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目的:研究心安宁胶囊的质量标准,以提高其质量标准。方法:建立了葛根和丹参的薄层鉴别方法,并采用高效液相色谱法(HPLC)测定方中葛根及丹参酚酸B含量,色谱条件为C18柱(4.6 mm×150 mm,5μm),流动相为甲醇-乙腈-甲酸-水(30∶10∶3∶59);流量1.0 mL.min-1;柱温室温;检测波长250 nm。结果:采用HPLC方法检测图谱清晰,简便准确,专属性强,重复性好,葛根素0.004～0.163μg线性关系良好(r=0.999 8),丹参酚酸B含量在0.144～1.44μg线性关系良好(r=0.999 9),葛根素、丹参酚酸B的平均回收率为97.69%,102.76%,RSD别为1.10%,1.34%。结论:薄层色谱法图谱清晰,简便准确,专属性强,重复性好,可有效地控制心安宁胶囊质量。
Objective: To study the quality standard of Xin’an Capsule in order to improve its quality standard. Methods: The TLC identification method of Radix Puerariae and Radix Salviae Miltiorrhizae was established. The content of Radix Puerariae and Radix Salviae Miltiorrhizae was determined by high performance liquid chromatography (HPLC). The chromatographic conditions were C18 column (4.6 mm × 150 mm, 5 μm) Phase methanol-acetonitrile-formic acid-water (30:10:3:59); flow rate 1.0 mL.min-1; column temperature at room temperature; detection wavelength 250 nm. Results: The HPLC method was simple, accurate and accurate. The specificity and repeatability of puerarin were good. The linearity of puerarin was 0.004 ~ 0.163μg (r = 0.999 8) and the content of salvianolic acid B was 0.144 ~ 1.44μg r = 0.999 9). The average recoveries of puerarin and salvianolic acid B were 97.69% and 102.76%, respectively, and the RSD values were 1.10% and 1.34%, respectively. Conclusion: The chromatogram of TLC is clear, simple and accurate, strong specificity and good reproducibility, which can effectively control the quality of Xinning capsule.