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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 a HPLC fingerprint of the total alkaloid complex phospholipid liposomes by HPLC and to study the stability of the preparation process and to provide a new method for its quality control. Methods The mobile phase was acetonitrile (A) - water: 0.2% acetic acid: 0.2% triethylamine (B) with gradient elution on a Licrospher C18 column (4.6 mm × 300 mm, 5 μm) Fingerprint similarity software for data analysis. Results Eight total peaks of the total alkaloid complex phospholipid liposomes of Strychnos nux vomica were determined. The RSDs of the precision, stability and reproducibility were all less than 3% Similarities are higher than 0.95. Conclusion Strychnos total alkaloids complex phospholipid liposome preparation process stability, fingerprinting technology for Strychnos total alkaloids complex phospholipid liposomes quality evaluation.