地黄寡糖胶囊(中药5类新药)的药学的研究.pdf

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 ofProclinical onRehmannia Study Pharmacy glutinosa of Chinese ClassV new Capsule(rI’he drug) oligosaccharides Abstract tothefleshor rootof dry objective：RehmanniaglutilosaLibosch．(Dihuang)refers Rehmannia ofthe dride herb glutilosa,a Scrophulariaceaefamily．Rehmannia from Hnand theeffectof heat Dihuang)has removingpathogenic blood，nourishing the of totheClassVofNewChinesein promotingproductionbodyfluids．According Drug of medicine and of theclassificationtheChineseherbl medicine，naturalregistrationrequest Annex Provisionsfor glutinosa l(the DrugRegistrationbySFDA)，Rehmannia hasbeenresearchedonthe the oligosaccharide(ROS)capsulepre-clinicalpharmacybyusing modem pharmaceuticaltechniques． was to theextractive optimize Methods：Orthogonalexperimentdesignapplied the and forRehmannia evaluatedthe of extract procedure glutinosaoligosaccharideby yields content cationandantionion andactivated ofstachy