| 引用本文: | 郭莘,史道华.18F-16α-17β-氟雌二醇注射液细菌内毒素检查法的建立[J].中国现代应用药学,2013,30(3):322-326. |
| GUO Shen,SHI Daohua .Establishment of Bacterial Endotoxin Test for 18F-16α-17β-Fluoroestradiol(18F-FES) Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(3):322-326. |
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| 摘要: |
| 目的 建立18F-16α-17β-氟雌二醇(18F-FES)注射液细菌内毒素检查法。方法 参照中国药典2010年版二部附录ⅥE收载的细菌内毒素检查法进行试验。结果 18F-FES注射液稀释10倍时对细菌内毒素检查无干扰，其细菌内毒素限值为5 EU·mL-1。10批样品的细菌内毒素检查均符合规定。结论 所建立的细菌内毒素检查法操作简单，重复性好，方法可靠，可用于18F-FES注射液的细菌内毒素检查。 |
| 关键词: 18F-16α-17β-氟雌二醇注射液 细菌内毒素检查 干扰试验 |
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| Establishment of Bacterial Endotoxin Test for 18F-16α-17β-Fluoroestradiol(18F-FES) Injection |
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GUO Shen1,2, SHI Daohua 1,3
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1.College of Pharmacy, Fujian Medical University, Fuzhou 350108, China;2.Centre of PET-CT, Fujian Provincial Hospital, Fuzhou 350001, China;3.Department of Pharmacy, Fujian Provincial Maternity and Children Health Hospital, Fuzhou 350001, China
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| Abstract: |
| OBJECTIVE To establish the method of bacterial endotoxin test for 18F-16α-17β-fluoroestradiol(18F-FES) injection. METHODS The test procedure was carried out according to the bacterial endotoxin test in China Pharmacopoeia (2010) VolumeⅡ. RESULTS Ten-fold dilution of 18F-FES injection had no interferential effect on the bacterial endotoxin test. The limit value of the bacterial endotoxin was 5 EU·mL-1. The results of bacterial endotoxin test were conformed to the required stipulation in 10 batches of samples. CONCLUSION The method of bacterial endotoxin test can be used to control the quality of 18F-FES injection. |
| Key words: 18F-16α-17β-fluoroestradiol(18F-FES) bacterial endotoxin test interference test |
