摘要
目的为保证蒲地灌肠液质量,建立其质量标准。方法采用薄层色谱法对紫花地丁、当归、香附、白芍进行鉴别;RP-HPLC法测定蒲地灌肠液中秦皮乙素与芍药苷的含量。采用Kromasil C18色谱柱(250 mm×4.6 mm,5μm),流动相为0.1%磷酸水溶液(A)-乙腈(B),梯度洗脱0~18 min,88%A;18~25 min,88%~80%A;25~35 min,80%A;35~40 min,80%~88%A;40~45min,88%A;流速为1.0 m L·min^(-1),检测波长为230 nm,柱温为30℃,进样量5μL。结果紫花地丁、当归、香附和白芍薄层色谱鉴别方法专属性强;秦皮乙素和芍药苷线性范围分别为4.24~67.84μg·m L^(-1)(r=0.9995)和8~320μg·m L^(-1)(r=0.9995);平均加样回收率分别为99.9%(RSD=1.9%)和100.9%(RSD=1.9%)。结论该方法简单、准确、重复性好,能有效地控制该制剂的质量。
Objective To establish a method to control the quality of Pudi enema. Methods Herba violae, An- gelica sinensis, Rhizoma Cyperi and Radix Paeoniae Alba were identified by TLC. RP-HPLC method was used to determine the content of aesculetin and paeoniflorin. The separation was performed on a Kromasil C18 ana- lytical column （250 mm×4.6 mm, 5 μm）. The mobile phases was 0.1% formic acid water solution （A） and ace- tonitfile solution （B） with a gradient elution mode. The detective wavelength was 230 nm. The flow rate was 1.0 mL · min^- 1. The column temperature was 30 ℃ . Results TLC identification ofHerba violae, Angelica sinen- sis, Rhizoma Cyperi and Radix Paeoniae Alba was specific and distinct. Aesculetin and paeoniflorin were well separated at 4.24 - 67.84 μg ·mL ^- 1 （r = 0.9995） and 8 - 320 μg · mL^- 1 （r = 0.9995）, respectively. The average recoveries were 99.9% （RSD = 1.9%） and 100.9% （RSD = 1.9%）. Conclusion The method is simple and stable with a good reproducibility, and can be used as the quality control method for Pudi enema.
出处
《中南药学》
CAS
2017年第2期228-232,共5页
Central South Pharmacy
关键词
蒲地灌肠液
秦皮乙素
芍药苷
质量控制
高效液相色谱法
薄层色谱法
Pudi enema
aesculetin
paeoniflorin
quality control
high performance liquid chromatography
thin-layer chromatography
