【作者】 关楠楠；

【导师】 范卓文；

【作者基本信息】 黑龙江中医药大学 ， 药物分析， 2009， 硕士

【摘要】 祛风凉血脂质体软膏处方由紫草、补骨脂、红花、蒺藜、川芎等八味中药组成,是临床经验方,以祛风润燥、活血通络为治疗原则,是用于治疗祛风凉血的纯中药现代外用制剂。本课题通过查阅大量的国内外文献资料和综述,设计并实施了对原料药材的提取工艺、脂质体软膏的成型工艺、制剂质量标准及制剂的稳定性研究。根据组方中每一味药材的理化性质、生物活性成分及中医药理论临床应用等特性,制定出用乙醇回流提取的制备工艺。通过单因素试验对浸泡时间进行了考察,通过正交试验,对提取时间、加乙醇量和提取次数、乙醇浓度进行了考察,并确定其最佳提取工艺参数条件;同时对脂质体软膏制剂的成型工艺及中试等都进行了全面系统的研究,建立了科学合理的工艺技术路线。为确保制剂的质量可控,充分利用现代分析手段对祛风凉血脂质体软膏的质量标准进行了研究。利用薄层色谱法(TLC)对制剂中补骨脂、川芎、当归等八味药材全部进行TLC鉴别;高效液相色谱法(HPLC)测定了君药补骨脂的有效成分补骨脂素和异补骨脂素的含量,并进行方法学考察。全面建立起了祛风凉血脂质体软膏的质量标准体系。最后,通过留样观察法对制剂进行了为期0月、1个月、2个月、3个月、6个月的稳定性考察(还将继续),定期对制剂的性状、鉴别、含量测定等各方面检测,结果表明各考察指标无显著性差异,均符合标准及药典等各方面的规定,稳定性良好。更多还原

【Abstract】 Qufeng Liangxue liposome cream is composed of eight Chinese medicinal herbs,which is an effective prescription to cure Qufeng Liangxue.It has the functions of Qufeng dampness、promoting the emergency of liver and kidney and activating blood circulation and dissipating blood stasis.The main topics of medicinal raw materials extraction process,liposomes ointment forming process,quality standards and the stability of formulations were studied.Most of the active substances in the prescription and theri pharmacologic action have been identified on the whole.Based on the former study results,the experiment extracted active substances according to their physical and chemical properties.Soaking time was studied singly.The potential influence factors to the performance of extraction were fully considered.The techniques of alcohol extract was 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 citerion.Also,the process conditions of and formulation were studied before the processing parameters were determined.In order to guarantee the quality and curative effects of Qufeng Liangxue liposome cream, quality standard its set up was with the help of modern science and technology,such as TLC and HPLC. After a series of experimental studies,the most important traditional Chinese medicine herb in the prescription was 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 six months,and all the items covered the certification.The experimental result suggested that the technology of Qufeng Liangxue liposome cream convenient and feasible,the physical and chemical properties stable and the quality controllable.更多还原