目的 研究Emprove 低内毒素蔗糖、无水乳糖、Emprove 低内毒素葡萄糖、Emprove 低内毒素甘露醇、Emprove低内毒素山梨醇、Emprove 低内毒素氯化钾、Emprove 低内毒素甘氨酸7 种不同类型常用冻干保护剂对利巴韦林冻干粉针性能的影响.方法 以外观和复溶效果为指标,考察了预冻时间、冻干保护剂用量、冻干时间的影响.测定了空白粉针剂和利巴韦林粉针剂冻干后含水量、pH 值和利巴韦林质量分数.结果 以无水乳糖为冻干保护剂,预冻时间6 h,冻干时间9 h,保护剂用量4%;以Emprove 低内毒素氯化钾为冻干保护剂,预冻时间9 h,冻干时间9 h,保护剂用量4%;以Emprove 低内毒素甘露醇为冻干保护剂,预冻时间6 h,冻干时间6 h,保护剂用量4%;以Emprove 低内毒素甘氨酸为冻干保护剂,预冻时间12 h,冻干时间9 h,保护剂用量4%.所得冻干粉针外观饱满、平整,迅速、完全复溶.结论 无水乳糖、Emprove低内毒素氯化钾、Emprove 低内毒素甘露醇、Emprove 低内毒素甘氨酸4 种冻干保护剂更适合制备利巴韦林冻干粉针,可为水溶性药物冻干粉针剂的制备提供了参考.

Objective To study the effects of seven types of common freeze-drying powder protective agents (Emprove low endotoxin sucrose, lactose, Emprove low endotoxin glucose, Emprove low endotoxin mannitol, Emprove low endotoxin sorbitol, Emprove low endotoxin potassium chloride, and Emprove low endotoxin glycine) on properties of Ribavirin Freeze-dried Powder. Methods Appearance and re-dissolving performance of Ribavirin Freeze-dried Powder and its blank were as indexes, and time of pre-freezing, dosage of freeze-drying powder protective agents, and time of freeze-drying were studied, as well as moisture content, pH value, and ribavirincontent were determined. Results Lactose was used as freeze-drying powder protective agent with time of pre-freezing as 6 h, time of freeze-drying as 9 h, and dosage of freeze-drying powder protective agents as 4%; Emprove low endotoxin potassium chloride was used as freeze-drying powder protective agent with time of pre-freezing as 9 h, time of freeze-drying as 9 h, and dosage of freeze-drying powder protective agent as 4%; Emprove low endotoxin mannitol was used as freeze-drying powder protective agent with time of pre-freezing as 6 h, time of freeze-drying as 6 h, and dosage of freeze-drying powder protective agent as 4%; Emprove low endotoxin glycine was used as l freeze-drying powder protective agents with time of pre-freezing as 12 h, time of freeze-drying as 9 h, and dosage of freeze-drying powder protective agent as 4%. The products were full, smooth, and with complete re-dissolving performance. Conclusion Lactose, Emprove low endotoxin potassium chloride, Emprove low endotoxin mannitol, and Emprove low endotoxin glycine are suitable for preparations of Ribavirin Freeze-dried Powder, which can provide references on freeze-drying preparation of soluble drugs.