Quality standard for Xin'an Soft Capsules

AIM To establish the quality standard for Xin'an Soft Capsules(seed oil of Zanthoxylum bungeanum Maxim,silybin,etc.).METHODS Silybin in the preparation was identified by TLC.And the content of silybin in the preparation was determined by HPLC on C18 column(5 μm,4.6 mm × 250 mm),with mobile phase of methanol-1% acetic acid(50∶ 50) and detection wavelength of 288 nm.The contents of oleic acid,linoleic acid and α-linolenic acid in the preparation were determined by GC on a coating cloth concentration of 15% DEGS stainless steel packed column(2 m×3 mm),with inlet temperature of 300 ℃,column temperature of 180 ℃,flame ionization detector temperature of 320 ℃,and high purity nitrogen as carrier gas(flow rate of 40 mL/min).RESULTS Silybin TLC had good specificity.Silybin regression equation was Y=11 264 551X-122 560 and r=0.999 2 in the concentration range of 0.016 4-0.822 0 mg/mL,and average recovery was 99.06%,and its RSD was 0.57%.Oleic acid regression equation was Y1=0.640 5X1+0.155 1 and r1=0.999 8 in the concentration range of 3.68-23.02 mg/mL,and correction factor and its RSD value were 1.03 and 1.73%,respectively.And the average recovery was 98.37%,and its RSD value was 0.65%.Linoleic regression equation was Y2=0.550 2X2+0.094 1 and r2=0.999 in the concentration range of 2.728-17.050 mg/mL,and the correction factor and its RSD value were 1.21 and 2.90%,respectively.And average recovery was 98.89% and its RSD value was 0.31%.α-linolenic acid in the regression equation was Y3=0.523 4X3+0.041 4 and r3=0.999 in the concentration range of 1.95-12.18 mg/mL,and the correction factor and its RSD value were 1.28 and 2.62%,respectively.And average recovery was 99.20% and its RSD was 0.60%.CONCLUSION The established method can be used for quality control of the preparation.