精源胶囊的质量标准研究
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篇名: 精源胶囊的质量标准研究
TITLE:
摘要: 目的:建立精源胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中的淫羊藿、太子参和何首乌进行定性鉴别。采用高效液相色谱法测定制剂中淫羊藿苷的含量:色谱柱为Odyssil C18,流动相为乙腈-水(28 ∶ 72,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;采用苯酚-硫酸法测定制剂中多糖的含量。结果:淫羊藿、太子参和何首乌TLC图斑点清晰,分离度好,阴性对照无干扰。淫羊藿苷检测质量浓度线性范围为0.027~0.135 mg/mL(r=0.999 9);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为97.87%~101.94%(RSD=1.47%,n=9)。葡萄糖检测质量浓度线性围为0.056~0.121 mg/mL(r=0.999 5);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为99.37%~100.38%(RSD=0.36%,n=6)。结论:本研究所建标准可用于精源胶囊的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Jingyuan capsule. METHODS: TLC was used for qualitative identification of Epimedium brevicornu, Pseudostellaria heterophylla and Fallopia multiflora in the preparation. HPLC method was used to determine the content of icariin. The determination was performed on Odyssil C18 column with mobile phase consisting of acetonitrile-water (28 ∶ 72,V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 270 nm, and the column temperature was 30 ℃. The sample size was 10 μL. The contents of polysaccharides was determined by phenol-sulfuric method. RESULTS: TCL spots of E. brevicornu, P. heterophylla and F. multiflora were clear and well separated without interference from negative control. The linear range of icariin ranged 0.027-0.135 mg/mL(r=0.999 9); RSDs of  precision, stability and repeatability test were all lower than 2.0%. The recoveries were 97.87%-101.94%(RSD=1.47%,n=9). The linear range of glucose ranged 0.056-0.121 mg/mL(r=0.999 5), and RSDs of precision, stability and repeatability tests were all lower than 2.0%. The recoveries were 99.37%-100.38%(RSD=0.36%,n=6). CONCLUSIONS: The established standard can be used for the quality control of Jingyuan capsule.
期刊: 2017年第28卷第9期
作者: 段丽,张永萍,徐剑,迮薇薇,闻家政,钟敬根
AUTHORS: DUAN Li,ZHANG Yongping,XU Jian,ZUO Weiwei,WEI Jiazheng,ZHONG Jinggen
关键字: 精源胶囊;质量标准;薄层色谱法;淫羊藿苷;多糖;高效液相色谱法
KEYWORDS: Jingyuan capsule; Quality standard; TLC; Icariin; Polysaccharide; HPLC
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