帕立骨化醇亚微乳注射剂的溶血性和血管刺激性实验 - 中国药房.pdf

帕立骨化醇亚微乳注射剂的溶血性和血管刺激性实验 ＊ 兰 洁 ，刘青春（重庆华邦制药有限公司，重庆 401121） 中图分类号 R965 文献标志码 A 文章编号 1001-0408（2014）21-2326-03 DOI 10.6039/j.issn. 1001-0408.2014.21.08 摘 要 目的：评价帕立骨化醇亚微乳注射剂的溶血性和血管刺激性。方法：以家兔红细胞为受试物，设帕立骨化醇亚微乳注射 剂（样品）组和市售帕立骨化醇注射液（市售品）组各5个剂量，加药量（5μg/ml ）分别为每管0.5、0.4、0.3、0.2、0.1ml ，观察3h 内的溶 血和红细胞凝聚情况，同时设阴性对照（0.9％氯化钠注射液）组和阳性对照（纯化水）组进行比较。取家兔随机分为5μg/ml 样品 和市售品的单次给药组和多次给药组，采用同体左右侧自身对比法，耳缘静脉左侧注射供试品0.5ml ，右侧注射0.9％氯化钠注射 液0.5ml ，多次给药试验隔天给药1次，共给药5次，观察注射部位血管刺激性症状，并进行病理组织学检查。结果：阴性对照组细 胞未见出现溶血和红细胞凝聚；阳性对照组细胞发生全溶血，未见红细胞凝聚；各剂量样品组和市售品组细胞3h 内均未出现溶血 或红细胞凝聚。样品的单次给药组和多次给药组家兔耳缘静脉均未见血管刺激性；市售品的单次给药组和多次给药组家兔耳缘 静脉均有血栓形成，对血管有轻度刺激性。结论：5μg/ml 的帕立骨化醇亚微乳注射剂对家兔未见溶血性和血管刺激性。 关键词 帕立骨化醇亚微乳注射剂；溶血性；血管刺激；兔 Hemolysis and Vascular Irritation of Paricalcitol Submicroemulsion Injection LAN Jie ，LIU Qing-chun （Chongqing Huapont Pharmaceutical Co. ，Ltd. ，Chongqing 401121，China ） ABSTRACT OBJECTIVE ：To evaluate the hemolysis and vascular irritation of Paricalcitol submicroemulsion injection. METH- ODS ：The red blood cells of rabbit was taken as the subject and divided into Paricalcitol submicroemulsion injection groups （sam- ple group ）and marketed Paricalcitol injection groups （marketed product groups ）at 5 different dose levels including 0.5，0.4，0.3， 0.2 and 0.1ml/tube with adding amount of 5 μg/ml. The hemolysis and red cell condensation were observed within 3h. They were compared with negative control group （0.9％Sodium chloride injection）and positive control group （purified water ）. Rabbits were randomly divided into single administration group and multiple administration group of 5 μg/ml sample and marketed product. Us- ing the self comparison of left and right side ，rabbits of each test group were injected 0.5 ml test samples into the left ear vein while 0.5 ml 0.9％ Sodium chloride injection into the right ear vein. Multiple administrati