丹参破壁饮片对大鼠急性、长期毒性试验研究  

Study on the Effect of Ultrafine Granular Powder of Salvia miltiorrhiza on the Acute and Long-term Toxicity of Rats

作　　者：雷夏凌 马会 邓雯 陈炜璇 张前亮 柳璐 吴少华 成金乐 杨威 LEI Xialing;MA Hui;DENG Wen;CHEN Weixuan;ZHANG Qianliang;LU Lu;WU Shaohua;CHENG Jinle;YANG Wei(Cuangdong Lewwin Pharmaceutical Research Institute Co.,Ltd.,Guangdong Pronincial Key Laboratory of Drug Non-eclinicnal Evaluation and Research,TCM Non-clinic Exaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine,Guangdong Engineering Research Center for lanovatite Drug Evaluation and Research,Guangzhou,Cuangdong 510990,China;Neu Drug Evalution Center of Shandong Aecadermy of Pharmaceutical Sciences,Jinan,Shandong 250101,China;Zhongshan Zhongzhi Pharmaceutical Group Co.,Ltd.,Zhongshan,Cuangdong 528437,China;KeyLaboratory of Technologies and Applications of Ulrafine Granular Pouder of Herbal Medicine,State Administration of Traditional Chinese Medicine,Zhongshan,Guangdong 528437,China)

机构地区：[1]广东莱恩医药研究院有限公司,广东省药物非临床评价研究企业重点实验室,国家中药现代化工程技术研究中心中药非临床评价分中心,广东省创新药物评价与研究工程技术研究中心,广东广州510090 [2]山东省药学科学院新药评价中心,山东济南250101 [3]中山市中智药业集团有限公司,广东中山528437 [4]国家中医药管理局中药破壁饮片技术与应用重点研究室,广东中山528437

出　　处：《今日药学》2021年第7期522-525,529,共5页Pharmacy Today

基　　金：广东省省级科技计划项目(2018B020207008);中山市科技计划项目(2017A1033);广东省工程实验室(粤发改创新函[2018]3149号);中山市协同创新中心(2016C1014)国家地方联合工程研究中心(发改办高技[2019]180号);广东省药物非临床评价研究企业重点实验室(2018B030323024);广东省重点领域研发计划“新药创制”重点专项(2019B020202001)。

摘　　要：目的评价丹参破壁饮片对SD大鼠的非临床安全性,并与传统丹参饮片比较,为临床研究及应用提供参考信息。方法丹参破壁饮片、丹参饮片12.8g·kg^(-1)单次灌胃给予SD大鼠,持续观察2周;丹参破壁饮片1.6,3.2,6.4 g·kg^(-1),丹参饮片6.4 g·kg^(-1),连续26周灌胃给予SD大鼠,恢复期4周,观察动物的外观体征,进行体重、摄食量、血液学、血液生化学、病理学等各项检查。结果丹参破壁饮片12.8 g·kg^(-1)(最大给药剂量)、丹参饮片12.8 g·kg^(-1)单次灌胃给予SD大鼠后,未见明显毒性反应;SD大鼠连续26周灌胃给予1.6,3.2,6.4 g·kg^(-1)丹参破壁饮片,未见明显毒性反应。结论丹参破壁饮片与丹参饮片对SD大鼠安全性与传统饮片差异无统计学意义。OBJECTIVE To evaluate non-clinical safety of Ultrafine Granular Powder of Salvia miltiorrhiza in SD rats,and to provide reference information for clinical research and application by comparing with traditional slices of Salvia miltiorrhiza.METHODS SD rats were given Ultrafine Granular Powder of Salvia miltiorrhiza and Salvia miltiorrhiza decoction pieces by single intragastric administration at 12.8 g·kg^(-1)with 2 weeks observation.SD rats were given Ultrafine Granular Powder of Salvia miltiorrhiza at 1.6,3.2,6.4 g·kg^(-1),while Salvia miltiorrhiza decoction pieces were at 6.4 g·kg^(-1)by intragastric administration for 26 weeks with 4 weeks recovery observation,and animal appearance,weight,food intake,hematology,blood biochemistry,pathology examination were checked during the administration and recovery observation period.RESULTS No obvious acute toxicity was observed for SD rats that given 12.8 g·kg^(-1)of Ultrafine Granular Powder of Salvia miltiorrhiza(maximum dose)and 12.8 g·kg^(-1)of Salvia miltiorrhiza decoction pieces by single intragastric administration.For SD rats given 1.6,3.2 and 6.4 g·kg^(-1)of Ultrafine Granular Powder of Salvia miltiorrhiza,no obvious acute toxicity was observed.CONCLUSION There was no significant difference in the safety of Ultrafine Granular Powder of Salvia miltiorrhiza and Salvia miltiorrhiza decoction pieces.

关 键 词：丹参破壁饮片 丹参饮片 SD大鼠 急性毒性 长期毒性 

分 类 号：R99[医药卫生—毒理学]