复方宁神颗粒的质量标准研究 点击下载
论文标题: 复方宁神颗粒的质量标准研究
英文标题:
中文摘要: 目的:建立复方宁神颗粒的质量标准。方法:采用薄层色谱法(TLC)对制剂中当归和白芍进行定性鉴别;采用高效液相色谱法测定制剂中斯皮诺素和毛蕊花糖苷的含量: 色谱柱为Kromasil C18,流动相为乙腈-0.1%乙酸溶液(16 ∶ 84,V/V),流速为1.0 ml/min,检测波长为330 nm,柱温为30 ℃。结果:当归和白芍的TLC图斑点清晰,分离度好,阴性对照无干扰。斯皮诺素和毛蕊花糖苷检测进样量线性范围分别为0.055 44~0.277 2 μg(r=0.999 4)、0.055 98 ~0.279 9 μg(r=0.999 5);精密度、稳定性、重复性试验的RSD<3.0%;加样回收率分别为95.62%~100.53%(RSD=1.77%,n=9)、95.63%~102.57%(RSD=2.74%,n=9)。结论:该研究所建标准可用于复方宁神颗粒的质量控制。
英文摘要: OBJECTIVE: To establish the quality standards for Fufang ningshen granule. METHODS: TLC was used for the qualitative identification of Radix angelicae and White paenoy; HPLC was adopted for the contents determination of spinosin and verbascoside: the column was Kromasil C18 with the mobile phase of acetonitrile-0.1% acetic acid (16 ∶ 84,V/V) at a flow rate of 1.0 ml/min, detection wavelength was 330 nm, column temerpature was 30 ℃. RESULTS: The TLC spots of R. angelicae and W. paenoy were clear with good separation, negative control without interference. The linear range was 0.055 44-0.277 2 μg for spinosin (r=0.999 4) and 0.055 98-0.279 9 μg for verbascoside (r=0.999 5); RSDs of precision, stability and reproducibility tests were lower than 3.0%; recoveries were 95.62%-100.53% (RSD=1.77%,n=9) and 95.63%-102.57% (RSD=2.74%,n=9). CONCLUSIONS: The standard can be used for the quality control of Fufang ningshen granule.
期刊: 2016年第27卷第30期
作者: 黄阳,臧文怡,毛春芹,陆兔林,周亚萍
英文作者: HUANG Yang,ZANG Wenyi,MAO Chunqin,LU Tulin,ZHOU Yaping
关键字: 复方宁神颗粒;薄层色谱法;高效液相色谱法;斯皮诺素;毛蕊花糖苷;质量标准
KEYWORDS: Fufang ningshen granule; TLC; HPLC; Spinosin; Verbascoside; Quality standard
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