胸腺肽注射液及系列产品生产新工艺的研究

Study of New Manufacturing Technology On the Thoracico—gland Peptide Injection

本文通过对超滤法生产胸腺肽注射液的传统工艺进行改进和简化,建立了以胸腺匀浆中加入一定量的胶原酶并用盐酸调整 pH4.6的新生产工艺,同时采用了先后两次以分子量1万道尔顿和8千道尔顿的超滤膜包进行越滤。经过超滤后半成品测试表明,蛋白含量提高了3.9倍,胸腺肽收率提高3.2倍。采用新生产工艺生产了近100批产品,产品质量稳定,安全性良好,重复性良好,并有操作简便的特点。

According to having improved and simplified the traditional technology of the ehoracico- gland peptide with the super—filter plant,we built new manufacturing technology which the thoracico- gland peptide even liquid was added the collager ferment and adjusted its value of ph(ph4.6)with hydrochloric acid,at the same time,we took the way of super—filler with 1000000 Dolton and 8000 Dolton respectively,its protein of semifinished product increased 3.9 times and the thoracico—gland peptide increased 3.2times after being super-filtered.We have produced 100 batch product by this new manufacturing technology,They have steady product quality,good salty and duplicity,simple operation.