复方苦参凝胶的质量标准研究  

Study on the Quality Standard of Compound Kushen Gelatum

作　　者：朱如彩[1] 周作的[1] 

机构地区：[1]湖南省中医药研究院中药研究所,湖南长沙410013

出　　处：《中医药导报》2006年第6期85-87,共3页Guiding Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的研究制定复方苦参凝胶的质量标准。方法采用TLC法对徐长卿、薄荷素油、冰片、甘草进行了定性鉴别;采用HPLC法测定复方苦参凝胶中苦参碱的含量,色谱柱为NH2柱(4.6mm×250mm,5μm),流动相为乙腈-0.02mol/L磷酸二氢钠(8020),流速1.0ml/min,检测波长220nm,柱温25℃。结果采用TLC法可鉴别出与徐长卿、薄荷素油、冰片、甘草对应的斑点;采用HPLC法测定苦参碱的含量,苦参碱在0.384μg^2.304μg范围内有良好的线性关系(r=0.9998),平均回收率为99.28%,RSD=0.54%(n=6)。结论所建立的质量标准简便可行、重复性好,可以用来评价复方苦参凝胶的质量。Objective： To establish the quality standard of Compound Kushen Gelatum. Method： Radix Et Rhizoma Cynanchi Panieulati, Oleum Menthae Dementholatum, Bomeolum Syntheticum and Radix Et Rhizoma Glycyrrhizae in Compound Kushen Gelatum were identified by TLC; Matrine content in Compound Kushen Gelatum was determined by HPLC. NH2 column （4.6 × 250mm, 51μm） as chromatographic column, Acetonitfile - 0.02mol/L Sodium Dihydrogen Phospate （ 80 ： 20 ） as mobile phase, flow rate ： 1. 0ml/min, detection wavelength ：220nm, temperature ：25℃. Result： The relevant spots in Radix Et Rhizoma Cynanchi Panieulati, Oleum Menthae Dementholatum, Borneolum Syntheticum and Radix Et Rhizoma Glycyrrhizae can be identified by TLC. The content of Matfine in Radix Sophorea Flaveseentis can be determined by HPLC. The lineafity of Matfine was good in the range of 0. 384 - 2. 304 μg （ r = 0. 9998）. The average recovery of Matrine was 99. 28% , RSD = 0.54 % （ n = 6）. Conclusion ： The established quality standard is simple, feasible and repeatable, and can be used for quality supervisory of Compound Kushen Gelatum.

关 键 词：复方苦参凝胶 苦参碱 HPLC TLC 质量标准 

分 类 号：R927.11[医药卫生—药学]