Effects Of Long - Term Toxicity Of Ruanjian Xiaoying Granule On Organs In Rats

Purpose：This topic belongs to traditional Chinese medicine Ruanjian gallparticle long-term toxicity studies,preparation of pre-pharmacy-basedexperiments proved Ruanjian gall particles,quality standards and stability,acute toxicity and pharmacodynamic basis,to further determine long-term use ofanimals Ruanjian gall particle toxicity has occurred,describe the nature andextent of toxicity(including toxicity start time,extent,duration,andreversibility,etc.) and the target organ,determine a safe range,and to explorethe mechanism of toxicity.This article focuses on the histopathology of rat brain,liver,heart,spleen,lungs,kidneys and other major organs of the study werediscussed.Material and method：l.Material:According to the research needs,the use of experimental animals (SPF), weighing120±20g of SD rat strains240,male and female sexes.Animal Certificate of Conformity.All animals are in line with requirements fornon-clinical safety studies of drugs in the country.The test drug is traditional Chinese medicine Ruanjian gall particles(radix,angelica,curcuma,citrus,fritillaria,seaweed,kelp,red peony,a total of eight herbs).The drugs provided by pharmaceutical preparation room Experimental Center of Liaoning University of Traditional Chinese Medicine Hospital.2.Methods:The240rats before the official start of the experimental animallaboratory medicine center(temperature18-23℃,humidity40%to60%)adaptationof conventional breeding one week at the Affiliated Hospital of LiaoningUniversity of Traditional Chinese Medicine.The rats were randomly assignedaccording to body weight,gender stratification.Divided Ruanjian gall low particle,medium and high dose group and normal saline control group60,male andfemale.Calculated by the weighed weekly dose.Normal saline control group1.5ml/100g2times/day;Ruanjian gall particles low-dose group8g crude drug/kg/d(1.51g powder/kg/d)(1.5ml/100g5%2times/day); Ruanjian Xiaoying particledose20g crude drug/kg/d(3.77g powder/kg/d)(1.5ml/100g12.56%2times/day);Ruanjian gall particles high dose group60g crude drug/kg/d(11.32g powder/kg/d)(1.5ml/100g37.68%2times/day);1.5ml/100g saline control group. Twice dailyorally administered six days a week, sunday to stop the administration forconsecutive six months.Recovery period of2weeks.In the administration of threemonths after the(interim),after six months (late),and after six and a half months(recovery)were randomly selected1/3of the number of rats were givenintraperitoneal injection of25%urethane anesthesia,carry out blood. After theblood system in rats autopsy,and weighed on the organ after organ coefficientwas calculated to do histopathological examination.Results：1.Ruanjian gall particle long-term toxicity test,the rats fur appearance,behavior,mental status no obvious abnormalities,mouth,nose,eyes,ears,etc.There was no abnormal glandular secretions.But Ruanjian gall low particle,ratfeces,mostly brown high-dose group,and its color and soft Jian Xiaoying granulesimilar consideration due to the drug itself color,non-toxic cause.2.Ruanjian gall particles of food intake in rats administered long-term impact,including low,medium and high dose group and the saline control group comparison,the results in Table1-1and Table1-2,can occur at different time periods P<0.05case,there are statistically significant.But researchers believe that the mainreason affecting food intake in rats a drug to stimulate the gastrointestinalabsorption and occupy a portion of the stomach space.3.Ruanjian gall particle long-term toxicity tests,which weighed weekly,low,medium and high dose group with the control group comparison,the results in Table2-1and Table2-2.Different time periods,the situation appears P<0.05,there is statistically significant.But researchers believe that multiple closely relatedwith food intake,due to the non-toxic.4.Ruanjian gall particle long-term administration in rats influential factoron the organ,in the interim,final,three stages of recovery,the low,medium andhigh dose group and the saline control group comparison,some organ coefficientP<0.05, statistically significant,but whether Ruanjian gall caused by long-termtoxicity particles for further study.5.Histopathological examination showed that rat low,medium and high dose groupcompared with the control group,the microscopic structure of major organs showedno abnormalities.Conclusion：1Ruanjian gall particle long-term use had no effect on the general situationin rats.2Ruanjian gall particle long-term use have some impact on their daily food intakein rats,but non-toxic cause.3Ruanjian gall particles have an impact on long-term use of rat body weight,but non-toxic cause.4Ruanjian gall particle long-term use of rat brain,liver,heart,spleen,lung,kidney and other organs organ coefficient influential,but most recoveryreversible.5Ruanjian gall particles in the long-term toxicity tests,histopathologicalexamination showed no abnormalities.6Ruanjian gall particles is an essential long-term drug safety.