摘要
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, p H 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.