CAJ | 학술논문

为了提高生产效率，降低生产成本，对注射用亚叶酸钙的冻干曲线进行优化。采用正交实验法L9（3^4）考察不同冻干参数对注射用亚叶酸钙成品质量的影响。优化之后的冻干工艺参数为：预冻温度-50℃，时间2．5h；升华干燥温度变化从-50℃升温至-20℃，再由-20℃升温至-10℃，总耗时14h，真空压力0．15mbar，解析干燥温度30℃，真空压力为0．02mbar，终点测试压力无变化时结束。对亚叶酸钙冻干参数筛选优化后，可得到较佳的冻干曲线，经验证该曲线适用于生产。
위료제고생산효솔，강저생산성본，대주사용아협산개적동간곡선진행우화。채용정교실험법L9（3^4）고찰불동동간삼수대주사용아협산개성품질량적영향。우화지후적동간공예삼수위：예동온도-50℃，시간2．5h；승화간조온도변화종-50℃승온지-20℃，재유-20℃승온지-10℃，총모시14h，진공압력0．15mbar，해석간조온도30℃，진공압력위0．02mbar，종점측시압력무변화시결속。대아협산개동간삼수사선우화후，가득도교가적동간곡선，경험증해곡선괄용우생산。
In order to improve the production efficiency and reduce the production cost, the optimized freeze drying process for Calcium Folinate for Injection was studied. The parameters of Calcium Folinate for Injection were optimized by means of orthogonal experimental design L9 (34). The optimized parameters were that prepare freezing temperature was at -50 ℃, time was 2.5 h, sublimation temperature was -50 ℃→ -20 ℃→10 ℃ and for 14 h, main drying vacuum was at 0. 15 mbar, desorption temperature was at 30 ℃, and main drying vacuum was at 0. 02 mbar, and the process was not finished until the vacuum pressure was stable. The optimized freeze drying strategy of Calcium Folinate for Injection was obtained by screening the parameters and it was applicable for the production.