【作者】 芦达；

【导师】 都晓伟； 田明；

【作者基本信息】 黑龙江中医药大学 ， 生药学， 2006， 硕士

【摘要】 仙蓟化斑胶囊处方由水牛角浓缩粉、小蓟、白芍、三七等十一味中药组成,具有凉血止血、活血化瘀、实肌固表的功效,是用于治疗过敏性紫癜的纯中药制剂。 方中单味中药的药效物质基础及药理作用已基本明确。本实验在此基础上,根据有效成分的理化性质采用分步提取法。充分考虑可能影响提取效果的因素,通过正交试验对乙醇提取工艺、水提取工艺进行科学、合理的试验设计,以代表性有效成分为指标,筛选出最佳的提取工艺技术条件。并对药材粉碎、干燥、成型工艺进行了研究,制订了科学、合理的工艺技术条件。 为了确保制剂的质量和疗效,本实验采用显微鉴别法、薄层层析法(TLC)、紫外分光光度法(UV)、高效液相色谱法(HPLC),制定了仙蓟化斑胶囊的质量标准。经过试验研究,对全方2/3的中药进行了定性鉴别,对两味中药进行了定量控制,并对质量标准的制定进行了说明。 最后对三批中试样品进行了三个月的初步稳定性试验考察,各考察项目均符合药典规定。 实验结果表明:仙蓟化斑胶囊工艺简便可行,性质稳定,质量可控。更多还原

【Abstract】 Xianjihuaban capsule is composed of eleven Chinese medicinal herbs, which is an effective prescription to cure allergic purpura. It has the functions of cooling blood and arresting bleeding, activating blood circulation and dissipating blood stasis, and reinforcing qi and consolidating the exterior.Most of the active substances in the prescription and their pharmacologic action have been identified on the whole. Based on the former study results, this experiment extracted active substances according to their physical and chemical properties. The potential influence factors to the performance of extraction were fully considered. The techniques of ethanol extract and water extract were designed in scientific and reasonable way with orthogonal design.The Reasonable extract equipments and technique conditions were optimized by taking those representative effective constituents as criterion. Also, the process conditions of grinding, drying and formulation were studied before the processing parameters were determined.In order to guarantee the quality and curative effects of Xianjihuaban capsule, quality standard its set up was with the help of modern science and technology, such as microscope identification, TLC, UV and HPLC. After a series of experimental studies, two over three of all the herbs in the prescription were dentificated qualitatively, two herbs were controled quantitatively, and the quality standards were established.In addition, primary stability was tested in three lots of pilot study samples during the period of three months, and all the items covered the certification.The experimental result suggested that the technology ofXianjihuaban capsule convenient and feasible, the physical and chemical properties stable and the quality controllable.更多还原