基于HPLC指纹图谱研究^(60)Co-γ射线辐射灭菌对除脂生发片化学成分的影响  

Effects of ^(60)Co-γRay Radiation on the Effective Components of Chuzhi Shengfa Tablets Based on HPLC Fingerprints

作　　者：李旸 Li Yang(Second Affiliated Hospital of Zhejiang Chinese Medicine University,Hangzhou 310000,China)

机构地区：[1]浙江中医药大学附属第二医院,杭州310000

出　　处：《中国药师》2022年第7期1271-1276,共6页China Pharmacist

摘　　要：目的:考察^(60)Co-γ射线辐照灭菌对除脂生发片中阿魏酸、藁本内酯、洋川芎内酯A、洋川芎内酯H、丹皮酚5个化学成分含量的影响及辐照前后指纹图谱变化,为除脂生发片辐照灭菌提供指导依据。方法:采用Waters Atlantis T5-C_(18)色谱柱(4.6 mm×250 mm,5μm),以甲醇(A)-0.3%磷酸溶液(B)为流动相,梯度洗脱,检测波长为254 nm(检测丹皮酚)及280 nm(检测阿魏酸、藁本内酯、洋川芎内酯A和洋川芎内酯H),建立除脂生发片HPLC指纹图谱,同时比较0,3,6,9 kGy剂量下^(60)Co-γ射线辐照对除脂生发片化学成分中阿魏酸、藁本内酯、洋川芎内酯A、洋川芎内酯H、丹皮酚的影响,以及对指纹图谱相似度的影响。结果:在指纹图谱研究中,共确定除脂生发片HPLC指纹图谱21个共有峰,不同剂量辐照前后指纹图谱的相似度均>0.90。在建立的色谱条件下试验5个化学成分分离度良好,方法精密度和重复性RSD值均<1.5%,供试品溶液在36 h内稳定,各成分具有良好的线性关系。结论:^(60)Co-γ射线辐照灭菌剂量不超过6 kGy时,对除脂生发片化学成分和指纹图谱影响较小,可作为除脂生发片的有效灭菌手段。Objective:To investigate the influence of ^(60)Co-γray radiation sterilization on the contents of five active ingredients including ferulic acid,ligustilide,senkyunolide A,senkyunolide H and paeonal,and the change of fingerprint before and after the radiation sterilization,so as to provide reference for the sterilization of Chuzhi Shengfa tablets.Methods:The analysis was carried out on a Waters Atlantis T5-C_(18) column(4.6 mm×250 mm,5μm)in a gradient elution mode with methanol(A)-0.3%phosphoric acid solution(B)as the mobile phase,and the detection wavelengths were 254 nm(paeonal)and 280 nm(ferulic acid,ligustilide,senkyunolide A and senkyunolide H).The fingerprint was established.The changes of the contents of ferulic acid,ligustilide,senkyunolide A,senkyunolide H and paeonal in Chuzhi Shengfa tablets before and after ^(60)Co-γray radiation sterilization at the dose of 0,3,6 and 9 kGy were compared,and the similarities of fingerprints were also compared.Results:The common mode of the fingerprint was set up with 21 common peaks for Chuzhi Shengfa tablets,and the similarity of fingerprint before and after different doses of irradiation was above 0.90.The five compounds were well separated under the determined chromatographic conditions.The RSDs of precison and repeatability experiment were all less than 1.5%and the sample solution was stable within 36 h,all the compounds had a good linearity and linear range.Conclusion:^(60)Co-γray radiation sterilization has mild effects on the effective components and fingerprint of Chuzhi Shengfa tablets,which can be used as an effective sterilization method for Chuzhi Shengfa tablets.

关 键 词：除脂生发片 ^(60)Co-γ射线 阿魏酸 藁本内酯 洋川芎内酯A 洋川芎内酯H 丹皮酚 指纹图谱 质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学]