Study on quality standard of sugarless Waiganfengsha Granules
LUO Yu-dong1,2,3, LU Shi-heng1, TAN An-qiang1, WU Yu-qiang1,3, CHEN Hong-tao1▲
1.Pharmaceutical Factory,Guangxi Traditional Chinese Medical University,Nan-ning 530023,China; 2.Key Laboratory of Zhuang Medicine Prescriptions Basis and Application Research of Guangxi Colleges and Universities,Nanning 530001,China; 3.Key Laboratory of Generic Technology Development of Chinese Medicine Preparation of Guangxi Colleges and Universities,Nanning 530001,China
Abstract：Objective To set up the quality control standard of sugarless Waiganfengsha Granules.Methods Thin layer chromatography (TLC) was used,and petroleum ether (60-90℃)-ethyl acetate-glacial acetic acid (16:2:1) was the developing agent,and 10% sulfuric acid ethanol solution selected as the chromogenic agent to qualitatively identify Streptocaulon griffithii.Toluene-ethyl acetate-glacial acetic acid (10:3:1) was the developing agent,and it was observed under ultraviolet lamp (365 nm) to qualitatively identify Holly root.HPLC was used,chromatographic column:Shimadzu C18 chromatographic column (4.6 mm×150 mm,5 μm) was adopted,and mobile phase:acetonitrile-0.4% phosphoric acid solution (13:87),current speed:0.5 ml/min,and column temperature:25℃,detection wavelength was 327 nm,sample size:10 μl,and sampling time was 60 min.The content of chlorogenic acid in the product was determined.Results According to TLC method,in test sample chromatography,in the corresponding position with Streptocaulon griffithii chromatogram of contrast medicinal material,1 or more than 1 spots in same color were displayed while in the corresponding position with Holly root chromatogram of contrast medicinal material 1 or more than 1 bright spots in same color were displayed,and the spots were clear,and the specificity was strong with good reproducibility,and it had no interference of negative.Chlorogenic acid had a good linear relationship with peak area in the range of 6.2968-201.5 μg (r=0.9991) of sample size,and the average recovery rate was 100.11%,and RSD was 0.14% (n=6).The average content of Chlorogenic acid was 1.1069 mg/g (RSD=0.45 %) among 10 batches of sample tablets.Conclusion The quality control method used has a characteristics of sensitive method,strong specificity,good reproducible and high stability,and it can be used as the quality standard control method of sugarless Waiganfengsha Granules.
罗宇东, 陆施衡, 谭安蔷, 吴玉强, 陈洪涛. 无糖型外感风痧颗粒质量标准的研究[J]. 中国当代医药, 2017, 24(25): 125-129.
LUO Yu-dong, LU Shi-heng, TAN An-qiang, WU Yu-qiang, CHEN Hong-tao. Study on quality standard of sugarless Waiganfengsha Granules. 中国当代医药, 2017, 24(25): 125-129.
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