色甘酸钠滴眼液中抑菌剂抑菌效力的评价

Evaluation of Bacteriostatic Efficacy of the Bacteriostatic Agent in Sodium Cromoglycate Eye Drops

建立了HPLC法测定色甘酸钠滴眼剂中抑菌剂羟苯乙酯的含量。采用《中华人民共和国药典》2020年版(ChP 2020)四部通则1121的抑菌效力检查法,以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白念珠菌和黑曲霉为试验菌,在不同时间测定存活菌数的对数值,考察市售7家企业的色甘酸钠滴眼液中抑菌剂的含量及抑菌效力。结果显示,7家企业的市售色甘酸钠滴眼液中羟苯乙酯的含量为0.18~0.45 mg/ml;在加入各试验菌后,6 h、24 h、7 d及14 d的菌落数对数下降值均未达到ChP 2020中眼用制剂的相应要求,提示企业应筛选出有效的抑菌剂,确保用药安全。

An HPLC method was established to determine the bacteriostatic agent(ethyl p-hydroxybenzoate)in sodium cromoglycate eye drops.Seven batches of commercially available sodium cromoglycate eye drops from different companies were examined on the content and bacteriostatic efficacy of the bacteriostatic agent according to the bacteriostatic efficacy inspection method of the general rules 1121 in the 2020 edition of the Pharmacopoeia of the People's Republic of China(ChP 2020).Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Candida albicans and Aspergillus niger were used as test microorganisms,and the logarithms of the number of viable microorganisms were determined at different times points.The results showed that the contents of ethyl p-hydroxybenzoate for the tested samples were in the range of 0.18–0.45 mg/ml,and at 6 h,24 h,7 d,and 14 d after adding different test microorganisms,the logarithmic reduction values of the seven tested samples did not meet the corresponding requirements of the ophthalmic preparations in ChP 2020.It suggested that the companies should screen out an effective bacteriostatic agent in prescriptions to ensure drug safety.