Study On Puerarin Semi-Solid Matrix Capsules

Semi-solid matrix formulation technology is a new technology by pouring floating semi-solid drug and its carriers into hard gelatin capsules. Compared with other traditional solid formulation technology, semi-solid matrix formulation technology has lots of advantages such as the flexible and simple formulation, and the simplest production process-just filling directly after drug and its carriers are mixed.HPLC method was developed for the assay of puerarin. The solubility of puerarin in different mediums was determined. Puerarin showed its good stability by the results of the accelerating experiments which is performed under high temperature, high humidity and strong light.Puerarin semi-solid matrix capsules were prepared through melting method, and the effect factors such as preparation time, preparation temperature and cooling speed are examined. The technology using a simple preparation condition was determined. In order to provide a scientific basis for the development and application of the study, a series of experiments had been performed as listed below: the preparation mechanism, the physicochemical properties and the stability studies.Puerarin was selected as model drug, S₄₀、F₆₈ and Gelucires（?）44/14 were selected as semi-solid matrix carriers to develop semi-solid matrix capsules. UV method was utilized for assaying release profile of puerarin. In vitro release rate was observed to evaluate the formulation. The stability of preparation was investigated. Results indicated that its release degree and content were satisfied through the whole stability study.The study of pharmacokinetics of the puerarin semi-solid matrix capsules in dogs was carried out. Tmax, Cmax and AUC_0-t of test preparation and reference-preparation were 104.90±1.59、88.72±0.89min、3.37±0.042、2.33±0.053μg·mL^-1 and 985.94±17.49、653.38±19.15μg·min·mL^-1 respectively. Compared with the common capsules, the relative bioavailability of puerarin semi-solid matrix capsules was 150.36%.