摘要
目的研究微球制剂工艺条件下胸腺肽α1的稳定性。方法采用高效液相色谱法(HPLC),研究胸腺肽α1在不同温度(-20℃、6～8℃、60℃)、不同超声时间(10～60s)及不同pH值(4.0、7.0、10.0)条件下的稳定性。结果胸腺肽α1在-20℃冷冻保存7d时仍很稳定,冷藏(6～8℃)时30d内可保持稳定,60℃水浴中12h内不降解;400W超声60s内不受影响;37℃时置于pH4.0的磷酸盐中12h内比较稳定。结论胸腺肽α1在本制备工艺条件下具有良好的稳定性。
Objective:To observe the stability of thymosin α_1 microspheres under preparation conditions.Methods: Using HPLC method,we investigated the influence of different temperatures(-20 ℃, 6-8℃,60℃),sonification time(10-60 s) and pH values (pH 4.0,7.0 and 10.0) on thymosin α_1 stability.Results: Under the conditions of frozen environment(-20℃) and refrigeration(6-8℃), thymosin α_1 remained stable for 30 d.Thymosin α_1 did not degrade in 60℃ water bath for 12 h or in phosphate buffer solution(PBS,pH 4.0) under 37℃ for 14 h.The sonification time within 60 s was found to be safe for the preparation.Conclusion: Thymosin α_1 is stable under these preparation conditions.
出处
《第二军医大学学报》
CAS
CSCD
北大核心
2005年第5期555-557,共3页
Academic Journal of Second Military Medical University
关键词
胸腺肽Α1
色谱法
高压液相
稳定性
微球
Thymosin α_1
chromatography,high pressure liquid
stability
microspheres
