普乐士泰胶囊的质量标准研究
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篇名: 普乐士泰胶囊的质量标准研究
TITLE:
摘要: 目的:建立普乐士泰胶囊的质量标准。方法:采用薄层色谱法(TLC)对制剂中太子参、石菖蒲、大血藤、茜草、王不留行进行定性鉴别;采用高效液相色谱法测定制剂中益母草碱的含量:色谱柱为Agilent Eclipse XDB-C18,流动相为甲醇-0.025 mol/L磷酸二氢钾溶液(用磷酸调pH至2.5)(24 ∶ 76,V/V),流速为1.0 mL/min,检测波长为277 nm,柱温为30 ℃,进样量为10 μL。结果:太子参、石菖蒲、大血藤、茜草、王不留行的TLC图斑点清晰,分离度好,阴性对照无干扰。盐酸益母草碱检测质量浓度线性范围为4.05~81.00 μg/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98.47%~103.83%(RSD=2.04%,n=9)。结论:该研究所建标准可用于普乐士泰胶囊的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard for Prostatitis capsules. METHODS: TLC method was performed to qualitatively identify Pseudostellaria heterophylla, Acortw tatarinowii,Sargentodoxa cuneata, Rubia cordifolia and Vaccaria segetalis in the preparation. HPLC method was adopted to determine the content of leonurine in the preparation. The determination was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of methanol-0.025 mol/L potassium dihydrogen phosphate (pH adjusted to 2.5)(24 ∶ 76,V/V) with phosphoric acidat the flow rate of 1.0 mL/min. The detection wavelength was set at 277 nm, and column temperature was 30 ℃. The sample size was 10 μL. RESULTS: The TLC spots of P. heterophylla, A. tatarinowii, S. cuneate, R. cordifolia, and V. segetalis were clear and well-separated without interference from negative control. The linear range of leonurine were 4.05-81.00 μg/mL(r=0.999 9). RSDs of precision, stability and reproducibility tests were all lower than 2.0%. The recovery was 98.47%-103.83%(RSD=2.04%,n=9). CONCLUSIONS: Established standard can be used for quality control of Prostatitis capsules.
期刊: 2017年第28卷第15期
作者: 叶绿萍,宾彬,龚敏阳,唐春丽,马儒清
AUTHORS: YE Lüping,BIN Bin,GONG Minyang,TANG Chunli,MA Ruqing
关键字: 普乐士泰胶囊;质量标准;薄层色谱法;益母草碱;高效液相色谱法
KEYWORDS: Prostatitis capsules; Quality standard; TLC; Leonurine; HPLC
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