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 m L/min,检测波长为270 nm,柱温为30℃,进样量为10μL;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/m L(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/m L(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。
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 m L/min. The detection wavelength was set at 270 nm,and the column temperature was 30 ℃. The sample size was 10 μ L. 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/m L（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 0.056-0.121mg/m L（r=0.999 5）,and RSDs of precision,stability and repeatability tests were all lower than 2.0%. The recoveries were99.37%-100.38%（RSD=0.36%,n=6）. CONCLUSIONS：The established standard can be used for the quality control of Jingyuan capsule.
出处
《中国药房》
CAS
北大核心
2017年第9期1231-1235,共5页
China Pharmacy
基金
国家工程技术研究中心组建项目(No.2014FΜ125Q09)
贵州省中药现代化科技产业研究开发专项项目(No.黔科合中药字〔2013〕5009)
贵州省普通高等学校工程研究中心建设项目(No.黔教合KY字〔2014〕22号)
贵州省高层次创新型人才培养项目(No.黔科合人才〔2015〕4030号)
