| Potentilla anserina L.having been widely used for health care in folk, it is famous as "RenShengguo". The Institute of Chinese Medicine of PLA finds that it is applicable for treating hepatitis B treatment. The registration of 2 patents about JMS is being applied and the clinical trial for JMS troche has been in the second phase. The thesis was aiming at the research of the extracts of bioactive site of JM, combining with other excipients, preparing extracts of bioactive site of JM sustained-release pellets. The coated pellets were evaluated by in vitro methods, The main research results followed as:Ultraviolet spectrophotometry method was developed for assaying during the study of physiochemical properties of the drug and release rate of the pellets.High-performance liquid chromatography with UV detection was developed for determining content of the pellets and content of JMGII in the extracts of bioactive site of JM, each method are proved to be exclusive,accurate, sensitive and repeatable. Results showed that the total content of detectable components in JMS is more than 50%,which meet the requirements of the V class of new Chinese drugs according to the State Act for Drug Registration. The process included the preparation of prompt-release pellets and coating of the pellets. Prompt-release pellets were prepared by the method of extrusion-spheronization. Based on the studies of the influence factors. Orthogonal test was used to optimize the experiment conditions. A fluid bed spray processor was adopted for coating the pellets. Using Kollicoat(?) SR 30 D as coating material, the thesis screened the coating process parameters, and produced the sustained-release pellets according to the design. The description of dissolution profiles suggested that among the kinetics, the first-order became the most appropriate model to describe.The main work of the pre-clinical researches of JMS sustained-release Capsule have been carried out according to the claims of State Act for Drug Registration. |
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