Traditional Chinese Medicine (tcm) Milk Yanning Urgent Slow Toxicity Experiment

Purpose：Theaimofthisstudyistoobservetheindicatorsoftheacutetoxicityof in mice and long-term toxicity in rats of Ruyanning Decoction to determinethe scope of safe dose, the evaluation of the safety of Ruyanning Decoction inorder to provide the experimental basis for the safety of clinical medicine.Method:1. Acute toxicity test:40Kunming mice were randomly divided into the controlgroup, the low dose group of Ruyan ning decoction, the medium dose group of Ruyanning decoction and the high dose group of Ruyan ning decoction. The low,mediumand high dose groups were given Ruyan ning concentrate decoction for gavage inaccordance with142.8g/kg,285.3g/kg,428.2g/kg respectively, respectively,equivalent to51.5times,103times,154.6times as the adult clinical dosedaily,while the control group was given the same volume of saline as other groups,mice of the four groups were fed water only and fasting for12h before theintragastric administration, gavage administration by0.4ml/10g weight for twotimes, in the morning and afternoon respectively, and an interval of eight hours,to breeding conventionally after gave medicine. Mice were observed continuouslyfor one week, to observe and take the record of the diet, activity, body weightand its poisoning and the number of death of mice every day in each group; thenthe blood of mice was taken after treatment24h and7days respectively to detectthe index of blood and the function of liver and kidney; on the seventh day,all the mice were killed by pulling off neck, heart, liver, spleen, lung andkidney were taken, each specimens were fixed in4%formaldehyde, paraffinembedded, sectioned, HE stained and observed the drugs’impact on these organsby light microscopy.2. Chronic toxicity test: The rats were randomly divided into into the controlgroup, the low dose group of Ruyan ning decoction, the medium dose group of Ruyan ning decoction and the high dose group of Ruyan ning decoction with20in eachgroup. For Ruyan ning decoction low, medium and high dose group, was given Ruyanning concentrate decoction according to27.7g/kg (equivalent to10timesclinical daily dose of adult),69.25g/kg (equivalent to25times clinicaldaily dose of adult) and173.13g/kg (equivalent to62.5times clinical dailydose of adult), while the control group was given the same volume of saline asother groups for consecutive60days. Continue to observe for two weeks afterstopping to give herb, the appearance, skin, hair, diet, activity and changesof weight of rats were observed both in the medication period and convalescentphase. The index of the hematology, blood biochemistry and vital organs wasdetected in medication period and the recovery phase,the histopathologicalchanges of vital organs were fixed in4%formaldehyde, paraffin embedded,sectioned, HE stained and observed the drugs’impact on these organs by lightmicroscopy.Results:1. All the mice in Ruyan ning decoction low, medium and high dose group didn’tobserve any symptoms of poisoning and death after giving the maximum dose herb,After the administration of experimental mice the diet, activity,excrement,urine of the mice in experimental groups were normal, weight of miceincreased gradually, compared with the control group, there was no significantdifference(P>0.05).2. The index of hematology and liver and kidney function of the mice in low,medium and high dose group was within the normal range, compared with the controlgroup, there were no significant differences(P>0.05);The pathologicalexamination of vital organs also showed no acute toxicity related to thepathologic changes.3. The appearance,symptoms, behavioral activity, diet, breathing, etc of ratsin Ruyan ning decoction chronic toxicity was normal, weight of mice increasedgradually, compared with the control group, there was no significant difference(P>0.05).4. The index of hematology and liver and kidney function of the rats in low,medium and high dose group was within the normal range, compared with the controlgroup, there were no significant differences(P>0.05);The pathologicalexamination of vital organs observed by the naked eye and optical microscopealso showed no acute toxicity related to the pathologic changes.So did it inthe recovery phase.Conclusions:Ruyan ning decoction doesn’t have acute and chronic toxicity reaction, Ruyanning decoction has certain safety for long-term application in accordance withthe clinical dose recommended security.