[Long-term toxicity of Shen Yan Ling tablet and its effect on male reproductive function in rats].
OBJECTIVE
Shen Yan Ling Tablet is an innovative compound of traditional Chinese medicine, scientifically prepared with Tripterygium wilfordii, Radix Astragali, and others, with precise efficacy on renal diseases and reduced adverse effects of Tripterygium wilfordii. Based on the Guiding Principles for New Drug Toxicity Research Before Clinical Application, we investigated the long-term toxicity of Shen Yan Ling Tablet and its effect on the reproductive function in rats.


METHODS
According to the clinical therapeutic dose and the results of the acute toxicity test of Shen Yan Ling Tablet, we equally divided 80 rats (males and females half-and-half) into a low-dose (1.25 g/kg body wt), a medium-dose (2.50 g/kg body wt), a high-dose (5.00 g/kg body wt) and a control group. After a 3-month medication, we conducted standardized long-term toxicity tests and observed the effects of Shen Yan Ling on the serum sexual hormones and epididymal sperm count.


RESULTS
After 3 months of treatment with Shen Yan Ling, no death occurred, the general status remained unchanged, and the parameters of blood cytology and biochemistry fluctuated within the normal range, without any significant changes (P > 0.05). Some blood parameters, RBC, WBC, HGB, AST and TBIL, showed statistic changes (P < 0.05), but with no clinical significance. There were no significant differences in the mass coefficients of the main organs between the medication and control groups. The high-dose group exhibited slight hepatic and pulmonary pathological changes and significantly reduced sperm counts in the epididymis, but no significant changes in serum sexual hormones (P < 0.05).


CONCLUSIONS
Three-month medication of Shen Yan Ling at 1.25 - 5.00 g/kg produced no significant accumulated toxicity on rats, but it had a negative effect on their reproductive function at a higher dose of > or = 5.00 g/kg.
Cui
Yu-gui
YG
Center of Clinical Reproductive Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, China.
Wang
Xing-hai
XH
Ma
Ding-zhi
DZ
Jia
Yue
Y
Cai
Rui-fen
RF
Gao
Li
L
Yang
Ming-de
MD
Tong
Jian-sun
JS
D000818:Animals; D004365:Drugs, Chinese Herbal / Q000633:toxicity; D004822:Epididymis / Q000187:drug effects*; D005260:Female; D008297:Male; D009393:Nephritis / Q000188:drug therapy; D009929:Organ Size; D008517:Phytotherapy; D010936:Plant Extracts / Q000633:toxicity*; D051381:Rats; D017207:Rats, Sprague-Dawley; D013094:Spermatozoa / Q000187:drug effects; D013607:Tablets; D023382:Toxicity Tests, Acute; D029757:Tripterygium
D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; D013607:Tablets