Wu Liqing, Takatsu Akiko, Park Sang-Ryoul, Yang Bin, Yang Huaxin, Kinumi Tomoya, Wang Jing, Bi Jiaming, Wang Yang
Division of Medical and Biological Measurements, National Institute of Metrology, No. 18 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100013, China,
Anal Bioanal Chem. 2015 Apr;407(11):3125-35. doi: 10.1007/s00216-014-8385-4. Epub 2014 Dec 23.
This article concerns the development and co-validation of a porcine insulin (pINS) certified reference material (CRM) produced by the National Institute of Metrology, People's Republic of China. Each CRM unit contained about 15 mg of purified solid pINS. The moisture content, amount of ignition residue, molecular mass, and purity of the pINS were measured. Both high-performance liquid chromatography-isotope dilution mass spectrometry and a purity deduction method were used to determine the mass fraction of the pINS. Fifteen units were selected to study the between-bottle homogeneity, and no inhomogeneity was observed. A stability study concluded that the CRM was stable for at least 12 months at -20 °C. The certified value of the CRM was (0.892 ± 0.036) g/g. A co-validation of the CRM was performed among Chinese, Japanese, and Korean laboratories under the framework of the Asian Collaboration on Reference Materials. The co-validation results agreed well with the certified value of the CRM. Consequently, the pINS CRM may be used as a calibration material or as a validation standard for pharmaceutical purposes to improve the quality of pharmaceutical products.
本文涉及由中华人民共和国国家计量院制备的猪胰岛素（pINS）标准物质（CRM）的研制及联合验证。每个CRM单元含有约15 mg纯化的固体pINS。对pINS的水分含量、炽灼残渣量、分子量和纯度进行了测定。采用高效液相色谱 - 同位素稀释质谱法和纯度扣除法测定pINS的质量分数。选取15个单元研究瓶间均匀性，未观察到不均匀性。稳定性研究得出结论，该CRM在-20℃下至少12个月稳定。该CRM的认定值为（0.892±0.036）g/g。在参考物质亚洲合作框架下，在中国、日本和韩国实验室之间对该CRM进行了联合验证。联合验证结果与CRM的认定值吻合良好。因此，pINS CRM可作为校准物质或用于制药目的的验证标准，以提高药品质量。
