朱砂安神丸高效液相色谱数字化指纹图谱研究

目的建立朱砂安神丸(Zhusha Anshen Wan,ZSASW)HPLC数字化指纹图谱,作为其整体质量控制的一个判据标准。方法采用反相HPLC法,使用Century SIL C18BDS柱(200 mm×4.6 mm,5μm),以0.2%H3PO4溶液(A)-0.1%H3PO4乙腈溶液(B)为流动相进行梯度洗脱(0~10 min,0→15%B;10~30 min,15%→30%B;30~50 min,30%→70%B;50~60 min,70%→85%B),流速1.0 mL.min-1,检测波长203 nm,柱温(30±0.15)℃,进样量5μL。以色谱指纹图分离量指数(chromatographic fingerprint resolution index,RF)为目标函数优化试验条件,用"中药色谱指纹图谱超信息特征数字化评价系统3.0"软件进行数字化评价。结果以盐酸小檗碱(berberine hydrochloride,BBR)为参照物峰,确定57个共有指纹峰,获得判别其质量的重要数字化信息,以系统指纹定量法鉴别出S1、S2、S3、S4、S9和S12质量极好,S5、S6和S10质量很好,S11质量好,S7和S8质量为劣。结论所建立的ZSASW-HPLC数字化指纹图谱可清晰反映ZSASW的局部和整体指纹的质量变异,用数字化指纹图谱控制中药质量准确可行。

Digitized HPLC fingerprints of Zhusha Anshen Wan

Objective To establish a digitized HPLC fingerprint for Zhusha Anshen Wan（ZSASW） as a digital criterion for its overall quality control.Methods The chromatographic fingerprints（CFP） were obtained by injecting 5 μL of the sample solution each time on a Century SIL C18 BDS column（200 mm×4.6 mm,5 μm） with the gradient elution solvent system composed of 0.2% phosphoric acid-water and 0.1% phosphoric acid-acetonitrile（0-10 min,0→15%B;10-30 min,15%→30%B;30-50 min,30%→70%B;50-60 min,70%→85%B）.The column temperature was（30±0.15）℃ and the detection wavelength was 203 nm.The CFPs were characteristically digitized and evaluated by digitized evaluation system for super-information characteristics of traditional Chinese medicine fingerprint,taking chromatographic fingerprint resolution index as the target function to optimize test conditions.Results A total of 57 common peaks were selected as the CFP peaks using berberine hydrochloride as the referential peak,and the identification results were obtained by systematic quantified fingerprint method which indicated that S1,S2,S3,S4,S9 and S12 were the best,S5,S6 and S10 were better,S11 was good,while S7 and S8 were inferior.Conclusion The established ZSASW digitized HPLC fingerprints clearly reflect the variation of ZSASW quality,and the digitized HPLC fingerprints can control the quality of traditional Chinese medicine accurately and feasibly.