丹参电子束辐照杀菌安全剂量的确定及质量评价

Determination of Safe Dose and Quality Evaluation for Sterilization of Salvia miltiorrhiza by Electron Beam Irradiation

为探究电子束辐照杀菌对丹参质量的影响,本研究采用2、4、6、8、10、12、14、16、18 kGy辐照剂量处理丹参样品,比较不同剂量下丹参微生物水平、8种化合物含量、抗氧化活性,结合正交偏最小二乘法判别分析模型确定最佳安全剂量;建立丹参辐照前后指纹图谱,判断电子束辐照杀菌前后丹参化学成分一致性是否良好;选取6批丹参验证最佳安全辐照剂量。结果表明,丹参电子束辐照杀菌剂量达10 kGy及以上时,微生物水平符合《中华人民共和国药典2020年版四部》规定标准;在10 kGy剂量内,辐照组与对照组的8种化合物总含量、4种抗氧化活性无显著差异,且10 kGy剂量组与对照组的抗氧化活性最接近。综上,确定10 kGy为丹参电子束辐照杀菌的最佳安全辐照剂量。辐照前后丹参高效液相色谱(HPLC)和拉曼光谱(SERS)指纹图谱相似度均大于0.9,提示化学成分一致性良好。6批丹参经10 kGy杀菌后的微生物水平符合药典规定;8种化合物含量、抗氧化活性、大鼠肝星状细胞(HSC-T6)存活率经t检验均无显著差异。本研究结果可为电子束辐照杀菌技术在丹参生产中的应用和质量评价提供科学依据。

To study the effect of electron beam irradiation on the quality of Salvia miltiorrhiza,this study treated Salvia miltiorrhiza samples with irradiation doses of 2,4,6,8,10,12,14,16 and 18 kGy,respectively.and compared the microbial level,8 compounds content and antioxidant activity of Salvia miltiorrhiza at different doses.The optimal safe dose was determined by orthogonal partial least square discriminant analysis model.The fingerprints of Salvia miltiorrhiza before and after irradiation were established to determine the chemical composition consistency.Six batches of salvia miltiorrhiza were selected to verify the optimal safe irradiation dose.The results showed that the microbial level was in line with the pharmacopoeia standard of the People’s Republic of China Pharmacopoeia 2020 Edition No.4 when the irradiation dose of Salvia miltiorrhiza electron beam sterilization reached 10 kGy or above,.The total content of 8 compounds of salviorrhiza was within 10 kGy,and there was no significant difference between the irradiation group and the control group.There were no significant differences in the antioxidant activities of the 4 kinds at the dose of 10 kGy,and the antioxidant activities of the 10 kGy dose group were the closest to the control group.In conclusion,10 kGy was the best safe irradiation dose for Salvia miltiorrhiza electron beam sterilization.The similarity of fingerprints of Salvia miltiorrhiza by high performance liquid chromatography(HPLC)and Raman spectroscopy(SERS)before and after irradiation was greater than 0.9 indicating good consistency of chemical components.After 6 batches of Salvia miltiorrhiza were sterilized by 10 kGy,the microbial levels were in line with pharmacopoeia regulations.There were no significant differences in the contents of 8 compounds,antioxidant activity and survival rate of hepatic stellate cells(HSC-T6)by t test.The results of this study can provide scientific basis for the application of electron beam irradiation sterilization technology in the production and quality evaluation of Salvia miltiorrhiza.