硫酸锌滴眼液的处方改进

目的:改进硫酸锌滴眼液处方,解决原处方制剂pH及渗透压摩尔浓度不合格的问题,保证产品质量。方法:调整处方中硼酸用量(17、16、15、14、13、12、11、10 g)以配制硫酸锌滴眼液,通过测定不同处方的pH及渗透压摩尔浓度比确定硼酸最佳用量,并观察该用量是否对处方中硫酸锌的含量有影响;通过初匀速试验和留样观察试验考察改进后处方在不同温度及放置时间下的稳定性。结果:确定硼酸用量为每1 000 ml滴眼液中加入13 g,所配制剂pH及渗透压摩尔浓度比均符合要求,且不同的硼酸用量对硫酸锌的含量未见影响,在考察期内各项稳定性指标未见明显变化。结论:改进后处方更能保证该制剂的质量。

Improvement of the Formulation of Zinc Sulfate Eye Drops

OBJECTIVE： To improve the formulation of Zinc sulfate eye drops, solve the unqualified pH and osmotic pressure molar concentration and guarantee the quality of preparation. METHODS： The amount of boric acid was adjusted （17, 16, 15, 14, 13, 12, 11 and 10 g） to prepare Zinc sulfate eye drops; pH and osmotic pressure molar concentration ratio of different formu- lation were detected to determine the optimal amount of boric acid, and the effects of the amount of boric acid on the amount of zinc sulfate were observed. The stability of formulation at different temperatures during different periods was investigated after im- proved. RESULTS： When 13 g boric acid was added into each 1 000 ml eye drops, pH and osmotic pressure molar concentration ratio were conform to the requirements; different amount of boric acid has no effect on the content of zinc sulfate. No significant change was found in stability index during observation period. CONCLUSIONS： Improved formulation can guarantee the quality of preparation.