摘要
目的:为修订《中国药典》2005年版相关质量标准,对国内不同企业的胰激肽原酶的产品纯度进行了质量评价,并制定合理的方法限度。方法:采用HPLC和SDS-PAGE电泳两种不同的方法测定了胰激肽原酶的纯度。结果:不同企业生产的胰激肽原酶的纯度具有差异,个别企业胰激肽原酶原料药纯度达到100%。结论:HPLC和SDS-PAGE电泳两种方法均能有效地控制胰激肽原酶的纯度,提高产品的纯度有利于稳定性的增强。
Objective： In order to improve the quality standard of pancreatic kininogenase in Chinese Pharmacopoeia 2005 Edition, the purity of pancreatic kininogenase from some domestic factories was determined and an appropriate method limit was established. Method ： The purity of pancreatic kininogenase was determined by HPLC and SDS-PAGE method, respectively. Result： The purity of pancreatic kininogenase from different factories was not the same,and one of them reached 100%. Conclusion： Both HPLC and SDS-PAGE method can effectively control the pancreatic kininogenase purity. Purity improvement can lead to more promising stability of the product.
出处
《中国药师》
CAS
2011年第2期179-181,共3页
China Pharmacist
