基于降血脂功效的决明子安全性评价

目的:观察决明子对高脂血模型大鼠的降脂作用,同时对主要毒靶器官组织病变进行检查,为决明子安全、合理的使用与相关质量标准的建立提供参考。方法:采用高脂饲料喂养的方法建立高脂血模型大鼠,喂养28 d后模型建立,并随机分为5组,决明子给药剂量按生药计0.315,1.575,3.15,6.30 g·kg~(-1),连续灌胃给药90 d,考察决明子对高脂血模型大鼠的一般情况、血清血脂水平、肝脏中血脂水平、血清生化指标及肝肾组织的病理切片的影响,评价不同剂量决明子量-效(毒)差异。结果:与模型组比较,决明子3.15,6.30 g·kg~(-1)剂量组血清中总胆固醇(TC),甘油三酯(TG),低密度脂蛋白(LDL-C)水平显著降低(P0.01),高密度脂蛋白(HDL-C)水平显著升高(P0.01)。肝脏中TC,TG水平显著降低(P0.01),总超氧化物歧化酶(T-SOD)明显升高(P0.05,P0.01),提示决明子具有一定的降血脂功效。决明子各剂量组肝组织切片可见肝细胞空泡样化、肿胀,肝细胞核固缩、坏死,肝窦内炎细胞浸润;肾组织切片可见肾小管上皮细胞肿胀变性、肾间质炎细胞浸润;且随着剂量的增大,病变例数越多,病变损伤越严重。决明子1.575,3.15,6.30 g·kg~(-1)剂量组血液中天冬氨酸氨基转移酶(AST),丙氨酸氨基转移酶(ALT)水平与模型组比较明显升高(P0.05,P0.01),提示决明子长期服用存在一定的肝毒性与肾毒性,不宜大剂量长期服用。结论:决明子长期服大剂量用存在一定的毒性作用,应谨慎使用。

Safety of Cassiae Semen Based on Hypolipidemic Effect

Objective: To observe the hypolipidemic effect of Cassiae Semen on hyperlipidemia model rats, and inspect tissue lesions of main toxic target organs, in order to provide the reference for safe, effective and rational use of traditional Chinese medicine Cassiae Semen. Method: The hyperlipidemia model was established with high-fat feeding for 28 d, and randomly divided into 5 groups: model group and 4 Cassiae Semen water decoction groups (0.315, 1.575, 3.15, 6.3 g·kg^-1). After continuous lavage for 90 d, the effect of Semen Cassiae on the hyperlipemia model rats on general conditions, serum lipid levels, liver blood lipid levels, serum biochemical index, and pathological sections of liver and kidney tissues were detected to evaluate the dose-effect (toxicity) differences among various doses of Cassiae Semen. Result: Compared with model group, Cassiae Semen 3.15, 6.30 g·kg^-1 dose group showed significant decreases in serum total cholesterol (TC), triglyceride (TG), and low density lipoprotein (LDL-C) (P<0.01), and significant increases in high density lipoprotein (HDL-C) (P<0.01). The levels of TC and TG in liver were significantly decreased (P<0.01), and the total superoxide dismutase (T-SOD) was significantly increased (P<0.01, P<0.05) in liver, suggesting that Cassiae Semen has a certain cholesterol-lowering effect. Liver tissue sections of various doses of Cassiae Semen showed vacuole-like degeneration and swelling in hepatocytes, hepatic nucleus pycnosis and necrosis, and inflammatory cell infiltration in hepatic sinus. Kidney tissue sections revealed renal tubule epithelial cell swelling and degeneration, and renal interstitial inflammatory cell infiltration. And with the increase in dose, the number of lesions increased, and lesion damage became more serious. The levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) in blood of three dose groups (3.15, 1.575, 6.30 kg^-1) were significantly higher than those of model group (P<0.01, P<0.05), suggesting that Cassiae Semen has a certain hepatotoxicity and nephrotoxicity after long-term intake, and thus shall not be taken in a high-dose manner for a long term. Conclusion: Cassiae Semen has a certain toxic effect after long-term intake, and thus shall be cautiously used.