Safety Evaluation Of Galla Chinensis Oral Solution

Galla Chinensis is a traditional Chinese medicinal material with various pharmacological activities such as antibacterial,antioxidant,astringent and pain relief.Preliminary laboratory research results show that Galla chinensis oral solution（GOS）prepared from Galla Chinensis extract has good anti-diarrhea effect on mouse diarrhea model caused by E.coli.Based on the"Veterinary Drug Research Technical Guiding Principles",this study carried out four aspects of the GOS acute toxicity test,30d subchronic toxicity test,safety pharmacology test,and target animal（piglet）safety test.The application provides the basis.The main findings are as follows:1.Study on acute toxicity of Galla chinensis oral solution to miceThe acute toxicity of GOS on oral LD₅₀of mice was evaluated.The pre-experimental results show that the 4/4 lethal dose of GOS is 7500mg/kg,and the 0/4 lethal dose is2500mg/kg.According to the above-mentioned formal test,four dose groups were designed,which were 2500mg/kg,3605.6mg/kg,5200.21mg/kg,and 7500mg/kg.Each dose group was administered by oral gavage.After the administration,observe and record the death of the mice.According to the modified Kou’s method,the LD₅₀of GOS orally to mice was 3247.47 mg/kg.2.Study on subchronic toxicity of Galla chinensis oral solution to rats for 30 daysAccording to"Veterinary Drug Research Technical Guiding Principles",80 rats were randomly divided into 4 groups.A blank group,a low,medium and high dose group of Galla Chinensis oral solution,20 rats in each group,half male and female,were administered by oral gavage once a day for 30 days.During the test,the daily feed intake of the rats was recorded,and the weight of the rats was measured every week;the blood of the rats was collected at the end of the test for hematology routine and blood biochemical indicators;the internal organs were collected,the organ coefficients and fixed organs were measured Organize and make pathological sections.The results of the study showed that:（1）Compared with the blank group,each dose group of GOS had no effect on the clinical status and body weight of the rats;（2）Compared with the blank group,there was no significant difference in blood routine indexes of each dose group of GOS（p>0.05）.（3）Compared with the blank group,each dose group of GOS can cause the aspartate aminotransferase and aspartate aminotransferase to increase,with a significant difference（p<0.05）.No significant effect on other indicators（p>0.05）（4）Compared with the blank group,histopathological results showed that the high-dose group of Galla chinensis oral solution can cause different degrees of granule degeneration and vacuolar degeneration in the liver and kidney.Distinguish clearly.3.Safety pharmacology of Galla chinensis oral solutionRats were randomly divided into 4 groups,10 in each group,half male and female.The reference principles for dose design are the same as for subchronic trials.The medicine is administered once daily for 7 days.The effects of gallnut oral solution on the respiratory system,central nervous system and cardiovascular system of rats were determined.The results of the study showed that:（1）Compared with the blank group,there was no significant difference between the GOS dose groups when performing the rod climbing test（p>0.05）.（2）Compared with the blank group,the GOS dose group had no significant effect on the rat’s heart rate and electrocardiogram（p>0.05）;（3）Compared with the blank group,the GOS dose group had no significant effect on the rat’s respiratory frequency（p>0.05）.4.Safety test of Galla chinensis on target animalsThe clinical recommended dose of GOS for target animals（piglets）is 100 mg/kg.According to the"Guidelines for Research Techniques in Veterinary Drugs",the dosing group for target animal safety trials should be set at 1,3,and 5 times the clinically recommended dose.The piglets were randomly divided into 4 groups,8 in each group.Divided into blank group,low dose（100mg/kg）,medium dose（300mg/kg）,high dose（500mg/kg）.The medicine was given orally,once a day for 7 days.The weight,temperature,heart rate,and respiratory rate of piglets were measured 1,3,5,and 7 days after the start of the test;the blood of the piglets was collected 1,5,7 days after the start of the test to determine the hematology routine and blood biochemical indicators;Groups and high-dose groups were dissected,internal organs were collected to measure organ coefficients and histopathological sections were made.The results of the study showed that:（1）Compared with the blank group,each dose group of GOS had no significant effect on clinical indicators such as body weight,body temperature,heart rate,and respiratory rate（p>0.05）;（2）Compared with the blank group,each dose group of GOS had There is no significant effect on the hematological routine indexes of piglets（p>0.05）;（3）Compared with the blank group,each dose group of gallnut oral solution can cause a slight increase in glutamic acid and aspartate transaminase of piglets,but there is no significant difference（p>0.05）,has no effect on other blood biochemical indicators;（4）Compared with the blank group,the high dose group of Galla chinensis oral solution can cause slight granule degeneration and vacuolar degeneration of liver and kidney of piglets,and has no effect on other internal organs.In summary:（1）The LD₅₀of GOS is 3264.46 mg/kg,which is a low-toxic drug;（2）The results of subchronic studies indicate that in addition to the reversible granule degeneration and vacuolar degeneration of liver and kidney cells,the Chinese gallnut oral solution has various doses for rats Body weight,organ coefficient,blood routine and other blood biochemical indicators have no effect;（3）safety research results show that:each dose of GOS has no effect on rat cardiovascular system,respiratory system and central nervous system;（4）Target animal（piglet）safety The test results show that within 5 times the clinically recommended dose,except for the reversible granule degeneration and vacuolar degeneration of liver and kidney cells,it has no effect on the clinical indicators,blood biochemistry,and blood routine of piglets.