参附益肾胶囊的质量标准研究
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篇名: 参附益肾胶囊的质量标准研究
TITLE:
摘要: 目的:建立参附益肾胶囊的质量标准。方法:检测制剂中手参的显微特征;采用薄层色谱法(TLC)对制剂中丹参、大黄、甘草、红景天、肉桂进行定性鉴别;采用高效液相色谱法测定制剂中黄芪甲苷的含量:色谱柱为Phenomenex Luna-C18,流动相为乙腈-水(35 ∶ 65,V/V),流速为1.0 ml/min,柱温为30 ℃。结果:制剂中手参显微特征显著。丹参、大黄、甘草、红景天、肉桂TLC图斑点清晰,分离度好。黄芪甲苷检测进样量线性范围为0.832 8~4.164 0 μg(r=0.999 9);精密度、稳定性、重复性试验的RSD≤2.03%;加样回收率为95.02%~104.33%(RSD=3.80%,n=6)。结论:该研究所建标准可用于参附益肾胶囊的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard for Shenfu yishen capsule. METHODS: The microscopic characteristics of Gymnadenia conopsea were detected; TLC was adopted for the qualitative identification of Salvia miltiorrhiza, Rheum palmatum, Glycyrrhiza uralensis, Rhodiola rosea and Cortex cinnamomi; HPLC was used for the content determination of astragaloside: the column was Phenomenex Luna-C18 with mobile phase of acetonitrile-water (35 ∶ 65,V/V) at a flow rate of 1.0 ml/min, column temerpature was 30 ℃. RESULTS: Microscopic identification features of G. conopsea were exclusive, TLC identification of S. miltiorrhiza, R. palmatum, G. uralensis,R. rosea and C. cinnamomi was well separated and specific; the linear range of astragaloside was 0.832 8-4.164 0 μg (r=0.999 9);RSDs of precision, stability and reproducibility tests were no higher than 2.03%;recovery was 95.02%-104.33%(RSD=3.80%,n=6). CONCLUSIONS: The standard can effectively control the quality of Shenfu yishen capsule.
期刊: 2016年第27卷第33期
作者: 盛春帅,周鹃,李海霖
AUTHORS: SHENG Chunshuai,ZHOU Juan,LI Hailin
关键字: 参附益肾胶囊;质量标准;薄层色谱法;高效液相色谱法;黄芪甲苷
KEYWORDS: Shenfu yishen capsule; Quality standard; TLC;HPLC; Astragaloside A
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