Study On The Safety Of Ruanjian Xiaoying Granule On Hematology And Blood Biochemistry In Rats

Purpose:The prescription of Ruanjianxiaoying Granules belongs on long-term chronictoxicity experimental study. Preparation of pre-pharmacy-based experiments provedRuanjianxiaoying Granules,quality standards and stability,acute toxicity andpharmacodynamic basis,to mainly observe the long-term toxicity reaction of hematology,blood biochemistry index of rats whether or not, in order to predict RuanjianxiaoyingGranules may cause the clinical adverse reactions, including the nature, extent of toxicity, therelationship between the dose and time reaction and reversibility; Repeat administrationspeculated that Ruanjianxiaoying Granules clinical toxic target organs or target groups; Topredict the initial dose of clinical trials and repeat medication safe dose range; Promptingclinical trials need to focus on monitoring indicators; The detoxification in clinical or rescuemeasures to provide reference information.And I would provide more reliable evidences tothe Ruanjianxiaoying Granules into the period of clinic experimentation,the foundation for thenew drug to enter clinical trials.Material and methods:120healthy SD rats(weight:120±20g)that male and femalewas equal,were randomly divided into four groups:the normal comparing group,lowdose-group、medium dose-group、high dose-group,and each group was60.The prescriptionadopts the method of Ruanjianxiaoying Granules into stomach to them. For every8hours,lavage twice a day. In3months,6months and after treatmenting,we would randomly takingarterial blood of1/3each group rats for testing. Leaving rats were executed after six and ahalf months and taken those inspections.Results:1The result of animals’long-term chronic toxicology test for Ruanjianxiaoying Granules isthat the appearance signs, activities had no abnormal change.2Each weight of the rats showed a trend of rise every week, and food intake increased with the increase of the weight. During the period of drug delivery, comparing every treatmentgroups with the normal comparing group,weighting and food intaking were obviouslydifferences (P＜0.05),and considered relating to drug delivery.3Hematology indexes,in the middle comparing rats of male in the low and mediumdose-group with the normal comparing group, WBC、LYMPH、RBC have obviouslydifferences (P＜0.05). Comparing the medium dose-group with the normal comparing group,MON has obviously differences (P＜0.05). Comparing rats in the low dose-group with thenormal comparing group, MCV、MCH、RC and female’s PT have obviously differences(P＜0.05).In the end,comparing the RBC of the medium dose-group and WBC、MCV of thehigh dose-group with the normal comparing group, they have obviously differences (P＜0.05).During the recovery, comparing the HGB of the medium dose-group and MCH of the highdose-group with the normal comparing group, they have obviously differences (P＜0.05).Comparing RBC in every dose-groups remaining with the normal comparing group,they haveobviously differences (P＜0.05); Comparing the Gran、RDW of the medium dose-group andthe high dose-group with the normal comparing group, they have obviously differences(P＜0.05),and the MCV、MCH、PLT of the high dose-group have obviously differences(P＜0.05).The results show that there was no significant difference (P>0.05).4Blood biochemical indicators,in the middle comparing ALT、AST and female’s rats CR ofevery dose-groups with the normal comparing group, they have obviously differences(P＜0.05). In the end,comparing the TP、ALB of the medium dose-group with the normalcomparing group, they have obviously differences (P＜0.05). During the recovery, comparingthe female’s rats in TP、ALB of the medium dose-group with the normal comparing group,they have obviously differences (P＜0.05). Comparing the CR of the medium and highdose-groups with the normal comparing group, they have obviously differences (P＜0.05).Allrates’GLU are higher than normal range. The remaining results show that there was nosignificant difference(P>0.05).Conclusion: It is very safe that people take Ruanjianxiaoying Granules in the dosage ofsecurity and the rat liver and kidney functions such as no obvious side effects.Therefore,Ruanjianxiaoying Granules can be put into the next stage of clinical trials.