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苏贝止咳颗粒中挥发油的质量标准初步研究
引用本文:袁青青,崔颖,王浩,田军,刘永,孙备,吕凌.苏贝止咳颗粒中挥发油的质量标准初步研究[J].安徽医药,2017,21(11):1994-1997.
作者姓名:袁青青  崔颖  王浩  田军  刘永  孙备  吕凌
作者单位:安徽中医药大学,安徽 合肥,230012;安徽省食品药品检验研究院,安徽省中药研究与开发重点实验室,安徽 合肥 230051
摘    要:目的 建立苏贝止咳颗粒中挥发油成分的质量标准.方法 采用气相色谱-质谱联用(GC-MS)对挥发油提取物的成分进行鉴定,共鉴定出10个色谱峰;采用气相色谱法(GC)测定制剂中挥发油的含量,其中 α-蒎烯、β-蒎烯、柠檬烯采用外标法进行测定.结果 α-蒎烯、β-蒎烯、柠檬烯线性范围分别为0.5908~75.625 mg·L-1(r=1),0.7781~24.90 mg·L-1(r=1),1.7194~220.08 mg·L-1(r=1),平均加样回收率分别为102.68%(RSD=4.82%)、108.09%(RSD=6.45%)和95.59%(RSD=5.43%)(n=9).结论 所建立的方法准确、可靠、专属性强,增加了能反映制剂临床疗效的质量控制指标,为质量标准的完善提供依据.

关 键 词:苏贝止咳颗粒  挥发油  气相色谱法  气相色谱-质谱联用
收稿时间:2017/3/21 0:00:00
修稿时间:2017/4/13 0:00:00

Quality standard study of the volatile oil of Subei zhike granules
YUAN Qingqing,CUI Ying,WANG Hao,TIAN Jun,LIU Yong,SUN Bei and LYU Ling.Quality standard study of the volatile oil of Subei zhike granules[J].Anhui Medical and Pharmaceutical Journal,2017,21(11):1994-1997.
Authors:YUAN Qingqing  CUI Ying  WANG Hao  TIAN Jun  LIU Yong  SUN Bei and LYU Ling
Institution:Anhui University of Traditional Chinese Medicine,Hefei,Anhui 230012,China,Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China,Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China,Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China,Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China,Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China and Anhui Institute of Food and Drug Control,Anhui Provincial Key Laboratory of R&D of Chinese Medicine,Hefei,Anhui 230051,China
Abstract:Objective To establish quality standard of Subei zhike granules volatile oil constituents. Methods The constituents of the volatile oil extracts were identified by GC-MS,there were 10 chromatographic peaks identified. The content of volatile oil was determined by GC,α-pinene,β-pinene and limonene were determined by the external standard method. Results The linearity ranges of α-pinene,β-pinene,Limonene were 0. 5908-75. 625 mg·L - 1 (r = 1),0. 7781-24. 90 mg·L - 1 (r = 1),1. 7194-220. 08 mg·L - 1 (r = 1),re-spectively. The average recovery rate was 102. 68% (RSD = 4. 82% ),108. 09% (RSD = 6. 45% ) and 95. 59% (RSD = 5. 43% )(n =9),respectively. Conclusions The establishment of accurate,reliable,specific method can reflect the quality control indicators of clini-cal efficacy and provide a basis for improvement of quality standards.
Keywords:Subei zhike granules  Volatile oil  GC  GC-MS
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