目的:对复方感冒灵颗粒经不同剂量强度的60Co辐照灭菌前后的安全性进行评价。方法:急性毒性试验以动物最大耐受剂量灌胃给药,观察急性毒性反应和死亡情况;30 d喂养试验观察大鼠的一般行为情况、体质量、血液学指标、血清生化指标、各脏器质量及脏器系数(脏器与体重的比值)。结果:急性毒性试验结果为未发现毒性反应。30 d喂养试验结果,与对照组相比,不同剂量强度辐照后各组大鼠一般情况、体质量无显著性差异,但血液学指标、血液生化指标、脏器质量及脏器系数、病理组织学检查均出现不同程度的改变,尤其集中在10 kGy辐照后雄性大鼠肝脏及生殖系统方面,但该变化可逆。结论:高剂量60Co辐照可能造成雄性大鼠肝损伤及生殖系统改变。
Objective: To evaluate the safety of Ganmaoling compound granules before and after 60Co irradiation with different dose intensities. Methods: In the acute toxicity test, the maximum tolerated dose was administered by gavage, and the acute toxicity and death were observed. The results of 30 days feeding test showed that compared with the control group, there was no significant difference in general condition and body mass of rats in each group after different dose intensity irradiation, but hematological indexes, serum biochemical indexes, viscera mass and organ coeffeicient(visceral body ratio), histopathological examination showed different degrees of changes, especially in coagulation of female rats, liver and reproductive system of male rats after 10 kGy irradiation. Results: The results of acute toxicity test were not found to be toxic. The results of 30 days feeding test showed that compared with the control group, there was no significant difference in general condition and body mass of rats in each group after different dose intensity irradiation, but hematological indexes, serum biochemical indexes, viscera mass and organ coefficient, histopathological examination showed different degrees of changes, especially in the liver and reproductive system of male rats after 10 kGy irradiation, but the change was reversible. Conclusion: High dose 60Co irradiation may cause liver injury and reproductive system changes in male rats.
[1] 雷震,杨光义,叶方,等.黄精多糖药理作用及临床应用研究概述[J].中国药师,2012,1(1):114
LEI Z, YANG GY, YE F, et al. Summary of pharmacological action and clinical application of Polygonatum polysaccharide[J].China Pharm, 2012, 1(1):114
[2] 中华人民共和国药典2020年版.四部[S]. 2020:204
ChP 2020. Vol Ⅳ[S]. 2020:204
[3] 白洁,迟玉明,金红宇,等.《中药辐照灭菌技术指导原则》解读[J].中成药,2017,39(7):1537
BAI J, CHI YM, JIN HY, et al. Interpretation of the guiding principles of irradiation sterilization technology of traditional Chinese medicine[J].Chin Tradit Pat Med,2017,39(7):1537
[4] 白羽.60Co-γ射线辐照对中药化学成分影响及辐照中药鉴定的热释光分析法研究[D]. 长春:吉林大学,2014
BAI Y. Effect of Gamma Irradiation on the Ingredients of Herbs and Detection Analysis Methods for Irradiated Herbs by Thermoluminescence[D]. Changchun: Jilin University,2014
[5] 牟学文,田喜莲.60Co-γ辐照对红花药材及醇提取物羟基红花黄色素A的影响[J].中国药事, 2012,26(3):232
MOU XW,TIAN XL.Influence of 60Co-γ ray radiant sterilization on the hydroxylsafflor yellow A in corthamus flower and ethanol extracts from carthamus flower[J].Chin Pharm Aff, 2012,26(3):232
[6] 赵安莎,孙于兰,周蓉,等.SD大鼠30天喂养试验血液学指标和血清生化指标参考值探讨[J].中国比较医学杂志,2003,13(1):13
ZHAO AS, SUN YL, ZHOU R, et al. Study of normal value ranges for hematology and biochemical indexes in serum of SD rat in 30 day feeding test[J].Chin J Comp Med,2003,13(1):13
[7] 孟兰贞,罗志平,李文萍,等.60Co-γ辐照灭菌对三七超微粉有效成分及止血作用的影响[J].今日药学,2017,27(8):510
MENG LZ, LUO ZP, LI WP, et al. Effects of 60Co-γ radiation sterilization on the active components and hemostatic function of superfine powders of Panax notoginseng[J].Pharm Today,2017,27(8):510
[8] 孙于兰,赵安莎,周蓉,等.SD大鼠30天喂养试验食物利用率及脏器系数正常值探讨[J].现代预防医学,2003,30(1):36
SUN YL, ZHAO AS, ZHOU R, et al. Study of normal value ranges for food efficiency ratio and organs relative weight of SD rats in the 30 day feeding test[J].Mod Prev Med,2003,30(1):36
[9] 李计萍.γ射线辐照灭菌法在中药及其制剂中应用现状和相关问题讨论[J].中国中药杂志,2007,19(32):2078
LI JP. Application status and related problems of γ-ray irradiation sterilization in traditional Chinese medicine and its preparations[J].China J Chin Mater Med,2007,19(32):2078
[10] 陈天朝,徐丽军,宋薇.中药固体制剂灭菌技术研究现状、问题及对策[J].中医学报,2003,28(182):1015
CHEN TC, XU LJ, SONG W. Sterilization research status, problems and the countermeasures of Chinese medicine solid preparation[J].China J Chin Med,2003,28(182):1015
[11] 张世才,李奉勤,史冬霞,等.辐照灭菌在中药方面的应用研究进展[J].中国药业,2009,18(20):76
ZHANG SC, LI FQ, SHI DX, et al. Research progress of irradiation sterilization in traditional Chinese medicine[J].China Pharm,2009,18(20):76
[12] 吉训恋,钟绍金,张雁.不同剂量60Co-γ射线辐照对小儿感冒颗粒挥发性成分的影响[J].药物分析杂志,2019,39(6):1011
JI XL, ZHONG SJ, ZHANG Y. Effect of different doses of 60Co irradiation on volatile components in children cold granules[J].Chin J Pharm Anal,2019,39(6):1011
[13] 李月梅,刘卫红,张娜娜,等.60Co-γ射线辐照前后大黄饮片中5种成分的含量变化研究[J].中国药房,2013,24(3):254
LI YM, LIU WH, ZHANG NN, et al. Research of content change for 5 components in Rhei Radix et Rhizoma decoction pieces before and after irradiation by 60Co-γ ray[J].China Pharm,2013,24(3):254
[14] 林春,张屏.低强度微波辐射对小鼠生殖功能的影响[J].海峡预防医学杂志,2012,18(3):55
LIN C, ZHANG P. Effects of low intensity microwave radiation on reproductive function in mice[J].Strait J Prev Med,2012,18(3):55
[15] 朱寿彭,王六一,胡启跃,等.睾丸中滞留的不同辐射体核素诱发生殖毒性比较研究[J].中华放射医学与防护杂志,1996,16(5):302
ZHU SP, WANG LY, HU QY, et al. Comparative study on retentive peculiarity in testes and reproductive toxicity induced by different radiators[J].Chin J Radiol Med Prot,1996,16(5):302
[16] 陈伟盛,简敏骞,关倩明,等.中药合理辐照灭菌剂量设定的初步研究[J].核农学报,2017,31(8):1515
CHEN WS, JIAN MQ, GUAN QM, et al. Study on reasonable irradiation sterilization dose setting of traditional Chinese medicine[J].J Nucl Agric Sci,2017,31(8):1515
