Résumé
Objective To explore the prescription factor on Ophiopogon japonicus saponin enteric microsphere by spray drying technique. Methods Observing the type and content of enteric coating material, the type of plasticizer, the type and dosage of antistickiness material by single factor. Optimizing the prescription by orthogonal test design. Results Both Eudragit Ⅱ and micronization silica gel made in China could meet the need of the preparation. The best prescription included the proportion between drug and enteric coating material (1∶4), the dosage of castor oil (1%), and the dosage of micronization silica gel (1.5%). Conclusion O. japonicus saponin enteric microsphere accorded with the expecting demand. The kind of medical subsidiary material made in China will be the main raw material in producing the enteric microsphere. The study of prescription design will provide the basis for realizing microencap-sulation in Chinese materia medica.
Résumé
Objective To study the relative bioavailability after ig rats with Ophiopogon japonicus saponin enteric microsphere in single-dose so as to give directly preparation quality evaluation. Methods(Establishing the) analysis method of HPLC-MS and dealing with the blood sample by solid phase extraction. Determining the diosgenin concentration in plasma after ig Ophiopogon japonicas saponin enteric microsphere and the suspension as comparison in single-dose, and calculating pharmacokinetic parameters and relative bioavailability. Results C_(max), t_(max), and AUC_(0-72) were (637.81?17.23) ng/mL, (4.0?0.0) h, and 7 840.01?412.03, respectively. Conclusion The characteristics of absorption, distribution, and elimination are resembled in rats between two preparations by ig in single-dose. The pharmacokinetic parameters are also identical. The relative bioavailability is (91.10?3.44)%.