高良姜-广藿香配伍溶液的质量标准研究OA北大核心CSTPCD

Objective:To establish the quality standard for the compatibility solution of Alpinia officinarum-Pogostemon cab-lin.Methods:Thin layer chromatography was used for qualitative identification for the two indicator components of galangin and pogostone in the compatibility solution of Alpinia officinarum-Pogostemon cablin:the mixture of anpetroleum ether-ethyl acetate(5:3),(5:1)as the developing solvent system on silica gel G thin layer plate,high-efficiency silica gel G thin layer plate;High per-formance liquid chromatography was used to determine the content of galangin and pogostone:C18 chromatographic column(4.6 mm×250 mm,5 μm)was used,and the mobile phase was methanol(A)-0.2%phosphoric acid(B),with a detection wavelength of 310 nm and gradient elution.Results:For the two indicator components of galangin and pogostone in the compatibility solution of Alpinia officinarum-Pogostemon cablin,the fluorescent spots were clear,without interference from negative controls;Mass concentration was between 10.00～1 000.00 μg/mL and 10.00～640.00 μg/mL,and the linear relationship coefficients with peak area within the range of were R²= 0.999 0,R²= 0.999 9,respectively;The precision RSD was 0.63%and 0.56%,the stability RSD was 1.82%and 0.24%,and the repeatability RSD was 1.30%and 0.89%;The average recovery rates(n=9)were 103.19%(RSD=0.93%)and 100.87%(RSD=0.4%),respectively;The content of these two indicator components should not be less than 233.71 μg/mL and 61.48 μg/mL.Conclusion:A research method has been established for the quality standard of Al-pinia officinarum-Pogostemon cablin compatibility solution.The precision,accuracy,stability,and repeatability of this method meet the requirements.