摘要
目的：研究注射用单磷酸阿糖腺苷与阿昔洛韦注射液的最佳配伍方案。方法选择温度、光照、放置时间、溶媒、溶媒用量5个影响因素，采用L18（35）正交试验表，用GWJ-4型智能微粒分析仪测定溶液中微粒含量，用HPLC法测定溶液中单磷酸阿糖腺苷与阿昔洛韦含量，对注射用单磷酸阿糖腺苷与阿昔洛韦注射液的配伍方案进行优选研究。结果单磷酸阿糖腺苷与阿昔洛韦的回归方程分别为A＝3.78×10^4C＋2.32， r＝0.9997（n＝5）；A＝7.11×10^5C－4.65， r＝0.9995（n＝5），结果表明，2者分别在200～900μg／mL与1000～4500μg／mL范围内线性关系良好。优选的最佳配伍条件为A2 B1 C2 D1 E1，即25℃、尽量避光，注射用单磷酸阿糖腺苷1支（0.1 g／支）和阿昔洛韦注射液1支（10 mL：0.5 g）与100 mL 0.9％氯化钠注射液配伍，且在配伍后的4 h内滴完。结论优选的最佳配伍方案重复性良好，溶液质量稳定，为临床安全合理用药提供科学参考。
Objective To study optimal compatibility scheme of vidarabine monophosphate for injection combined with aciclovir injection. Methods L18（35） of orthogonal design was used with five factors： temperature, illumination,storage time,solvent and solvent dosage;the insoluble particles were observed by GWJ-4 type particle analyzer.The content of vidarabine monophosphate and aciclovir was detected by HPLC.Optimization of the best scheme of vidarabine monophosphate for Injection combined with aciclovir injection was studied.Results The regression equation of vidarabine monophosphate and aciclovir were A=3.78 ×10^4C＋2.32, r=0.9997（n=5）and A=7.11×10^5C-4.65, r=0.9995（n=5）,The results showed that the relationship between the range of 200-900μg/mL（vidarabine monophosphate） and the range of 1000-4500μg/mL（aciclovir） was good.The optimal compatibility conditions are the follows：temperature of 25,as far as possible away from light;Vidarabine monophosphate for injection 1 （0.1 g/branch） and 1 acyclovir injection （10 mL：0.5 g） mixed with 100 mL 0.9% sodium chloride injection,and dropping out within 4 h after compatibility. Conclusion The optimal compatibility scheme has good repeatability,injection solution stability is good.It prouides scientific reference for the safty of clinical rational drug use.
出处
《中国生化药物杂志》
CAS
2015年第6期143-146,共4页
Chinese Journal of Biochemical Pharmaceutics
关键词
注射用单磷酸阿糖腺苷
阿昔洛韦注射液
正交试验
最佳配伍
vidarabine monophosphate for injection
aciclovir injection
orthogonal test
optimize compatible
