摘要
目的为了有效的控制白康冲剂的质量,建立白康冲剂的鉴别及含量测定的质量控制方法。方法采用薄层色谱法对制剂中的丹参中的丹参酮I(石油醚—乙酸乙酯=8∶2为展开剂)和当归中的齐墩果酸(石油醚—氯仿—乙酸=10∶10∶2为展开剂)分别进行定性鉴别,采用高效液相色谱法(流动相为甲醇—0.1mol/L磷酸溶液=8∶2,检测波长254nm)对制剂中的制首乌的大黄素含量进行测定。结果定性鉴别方法重现性好、专属性强;含量测定方法的进样量在0.2537~4.06μg范围内线形关系良好,r=0.9999;加样回收率为101.10%,RSD=2.53%(n=6)。结论质量控制方法简单、方法准确可靠,专属性及重现性均良好,可以作为该药的质控指标。
Objective To establish a method for the quality control of baikang granule. Methods The qualitative analysis of tanshinone I in Salvia ( petroleum ether-ethyl acetate = 8 : 2 as developing sol- vent) and oleanolie acid in Chinese Angelica (petroleum ether-chloroform-acetic acid = 10: 10:2 as devel- oping solvent) in baikang granule were identified by TLC. The content of emodin in Polygonum muhiflorum was determined by HPLC (Methanol-0. 1 mol/L phosphoric acid solution = 8:2 as mobile phase, 254 nm as the detection wavelength ). Results The qualitative identification was specific and reproducible. The HPLC method of linear range of calibration curve was 0. 2537 -4. 06 μg, with the relative coefficiency of 0. 9999, standard recovery was 101.10% , and RSD = 2. 53%. Conclusion The method has good speci- ficity and reproducibility and can be used as quality control.
出处
《环球中医药》
CAS
2013年第3期175-177,共3页
Global Traditional Chinese Medicine
关键词
白康冲剂
薄层色谱法
高效液相色谱法
大黄素
Baikang granule
Thin layer chromatography
High performance liquid chroma-tography
Emodin