摘要
目的考察在不同溶剂、稀释度条件下,地西泮注射液的澄明度和不溶微粒数量,规范配置方法。方法将A厂、B厂地西泮注射液(分别简称A药、B药)分别用0. 9%氯化钠注射液或5%葡萄糖注射液按1∶5,1∶10,1∶20,1∶30,1∶40,1∶50,1∶100的比例稀释,在光学显微镜下计数不溶性微粒数量,分别在0,0. 5,1,2,4 h时肉眼观察并记录溶液澄明度变化。结果 A药按1∶5和1∶10倍稀释后分别在0. 5 h和4 h出现白色浑浊,B药按1∶5和1∶10倍稀释后立刻生成肉眼可见白色浑浊,且随静置时间增加浑浊程度逐渐增加,A药、B药按1∶20~1∶100倍稀释后溶液澄清且静置后无沉淀生成。同种药物使用0. 9%氯化钠注射液或5%葡萄糖注射液稀释后,未观察到两者的澄明度变化有明显差异。A药、B药的氯化钠稀释液在光学显微镜下都有不溶微粒的存在,其不溶微粒数随稀释度变大而减少。结论采用0. 9%氯化钠注射液或5%葡萄糖注射液高浓度稀释的地西泮注射液会出现浑浊现象,且溶液澄明度随静置时间延长而降低。
Objective To investigate the clarity and the number of insoluble particles in Diazepam Injections with dirt）rent solvents and dilution, in order to standardize the configuration method. Methods Diazepam Injections from A manufacturer（A drug） and B manufac- turer（B drug） were diluted with 0. 9% Sodium Chloride Injection and 5% Glucose Injection at ratio of 1： 5, 1： 10, 1： 20, 1： 30, 1：40, 1： 50, 1： 100. Insoluble particles of sodium chloride dilution were counted by optical microscope. The degree of turbidity was observed by naked eye at 0, 0.5, 1, 2, 4 h. Results The A drug was diluted in 5 times and 10 times volume of solvents, the white turbidity appeared after placing for 0.5 h and 4 h, respectively. The B drug was diluted in 5 times and 10 times volume of solvents, the white turbidity appeared immediately, the turbidity increased gradually with the increasing time. After dilution of A drug and B drug by 20- 100 times, the solution was clarified and there was no precipitation after placement. There was no significant dift-rence in the clarity after the same drug diluted by 0. 9% Sodium Chloride Solution and 5% Glucose Solution. Both sodium chloride diluent of two drugs had insoluble particles through counting by optical microscope, and the number of insoluble particles decreased with the dilution. Conclusion Di- azepam Injection with high concentration, which diluted in 0. 9% Sodium Chloride Injection or 5% Glucose Injection may has turbidity, and the clarity of the solution decreases with the placement time.
作者
王丽昕
张茜
施彬彬
Wang Lixin;Zhang Qian;Shi Binbin(Suzhou Hospital Affiliated to Nanjing Medical University,Suzhou,Jiangsu,China 215008;College of Pharmacy,Nanjing Medical University,Nanjing,Jiangsu,China 210029)
出处
《中国药业》
CAS
2018年第23期12-14,共3页
China Pharmaceuticals
