“即配即用”药物-哌拉西林钠他唑巴坦钠的配伍稳定性考察  

Compatible stability of instant formulation and immediate use of piperacillin sodium and tazobactam sodium for injection

作　　者：邱博[1] 杨浩天 安静[1] 董占军[1] Qiu Bo;Yang Hao-tian;An Jing;Dong Zhan-jun(Department of Pharmacy,Hebei General Hospital,Shijiazhuang 050051)

机构地区：[1]河北省人民医院药学部,石家庄050051

出　　处：《中国抗生素杂志》2021年第8期789-794,共6页Chinese Journal of Antibiotics

基　　金：河北省医学科学研究重点课题计划(No.20180045);河北省自然科学基金青年基金项目(No.H2020307020)。

摘　　要：目的考察“即配即用”药物注射用哌拉西林钠他唑巴坦钠与不同溶媒在不同条件下的配伍稳定性。方法注射用哌拉西林钠他唑巴坦钠与0.9%氯化钠注射液和5%葡萄糖注射液配伍,将配置好的溶液放置于40℃恒温、光照(4500Lx)、遮光和室温环境下,比较两种规格注射用哌拉西林钠他唑巴坦钠的性状、pH值、不溶性微粒和哌拉西林钠以及他唑巴坦钠的含量随时间变化情况。结果注射用哌拉西林钠他唑巴坦钠成品液在放置24h内,颜色未见明显变化。pH值在室温和遮光条件放置24h后略有下降;高温和光照条件下12h后pH值下降。配置后12h,各配伍液中≥10μm的微粒数目符合2020年版《中华人民共和国药典》的规定;在40℃恒温条件下,配置后8h配伍液中≥25μm不溶性微粒数目超出药典规定,与2.25g规格注射用哌拉西林钠他唑巴坦钠配伍液相比,1.25g规格配伍液中≥25μm不溶性微粒数目超出药典规定更多。在室温和遮光条件下两种主要有效成分的相对百分含量变化不大;在光照(4500 Lx)和40℃恒温条件下放置24h后,两种主要有效成分的相对百分含量均有下降。结论配置后8h内,不同规格(2.25g和1.25g)注射用哌拉西林钠他唑巴坦钠的成品输液稳定性无明显差异;配制8h后,2.25g规格配伍液稳定性优于1.25g规格配伍液;注射用哌拉西林钠他唑巴坦钠与0.9%氯化钠配伍,稳定性更好;高温和光照条件影响其成品液稳定性,建议注射用哌拉西林钠他唑巴坦钠配置后室温保存,并在8h内输注完毕。Objective To investigate the compatible stability of piperacillin sodium and tazobactam sodium for injection(PP/TZ)mixed with different solvents under different conditions.Methods Referring to clinical common concentration,different specifications of PP/TZ were respectively mixed with 100 mL glucose injection or 100mL sodium chloride injection.Under the conditions of room temperature,shading,illumination(4500 Lx),40℃in constant temperature environment,the appearance of mixtures,the pH value,and the number of insoluble particles were investigated at 0,1,2,4,8,12,24,and 48h.The contents of piperacillin sodium and tazobactam sodium in mixtures were determined by HPLC.Results Under above condition,the color of the mixtures changed slightly,precipitation and turbidity was found.There was slight change in the pH value under the condition of room temperature and shading,but the pH value significantly decreased after 12h under 40℃and illumination conditions.The number of≥10μm insoluble particles was in accordance with Chinese Pharmacopoeia at 12 h.The number of≥25μm insoluble particles exceeded the requirement of Chinese Pharmacopoeia at 8h under 40℃.Compared with the PP/TZ(2.25g),the number of insoluble particles≥25μm exceeded the requirement more than PP/TZ(1.25g).The relative percentage of the two main active ingredients changed little under room temperature and shading conditions.After 24 hours of exposure to light(4500 Lx)and constant temperature of 40℃,the relative percentage of the two main active ingredients decreased,and the content of tazobactam decreased more than piperacillin.Conclusion The stability of PP/TZ had no significant difference among different specifications within 8h.The stability of PP/TZ was more stable mixed with 0.9%sodium chloride.The 40℃in constant temperature and illumination conditions affect the stability of PP/TZ.It is recommended that PP/TZ should be stored at room temperature after configuration,and the infusion should be completed within 8h.

关 键 词：哌拉西林钠他唑巴坦钠 配伍稳定性 “即配即用”药物 高效液相色谱法 

分 类 号：R978.1[医药卫生—药品]