Experimental Study About Toxic Effect Of The Treatment Of Pregnant Rats With Chinese Medicine Bushen-Yichong-Wan On Newborn Rats

ObjectivesThis study investigates the toxic effect of the treatment of pregnant rats with Kidney-tonifying Chinese Medicine formula BuShen-YiChong-Wan (BSYCW) on newborn animals. The present study aims to provide further experimental evidence for the clinical safety of BSYCM and to explore the methods to develop new drugs in Chinese Medicine for the treatment of sterility in reproductive toxicologyMethodsAdult and healthy Sprague-Dawley (SD) rats (ratio of male:female at 2:1) were hold in one cage. We performed vaginal plug or smear examination every morning to determine the presence of sperm and confirm the pregnant status. The time point with positivity of vaginal plug or smear examination was determined as the 1st day of pregnancy. All the pregnant female animals were divided into four groups:BSYCM low dosage group, BSYCM middle dosage group, BSYCM high dosage group, and vehicle control group with physiological saline. All the drugs were administrated via gavage during the whole period of pregnancy till delivery. Observation of general conditions, assessment of physical development, routine test of blood, and serum biochemical determination of newborn rats at the baseline and in the 15th day were performed. In addition, body weight, heart, liver, kidney, and other organs were examined by dissection and histological determination. All the data were analyzed to calculate the statistical difference of all the parameters among four groups. Results1. There was no significant difference of live birth numbers and survival rates of new born rats among four groups. One newborn animal with shorter tail was observed in BSYCM middle dosage group. All the other newborn rats had normal general appearance and did not show obvious symptoms of toxicity. There were no significant difference of the body length, tail length, and body weight between BSYCM groups and vehicle control group at the time point of 1st day after birth. For the tail length at the time point of 15th day after birth, there was significant difference between BSYCM low dosage group and vehicle control group. But among BSYCM middle dosage group, BSYCM high dosage group, and vehicle control group, no significant difference was observed. For the body length and body weight at the time point of 15th day after birth, there was no significant difference between BSYCM groups and vehicle control group.2. At the time point of 1st day after birth, there was significant difference of white blood cells, neutrophilic granulocytes between BSYCM high dosage group and vehicle control group (P< 0.05). No significant difference of red blood cells, hematoglobin, and platelet was observed between these two groups. At the time point of 15th day after birth, there was no significant difference of blood routine test, serum biochemical determination among all the four groups.3. There were no significant differences of organ indexes at the time points of both the 1st and 15th day after birth between BSYCM groups and vehicle control group. Furthermore, no obvious abnormalities in BSYCM high dosage group were observed via histological examination. ConclusionsBSYCM treatment in pregnant rats at the equivalent dose has no obvious toxic effect on newborn rats, implicating the clinical safety of BSYCM for clinical application of this TCM formula.