Objective: To study the effect of Rubiae Radix et Rhizoma 70% ethanol extract on hepatotoxicity

nephrotoxicity and colonic toxicity in rats after long term use

and provide a certain basis for clinical rational drug use. Method: The 48 Wistar rats were randomly divided into blank control group

Rubiae Radix et Rhizoma high dose

medium dose and low dose groups (30

10

5 g·kg-1

respectively equivalent to 36

12

6 times of clinical human dose) under SPF experimental conditions

n=12 in each group

6 males and 6 females. The rats in control group received the same volume of distilled water

and all these rat were continuously lavaged for 60 days. During the treatment

the general situations of rats (activities

mental state

diet

color luster

urine color) were observed and recorded. After the last oral administration

the blood biochemical indicators of animals

viscera coefficient and the change of pathological histology were observed. Result: As compared with the blank group

liver

kidney and spleen indexes were increased in each dose Rubiae Radix et Rhizoma groups (P<0.05); the levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were increased significantly(P<0.01); the levels of β2-MG and Cys-C in male rats were also increased (P<0.05

P<0.01)

but in female rats

β2-MG was significantly increased only in high dose group (P<0.01)

and there was no difference in Cys-C as compared with blank group. In addition

there was no statistical difference in urea nitrogen (BUN) between each dose Rubiae Radix et Rhizoma groups and blank group

and there were no obvious pathological changes in liver and kidney morphology. Finally

colon tissue morphology

melanin staining and cell apoptosis in each dose group of Rubiae Radix et Rhizoma had no significant differences as compared with the blank control group. Conclusion: Rubiae Radix et Rhizoma 70% ethanol extract had mild hepatotoxicity and nephrotoxicity

but had no toxicity on colon and would not induce melanosis coli (MC) after long term use at the dose ≥5 g·kg-1.