马来酸噻吗洛尔滴眼液中抑菌剂的质量控制

发布时间：2018-08-16 17:44

【摘要】：目的:建立同时对马来酸噻吗洛尔滴眼液中常用的7种抑菌剂的定性分析、4种抑菌剂的定量测定方法,以筛查该滴眼液中所含抑菌剂的种类与含量是否与处方标注内容一致。方法:样品来自15家生产企业的85批马来酸噻吗洛尔滴眼液。以保留时间和二极管阵列检测器(DAD)光谱图作为定性依据,采用高效液相色谱(HPLC)-DAD法同时对各样品中的7种抑菌剂(山梨酸、硫柳汞、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯、苯扎溴铵)进行定性分析;采用HPLC法同时定量测定样品中的羟苯乙酯与苯扎溴铵,采用原子荧光光谱法同时定量测定样品中的硫柳汞和醋酸苯汞。结果:定性分析结果表明,85批样品所含抑菌剂的种类均与处方标注的一致;定量测定结果表明,抑菌剂含量以处方量的±20%为限度计,样品不合格率为15.2%,企业不合格率为53.8%。结论:所建立的方法适用于马来酸噻吗洛尔滴眼液中抑菌剂的质量控制。建议在马来酸噻吗洛尔滴眼液的质量标准中设置抑菌剂的含量检查项。
[Abstract]:Objective: to establish a quantitative method for the determination of seven kinds of antimicrobial agents commonly used in tiamolol maleate eye drops at the same time, and to screen whether the kinds and contents of bacteriostatic agents contained in the eye drops are the same as those marked by prescriptions. Methods: 85 batches of thiamolol maleate eye drops were collected from 15 enterprises. On the basis of retention time and (DAD) spectrum of diode array detector, seven kinds of bacteriostatic agents (sorbic acid, thiomersal, hydroxyphenyl methyl ester, hydroxyphenyl ethyl ester, hydroxypropyl ester, hydroxyphenyl butyl ester) in each sample were simultaneously determined by high performance liquid chromatography (HPLC) DAD). HPLC method was used to determine hydroxyphenylethyl ester and benzalkonium bromide simultaneously, and thiomersal and phenylmercury acetate in samples were determined by atomic fluorescence spectrometry. Results: the results of qualitative analysis showed that the types of antimicrobial agents in 85 batches of samples were the same as those marked by prescriptions, the quantitative determination results showed that the content of bacteriostatic agents was limited by 卤20% of the prescribed amount, the unqualified rate of samples was 15.2and the unqualified rate of enterprises was 53.8%. Conclusion: the established method is suitable for the quality control of antifungal agent in tiamolol maleate eye drops. It is suggested that the quality standard of thiamolol maleate eye drops should be used to check the content of bacteriostatic agents.
【作者单位】：江西省药品检验检测研究院;江西省药品与医疗器械质量工程技术研究中心;南昌大学医学院;
【分类号】：R927.11

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