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目的:研究神经生长因子(NGF)冻干制剂及其水溶液在不同条件下贮存的稳定性。方法:将纯化得到的小鼠颌下腺2.5S NGF加入赋形剂和保护剂制成冻干制剂及其水溶液。冻干制剂-20℃以下,4℃,室温和40℃贮存。水溶液在4℃和40℃贮存。经6,30,60,90,180和360 d测定各样本的活性。结果:冻干制剂在-20℃以下和4℃贮存360 d,室温贮存90 d40℃贮存30 d,其活性保持稳定。水溶液在4℃贮存60 d,40℃贮存6 d,活性无改变。结论:NGF冻干制剂是稳定的,较高的温度和湿度不利于贮存。
Objective: To study the stability of nerve growth factor (NGF) lyophilized preparation and its aqueous solution under different conditions. Methods: Purified mouse submandibular gland 2.5S NGF was added into excipient and protectant to make lyophilized preparation and its solution. Freeze-dried formulations below -20 ° C, 4 ° C, room temperature and 40 ° C. The aqueous solution is stored at 4 ° C and 40 ° C. The activity of each sample was determined at 6, 30, 60, 90, 180 and 360 d. Results: The freeze-dried preparations were stored below -20 ℃ and 4 ℃ for 360 days, stored at room temperature for 90 days and stored at 40 ℃ for 30 days. The activity remained stable. The aqueous solution was stored at 4 ℃ for 60 days and stored at 40 ℃ for 6 days without any change in activity. Conclusion: NGF freeze-dried formulations are stable, and higher temperatures and humidities are not conducive to storage.