滴眼剂中辅料的处方相容性研究

Formulation Compatibility Study of Excipient in Eye Drops

目的通过稳定性试验,评估滴眼剂中辅料的处方合理性。方法通过加速试验采用正交法,考察处方中不同种类的抑菌剂与辅料的相容性。结果通过在60℃放置5天的加速试验显示,抑菌剂硫柳汞与氯化钠合用,其含量下降50%;与辅料硼酸合用,其含量下降15%。结论抑菌剂硫柳汞与辅料硼酸、氯化钠的相容性较差,抑菌剂苯扎溴铵和羟苯乙酯与辅料相容性较好。

OBJECTIVE To evaluate the formulation rationality of excipient on eye drops by stability test.METHODS The compatibility of different antibacterial agents and excipient was investigated by the accelerated test with orthogonal method.RESULTS The accelerated tests was showed the content of antibacterial agent ethylmercurithiosalicylic acid would be declined 50%because of blending with sodium chloride if conserving 5 days at 60℃;And when it blending orthoboric acid,it was declined 15%.CONCLUSION The compatibility of antibacterial agent ethylmercurithiosalicylic acid is poor with excipient sodium chloride and orthoboric acid.The compatibility of antibacterial agent benzalkonium bromide and ethylparaben is good.