液体创可贴的质量控制标准与安全性研究

目的 考察液体创可贴的质量与安全性，建立可靠的质量控制方法。方法 通过外观性状、成膜时间、舒适性及防水透气性和HPLC法测定含量，对液体创可贴的质量进行考察，通过皮肤刺激性试验和变态反应试验考察液体创可贴的安全性。结果 自制液体创可贴均匀细腻，涂展性好，成膜快，所成薄膜的机械强度和防水透气性良好，药效成分的含量符合规定；对皮肤无明显刺激性，无变态反应。结论 建立的质量控制方法科学合理，液体创可贴的安全性良好。

Research on quality control standard and safety of liquid bandage

Objective To investigate the quality and safety of liquid bandage and establish a reliable quality control method. Methods The quality of liquid bandage was evaluated by appearance, film forming time, viscosity, comfort, waterproof and air permeability. The content was determined by HPLC. The safety of liquid bandage was investigated with skin irritation test and allergy test. Results The self-made liquid bandage was uniform and delicate, with good ductility, fast film formation, good mechanical strength, waterproof and air permeability. The content of active pharmaceutical ingredients in the film met the requirements. It had no obvious irritation to the skin and no allergic reaction. Conclusion The established quality control method was reliable. The liquid bandage had good safety profile.