黎药裸花紫珠散剂质量标准研究  

Quality standard study of Li folk medicine callicarpa nudiflora powder

作　　者：侯杰[1] 周欣欣 张俊清[1,2] 赖伟勇[1,2] HOU Jie;ZHOU Xin-xin;ZHANG Jun-qing;LAI Wei-yong(School of Pharmaceutical Sciences,Hainan Medical University,Haikou 571199,China;Hainan Provincial Key Laboratory of R&D on Tropical Herbs,Haikou 571199,China;Harbin University of Commerce,Harbin150076,China)

机构地区：[1]海南医学院药学院,海南海口571199 [2]海南省热带药用植物研究开发重点实验室,海南海口571199 [3]哈尔滨工商大学,黑龙江哈尔滨150076

出　　处：《海南医学院学报》2021年第10期735-740,共6页Journal of Hainan Medical University

基　　金：海南省自然科学基金创新研究团队项目(2018CXTD339)。

摘　　要：目的:利用现代分析方法对黎药裸花紫珠散剂进行研究,建立该散剂的质量标准。方法:采用薄层色谱法对裸花紫珠散剂进行鉴别。利用火焰原子吸收法和氢化物原子荧光法,对裸花紫珠散剂中铅、镉、砷、汞、铜5种重金属及有害元素进行限量检查。利用高效液相法对裸花紫珠散剂中木犀草苷、毛蕊花糖苷两种有效成分的含量进行限度检测。结果:黎药裸花紫珠散剂的薄层鉴别荧光斑点清晰可见,其中两种主要成分分离度好,专属性、重现性和耐用性良好,可用于该散剂的鉴别。建立了裸花紫珠散剂鉴别的重金属检查项,规定:按照检测铅、镉、砷、汞、铜含量方法测定,铅不超过5 mg/kg;镉不超过0.3 mg/kg;砷不超过2mg/kg;汞不超过0.2 mg/kg;铜不超过20 mg/kg。利用高效液相色谱法检测裸花紫珠散剂中木犀草苷、毛蕊花糖苷含量,建立了裸花紫珠散剂含量测定项,规定裸花紫珠散剂中木犀草苷和毛蕊花糖苷含量应不低于0.48%和5.83%,据此可用于裸花紫珠散剂的含量限度检查。结论:本研究所建立裸花紫珠散剂质量标准方法先进可操作性强,能用于裸花紫珠散剂的质量控制。Objective:To establish the quality standard of Li folk medicine callicarpa nudiflora powder by modern analytical method.Methods:TLC was used to identify the powder.Five heavy metals and harmful elements(Pb,Cd,As,Hg and Cu)in the powder were determined by flame atomic absorption spectrometry and hydride atomic fluorescence spectrometry.The content of luteolin and Mullein glycoside in the powder was determined by HPLC.Results:The fluorescent spots of TLC identification of powder were clear,and the separation of the two main components was good.It has good specificity,reproducibility and durability,which can be used for the identification of the powder.The inspection items of heavy metals for the identification of powder were established.It was stipulated that:according to the determination method,the lead should not exceed 5 mg/kg;the cadmium should not exceed 0.3 mg/kg;the arsenic should not exceed 2 mg/kg;the mercury should not exceed 0.2 mg/kg;the copper should not exceed 20 mg/kg.The content of luteolin and Mullein glycoside in the powder were determined by HPLC and the content inspection item of the powder was established.It was stipulated that the content of luteolin and Mullein glycoside in the powder should not be less than 0.48%and 5.83%,which can be used for the content limit inspection of the powder.Conclusion:The quality standard method established by our institute is advanced and operable,and can be used for the quality control of the powder.

关 键 词：黎药 裸花紫珠 散剂 质量标准 

分 类 号：R29[医药卫生—民族医学]