excipient,3% pharmaceutical additives 5 solution was used as adhesives , fⅲHz was chosen as the turntable frequency, FⅱHz was chosen as fans frequency, Rⅲrpm was chosen as the rotary speed of peristaltic pump and Tⅰ℃was chosen as the drying temperature.②The drug-loaded pellets were suitable for preparing the compound Danshen film clothing pellets, which were prepared according to optimal technology parameters of the drug-loaded pellets: PⅠMPa was chosen as atomization pressure, FⅡHz was chosen as fans frequency, RⅠrpm was chosen as the rotary speed of peristaltic pump andTⅡ℃was chosen as materials temperature. The best-fit model of panaxsaponin Rg1, tanshinoneⅡA and borneol was first order model, the salvianolic acid B was Higuchi's model.③The best-fit model of salvianolic acid B and tanshinoneⅡA from the compound Danshen sustained-release tablets, which contained 15% K1 excipient, was Ritger-Pappas model(n=0.852), panaxsaponin Rg1 was first order model, and borneol was Higuchi model; compared with the sustained-release tablets, the different active components from the sustained-release pellets achieved similar drug release rate.Conclusion The optimal technology parameters were suitable for preparing the compound Danshen sustained-release tablets and the compound Danshen sustained-release pellets, and the cumulative release in vitro of their active components were all met development requirements.