目的 研究Emprove 低內(nèi)毒素蔗糖、無(wú)水乳糖、Emprove 低內(nèi)毒素葡萄糖、Emprove 低內(nèi)毒素甘露醇、Emprove低內(nèi)毒素山梨醇、Emprove 低內(nèi)毒素氯化鉀、Emprove 低內(nèi)毒素甘氨酸7 種不同類型常用凍干保護(hù)劑對(duì)利巴韋林凍干粉針性能的影響.方法 以外觀和復(fù)溶效果為指標(biāo),考察了預(yù)凍時(shí)間、凍干保護(hù)劑用量、凍干時(shí)間的影響.測(cè)定了空白粉針劑和利巴韋林粉針劑凍干后含水量、pH 值和利巴韋林質(zhì)量分?jǐn)?shù).結(jié)果 以無(wú)水乳糖為凍干保護(hù)劑,預(yù)凍時(shí)間6 h,凍干時(shí)間9 h,保護(hù)劑用量4%;以Emprove 低內(nèi)毒素氯化鉀為凍干保護(hù)劑,預(yù)凍時(shí)間9 h,凍干時(shí)間9 h,保護(hù)劑用量4%;以Emprove 低內(nèi)毒素甘露醇為凍干保護(hù)劑,預(yù)凍時(shí)間6 h,凍干時(shí)間6 h,保護(hù)劑用量4%;以Emprove 低內(nèi)毒素甘氨酸為凍干保護(hù)劑,預(yù)凍時(shí)間12 h,凍干時(shí)間9 h,保護(hù)劑用量4%.所得凍干粉針外觀飽滿、平整,迅速、完全復(fù)溶.結(jié)論 無(wú)水乳糖、Emprove低內(nèi)毒素氯化鉀、Emprove 低內(nèi)毒素甘露醇、Emprove 低內(nèi)毒素甘氨酸4 種凍干保護(hù)劑更適合制備利巴韋林凍干粉針,可為水溶性藥物凍干粉針劑的制備提供了參考.

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.