胶体磷[^(32)P]酸铬注射液无菌检查及核纯度检查方法研究

Sterility and Radionuclide Purity Examination Methods of Colloidal Chromium Phosphate[^(32)P] Injection

对胶体磷[^(32)P]酸铬注射液的无菌检查和核纯度检查方法进行研究,以对其无菌检查方法进行验证并建立核纯度检查方法。结果表明,可采用直接接种法,接种0.2 mL供试品至7.5 mL培养基管进行该产品的无菌检查;在核纯度检查方面,对放射性吸收套进行设计加工,改变了主核素和杂质核素测量比,用高纯锗γ谱仪测量出γ杂质的活度,用活度计测量出^(32)P活度,根据^(32)P和杂质核素的活度计算^(32)P核纯度。检查方法经验证准确可靠、简单易行,为产品的质量控制提供保证。

The sterility and radionuclide purity analytical methods of colloidal chromium phosphate[-（32）P]injection were investigated to validate the sterility examination and establish the radionuclide purity analytical method.It was indicated that the direct inoculation method can be used with 0.2 mL samples inoculated into 7.5 mL medium to conduct the sterility analysis.Regarding the radionuclide purity test,radioactive absorbing sleeve was designed and processed,which changed the measurement ratio of main nuclide and impure nuclide.In the work,the activity of γ impurities was measured by the highly purified germanium gamma spectrometer,followed by the analysis of the-（32）P activity using the activity meter.The radionuclide purity of-（32）P was eventually calculated based on the activity of-（32）P and impure nuclide.The analytical method is revealed to be conducted to ensure good quality control of the product.