注射用复合辅酶渗透压摩尔浓度考察与肌肉刺激实验研究  

Osmolarity and muscle stimulation test of coenzyme complex for injection

作　　者：吴森 吕晓君 韩玮 王平慧 杨雅婷 周大庆 沈佳特 WU Sen;LYU Xiao-jun;HAN Wei;WANG Ping-hui;YANG Ya-ting;ZHOU Da-qing;SHEN Jia-te(Hubei Institute for Drug Control,Wuhan 430064;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430064)

机构地区：[1]湖北省药品监督检验研究院,武汉430064 [2]湖北省药品质量检测与控制工程技术研究中心,武汉430064

出　　处：《中南药学》2022年第4期812-816,共5页Central South Pharmacy

摘　　要：目的对不同批次的注射用复合辅酶渗透压摩尔浓度进行考察,并观察其对家兔的肌肉刺激性。方法32批注射用复合辅酶分别用50 mL 5%葡萄糖注射液(临床用于静脉滴注)或1 mL、2 mL 0.9%氯化钠注射液(临床用于肌内注射)溶解后检测渗透压摩尔浓度;4批注射用复合辅酶分别用1 mL、2 mL 0.9%氯化钠注射液配制成高、低剂量溶液进行肌肉刺激实验,采用家兔同体左右侧自身对比法、股四头肌注射方式,单次给药,1 mL/只,于给药后48 h剖检观察注射局部的刺激反应并进行组织病理学检查。结果注射用复合辅酶在临床静脉滴注时,渗透压与正常人体相近;肌内注射时的渗透压远大于正常人体的范围,与其对家兔产生的肌肉刺激的严重程度成正相关。不同剂量的注射用复合辅酶对家兔的肌肉刺激等级分别为无、轻度、中度、重度,其肌肉刺激性反应呈现剂量依赖性。结论注射用复合辅酶对家兔有肌肉刺激性,可能与其渗透压摩尔浓度有关。Objective To determine the osmolarity of different batches of coenzyme complex for injection,and observe its muscle stimulation in rabbits.Methods Thirty-two batches coenzyme complex for injection were respectively dissolved with 50 mL 5%glucose injection(intravenous drip)or 0.9%sodium chloride injection(1 mL or 2 mL,intramuscular injection).The osmolarity of coenzyme complex solution was detected.Four batches coenzyme complex for injection were prepared into a high-dose and low-dose solution with 1 mL or 2 mL 0.9%sodium chloride injection,for the muscle stimulation test.The quadriceps femurs were injected before comparing the left and right sides of the same rabbits.After the single administration(1 mL for a animal).The local stimulation reaction was observed and histopathological examination was carried out 48 hours after the administration.Results The osmolarity in rabbits was similar to that of normal human body when the coenzyme complex was used for intravenous drip.The osmolarity of coenzyme complex for intramuscular injection in rabbits was much higher than that in normal human body,with positive correlation between the osmolarity and the severity of muscle stimulation in rabbits.Conclusion The coenzyme complex for injection may stimulate the muscles in rabbits which may be related to its osmolarity.

关 键 词：注射用复合辅酶 渗透压摩尔浓度 肌肉刺激 

分 类 号：R965[医药卫生—药理学]