Study on the Formulation and Technology of Sinomenine Hydrochloride Enteric Sustained-release Pellets and Release Mechanism in vitro

OBJECTIVE:To study the prescription and technology of Sinomenine hydrochloride enteric sustained-release pellets and release mechanism in vitro. METHODS:The prescription and technology of the pellets was optimized by orthogonal test with ratio of EC to HPMC K50 LV,spheronization speed and spheronization time as factors using sphericity and release rate as index. The release rate of the pellets was determined,and its release mechanism was summarized. RESULTS:The optimized formulation and technology was as follows:sinomenine hydrochloride∶MCC∶EC∶HPMC K50 LV of 25∶50∶15∶10(m/m/m/m),extrusion speed of 50 r/min,spheronization speed of 800 r/min,spheronization time of 9 min. The release mechanism of pellets in vitro were in line with Higuchi model,and the process of drug release was drug diffusion and skeleton corrosion. CONCLUSIONS:The pellets show good enteric sustained-release effect.