临时用重组人干扰素α-2b鼻腔喷雾剂的配制和稳定性考察  

Preparation and stability of recombinant human interferonα-2b nasal spray for temporary use

作　　者：阮丽梅 倪晓燕[2] 吕凤文 陆静金 戴根苗[1] 程钢[1] RUAN Li-mei;NI Xiao-yan;LYU Feng-wen;LU Jing-jin;DAI Gen-miao;CHENG Gang(Department of Pharmacy,the First Affiliated Hospital of Anhui Medical University,Grade Three Pharmaceutical Chemistry Laboratory of State Administration of Traditional Chinese Medicine,Hefei 230022;Anhui Anke Biotechnology(Group)Co,Ltd,Hefei 230088)

机构地区：[1]安徽医科大学第一附属医院药剂科,国家中医药管理局中药化学三级实验室,合肥230022 [2]安徽安科生物工程(集团)股份有限公司,合肥230088

出　　处：《中南药学》2021年第8期1629-1633,共5页Central South Pharmacy

基　　金：安徽省临床重点专科建设项目(卫科教秘(2017)529号)。

摘　　要：目的考察重组人干扰素α-2b注射液配制成鼻腔喷雾剂后的稳定性,为一线医务人员防护新型冠状病毒肺炎提供保障。方法在无菌条件下将3批重组人干扰素α-2b注射液与0.9%氯化钠注射液混合配制成浓度为1.0×10^(6) IU·mL^(-1)的溶液,装入鼻腔喷雾装置,制成鼻腔喷雾剂;依据《中国药典》2015年版四部测定在不同的温度下[(5±3)℃、(25±2)℃、(37±2)℃]以及在振摇、冻融、模拟使用等影响因素下样品的外观、pH值、无菌、生物学活性。结果样品在(5±3)℃和(25±2)℃条件下保存3个月、在(37±2)℃条件下保存1个月,外观、pH值、无菌、生物学活性均无明显变化,符合质量标准;在振摇14 d、冻融4次及模拟使用后2个月后的外观、pH值、无菌、生物学活性均无明显变化,符合质量标准。结论该制剂稳定性良好,可作为新型冠状病毒肺炎预防用药在短期内供医务人员使用。Objective To determine the stability of nasal spray prepared by recombinant human interferonα-2b injection,and to ensure the safety for the front-line medical staff against corona virus disease 2019(COVID-19).Methods Three batches of recombinant human interferonα-2b injections were respectively filled into borosilicate glass vials,diluted to 1.0×10^(6) IU·mL^(-1) with physiological solution of sodium chloride,and sealed with spray pumps under aseptic conditions.The appearance,pH value,sterility and biological activity of the nasal spray were detected at(5±3)℃,(25±2)℃,and(37±2)℃under shaking,freezing and thawing,and simulated conditions according to the requirements in Chinese Pharmacopoeia(VolⅣ,2015 Edition).Results The appearance,pH value,sterility,and biological activity of the nasal spray met the quality standards after storage at(5±3)℃and(25±2)℃for 3 months and at(37±2)℃for 1 month,without obcious change.After repeated shaking for 14 d,freezing and thawing 4 times and simulation test for 2 months,no obvious changes in appearance,pH value,sterility and biological activity were found,which met the standard.Conclusion The spray is stable and can be used as a preventive drug for medical staff against COVID 19 in a short time.

关 键 词：新型冠状病毒肺炎 重组人干扰素Α-2B 鼻腔喷雾剂 稳定性 预防用药 

分 类 号：R95[医药卫生—药学]