论文部分内容阅读
我国现行的第8次胰岛素国家标准品是猪胰岛素，而国内DNA重组人胰岛素（rh－Insulin）已获新药证书，其质量标准已被我国部颁标准收载，拟上2000版中国药典。因此迫切需要建立与临床供试品同质的国家标准品，为此制备、标定了第一次rh-Insulin国家标准品。经生物测定和HPLC测定，活性效价定为26IU／mg。
China’s current 8th insulin national standard is porcine insulin, and domestic recombinant DNA (rh-Insulin) has been a new drug certificate, the quality standards have been included in our ministerial standards, to be on the 2000 version of the Chinese Pharmacopoeia. Therefore, there is an urgent need to establish a national standard with clinical samples for testing, preparation, calibration of the first rh-Insulin national standards. Bioassay and HPLC determination, the activity of titers set at 26IU / mg.