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柑柏止痒浴液的质量标准研究
引用本文:余晓霞,;伍俊妍,;刘春霞,;温预关.柑柏止痒浴液的质量标准研究[J].中国药房,2014(31):2939-2941.
作者姓名:余晓霞  ;伍俊妍  ;刘春霞  ;温预关
作者单位:[1]中山大学孙逸仙纪念医院药学部,广州510120; [2]广州市脑科医院药剂科/国家药品临床研究基地,广州I510370
摘    要:目的:建立柑柏止痒浴液的质量标准。方法:采用薄层色谱(TLC)法对处方中薄荷脑和黄柏进行定性鉴别;采用高效液相色谱法测定黄柏中盐酸小檗碱的含量:色谱柱为Agilent Eclipse Plus C18(100 mm×4.6 mm,5μm),流动相为甲醇-0.03 mol/ml乙酸铵溶液(45∶55,V/V),检测波长为346 nm。结果:TLC图专属性强,阴性对照无干扰。盐酸小檗碱的质量浓度在1200μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 8);精密度、稳定性、重复性试验的RSD<2%;平均加样回收率为100.28%,RSD=1.58%(n=6)。结论:所建标准可用于柑柏止痒浴液的质量控制。

关 键 词:柑柏止痒浴液  质量标准  薄层色谱法  高效液相色谱法  盐酸小檗碱

Study on Quality Standard of Ganbai Zhiyang Lotion
Institution:YU Xiao-xia, WU Jun-yan, LIU Chun-xia, WEN Yu-guan( 1.Dept. of Pharmacy, Sun Yat-sen Memorial Hospi- tal, Sun Yat-sen University, Guangzhou 510120, China; 2.Dept. of Pharmacy, Guangzhou Brain Hospital/State Clinical Drug Research Base, Guangzhou 510370,China)
Abstract:OBJECTIVE: To establish the quality standard of Ganbai zhiyang lotion. METHODS: Menthol and Phellodendron chinense were identified by TLC. The content of berberine hydrochloride in P chinense was determined by HPLC. The determination was performed on Agilent Eclipse Plus C18 (100 mm×4.6mm,5μm) column with mobile phase consisted of methanol-0.03 mol/ml ammonium acetate(45: 55, V/V). The detection wavelength was set at 346 nm. RESULTS: TLC identification method exhibited good specificities without interference from negative samples. The linear range berberine hydrochloride were 1-200 μg/ml(r= 0.999 8) ; RSDs of precision, stability and reproducibility tests were all lower than 2% ; average recovery was 100.28% (RSD= 1.58% ,n=6). CONCLUSIONS: The established standard can be used for the quality control of Ganbai zhiyang lotion.
Keywords:Ganbai zhiyang lotion  Quality standard  TLC  HPLC  Berberine hydrochloride
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