Juema Hormone Release Pellets Preparation And Related Quality Control Study

Potentilla anserina L. has been widely used for health care in folk. The Institute of Chinese Materia Medica of PLA found that it is applicable for hepatitis B treatment. In this thesis, the preparation technique and quality standard were studied of JMS sustained-release pellets. The main contents of the thesis were indicated as follows:1. The JMS pellets were prepared by the method of extrusion-spheronization and then coated in the fiuid-bed with Kollicoat SR 30D. Prepared JMS sustained-release pellets had such advantages as simple technique, uniformity in diameters and high loading with even contents. They could release drug for 24 h.2. The 10 samples from different producing areas of Potentilla anserina were analyzed by HPLC. With a reference of JMG peak, 9 peaks were identified as common ones and the fingerprint was established. It was found the fingerprint could well reflect the characteristics and be used for the identification and quality control of Potentilla anserina.3. HPLC method was developed for quantitative determination of JMGⅠand JMG of Potentilla anserina from different producing areas. The results showed that the contents of JMGⅠand JMG of Potentilla anserina from different sources were quite different. The method was simple, accurate and efficacious for evaluating the quality of Potentilla anserina.4. The enhancing effect of Hydroxypropyl-β-cyclodextrin(HP-β-CD) on the solubility of JMS was investigated by the phase-solubility method. The solubility of JMG increased linearly with the increase of HP-β-CD concentration in various aqueous solutions, which showed typical AL-type phase solubility profile. The inclusion complex of JMS with HP -β- CD was prepared by freeze-drying method. The water solubility and stability of JMS were significantly improved by converting to the inclusion product,JMS-HP-β-CD.