地黄寡糖胶囊中药5类新药的药学研究药理学专业论文.docxVIP

结论研究结果表明：地黄寡糖胶囊的提取工艺、制备工艺合理可行，所建质量标准客观、准确，均符合药典要求，能够控制成品质量。 结论研究结果表明：地黄寡糖胶囊的提取工艺、制备工艺合理可行，所建质量标 准客观、准确，均符合药典要求，能够控制成品质量。 关键词地黄寡糖；胶囊：糖尿病；中药新药；临床前研究 Study Study of Proclinical Pharmacy on Rehmannia glutinosa oligosaccharides Capsule(rI’he Class V of new Chinese drug) Abstract objective：Rehmannia glutilosa Libosch．(Dihuang)refers to the flesh or dry root of Rehmannia glutilosa,a herb of the Scrophulariaceae family．Rehmannia dride rhizome(Sheng Dihuang)has the effect of removing pathogenic heat from blood，nourishing Hn and promoting the production of body fluids．According to the Class V of New Chinese Drug in the classification of the Chinese herbl medicine，natural medicine registration and request of Annex l(the Provisions for Drug Registration by SFDA)，Rehmannia glutinosa oligosaccharide(ROS)capsule has been researched on the pre-clinical pharmacy by using the modem pharmaceutical techniques． Methods：Orthogonal experiment design was applied to optimize the extractive procedure for Rehmannia glutinosa oligosaccharide evaluated by the yields of the extract and content of stachyose；The cation and antionion exchange chromatography and activated carbonchromatographic column were used to purify the different parts of Rehmannia glutinosa oligosaccharide；Hydroscopicity was selected as an evaluation parameter,the single factor test was adopted to select the best condition of the capsule．With the prescription and amplify to 10 times for pilot scale productin；The quality criteria was researched according to the((Pharmacopoeia of the People’S Republic of China))，The quality standard of the drug was established by using TLC to determine the nature of the herb and HPLC to quantitate the content of stachyose in Rehmannia glutinosa oligosaccharide(ROS)capsule．The preliminary stability of the three samples was studied． Results：With the orthogonal experiment and statistics analysis，the optimum extracting conditions for Rehmannia glutinosa oligosaccharide were as follows：extracted wit