Toxic Trial Of Gan Kang Capsule And Its Protection Of Hepatic Injury

Objective : To study acute toxicity and Long-term toxicity of the GKKL in the mice; To investigate the protective effects of the GKKL on those hepatic injury models by hepatic fibrosis animal model evoked by CCl₄; To study the effects of GKKL and its mechanisms on immunological liver injury induced by BCG and LPC in mice.Methods: GKKL was intragastrically administered of mice with maximum concentration and maximum volume in the acute toxicity testing, two times a day, to investigate the reaction and determine the MTD; GKKL was intragastrically administered of mice in four groups for six months respectively, five times a week, determining some index such as biochemical examination; In hepatic injury models established by CCl₄, six groups including normal group, model group, positive group and the three GKKL groups were exposed to different substances and compared effects of the GKKL and DDB on hepatic injury; Experimental liver injury was induced by tail vein injection of BCG +LPC in female mice, and administered LPC12d later, compared effects of the GKKL and DDB on those injury models.Results: The MTD of GKKL is 20g·kg^-1 in the acute toxicity testing, the amount of which is nearly 58 times as the dose used on the clinical; The results of the Long-term toxicity show that the effects of the three different GKKL groups have no significantly difference compared with the normal group regarding blood examination, blood biochemistry examination and the organ coefficient, also routine observation show that no poisoned organ was found, there was no toxic reaction in the recovery phase. Hepatic injury model was successfully established, the results show that the three different GKKL groups have significantly difference (P <0.05) compared with the blank group in the aspects of decreasing transaminase, inhibiting hepatic fibrosis, improving Hepatic function and tissue damages. Also, there have no significantly difference (P>0.05) compared with the positive group; Immunological liver injury induced by BCG+LPS was successful. The three GKKL groups were found significantly (P <0.05) decreasing serum ALT and AST level and the content of MDA in the liver plasma, the liver tissue 'damages were also ameliorated (P<0.05) .Conclusion: GKKL is safe and it has no adverse reaction, it can protect liver cells, improve hepatic function and tissue damages, decrease transaminase, inhibit hepatic fibrosis, GKKL also showed significant protective action on the immunological liver injury induced by BCG and LPS in mice.