抗皮肤癣菌用姜油树脂凝胶的质量控制

Quality-control standard of antidermatophyte ginger oleoresin gel

关键词:  姜油树脂凝胶  高效液相色谱法  质量控制

Key words:  dermatophyte  ginger oleoresin gel  HPLC  observation of efficacy quality control

摘要:

［目的］建立抗真菌用姜油树脂凝胶制剂的质量控制标准。［方法］以6-姜酚为对照品，采用高效液相色谱法，色谱柱为HYPERSIL BDS C18（5 μm，4.6 mm×250 mm）加预柱，流动相为甲醇∶水=65∶35，检测波长280 nm，测定姜油树脂凝胶中6-姜酚的含量。［结果］6-姜酚的线性范围是0.06~1.2 mg/mL，r=0.9999；精密度、重复性、稳定性的RSD值均<2%，平均回收率为98.30 %，RSD=0.95%。［结论］本实验建立的测定姜油树脂凝胶中6-姜酚含量的高效液相色谱法，结果可靠，操作简便，可以作为姜油树脂凝胶的质量控制标准。

Abstract:

［Objective］To institute the quality-control standard of ginger oleoresin gel praeparatum.［Methods］We used HPLC to measure the content of 6-gingerol in ginger oleoresin gel (the reference substance was 6-gingerol, the chromatographic column was HYPERSIL BDS C18 “5 μm,4.6 mm×250 mm”, the mobile phase was methanol and water 65:35, the detection wavelength was 280 nm,institute the quality control standard of ginger oleoresin gel.［Results］The linear range of 6-gingerol was 0.06~1.2 mg/mL(r=0.9999) ; the relative standard deviation(RSD) of precision,repeatability and stability was no more than 2%;the average recovery and its RSD was 98.30% and 0.95%.［Conclusion］The HPLC method in this study for determinating the content of 6- gingerol in ginger oleoresin gel has simple operation and reliable results ,could be used for ginger oleoresin gel's quality control.