不同溶媒配制鹿瓜多肽注射液的稳定性研究  

Research on stability of cervus and cucumis polypeptide injection prepared with different solvents

作　　者：曾菲 张成 杨雅莉 李红[1] 刘小萍 康传哲[1] Zeng Fei;Zhang Cheng;Yang Yali;Li Hong;Liu Xiaoping;Kang Chuanzhe(Department of Pharmacy, Hospital 452 of PLA, Chengdu, Sichuan, 610021, China)

机构地区：[1]解放军452医院药剂科,成都610021

出　　处：《西南国防医药》2018年第3期225-227,共3页Medical Journal of National Defending Forces in Southwest China

摘　　要：目的考察4种常用溶媒配制鹿瓜多肽注射液的稳定性,优选最佳溶媒配制方案,为促进临床安全用药提供依据。方法按照药品说明书规定的用量,将鹿瓜多肽注射液用0.9%氯化钠注射液、葡萄糖氯化钠注射液、5%葡萄糖注射液、10%葡萄糖注射液4种临床常用溶媒分别配制,定时观察配制溶液的外观、pH值和不溶性微粒变化。结果鹿瓜多肽与4种溶媒混合配制后,外观和pH值均无明显变化,但不溶性微粒均随着配制时间的延长而增多,不溶性微粒增幅依次为10%葡萄糖注射液>5%葡萄糖注射液>葡萄糖氯化钠注射液>0.9%氯化钠注射液,4 h后≥10μm不溶性微粒数均超过2015年版《中国药典》规定的限度。其中与10%葡萄糖注射液配制1 h后,≥10μm不溶性微粒数就已超过药典规定的限度,4 h后≥25μm不溶性微粒数也超过2015年版《中国药典》规定的限度。结论鹿瓜多肽注射液最佳配制溶媒是0.9%氯化钠注射液,其次为葡萄糖氯化钠注射液和5%葡萄糖注射液,且配制后的溶液应在4 h内使用完毕,不建议使用10%葡萄糖注射液配制。Objective To explore the stability of cervus and cucumis polypeptide injection prepared with four common solvents,so as to determine the optimal preparation scheme and provide bases for drug-use safety in clinical practices. Methods Cervus and cucumis polypeptide injection was respectively prepared by use of four solvents commonly used in clinical practices： 0.9% sodium chloride injection, glucose and sodium chloride, 5% glucose injection and 10% glucose injection according to the dosage prescribed in the product instruction. The appearance, pH value and the change in insoluble particles in prepared solutions were regularly observed.Results There were no significant changes in the appearance and the pH of cervus and cucumis polypeptide injection after the preparation. It was found that the amount of insoluble particles increased with the prolongation of the time for preparation. According to the increment of insoluble particles, the sequence of the solvents is： 10% glucose injection 5% glucose injection glucose and sodium chloride 0.9% sodium chloride injection. After four hours, the amount of insoluble particles ≥10 μm exceeded the limits specified in Chinese Pharmacopoeia（2015） for all prepared solutions. One hour after the preparation with 10% glucose injection, the amount of insoluble particles ≥10 μm exceeded the limits specified in Chinese Pharmacopoeia（2015） for all prepared solutions. Four hours later, the amount of insoluble particles ≥25 μm exceeded the limits specified in Chinese Pharmacopoeia（2015） for all prepared solutions. Conclusion The 0.9% sodium chloride injection is the optimal solvent for preparing cervus and cucumis polypeptide injection, followed by glucose and sodium chloride and 5% glucose injection. The prepared solutions should be used up within four hours. It is not suggested to prepare the injection with 10% glucose injection.

关 键 词：鹿瓜多肽注射液 溶媒 配制 稳定性 

分 类 号：R285.5[医药卫生—中药学]