尿素14C胶囊中14C核素的鉴别

Identification of 14C Nuclides in 14C-urea Capsules

  • 摘要: 14C-尿素呼气试验是幽门螺杆菌检测的“金标准”,检测时受试者需要服用14C标记的尿素胶囊,为保证药品质量,需对尿素14C胶囊中的有效成分14C进行核素鉴别,目前尚缺乏简单可行的核素鉴别方法。本工作建立了一种基于液闪测量的尿素14C胶囊中14C核素鉴别方法。通过研究氧气和乙醇对液闪β谱图的影响,确定了低淬灭14C样品制备方法,去除氧气时间大于10 min,乙醇添加量应小于1.67%,样品“有效期”为30 min。在相同测量条件下,通过比较低淬灭样品和无淬灭14C标准源的β谱图的特征点,实现了尿素14C胶囊中14C核素的鉴别。采用所建立的方法对上海某公司3批次尿素14C胶囊中的14C进行鉴别,证明了建立的14C核素鉴别方法可行有效。

     

    Abstract: Helicobacter pylori is a type of bacteria that is commonly found in the stomach lining and is known to cause gastritis, gastric ulcers, and gastric cancer. Detection and diagnosis of Helicobacter pylori infection are crucial for effectively eradicating the pathogen. Currently, the 14C-urea breath test is widely considered the gold standard for detecting the infection. During the test, patients ingest capsules containing 14C-labeled urea. It is important to identify the active ingredient, 14C, in the 14C-urea capsules to ensure the quality and safety of the medication. Unfortunately, there is no clear method provided by the Chinese Pharmacopoeia or the United States Pharmacopoeia for identifying the 14C nuclide. To address this gap, a method for identifying the 14C nuclide in 14C-urea capsules using liquid scintillation counter measurement was developed in this paper. In the experiment, a solution of 14C-urea was mixed with ethanol and low-quenching scintillation cocktails, and then argon gas was used to remove oxygen and prepare a low-quenching sample. The liquid scintillation counter was used to measured the β spectrum, and five characteristic points were selected for comparison with the β spectrum of a standard non-quenched 14C source. The identified characteristic points included the maximum apparent energy value, the apparent energy value at the right end of the half-peak height, the apparent energy value at the right end of the 90% peak height, the 90% peak energy width, and half-height width. Successful identification of the 14C nuclides is achieved by comparing the β spectrum of the low-quenching sample with the standard non-quenched 14C source. Oxygen and ethanol are the main sources of quenching during the preparation of low-quenching samples. However, the experimental study shows that the dissolved oxygen in the scintillation cocktails could be effectively removed by flowing argon gas for 10 minutes, which significantly reduces the quenching degree and extends the validity period of the sample to 30 minutes. Furthermore, adding less than 1.67% ethanol to the sample results in no significant quenching. To avoid introducing new quenching sources, the distribution of 14C-urea in the capsule was analyzed, and it is found that more than 90% of the 14C-urea is located at the bottom of the capsule. The established nuclide identification method was used to identify 14C in three batches of 14C-urea capsules from a company in Shanghai, and the results are all qualified, validating the effectiveness and feasibility of the established method. In summary, the nuclide identification method developed in this paper can provide valuable experience for identifying nuclides in other radiopharmaceuticals, enhancing the safety and effectiveness of radiopharmaceuticals. Accurate identification of active ingredients in medications is essential for ensuring the safety of patients and improving the quality of healthcare.

     

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