| Objective：Tuo Guan San has Scattered by the pipe of musk, light powder and the mixedmedicine composition such as withered alum, of Tuo Guan San college of traditional Chinesemedicine hospital preparations, widely used in orthopedic and surgical, often used for woundinfection, chronic painless for the treatment of wounds and diseases such as osteomyelitis. Inthe study of the characteristics, in accordance with the requirements for new drug research,adopts the method of toxicological experiments, the preliminary safety evaluation of thepowder, offer to take off the tube of clinical medication safety.Methods:(1) acute toxicity test: Select Wistar rats30, male and female, wererandomly divided into three groups of10each. Control group, Tuo Guan San high and lowdose groups. Before administration to rats back hair removal, even with a blade scratch,scratch area of about9cm2, with " bleeding " for the degree. The test substance evenly on theskin at the damaged rat administered volume1mL/150g wt, control group peers orange smearof distilled water. After the applicator, bandage fixed24h, and carried scratch coatingadministered once daily, continuous applicator14days.(2) Long-term toxicity tests in rats:Select Wistar rats80, male and female, were randomly divided into four groups, each20.Control group, Tuo Guan San high, medium and low dose groups. Before administration torats back hair removal, even with a blade scratch, scratch area of about9cm2, with " bleeding" for the degree. The test substance evenly on the skin at the damaged rat administeredvolume1mL/150g wt, control group peers orange smear of distilled water. After theapplicator, bandage fixed24h, and carried scratch coating administered once daily,continuous applicator four weeks, stopping recover four weeks.(3)skin irritation test: SelectWistar rats20, male and female, were randomly divided into two groups, each10,conducted in rats with damaged skin irritation test using the body ’s own laws about contrast,in the24hours before administration after using the rat back hair removal, even with a bladescratch, scratch area of about9cm2, with " bleeding " for the degree. In each test drug-coated1ml damaged skin area in left and right Tu Fu1ml distilled water as blank control.24hours after applicator with warm water to remove residual test substance "After1,24,48,72hour observation skin reactions. Results：(1) acute toxicity test: After the observation time in the effective range of asingle dose of the test substance, two weeks, the rats no one died. High and low dose groupsskin, mucous membranes, diet did not change compared with the control group, noabnormal changes in various systems. Said the rats were taken before and after the weight,no significant difference in all the same point in time,(P>0.05).(2) Long-term toxicity test:four weeks of continuous administration of the test substance and withdrawal recovery afterfour weeks, the rats were no deaths. Compared with the control group, high, medium andlow dose groups of rats skin, and mucous membranes, diet did not change, and no abnormalchanges in various systems. Weight: medication withdrawal period and the recovery period,rats were weighed once a week, there was no significant difference (P>0.05) in all the samepoint in time. In the24hours after the last administration there was no significant differencebetween blood and blood biochemical test results and organ coefficient of each group (P>0.05). Each organ pathology results showed no abnormality.(3) skin irritation test: WhenTuo Guan San5mg/ml and50mg/ml topical, compared with the control area, there was nosignificant difference, neither erythema nor edema results showed that in rats Tuo Guan Sandamaged skin irritation.Conclusion: The term experimental study showed that a dose range and effectiveobservation time, for no serious systemic absorption toxicity in rats, the rats damaged skinwithout irritation. |
PDF Full Text Request