^(60)Co-γ辐照灭菌对三七超微粉有效成分及止血作用的影响  

Effects of ^(60)Co-γ Radiation Sterilization on the Active Components and Hemostatic Function of Superfine Powders of Panax Notoginseng

作　　者：孟兰贞[1] 罗志平 李文革 聂红[3] 李俊杰 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广东广州510080 [2]湖南省核农学与航天育种研究所,湖南长沙410125 [3]暨南大学药学院,广东广州510632

出　　处：《今日药学》2017年第8期510-513,共4页Pharmacy Today

基　　金：湖南省科技厅重点研发计划(2015WK3045)

摘　　要：目的研究^(60)Co-γ辐照灭菌对三七超微粉(SPPN)中皂苷类活性成分及其止血作用的影响。方法采用微生物限度法测定辐照处理前后SPPN微生物含量的变化,高效液相色谱(HPLC)法测定皂苷类成分含量,小鼠断尾法和玻片法等测定SPPN对小鼠的止血功能及体内凝血系统等相关指标的影响。结果^(60)Co-γ辐照剂量4.2 kGy可以达到对SPPN灭菌的效果;14.2 kGy以内的辐照剂量对SPPN中的人参皂苷Rg_1、Rb_1和三七皂苷R_1含量无明显影响,该剂量对SPPN减少断尾小鼠的出血量、缩短止血时间和凝血时间等药理作用无影响,对小鼠体内的凝血系统相关指标(如PT、APTT及FIB)也均无明显影响。结论剂量为4.2 kGy的^(60)Co-γ辐照灭菌对SPPN的主要皂苷类活性成分以及止血作用无明显影响。中药辐照灭菌应参照相关指导原则进行研究,并按注册管理办法的相关要求进行申报。OBJECTIVE To investigate the effects of^（60）Co-γ radiation sterilization on the active components and hemostatic function of superfine powders of Panax notoginseng（ SPPN）. METHODS Change of microbial contents and saponins in SPPN were determined by microbial limit test and HPLC,respectively. The effects of SPPN on the bleeding time,hemorrhagic amount,clotting time,and the indicators relate to coagulation system in mice were studied by tail cutting and slide method. RESULTS The^（60）Co-γirradiation with dosage of 4.2 kGy could sterilized the SPPN. The dosage of irradiation under 14.2 kGy had no effect on the content of ginsenoside Rg_1,Rb_1 and saponin R_1 in SPPN. Meanwhile,this dosage did not influence the SPPN＇s hemostatic effect on mice,such as shorten the bleeding and clotting time and reduced the hemorrhagic amount. Both irradiated nor un-irradiated SPPN had no effect on the PT,APTT and FIB in mice. CONCLUSION^（60）Co-γ radiation sterilization with dosage of 4. 2 kGy has no effects on the saponins contents and hemostatic function of SPPN. The TCMs that use radiation sterilization need further study and complete registration application according to the related guidelines and provisions for drug registration.

关 键 词：三七超微粉 60Co-γ辐照灭菌 皂苷 止血作用 

分 类 号：R284[医药卫生—中药学]