Preliminary Study On The Safety Of Ganoderma Recombinant Immunomodulatory Protein

Ganodermarecombinant immunomodulatory protein (rLZ-8), be isolated fromthe fruiting bosy of Ganoderma Lucidum, is a fungus protein what possesses immunemodulating function. Until now, it has found that rLZ-8owns the biological activityof anti-tumor and increasing the quantity of leukocyte. As an usual complication ofchemotherapy during cancer treatment, Leukopenia affects almost10million patientsworldwide. The several drugs using in Leukopenia clinical treatment at present havetheir shortcomings more or less, by contrast, rLZ-8has some advantages, such as lowtoxicity. Therefore, the research and development of rLZ-8as a Leukopeniatherapeutic has vast develop prospects.In the process of the research of rLZ-8, its study and evaluation of safety is avery significant portion, and the foundation of further development. Based on theseproblems, this study suggests how to preliminary research the safety of rLZ-8bymeans of acute toxicity test and chronic toxicity test.This study observes the mouse’s pathological reations after treating in differentdoses of rLZ-8, explores the rLZ-8maximum tolerance dose. As a result, the toxicdoses of male and female mice are both over381.73times of the minimum effect dose.The lethal doses have differences between male mice and female mice, the former isover457.99times, the latter has stronger tolerance with572.60times. Thus, the toxicand lethal doses of rLZ-8have wide gaps with the minimum effect doses. As can beseen that rLZ-8has low toxicity and reliable safety.In addition, the chronic toxicity test of rLZ-8is completed by rats. The purposeis to find out the optimal dose by observing the index variation tendency of rats in different doses of rLZ-8, and to explore the impacts on the vital viscera. As aconsequence, rLZ-8don’t cause any harmful effect on liver, kidney, even whole vitalviscera.To sum up, in the process of Leukopenia treatment, the toxicity of rLZ-8isparticular low, and there is no harmful effect on the vital viscera. Through thepreliminary study suggests that rLZ-8is a drug with high safety.