^18F-脱氧葡萄糖注射液质量研究

Quality study on ^18F-fluorodeoxyglucose injection

目的考察国内医疗机构制备的^18F-脱氧葡萄糖（FDG）注射液的质量状况，并验证国家食品药品监督管理局标准YBH05262005（试行）用于不同医疗机构、采用不同工艺制备的^18F-FDG注射液质量控制的适用性。方法依据国家食品药品监督管理局标准YBH05262005（试行）对不同医疗机构、采用不同生产工艺制备的33批^18F-FDG注射液样品进行全项检验；对国家食品药品监督管理局标准YBH05262005（试行）中的部分项目进行方法学验证实验；任选其中16批样品，按顶空进样毛细管气相色谱法进行有机溶剂残留量检验，并进行了方法学研究。结果（1）33批^18F-FDG注射液样品中，6批样品的检验结果不符合国家食品药品监督管理局标准YBH05262005（试行）规定。（2）方法学验证实验结果表明，国家食品药品监督管理局标准YBH05262005（试行）“【鉴别】（3）”项规定的^18F-FDG附值范围（0．6～0．7）与实验结果（0．9～1．0）有一定差异，其他项目方法适于注射液的质量控制。（3）方法学研究结果表明，顶空进样毛细管气相色谱法适于样品有机残留量的检查，16批样品检验结果中有1批样品的乙腈残留量（0．510 64％）超出中国药典（2005年版）二部附录（ⅧP）和美国药典（31版）规定的限度，乙醚和乙醇残留量结果均符合上述中国和美国药典规定。结论为确保^18F-FDG注射液用药安全有效，其制备医疗机构需进一步加强制备和质量管理；国家食品药品监督管理局标准YBH05262005（试行）也需进一步完善，如修订“【鉴别】（3）”，并增订有机溶剂残留量检查项等。

Objective This study was to survey the quality of lSF-fluorodeoxyglucose （FDG） injection prepared by medical institutions in China, and to validate the applicability of the national standard for FDG injection prepared through different preparation procedures and by different medical institutions. Methods According to the national standard for FDG injection, the full quality control tests on 33 batches of FDG injection prepared through different preparation procedures and by different medical institutions were carried out. The method validation on part quality control testing of the national standard for FDG injection was performed. Residual solvents were tested on 16 batches of FDG injection by use of Headspace Sampling Capillary Gas Chromatography, and the method was also validated. Results The results of 6 batches of FDG injection did not conform to the national standard. The measurement results of Rf value of FDG injection was lower than the national standard （0.6 -0.7 vs 0.9 - 1.0）. Of the 16 batches, the residual acetonitrile did not conform to Chinese Pharmacopoeia （2005 edition） and US Pharmacopoeia （ 31 edition）. All the results of aether and ethanol conform to Chinese Pharmacopoeia （2005 edition） and US Pharmacopoeia （31 edition）. Conclusions To have the maximum benefit of patients who had FDG injection, quality as- surance of FDG before injection was warrant. In keeping with the international standard, revision of Chinese Pharmacopoeia （2005 edition） was essential.