舒肝颗粒的制备工艺和质量标准研究

【作者】 王文苹；

【导师】 周淑芳；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2003， 硕士

【摘要】 背景：肝纤维化是慢性肝病的重要病理特征，也是进一步向肝硬化发展的主要中间环节，并可能导致肝细胞癌而危及患者生命，因此防治肝纤维化具有重要意义。舒肝汤是中医临床治疗肝纤维化和慢性乙肝瘀热证的有效方，由赤芍、丹参、黄芪等五味中药组成，为方便用药、提高药物稳定性，本课题通过系统科学的研究将其制成中药新药供更多患者选用。方法：以传统中医药理论为指导原则，根据处方功能主治和药物成分的性质，结合中药新药研究的有关要求，运用现代制剂技术，采用比较和正交试验法以及多指标综合评价法，研究确定舒肝颗粒的制备工艺和质量标准；并采用留样观察法考察其初步稳定性；同时考察了薄膜包衣技术对颗粒性质的影响。结果：筛选出最佳制备工艺为：丹参和郁金共加12倍量80％乙醇回流提取2次、每次1小时，药渣与其余药材加6倍量水煎煮3次、每次1小时；乙醇提取液直接用350目滤布滤过、滤液减压回收乙醇，水提取液采用16000转／分钟的转速进行高速离心除杂，所得上清液减压浓缩；然后采用“喷雾干燥——步制粒”技术进行干燥、成型。包衣后颗粒的吸湿性降低，稳定性和口感得到改善。结论：结果表明，舒肝颗粒制备工艺合理可行，质量标准可控，成品质量基本稳定。更多还原

【Abstract】 Background. As an important pathogenic characteristic of chronic diseases of liver, hepatic fibrosis is the key step leading to cirrhosis which may cause hepatoma and even kill the patient. Shugan Decoction, consisting of Chishao (Radix Paeoniae), Huangqi(Radix Astragali), Danshen (Radix Salviae Miltriorrhizae) and two other herbs, is an effective prescription in treating hepatic fibrosis and chronic hepatitis B with the syndrome of blood stasis and heat, and possesses the function of activating blood and soothing liver to relieve pain, invigorating Qi and supplementing asthenia. For convenient application and better stability, scientific and systematic research was made to provide a new TCM product. Methods and results. The guidance of the theories of TCM and pharmacy, the related statutes to new TCM products in the"Examining and Approving Method of New Medicine" , and the function of the prescription and properties of active agents in the herbs were all taken into consideration during the design and practice of the research. Adopting modern pharmaceutical techniques and methods of comparison and orthogonal design with multifactor evaluation comprehensively, this paper focused on the preparation procedure, the quality standard, the preliminary stability, and investigations on the changes of properties of film-coated granule. Conclusion. The results suggest that the preparation procedure is reasonable and practical, the standard is controllable, and the quality is stable on the whole.更多还原