ABSTRACT
OBJECTIVE：To study the toxic effect of the extract from Tripterygium hypoglaucum on pregnant animal and embryo-fetal development . METHODS ：Successfully mated New Zealand female rabbits were randomly divided into solvent control group，positive control group （cyclophosphamide，20 mg/kg）and T. hypoglaucum extract high-dose ，medium-dose and low- dose groups（15.0，7.50，3.75 g/kg，by the amount of crude drug ）according to their body weight ，with 18 rabbits in each group at least. The female rabbits in solvent control group and T. hypoglaucum extract groups were given water or the corresponding T. hypoglaucum extract solution from 6th to 18th day of pregnancy ，5 mL/kg，once a day. Positive control group was given cyclophosphamide subcutaneously into the neck from 10th to 13th day of pregnancy ，1 mL/kg，once a day. According to the related requirements of Technical Guidelines for the Study of Drug Reproductive Toxicity ，the general situation ，body weight ，body weight increase and food intake of female rabbits were observed and recorded during the experiment ，and euthanasia was carried out on 28th day of pregnancy ；the relative indexes of main organs ，fetal uterus ，placenta uterus ，placenta，ovary，implantation gland ， absorption fetus ，stillbirth，live fetus and corpus luteum were observed and recorded after anatomy ；the relative indexes of body weight，appearance，visceral and skeletal alterations of the fetus were detected . RESULTS ：Compared with solvent control group ， the body weight ，body weight increase ，food intake ，main organs ，pregnancy of pregnant rabbits ，as well as reproductive function，embryo formation ，fetal growth and development ，appearance，visceral and skeletal development indexes in T. hypoglaucum extract groups had no significant abnormal changes （P＞0.05）；above indexes in the positive control group had significant changes （P＜0.05），and significant maternal toxicity and embryotoxicity were found. CONCLUSIONS ：T. hypoglaucum extract 15.00-3.75 g/kg（by the amount of crude drug ）have no significant maternal toxicity ，embryotoxicity or fetal development toxicity to New Zealand rabbits.
ABSTRACT
Objective To observe the anaphylactoid reactions of Shuanghuanglian injection, determine the serum histamine level of sensitized animal, and to investigate its correlation with anaphylactoid reactions.Methods The guinea pigs were randomly selected to observe the anaphylactoid reactions using Shuanghuanglian injections in the different injection speed or different doses, and the serum histamine and the serum IgE of sensitized animals were determined by ELISA. Results The anaphylactoid reactions were induced by Shuanghuanglian injections in the different conditions of injection speed and doses in guinea pigs. There were no obvious difference about the serum IgE level between Shuanghuanglian group and saline group were injected in injection speed and doses. The serum histamine level was significantly increased in Shuanghuanglian group both different conditions of injection speed and doses, and it related to doses and speed. Conclusion Shuanghuanglian injection can cause anaphylactoid reactions in guinea pigs, and the changes of serum histamine level are related to injection speed and doses of Shuanghuanglian injection.