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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 study the effect of ~ (60) Co-γ irradiation sterilization on the active components of saponins in Panax notoginseng powder (SPPN) and their hemostatic effects. Methods The microbiological limit method was used to determine the changes of SPPN microbiological content before and after irradiation. The content of saponins was determined by high performance liquid chromatography (HPLC), the hemostatic function of SPPN in mice and in vivo Coagulation system and other related indicators. Results The radiation dose of ~ (60) Co-γ 4.2 kGy could achieve the effect of sterilizing SPPN. The dose of 14.2 kGy had no significant effect on the content of ginsenoside Rg_1, Rb_1 and notoginsenoside R_1 in SPPN, It has no effect on SPPN to reduce the amount of bleeding, shorten the time of hemostasis and clotting time, and has no significant effect on the relevant indexes of coagulation system (such as PT, APTT and FIB) in mice. Conclusion Sterilization with ~ (60) Co-γ irradiation at a dose of 4.2 kGy has no significant effect on the active components of the saponins and the hemostatic effect of SPPN. Radiation sterilization of traditional Chinese medicine should be based on the relevant guidelines for research, and according to the relevant requirements of the registration management approach to declare.