复方石斛消渴颗粒特征图谱及2个成分定量方法的建立  

Establishment of Characteristic Chromatogram and Determination of Two Constituents for Compound Shi Hu Xiao Ke Granules

作　　者：林巧之 LIN Qiao-zhi(Fujian Fuzhou Institute for Food and Drug Control,Fuzhou 350007)

机构地区：[1]福州市食品药品检验所,福建福州350007

出　　处：《海峡药学》2022年第11期60-65,共6页Strait Pharmaceutical Journal

摘　　要：目的 建立复方石斛消渴颗粒特征图谱并测定其主要成分葛根素、丹酚酸B的含量。方法 采用HPLC法,资生堂C_(18)反相色谱柱(250 mm×4.6 mm, 5μm),流动相乙腈(A)-0.1%磷酸溶液(B),梯度洗脱,二极管阵列检测器检测,检测波长分别为250 nm、286 nm,流速1.0 mL·min^(-1),柱温35℃。结果 特征图谱试验中,通过与对照药材色谱图的对比,10批供试品色谱图中有7个共有峰。以葛根素为参比峰,测定方法的精密度、重复性、稳定性试验中的各共有峰的相对保留时间的RSD均小于1%,相对峰面积的RSD均小于2%;含量测定方法中,葛根素、丹酚酸B分别在21.83~218.28μg·mL^(-1)、20.36~203.56μg·mL^(-1)内线性关系良好,平均加样回收率分别为98.4%、97.8%,RSD分别为1.23%、1.02%。结论 该方法稳定可靠,可用做复方石斛消渴颗粒的质量控制。OBJECTIVE To establish the characteristic chromatogram of Compound ShiHu XiaoKe granules and determine the contents of puerarin and salvianolic acid B.METHODS HPLC was used with Shiseido C_(18) reversed phase chromatographic column(250 mm×4.6 mm, 5 μm),mobile phase acetonitrile(A)-0.1% phosphoric acid solution(B),gradient elution, diode array detector detection, detection wavelength 250 nm and 286 nm, flow rate 1.0 mL·min^(-1),column temperature 35 ℃.RESULTS In the characteristic chromatogram test, there were 7 common peaks in the chromatogram of 10 batches of test samples.Taking puerarin as the reference peak, the RSDs of the relative retention time of each common peak in the precision, repeatability and stability test were less than 1%,and the RSDs of the relative peak area were less than 2%;The Linear range of Puerarin and salvianolic acid B were 21.83-218.28 μg·mL^(-1)and 20.36-203.56 μg·mL^(-1).The internal linearity were good.The average recoveries were 98.4% and 97.8% respectively, and the RSD were 1.23% and 1.02% respectively.CONCLUSION The method is stable and reliable, and can be used for the quality control of Compound ShiHu XiaoKe granules.

关 键 词：复方石斛消渴颗粒 特征图谱 高效液相色谱 葛根素 丹酚酸B 

分 类 号：R927[医药卫生—药学]