Quality standard of Yuquan Micropill / 中成药

ABSTRACT

AIM:To establish the quality standard of the composition of Yuquan Micropill(Radix Rehmanniae,Fructus Schisandrae Chinensis,Radix Puerariae lobatae,etc.). METHODS: The composition of Yuquan Micropill were identified by TLC and the content was determined by HPLC.Puerarin could be separated through Diamonsil~(TM) C_(18) column(5 ?m,250 mm?4.6 mm) with methanol-water(1.2∶3 by volume) as a mobile phase.The flow rate was 1.0 mL/min,the detection wavelength was set at 250 nm and the column temperature was maintained at 40 ℃.?-Schizandrin could be separated through Kromasil KR100-3.5 C_(18) column(100 mm?4.6 mm) with methanol-water(3.5∶1 by volume) as a mobile phase.The flow rate was 0.6 mL/min and the detection wavelength was set at 254 nm. RESULTS: The spots in the TLC were clear and could be well separated,the blank and adjuvant contrast could not be interfered.HPLC showed a good peak form,good resolution and could not be interfered by the foreign matter.The average recovery of puerarin was 99.24%,RSD=0.84%,RSD of precision was 0.95%,RSD of reproducibility was 0.86%,RSD of stability was 0.44%.The average recovery of ?-schizandrin was 99.74%,RSD=0.78%,RSD of precision was 1.89%,RSD of reproducibility was 1.76%,RSD of stability was 1.82%. CONCLUSION: The method is simple and has good resolution,strong specificity and good reproducibility,It can be used for the quality control of the composition of Yuquan Micropill.