抗瘤丸的质量标准研究.PDFVIP

环球中医药2017年5月第10卷第5期摇 Global Traditional Chinese Medicine,May2017,Vol郾10,No郾5 摇摇 527 ·论著 · 抗瘤丸的质量标准研究 冯英楠摇 陈菲摇 张鹏摇 庄伟摇 林晓兰 揖摘要铱摇 目的摇 建立抗瘤丸系统的质量标准,以提高其质量。方法摇 分别采用薄层色谱法对 院内制剂抗瘤丸中三七、土茯苓、沉香、制何首乌及显微鉴别法对炒山楂进行定性鉴别;并用高效液 相色谱法对制剂中的三七、土茯苓进行含量测定。结果摇 薄层色谱斑点清晰,阴性对照无干扰;三七 皂苷R 、人参皂苷 Rg 、落新妇苷分别在0.3331 ~5.3302 滋g(r=0.9999)、0.7857 ~12.5709 滋g 1 1 (r=0.9999)、0.1478~2.3654 滋g(r=1.0000)范围内呈良好的线性关系,平均回收率分别为 98郾70%、99.08%、98.76%。结论摇 该法灵敏、简便、准确和重复性好,可作为抗瘤丸的质量控制 标准。 揖关键词铱摇 抗瘤丸;摇 质量标准;摇 高效液相色谱法;摇 薄层色谱法 揖中图分类号铱摇 R286摇 揖文献标识码铱摇 A摇 doi:10郾3969/ j郾issn郾1674鄄1749郾2017郾05郾004 Quality standard forKangLiuWan摇 FENG Yingnan,CHEN Fei,ZHANGPeng,et al.摇 Department of Pharmacy Xuanwu,Hospital of CapitalMedical University,Beijing 100053,China Corresponding author:LIN Xiaolan,E鄄mail:xllin83@163.com 揖Abstract铱摇 Objective摇 To establish the quality standards of KangLiuWan(KLW),to improve its quality. Methods摇 Thin layer chromatography(TLC) was used to qualitative identification of Notoginseng Radix et Rhizoma、Smilacis Glabrae Rhizoma、Aquilariae Lignum Resinatum、Polygoni Multiflori Radix Praeparata,andmicroscopicidentificationmethodwasusedtoqualitativeidentificationof CrataegiFructus; HPLCwas applied to quantitatively determiningthecontentsof Notoginseng Radix et RhizomaandSmilacis Glabrae Rhizoma. Results 摇 The TLC spots were clear and well鄄separated;Notoginsenoside R , 1 ginsenosides Rg ,and Chinese astilbin showed good relationshipswithin the ranges of0.3331~5.3302 滋g 1 (r=0.9999)、0.7857 ~ 12.5709 滋g (r=0.9999)、0. 1478 ~2.3654 滋g (r=1.0000),the average recovery were98.70%、99.08%、98.76%,respectively. Conclusion摇 The method is simple,sensitive, accurate and reproducible,and can be used as the quality control standard of KLW. 揖Key words铱摇 KLW;摇 Qualit