60 Co-γ射线辐照灭菌对康尔心胶囊指纹图谱和有效成分含量的影响

Influence of 60Co-γRays Radiation Sterilization on the Fingerprint Chromatography and Contents of Effective Constituents in Kangerxin Capsules

目的:探索60Co-γ射线辐照灭菌对康尔心胶囊有效成分的影响及辐照前后指纹图谱的变化,为康尔心胶囊辐照灭菌提供指导依据。方法:采用YMC-Pack ODS-A C18色谱柱(250 mm×4.6 mm,5μm),以乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱,检测波长为230 nm(三七皂苷R1、丹酚酸B、人参皂苷Rg1、人参皂苷Rb1)、270 nm(丹参酮ⅡA);建立康尔心胶囊HPLC指纹图谱,比较60Co-γ射线辐照对活性成分三七皂苷R1、丹酚酸B、人参皂苷Rg1、人参皂苷Rb1和丹参酮ⅡA的影响。结果:60Co-γ射线辐照前后康尔心胶囊中三七皂苷R1、丹酚酸B、人参皂苷Rg1、人参皂苷Rb1和丹参酮ⅡA含量差异无统计学意义(P>0.05),辐照灭菌后指纹图谱中7,8,26,33号色谱峰消失。结论:60Co-γ射线辐照灭菌法对康尔心胶囊5个成分含量及指纹图谱影响很小,可作为康尔心胶囊的有效灭菌手段。

Objective:To explore the influence of 60Co-γrays radiation sterilization on the fingerprint chromatography before and after the radiation sterilization to provide basis for the feasibility of gamma-ray radiation sterilization for Kangerxin capsules and study the effective constituents in Kangerxin capsules.Methods:The analysis was carried out on an analytical column YMC-Pack ODS-A C18(250 mm×4.6 mm,5μm)with gradient elution by acetonitrile(A)-0.1%phosphoric acid solution(B)at the detection wavelength of 230 nm(notoginsenoside R1,salvianolic acid B,ginsenoside Rg1 and ginsenoside Rb1)and 270 nm(tanshinoneⅡA).The fingerprint chromatography and the contents of notoginsenoside R1,salvianolic acid B,ginsenoside Rg1,ginsenoside Rb1 and tanshinoneⅡA in Kangerxin capsules were established and compared before and after the 60Co-γrays radiation sterilization.Results:The contents of notoginsenoside R1,salvianolic acid B,ginsenoside Rg1,ginsenoside Rb1 and tanshinoneⅡA had no changes basically before and after the gamma-rays radiation sterilization(P>0.05).The number of characteristic peaks in the fingerprint chromatography reduced by four after the radiation sterilization,namely the 7,8,26 and 33 characteristic peaks disappeared in the pasteurized chromatography.Conclusion:60Co-γrays radiation sterilization has a mild effect on the fingerprint chromatography and the contents of notoginsenoside R1,salvianolic acid B,ginsenoside Rg1,ginsenoside Rb1and tanshinoneⅡA in Kangerxin capsules,which can be used for the sterilization of the capsules.