γ-射线辐照灭菌对四妙君逸软膏中有效成分含量和指纹图谱的影响  

Influence of Gamma-rays Radiation Sterilization on the Content and Fingerprint Chromatography of Effective Constituents in Simiao Junyi Ointment

作　　者：何群[1,2] 陈光宇[1] 王适[3] 彭思源[1] 何永恒[3] 罗堃[1] He Qun Chen Guangyu Wang Shi Peng Siyuan He Yongheng Luo Kun(College of Pharmacy, Hunan University of Chinese Medicine, Changsha 410208, China Key Disciplinary of the Twelfth of Pharmacy of Education Department in Hunan Province The Second Clinical Medicine College in Hunan University of Chinese Medicine)

机构地区：[1]湖南中医药大学药学院,长沙410208 [2]湖南省教育厅药学"十二五"重点学科 [3]湖南中医药大学第二临床医学院

出　　处：《中国药师》2017年第3期405-408,共4页China Pharmacist

基　　金：湖南省长沙市科技局计划课题(编号:K1508030-31;K1003068-31);湖南省科技厅计划项目(编号:2009SK3125)

摘　　要：目的:探索γ-射线辐照灭菌对四妙君逸软膏有效成分的降解作用和灭菌前后指纹图谱的变化,为四妙君逸软膏能否采用γ-射线辐照灭菌提供依据。方法:HPLC测定四妙君逸软膏中延胡索乙素和三七总皂苷的含量,建立四妙君逸软膏HPLC指纹图谱分析方法,比较同一批和不同批次四妙君逸软膏γ-射线辐照灭菌前后延胡索乙素和三七中三种皂苷总量的变化,以及指纹图谱相对保留时间和相对峰面积的改变。结果:γ-射线辐照灭菌前后延胡索乙素含量基本上无变化(P>0.05);三七中三种皂苷总量无改变(P>0.05);比较γ-射线辐照灭菌与未灭菌软膏在280 nm处的HPLC指纹图谱,相对保留时间变化有统计学意义(P<0.05),相对峰面积变化无统计学意义(P>0.05),特征峰减少了1个,即C8号峰在辐射灭菌图谱中消失,C6、C9、C14号峰相对峰面积明显减小,C12号峰相对峰面积增大。结论:γ-射线辐照灭菌对四妙君逸软膏中延胡索乙素含量和三七中三种皂苷总量无影响;四妙君逸软膏可采用γ-射线辐照灭菌法灭菌。Objective： To explore the degradation effect of gamma-rays radiation sterilization on the effective constituents in Simiao Junyi ointment and study the changes of fingerprint chromatography before and after the sterilization to provide basis for the feasibility of gamma-rays radiation sterilization for Simiao Junyi ointment. Methods： The contents of tetrabydropalmatine and PNS （ Panax Notogin- seng saponins） in Simiao Junyi ointment were determined by HPLC, and the fingerprint chromatography was established. The content changes of tetrahydropalmatine and PNS in Simiao Junyi ointment before and after the gamma-rays radiation sterilization were compared among the same batch and various batches, and the relative retention time and relative peak area in the fingerprint chromatography were also compared. Results ： The content of tetrahydropalmatine had no change basically before and after the gamma-rays radiation steriliza- tion（P 〉 0.05 ）, and there was no change in the total content of PNS （P 〉 0.05）. Comparing the HPLC fingerprint chromatography at 280 nm, the relative retention time had statistically significant change after the gamma-rays radiation sterilization （ （P 〈 0.05 ）, while the relative peak area had no statistically significant change （P 〉 0.05 ）. The number of characteristic peaks reduced by one, namely the C8 characteristic peak disappeared in the pasteurized chromatography, and the areas of C6, C9 and C14 peak decreased significantly, while that of C12 increased. Conclusion： Gamma-rays radiation sterilization have no notable effect on the content of tet- rahydropalmatine and PNS in Simiao Junyi ointment, it can be used for the sterilization of Simiao Junyi ointment.

关 键 词：四妙君逸软膏 γ-射线辐照灭菌 延胡索乙素 三七总皂苷 HPLC指纹图谱 

分 类 号：TQ460.72[医药卫生—药物分析学]