Zhou Xuerong, Rong Qian, Xu Min, Zhang Yuanli, Dong Qi, Xiao Yuanling, Liu Qiji, Chen Helin, Yang Xiaoyu, Yu Kaisheng, Li Yinglun, Zhao Ling, Ye Gang, Shi Fei, Lv Cheng
College of Veterinary Medicine, Sichuan Agricultural University, Chengdu, Sichuan, 611130, People's Republic of China.
BMC Vet Res. 2017 Jun 17;13(1):179. doi: 10.1186/s12917-017-1095-3.
Jinqing granules which are made of a mixture extract that contains Radix Tinosporae and Canarii fructus in proportions according to a longstanding formula have a good effect on the prevention and treatment of gastric ulcer disease. It has not been through safety through systematic toxicological studies, however. To provide basis for clinical application, we performed safety pharmacology and subchronic toxicity experiments in specific pathogen-free Sprague-Dawley rats.
In safety pharmacology experiments, Jinqing granules had no evident adverse effects on the central nervous, cardiovascular, or respiratory systems. In subchronic toxicity study, 2-8 g/kg of Jinqing granules induced no evident adverse effects on Clinical signs, body weight changes, food and water intake, death daily, indicators of urine, hematological assay, serum biochemistry, organ coefficient and histopathological examination. However, the 16 g/kg dose was associated with slightly slowed weight growth, decreased number of sperm in seminiferous tubules and increased values of serum aspartate aminotransferase and bilirubin. During the 30-day feeding test, 3 rats that received the 16 g/kg dose died, but the deaths were most likely due to trauma of oral gavage, not to drug toxicity.
Jinqing granules given to Sprague-Dawley rats orally for 30 days at a dose of 8 g/kg or less appears safe, but higher doses were not proven safe. The significance of these observations with respect to animal usage of Jinqing granules deserves thorough investigation.
金青颗粒由按照长期配方比例混合的金果榄和青果提取物制成，对胃溃疡疾病的防治效果良好。然而，尚未通过系统毒理学研究验证其安全性。为临床应用提供依据，我们在无特定病原体的斯普拉格-道利大鼠中进行了安全药理学和亚慢性毒性实验。
在安全药理学实验中，金青颗粒对中枢神经、心血管或呼吸系统均无明显不良反应。在亚慢性毒性研究中，2 - 8克/千克的金青颗粒对临床体征、体重变化、食物和水摄入量、每日死亡情况、尿液指标、血液学检测、血清生化、器官系数和组织病理学检查均未产生明显不良反应。然而，16克/千克剂量组出现体重增长略有减缓、曲细精管精子数量减少以及血清天冬氨酸转氨酶和胆红素值升高的情况。在为期30天的喂养试验中，接受16克/千克剂量的3只大鼠死亡，但死亡很可能是由于灌胃创伤所致，而非药物毒性。
以8克/千克或更低剂量给斯普拉格-道利大鼠口服金青颗粒30天似乎是安全的，但更高剂量未被证实安全。这些观察结果对于金青颗粒动物用药的意义值得深入研究。
