参附舒络丸的质量控制及急性毒性实验研究

Study on Quality Standards and Toxicity Test of Ginseng and Aconite Collateral-Dredging Pill

目的:明确参附舒络丸的质量控制标准,并观察ICR小鼠灌胃参附舒络丸的毒性反应。方法:考察参附舒络丸的质量标准,包括性状鉴别、水分测定、重量差异、装量差异、照丸剂装量、溶散时限、照崩解时限、微生物限度等。将60只ICR小鼠,雌雄各半,按体质量随机分为参附舒络丸组(8 g·kg^(-1))、参附舒络丸组(6.0 g·kg^(-1))、参附舒络丸组(4.5 g·kg^(-1))、参附舒络丸组(3.4 g·kg^(-1))、参附舒络丸组(2.6 g·kg^(-1))、参附舒络丸组(2.0 g·kg^(-1)),每组各10只,各组按20 mL·kg^(-1)均给予相应药物进行灌胃,给药前禁食14~16 h,给药后观察6 h,每日观察1次,共14 d。结果:参附舒络丸的质量标准均符合要求;参附舒络丸组(8 g·kg^(-1))、参附舒络丸组(6.0 g·kg^(-1))、参附舒络丸组(4.5 g·kg^(-1))、参附舒络丸组(3.4 g·kg^(-1))24 h单次给药,小鼠出现活动减少、俯卧不动、呼吸频率加快急促或减慢或加深、步履不稳、抽搐、尿失禁、排稀便、翻正反射消失等症状,出现毒性反应的程度、数量与剂量相关;参附舒络丸组(2.6 g·kg^(-1))、参附舒络丸组(2.0 g·kg^(-1))小鼠未见异常情况。参附舒络丸半数致死量为6.7 g·kg^(-1)。结论:参附舒络丸的质量标准符合《中华人民共和国药典》所规定的要求;参附舒络丸所引起的毒性反应与剂量有关。

Objective:To determine the quality standards of Ginseng and Aconite Collateral-Dredging Pill(GACDP)and observe the toxicity reaction of it in ICR mice after being administered by gavage.Methods:The quality standards of GACDP were investigated,including property identification,moisture determination,weight difference,loading difference,loading amount,dissolution time limit,disintegration time limit,microbial limit,etc.A total of 60 ICR mice,half male and half female,were randomly divided into the group of GACDP(8 g·kg^(-1)),the group of GACDP(6.0 g·kg^(-1)),the group of GACDP(4.5 g·kg^(-1)),the group of GACDP(3.4 g·kg^(-1)),the group of GACDP(2.6 g·kg^(-1)),and the group of GACDP(2.0 g·kg^(-1)),with 10 mice in each group.Each group was given corresponding drugs according to 20 mL·kg^(-1)by gavage,fasting for 14 to 16 hours before administration,observation for 6 hours after administration,once a day for 14 days.Results:The quality standards of GACDP all met the requirements.After 24 h single administration,the mice in the group of GACDP(8 g·kg^(-1)),the group of GACDP(6.0 g·kg^(-1)),the group of GACDP(4.5 g·kg^(-1)),and the group of GACDP(3.4 g·kg^(-1))showed symptoms such as decreased activity,prone immobility,respiratory rate accelerated or slowing down or deepening,unstable gait,convulsion,urinary incontinence,defecation,disappearance of righting reflex,and the degree and quantity of toxic reaction were related to the dose.However,No abnormality was found in mice in the group of GACDP(2.6 g·kg^(-1)),and the group of GACDP(2.0 g·kg^(-1)).The LD50 of GACDP was 6.7 g·kg^(-1).Conclusion:The quality standards of GACDP all meet the requirements of Pharmacopoeia of the People′s Republic of China.The toxic reaction caused by GACDP is related to the dose.