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Abstract：
Background: Porcine bile powder (PBP) is a traditional Chinese medicine that has been used for centuries in various therapeutic applications. However, PBP has not previously undergone comprehensive component analysis and not been evaluated for safety through standard in vivo toxicological studies. Methods: In our study, we characterized the component of PBP by liquid chromatography-mass spectrometry. The acute and subchronic oral toxicity, genotoxicity, and teratogenicity studies of PBP were designed and conducted in Kunming mice and Sprague-Dawley (SD) rats. Results: The chemical analysis of PBP showed that the main components of PBP were bile acids (BAs), especially glycochenodeoxycholic acid. There were no signs of toxicity observed in the acute oral test and the subchronic test. In the genotoxicity tests, no positive results were observed in the bacterial reverse mutation test. Additionally, in the mammalian micronucleus test and mouse spermatocyte chromosomal aberration test, no abnormal chromosomes were observed. In the teratogenicity test, no abnormal fetal development was observed. Conclusion: Our findings demonstrate that PBP, composed mainly of BAs, is non-toxic and safe based on the conditions tested in this study.
摘要：
背景：猪胆汁粉（PBP）是一种传统的中药，已在各种治疗应用中使用了数百年。然而,PBP以前没有进行过全面的成分分析，也没有通过标准的体内毒理学研究进行安全性评估。方法：在我们的研究中，我们用液相色谱-质谱联用技术对PBP的成分进行了表征。急性和亚慢性口服毒性，遗传毒性，设计并在昆明小鼠和Sprague-Dawley（SD）大鼠中进行了PBP的致畸研究。结果：PBP的化学分析表明，PBP的主要成分为胆汁酸（BAs），尤其是糖脱氧胆酸.在急性口服试验和亚慢性试验中没有观察到毒性的迹象。在遗传毒性测试中，在细菌回复突变试验中未观察到阳性结果.此外,在哺乳动物微核试验和小鼠精母细胞染色体畸变试验中，未观察到异常染色体。在致畸试验中,未观察到胎儿发育异常。结论：我们的研究结果表明，PBP，主要由BA组成，根据本研究中测试的条件，是无毒和安全的。
