Safety Evaluation Of The Granular Preparation Of Sophora Alopecuroides Alkaloids For Veterinary Usage

Sophora alopecuroides is widely distributed in northwest region of China.It is easy and cheap to obtain.The alkaloids of Sophora alopecuroides show great antimicrobial and anti-parasitic effect.Thus,the granular preparation of Sophora alopecuroides Alkaloids was explored by Ningxia Vocational and Technical College.This paper evaluated the safety of the alkaloids of Sophora alopecuroides using acute toxicity（mice and rats）,a 30-day feeding test（rats）,ames mutagenic effects,bone marrow MCN（mice）,sperm malformation test（mice）and teratogenicity test（rats）.The results were as follow.The alkaloids of Sophora alopecuroides was of medium acute toxicity.Animals showed symptoms of acute poisoning,including acting depressed,lags in response,noneating,black and brown loose stools,nerve symptoms of general shaking,and dark color in liver,spleen,small intestine.The LD₅₀was assayed with improved karbers method with the value of 216.52mg/kg b.w.in mice and 496.53mg/kg b.w.in rat.The 30-day feeding test included four groups with doses of 100,30,10 and 0 mg/kg b.w..The physiological status and blood biochemical indexes of animals in medicated groups were normal.Thus,we could conclude that the alkaloids of Sophora alopecuroides didn’t show subchronic toxical effect under the dose of 100 mg/kg b.w.The Ames test showed that The colonies numbers between medicated groups with the concentration of alkaloids of Sophora alopecuroides ranging from 0.008 mg to 5 mg and the negative control were of little differences.The mutagenic effect was negative.The bone marrow MCN test showed that significant differences in micronucleus rate between medicated groups and the negative control was not found.The results emphasized no genotoxicity in the alkaloids of Sophora alopecuroidesThe groups for sperm malformation test were the same as bone marrow MCN test.The sperm aberration rate in negative group was in the normal range.The rate in drug test groups showed no differences compared to negative group.Thus we can conclude that no reproductive genotoxicity were found in this situation.The teratogenicity test included four groups（200,50,12.5 and 0 mg/kg b.w.）.No abnormal clinical presentation was observed during the experiment period for animals in the four groups.Compared with negative control,the number of corpus luteum,uteruses weight,absorpted foetus number,died foetus number,the amount of fetus showed no obvious differences in the other test groups.There were of little differences in appearance,sex retio,body weight,stem length,bone and internal organs of the fetus between the medicated groups and the negative control.The results emphasized that no reproductive toxicity was observed under the dose of 200 mg/kg b.w.of alkaloids of Sophora alopecuroides.