^(60)Co-γ射线辐照灭菌对牡丹皮质量影响的多元评价研究

Multiple Evaluation for the Effect of ^(60)Co-γIrradiation Sterilization on Cortex Moutan

为考察^(60)Co-γ射线辐照灭菌对牡丹皮质量的影响,本研究采用不同吸收剂量(0、5、10、20、30 kGy)^(60)Co-γ射线辐照处理试验样品,比较辐照前后样品微生物负载变化、高效液相色谱(HPLC)指纹图谱相似度、水提物抑菌活性的变化,并建立牡丹皮近红外光谱一致性评价模型。结果表明,当吸收剂量为5 kGy时即可让微生物负载超标样品中的需氧菌总数、霉菌和酵母菌总数及耐胆盐革兰阴性菌数量降至标准规定(《美国药典》USP-NF2023)以下;随着吸收剂量的增加,牡丹皮样品指纹图谱相似度呈下降趋势;辐照后样品水提物对金黄色葡萄球菌的抑菌圈直径与未辐照相比无显著差异(P>0.05);采用近红外光谱一致性评价模型能够较好地区分辐照与未辐照样品。鉴于不适宜的^(60)Co-γ射线辐照剂量可能会对牡丹皮质量造成一定影响,建议牡丹皮的辐照吸收剂量不超过5 kGy。本研究结果可为牡丹皮辐照灭菌吸收剂量的选取提供参考依据。

In order to investigate the effect of ^(60)Co-γirradiation sterilization on the quality of Cortex Moutan,samples were treated with different absorbed dosage(0,5,10,20,30 kGy).The variety of microbial load,high performance liquid chromatography(HPLC)finger-print and inhibitory activity of water extract against Staphylococcus aureus were compared before and after irradiation.A near-infrared spectrum(NIR)consistency model of Cortex Moutan was established by near-infrared spectroscopic methodology.Results showed that the total aerobic microbial,the total combined yeast/mold and the bile-tolerant gram-negative bacteria in the Cortex Moutan decreased below the standard of USP-NF2023 when treated with 5 kGy.The similarity of fingerprints decreased with the increasing of irradiation absorbed doses.The water extract against staphylococcus aureus before and after irradiation in each sample showed no significant difference(P>0.05).The near-infrared spectral consistency evaluation model was established to determinate the irradiated samples.^(60)Co-γirradiation sterilization may affect the quality of Cortex Moutan,and thus the irradiation sterilization absorption dose was recommended not exceeded 5 kGy.Overall,this study provided a basis for the use of ^(60)Co-γirradiation on Cortex Moutan.