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采用质谱法对重组人及重组牛促甲状腺激素制剂进行特征分析,并测定其内毒素含量。

Characterization of recombinant human and bovine thyroid-stimulating hormone preparations by mass spectrometry and determination of their endotoxin content.

机构信息

Clinic for Small Animal Internal Medicine Vetsuisse Faculty, University of Zurich, Zurich, Switzerland.

出版信息

BMC Vet Res. 2013 Jul 16;9:141. doi: 10.1186/1746-6148-9-141.

Abstract

BACKGROUND

The TSH stimulation test to confirm canine hypothyroidism is commonly performed using a recombinant human TSH (rhTSH), as up to date, canine TSH is not yet commercially available. Limiting factors for the use of rhTSH are its high costs and occasional difficulties in product availability. Less expensive bovine TSH preparations (bTSH) purified from bovine pituitary glands are readily commercially available. The aim of this study was to evaluate two different bTSH products as alternative to rhTSH using mass spectrometry.

RESULTS

More than 50 proteins, including other pituitary hormones, bovine albumin, hemoglobin, and tissue proteins were identified in the bTSH preparations. In contrast, rhTSH proved to be a highly pure product. Significantly higher endotoxin levels could be detected in all bTSH products compared to the rhTSH.

CONCLUSIONS

Both bTSH products are crude mixtures and therefore not an acceptable alternative to rhTSH. Their use should be discouraged to prevent unintended side effects.

摘要

背景

目前尚未商业化生产犬促甲状腺激素(TSH),因此,常使用重组人 TSH(rhTSH)进行 TSH 刺激试验以确诊犬甲状腺功能减退症。rhTSH 的使用受到成本高和偶尔供应困难的限制。从牛垂体中纯化得到的较廉价牛 TSH 制剂(bTSH)可随时大量供应。本研究旨在使用质谱法评估两种不同的 bTSH 产品作为 rhTSH 的替代品。

结果

bTSH 制剂中鉴定出 50 多种蛋白质,包括其他垂体激素、牛白蛋白、血红蛋白和组织蛋白。相比之下,rhTSH 被证明是一种高度纯净的产品。与 rhTSH 相比,所有 bTSH 制剂中的内毒素水平均显著更高。

结论

这两种 bTSH 产品均为粗制混合物,因此不能替代 rhTSH。应避免使用这些制剂,以防止出现意外的副作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/929d/3717043/7ab370a4f22c/1746-6148-9-141-1.jpg

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