普乐士泰胶囊的质量标准研究  

Study on Quality Standard of Prostatitis Capsules

作　　者：叶绿萍[1] 宾彬[1] 龚敏阳[1] 唐春丽[1] 马儒清[1] 

机构地区：[1]广西中医药大学第一附属医院,南宁530023

出　　处：《中国药房》2017年第15期2104-2107,共4页China Pharmacy

基　　金：广西壮族自治区卫生厅中医药科技专项课题(No.GZYZ1105)

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-C_(18),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10μL。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4.05~81.00μg/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。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 segeta- lis 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 phos- phate （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 10μL. RESULTS： The TLC spots ofP heterophylla, A. tatarinowii, S. cuneate, R. cordifolia, and 14. segetalis were clear and well-separated without interference from negative control. The linear range of leonurine were 4.05-81.00μg/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.

关 键 词：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 

分 类 号：R927[医药卫生—药学]