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目的:建立测定枳壳与常山胡柚及多个炮制品中柚皮苷和新橙皮苷含量的方法,评价枳壳与常山胡柚及其不同炮制品的质量。方法:按2010年版《中国药典》(一部)及《浙江省中药炮制规范(2005年版)》枳壳项下的规定,对枳壳与常山胡柚及两者的不同炮制品进行水分和灰分的检查,并对所含的柚皮苷和新橙皮苷的含量采用高效液相色谱法进行测定。色谱柱为ZORBAX SB-C18,流动相为乙腈-水(20∶80,V/V),流速为1.0 ml/min,检测波长为283 nm,柱温为40℃,进样量为10μl。结果:枳壳与常山胡柚经炮制后水分减少、灰分无明显变化。不同炮制品中,柚皮苷和新橙皮苷的含量均有所下降,其中枳壳炭下降显著,除枳壳炭外均符合2010年版《中国药典》(一部)要求。柚皮苷、新橙皮苷进样量线性范围分别为0.028 45~0.284 5、0.085 9~0.858 6μg(r=0.999 7、0.999 6);精密度、稳定性、重复性试验的RSD≤1.36%;平均加样回收率分别为96.45%~100.43%、98.36%~102.00%,RSD分别为1.45%、1.26%(n=6)。结论:枳壳与常山胡柚的检查和含量测定结果差异无统计学意义。建议对2010年版《中国药典》(一部)和炮制规范中含量测定的限量进行调整。
Objective: To establish a method for the determination of content of naringin and neohesperidin in Citrus aurantium, Changshan Huyou and several processed products, and to evaluate the quality of Citrus aurantium, Changshan Huyou and its different processed products. Methods: According to the prescriptions of Chinese Pharmacopoeia (2010) and Citrus aurantium (2005) in Zhejiang Province, the different processed products of Citrus aurantium and Changshan Huyou and their processed products were subjected to water and ash The contents of naringin and neohesperidin contained were determined by high performance liquid chromatography. The chromatographic column was ZORBAX SB-C18 with acetonitrile-water (20:80, V / V) as the mobile phase at a flow rate of 1.0 ml / min. The detection wavelength was 283 nm and the column temperature was 40 ℃. Results: Citrus aurantium and Changshan grapefruit after hydration decreased, no significant changes in ash. The contents of naringin and neohesperidin decreased in different processed products, among them, Fructus Aurantii decreased significantly, except the Citrus aurantium conformed to the 2010 edition of “Chinese Pharmacopoeia” (Part 1). The linear ranges of naringin and neohesperidin were 0.028 45 ~ 0.284 5,0.085 9 ~ 0.858 6μg (r = 0.999 7,0.999 6) respectively. The RSD of precision, stability and repeatability test were less than 1.36% The mean recovery was 96.45% -100.43% and 98.36% -102.00%, respectively. The RSDs were 1.45% and 1.26%, respectively (n = 6). Conclusion: Citrus aurantium and Changshan pomelo test results and determination of the content of the difference was not statistically significant. It is recommended that the 2010 edition of “Chinese Pharmacopoeia” (a) and the processing of the contents of the specification limit adjustment.