Invigorating The Kidney And Bone Paste Treatment Of Perimenopausal And Postmenopausal Osteoporosis Toxicology

Bu Shen Yi Gu Gao(BSYGG) is formulated according to the clinical experiences of speciality on climacteric syndrome of Guangdong Hospital of TCM. It is used clinically about 10 years and proved effective on climacteric syndrome. Preliminary study on clinical efficacy and pharmacyodynamics of the medicine on peri-menopausal and post-menopausal osteoporosis under the support of study fund provided by State Administration of TCM in 1996. The study obtained second prize on science and technology progresss of Guangzhou University of TCM and Guangdong province in 1999 and 2000 respectively. Since 1999, Council of Science and Technology of Guangdong began to support the studies of BSYGG as a candidate of new strategy of treating peri- and post- menopausal osteoporosis. So a series of pharmacodananiic, pharmacological and toxic, and clinical studies were done. And the contents are the results of one of these studies梩oxic study.It is necessary to definiting optimal dose in clinics to access the toxicity and its reversibility through experiments. So we did a series of long-term and acute toxicity tests with the guidance of Huang Zhiying of Insititute of Medicine produce of Guangzhou according to the rules of Manual on Study of New Medicines of TCM made by Drug Administration Ministry of Health P.R.C. The results are as below:1. The results of acute toxicity tests:The results of the maximum tolerant dose test on mice show that the maximum dose that mice can tolerate is 117 times as much as the clinical dose. So it can be proved that BSYGG has no apparent toxicity and it's safe to be used in clinics.2. The results of long-term toxicity tests(1) Long-term and high dose administration of BSYGG will not affect the normal behave of rats.(2) Long-term and high dose administration o f BSYGG will not affect the growth of rats.(3) Long-term and high dose administration of BSYGG may reduce the valueof RBC and Hb of female rats, but they all can recover after stopping treatment. And there isn't effect on the other items .(4) Long-term and high dose administration of BSYGG will not apparently affect heart, spleen, lung, uterus, ovary, testis, and adrenal gland of rats.(5) Long-term and high dose administration of BSYGG may slightly damage liver and kidney of rats, but it is reversible.(6) The safe dose of BSYGG on rats is about 15.0g/kg, and it is about 13.6 times as much as clinical dose.Conclusions:1. The safe dose to long-term use on rats of BSYGG is less than 15.0g/kg, and it's 13.6 times as much as clinical dose. So the conclusion can be drawn that the clinical dose is safe and no apparent toxicity.2. Long-term high dose administration may have some effects on the function of liver and kidney, But the effects may disappear when the treatment stopped. To other organs, no side-effects were found. So if long-term high dose administration were needed in clinics, function of liver and kidney should be monitored.