Safety Evaluation Of Shuhou Yangshen Oral Liquid

Objective:To observe the acute toxicity in mice and the long-term toxicity in rats of Shuhou Yangshen oral liquid.Methods:Acute toxicity study:40 mice (20 males and 20 females) were divided randomly into 2 groups (10 males and 10 females a group)—Shuhou Yangshen oral liquid group and blank control group. Maximum administration dosage (MAD) was determined, and the times equal to human were calculated accordingly, then monitored the toxicity effects for 14 days. Long-term toxicity study:80 rats (40 males and 40 females) were divided randomly into 4 groups (10 males and 10 females a group)—blank control group, Shuhou Yangshen oral liquid low-dose group?middle-dose group and high-dose group. Animals in medication groups were daily administered Shuhou Yangshen oral liquid once on dose levels of 44,22, llg crude drugs·kg-1·d-1 and animals in the blank control group were administered distilled water for 13 weeks, then animals were withdrawn drugs for 4 weeks. The changes of body weigh?blood biochemistry?hematology?organ indexes and histopathology were monitored. Results:Acute toxicity study:All animals were survived. The MAD of Shuhou Yangshen oral liquid was 637.6g/kg (equal to 733times dosage in human).Long-term toxicity study:All animals were survived. The indexes of body weight, organ indexes and histopathology were in normal ranges. In the hematological examination results, after taking drugs 13 weeks, low-dose group's MCHC?middle-dose group's NEU were significantly different in comparisons of blank control group's results(p<0.05). After drug withdrawal for 4 weeks, high-dose group's BASO% was significantly different in comparisons of blank control group's results(p<0.05); low-dose?middle-dose group's PT and PTINR were very significantly different in comparisons of blank control group's results (p<0.01). In the blood biochemistry examination results, after drug withdrawal for 4 weeks, low-dose group's CL content was significantly different in comparisons of blank control group's results(p<0.05). The rest results of hematology and blood biochemistry were in normal range(p >0.05).Conclusion:It could be concluded that Shuhou Yangshen oral solution is safe to be administrated on the recommended dose level, but we should pay attention to the change of PT after long-term heavy use.