摘要
目的采用高效液相色谱法建立马钱子总生物碱复合磷脂脂质体的HPLC指纹图谱,并考察制剂工艺稳定性,为其质量控制提供新方法。方法以LicrospherC18(4.6 mm×300 mm,5μm)柱为色谱柱,流动相为乙腈(A)-水∶0.2%乙酸∶0.2%三乙胺(B),梯度洗脱,检测波长为254 nm;采用指纹图谱相似度软件进行数据分析。结果确定了马钱子总生物碱复合磷脂脂质体8个共有峰,通过方法学考察,精密度、稳定性、重现性试验RSD均小于3%,10批马钱子复合磷脂脂质体相似度均高于0.95。结论马钱子总生物碱复合磷脂脂质体制剂工艺稳定,指纹图谱技术适用于马钱子总生物碱复合磷脂脂质体的质量评价。
Objective To establish the HPLC fingerprint of novel liposomes containing total alkaloids from Semen Strychni and to study the stability of preparation process,thus to provide a new method for quality control of Semen Strychni.Methods Separation was performed on Licrospher C18（4.6 mm × 300 mm,5 μm） chromatographic column with acetonitrile（A）-H2O ∶ 0.2 % Acetic acid： 0.2 % Triethylamine（B） as the mobile phase in gradient elution.The detection wavelength was at 254 nm.The data was processed with the fingerprint similarity software.Results Eight common peaks in chromatograms were separated from the 10 batches of samples.After methodological inspection,the RSD of tests of precision,stability,repeatability were less than 3 %.The similarity of the 10 batches of samples was higher than 0.95.Conclusion The preparation process of novel liposomes containing total alkaloids from Semen Strychni is stable,and fingerprint technology is applicable for the quality evaluation of novel liposomes containing total alkaloids from Semen Strychni.
出处
《中药新药与临床药理》
CAS
CSCD
北大核心
2010年第6期637-639,共3页
Traditional Chinese Drug Research and Clinical Pharmacology
基金
国家自然科学基金项目(30701111)
