Epimedium Flavonoids Anti-osteoporosis Second Class Drug Research

The article is the mainly part of "The researching of new drug from Epimedium Koreanum Nakai", which is belong to the science and technical title of liaoning Province. In the course of study, according to the technical claim of examination and approval method of new drug which was issued by State Drug Demonstration ,technological process, quality standard and pharmacodynamics related to valid part of material were studied in order.Studies of pharmacodynamics: Rat osteoporosis models induced by 80mg/kg Retinoic Acid (RA) were used to evaluate the function of total flavonoids of Epimedium Koreanum Nakai (EKF) on osteoporosis. Three doses of (150, 300 and 600mg/kg) were given for four weeks by oral administration. EKF can reduce the bone loss and prevent osteoporosis in model rats.Ovariectomized rat models were used to evaluate the effects of EKF. Female adult Wistar rats were divided randomly in to normal control, Ovariectomized, ovx plus Xianling Gubao, ovx plus 150ng/kg EKF, ovx plus 300mg/kg EKF, ovx plus 600mg/kg EKF, Compared with model group, 600mg/kg EKF decreased serum ALP in rats, and increased femur density (P<0. 05).Studies of technological process: On the study of technological process, techno-logical process was optimized according to the result of the orthogonal experiment, fingerprinting was made deep studies in identification of Epimedium Koreanum Nakai. We defined HPLC identification method for Epimedium Koreanum Nakai quality standard and draft clarification of fingerprinting.In short, through studies of technological process, quality standards and pharmacodynamics, it can be certificated that technique of the new drug is stable, quality standard is controllable, pharmacodynamics effect is reliable.