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作 者:李润萍[1] 蔡延渠[1] 陈健[1] 黄娟萍[1] 朱盛山[1]
机构地区:[1]广东药学院中药开发研究所,广东广州510006
出 处:《时珍国医国药》2012年第9期2317-2319,共3页Lishizhen Medicine and Materia Medica Research
基 金:国家"十二五"重大新药创制科技重大专项(No.2011ZX09102-011-01)
摘 要:目的考察内蒙古、宁夏地产草麻黄质量,为喘平滴丸新药临床前研究及其产业化提供质量的保障。方法研究人员于2011年8月到内蒙古、宁夏实地考察麻黄药材资源并采集样品,并委托当地相关人员采集9月份样品。麻黄药材样品共7个,均按药典方法进行定性与定量分析。结果 7个麻黄经鉴定均是草麻黄,在供试品薄层色谱中与对照品色谱相应的位置上,显相同的红色斑点。高效液相法测定的麻黄碱与伪麻黄碱总量分别为:内蒙古通辽周日河草原8月采收的为1.464%,9月采收的是0.944%;内蒙古呼和浩特希拉穆仁草原8月采收两个样品分别是2.192%、1.038%,9月采收的为1.178%;宁夏唐明基地8月采收的是0.794%,9月采收的是1.746%。结论研究结果表明,现市场上出售的麻黄以草麻黄占绝大多数,而内蒙古、宁夏地产草麻黄的质量(除8月采收宁夏唐明基地的草麻黄)均符合《中国药典》规定,能够保障喘平滴丸新药临床前研究及其产业化的实现,因此喘平滴丸新药及其产业化研究选择草麻黄。Objective To provide quality ensurence for the preclinical studies as well as the industrialization of the new drug of chuanping driping pills, the quality of Ephedra sinica Stapf produced in Inner Mongolia and Ningxia were studied. Methods Re- searchers went to Inner Mongolia and Ningxia to investigate medicinal resources of Ephedra in August,2011, and collect samples. The samples in September were collected by the local related personnel. A total of seven samples of Ephedra herbs were analysed according to the Pharmacopoeia method both qualitatively and quantificationally. Results Seven samples of Ephedra were all iden-tified as Ephedra sinica Stapf through the test of TLC in which the sample showed the same red spot with the reference substance in the corresponding position. The total content of ephedrine and pseudoephedrine was determined by HPLC, and the results were : sample from Inner Mongolia Sunday River grassland contained 1. 464% and 0. 944% respectively in August and September,while the content were 2. 192% and 1. 038% for samples from Inner Mongolia Hohhot Xilamuren grassland in August,and 1. 178% in September, and there were 0. 794% and 1. 746% contained in samples collected in August and in September from Ningxia Tang- ming base. Conclusion Both the field survey and the research report show that Ephedra on sale nowadays are mostly Ephedra sini- ca Stapf. The quality of Ephedra from Inner Mongolia and Ningxia( except samples from TangMing base in Ningxia in August) con- forms to the standard of Chinese pharmacopeia, and can guarantees the preclinical studies of the new drug of chuanping driping pills and its industrialization. So Ephedra sinica Stapf is chosen for the preclinical studies of the new drug of chuanping driping pills and its industralization.
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