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目的:建立妇康口服液的质量控制方法。方法:采用薄层色谱法对黄芪、何首乌、当归、川芎、丹参进行定性鉴别;HPLC色谱法(Spherigel ODS C_(18)(250mm×4.6mm,5μm)柱,0.05 mol·L~(-1)磷酸二氢钾溶液-乙腈(85:15)为流动相,检测波长为为230nm,流速为1.0ml·min~(-1))测定芍药苷含量。结果:芍药苷的量在0.32～1.58μg范围内呈良好的线性关系(r= 0.9997),回归方程为A=970296 C+48342。精密度试验RSD为0.38%,该方法平均回收率为98.60%,RSD=1.84%。结论:该方法对妇康口服液质量可控。
Objective: To establish the quality control method of Sukang Oral Liquid. Methods: The contents of Astragalus membranaceus, Polygonum multiflorum, Radix Angelicae Sinensis, Rhizoma Chuanxiong and Radix Salviae Miltiorrhizae were identified by thin layer chromatography (HPLC). The HPLC chromatograms of Spherigel ODS C 18 (250 mm × 4.6 mm, The concentration of paeoniflorin was determined by potassium dihydrogen phosphate solution - acetonitrile (85:15) as the mobile phase at the detection wavelength of 230 nm and the flow rate of 1.0 ml · min -1. Results: The linear range of paeoniflorin was 0.32 ~ 1.58μg (r = 0.9997). The regression equation was A = 970296 C + 48342. The RSD of precision test was 0.38%. The average recovery of this method was 98.60%, RSD = 1.84%. Conclusion: This method can control the quality of oral liquid of Fukang.