蕨麻素缓释微丸制备及相关质量控制研究

【作者】 侯陆星；

【导师】 张卓勇； 蔡光明；

【作者基本信息】 首都师范大学 ， 分析化学， 2008， 硕士

【摘要】 蕨麻为蔷薇科植物鹅绒委陵菜(Potentilla anserina L.)的根。在民间被长期用作营养保健品与药品食用。中国人民解放军302医院中药研究所经过十余年开发,发现其具有良好的抗乙肝病毒的功效。本文对蕨麻素缓释微丸的制备工艺及质量标准进行了考察研究。主要研究内容如下:1.应用挤出滚圆法制备蕨麻素微丸,采用流化床包衣技术,使用聚醋酸乙烯酯30%水分散体(Kollicoat SR 30D)为包衣液对蕨麻素微丸进行缓释包衣。微丸制备工艺简单,载药量大且药物含量均匀,达到了缓释24小时的试验设计要求。2.利用高效液相色谱法对不同产地的蕨麻药材进行了色谱分析,以蕨麻苷的色谱峰为参照峰,确定了9个共有峰,建立了蕨麻药材的指纹图谱。结果表明:所建立的指纹图谱能够反应蕨麻药材的共性和特征性,可用于该药材的鉴定及质量评价。3.建立高效液相色谱法同时测定不同产地蕨麻药材中蕨麻苷Ⅰ和蕨麻苷含量的方法。研究结果表明:不同地区蕨麻药材中两个成分的含量有较大差别;该法简便、准确,可作为评价蕨麻质量的有效分析方法。4.采用相溶解度法研究羟丙基-β-环糊精对蕨麻总皂苷类成分的增溶作用。在水溶液中,蕨麻苷的浓度随羟丙基-β-环糊精浓度的增加而呈线性增加,相溶解度曲线为AL型。运用冷冻干燥法制备蕨麻总皂苷-羟丙基-β-环糊精包合物。所制包合物能显著增加蕨麻总皂苷在水中的溶解度,提高药物的稳定性。更多还原

【Abstract】 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.更多还原