龙胆配方颗粒的质量标准研究 点击下载
论文标题: 龙胆配方颗粒的质量标准研究
英文标题:
中文摘要: 目的:建立龙胆配方颗粒的质量标准。方法:采用薄层色谱法(TLC)对制剂中龙胆进行鉴别;采用高效液相色谱法测定制剂中龙胆苦苷的含量:色谱柱为Dionex C18,流动相为甲醇-水(25 ∶ 75,V/V),流速为1.0 ml/min,检测波长为270 nm,柱温为30 ℃,进样量为10 μl。结果:龙胆的TLC图斑点清晰,分离良好。龙胆苦苷检测进样量线性范围为0.302 6~3.026 μg (r=0.999 9);精密度、稳定性、重复性试验的RSD<2%;加样回收率为98.27%~99.56%(RSD=0.68%,n=6)。结论:该研究所建标准可用于龙胆配方颗粒的质量控制。
英文摘要: OBJECTIVE: To establish the quality standard for Gentiana scabra dispensing granule. METHODS: TLC was adopted to identify G. scabra in the preparation; HPLC was adopted to determine the content of gentiopicroside in the preparation: the column was Dionex C18 with mobile phase of methanol - water (25 ∶ 75,V/V) at a flow rate of 1.0 ml/min, the detection wavelength was 270 nm, column temperature was 30 ℃, the injection volume was 10 μl. RESULTS: TLC showed clear spots and good separation. The linear range of gentiopicroside injection volume was 0.302 6-3.026 μg (r=0.999 9); RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 98.27%-99.56% (RSD=0.68%,n=6). CONCLUSIONS: The established standard can be used for the quality control of Gentiana scabra dispensing granule.
期刊: 2016年第27卷第15期
作者: 李海兵,张霞,周永妍,王正品,张岩岩,李军山,陈军霞
英文作者: LI Haibing,ZHANG Xia,ZHOU Yongyan,WANG Zhengpin,ZHANG Yanyan,LI Junshan,CHEN Junxia
关键字: 龙胆;配方颗粒;薄层色谱法;高效液相色谱法;质量标准
KEYWORDS: Gentiana scabra; Dispensing granule; TLC; HPLC; Quality standard
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