狗皮膏安全性评价研究

Safety evaluation of Goupi Gao

目的对狗皮膏的皮肤用药安全性进行评价研究。方法取不同厂家样品10批分别进行家兔急性皮肤刺激性试验和豚鼠皮肤过敏性试验,同时采用原子吸收分光光度法测定给药后家兔血铅浓度的变化。结果 10批样品中有7批出现皮肤刺激反应,除A厂家1批为中度刺激性,其余为轻度刺激性;10批样品均未见皮肤过敏反应;狗皮膏连续给药7d后,给药组的血铅浓度与对照组相比差异有统计学意义(P<0.01),连续给药14d后的血铅浓度与连续给药7 d相比差异有统计学意义(P<0.05)。结论狗皮膏引起皮肤刺激反应的风险较大,且不同厂家间、厂内批次间存在差异;久贴狗皮膏可引起血铅升高,建议改善制剂以减轻不良反应。

Objective To evaluate and study the safety of Goupi Gao （a traditional black plaster） on skin. Methods Acute dermal irritation test of rabbit and dermal sensitivity test of guinea pig was carried out using 10 batches of samples from different manufacturers. Atomic absorption spectrophotometry was used to detect the variation of blood lead concentration in rabbits. Results Dermal irritation in rabbits and dermal sensitivity in guinea pig were observed in seven among 10 batches of samples. One sample from A manufacturer showed moderate irritation, and others showed light irritation. No sample had the hypersensitive effect; After continuous administration for 7 d, the difference of blood lead concentration in Goupi Gao group showed the statistical significance compared with that in the control group （P 〈 0.01）. After continuous administration for 14 d, the difference of blood lead concentration had the statistical significance compared with that for 7 d （P 〈 0.05）. Conclusion The risk of the dermal irritation with the use of Goupi Gao is higher, while there are obvious differences among the products from different manufacturers or the different batches from the same manufacturer. Using Goupi Gao for a long time may induce high blood lead. It is suggested that the preparation should be readjusted for decreasing its adverse reactions.