复合维生素B注射液致家兔肌肉刺激的研究  

The stimulation induced by Vitamin B Complex Injection in rabbit muscle irritation test

作　　者：吴彦霖 耿颖 张媛 张铭露 何兰 高华 WU Yan-lin;GENG Ying;ZHANG Yuan;ZHANG Ming-lu;HE Lan;GAO Hua(Division of Pharmacology,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China;Division of Chemical Drug,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所药理室,北京102629 [2]中国食品药品检定研究院化学药品检定所化药室,北京102629

出　　处：《中国新药杂志》2022年第18期1838-1844,共7页Chinese Journal of New Drugs

摘　　要：目的:考察出现可见异物现象的复方维生素B注射液对家兔股四头肌肌肉刺激现象及刺激物的鉴定。方法:选取2个厂家的出现可见异物现象的复方维生素B注射液进行家兔股四头肌的肌肉刺激实验,对照组为同厂家未检出可见异物的复方维生素B注射液,阳性组为1.7%(w/v)乙酸溶液。选取2个厂家的出现可见异物现象的复方维生素B注射液进行L929细胞毒性实验。通过扫描电镜确定出现可见异物现象的复方维生素B注射液中可见异物的成分。结果:2个厂家的出现可见异物现象的复方维生素B注射液均导致家兔股四头肌产生肌肉刺激和炎症,对照组为阴性。与可见异物未检出的复合维生素B注射液相比,出现可见异物现象的复方维生素B注射液导致L929细胞毒性结果无明显差异。扫描电镜结果筛查出出现可见异物现象的复合维生素B注射液玻璃安瓿瓶的瓶底和内表面出现不同程度的侵蚀和脱片现象。结论:出现可见异物现象的复方维生素B注射液对家兔股四头肌肌肉产生局部刺激和炎症反应,刺激物为安瓿瓶内玻璃片样的脱落物。Objective:To investigate muscle irritation caused by the visible foreign matter unqualified Vitamin B Complex Injection in rabbit and identify the stimulus.Methods:Vitamin B complex injections from two manufacturers with unqualified visible foreign matters were tested for muscle irritation in rabbit,using the the qualified injection as the negative control and 1.7%(w/v)acetic acid solution as the positive control.Vitamin B complex injections from two manufacturers with unqualified visible foreign matters were tested for L929 cell toxicity.To determine The visible particles in unqualified Vitamin B complex injection with visible foreign matter were observed using scanning electron microscopy(SEM).Results:Compared with Control,unqualified Vitamin B complex injection with visible particles from two companies both caused stimulation and inflammation.There were no obvious difference between visible particle-unqualified and-qualified Vitamin B complex injection in L929 cell toxicity test.By SEM,glass take-off and erosion were investigated in unqualified Vitamin B complex injection,which is in different degrees observed at the bottom and inner surface of the ampoules.Conclusion:The visible particle-unqualified Vitamin B complex injection caused rabbit muscle irritation and inflammation,which may be caused by pieces of glass taken off from the ampoule.

关 键 词：家兔肌肉刺激 玻璃脱片 安瓿瓶侵蚀 复合维生素B注射液 可见异物 

分 类 号：R965[医药卫生—药理学]