国产妥布霉素滴眼液质量评价
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摘要
目的综合评价妥布霉素滴眼液的质量现状。方法采用现行法定标准结合探索性研究对市场上21家生产企业的174批妥布霉素滴眼液的质量进行系统比较,通过对有关物质、杂质谱分析及抑菌剂合理使用,分析不同企业产品妥布霉素滴眼液的质量差异。结果法定标准检验174批妥布霉素滴眼液1批不合格,合格率为99.4%;探索性研究揭示现行标准中有关物质检查方法需进一步提高,同时发现部分企业抑菌剂使用不合理。结论国内妥布霉素滴眼液整体质量一般,质量标准有待统一和提高。
Objective To evaluate the quality status of tobramycin eye drops. Methods By adoping statutory methods and combining with the exploratory studies, the quality of 174 batches of tobramycin eye drops from 21 producers was compared systematically and analyzed using the related substance, impurity spectrum, and reasonable use of preservatives. Results The pass rate of quality was 99.4% using the statutory methods in 174 bathes. But exploratory studies showed that the quality of samples was not able to be controlled because of the lack of related substance and unreasonable use of preservatives. Conclusion The quality of tobramycin eye drops is good. The quality standard needs to be integrated and improved.
Objective To evaluate the quality status of tobramycin eye drops. Methods By adoping statutory methods and combining with the exploratory studies, the quality of 174 batches of tobramycin eye drops from 21 producers was compared systematically and analyzed using the related substance, impurity spectrum, and reasonable use of preservatives. Results The pass rate of quality was 99.4% using the statutory methods in 174 bathes. But exploratory studies showed that the quality of samples was not able to be controlled because of the lack of related substance and unreasonable use of preservatives. Conclusion The quality of tobramycin eye drops is good. The quality standard needs to be integrated and improved.
引文
[1]国家药典委员会.中国人民共和国药典(2015年版二部)[S].北京:中国医药科技出版社,2015:512-513.
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[7]Reconstructed human Cornea-like Epithelium(RhCE)testmethod for identifying chemicals not requiring classificationand labelling for eye irritation or serious eye damage,OECD Guidelines for the Testing of Chemicals,Section 4 Health Effects No.492[S].2015.
[8]Susanne N K,Ursula G S,Maria C R,et al.Eye irritationtesting of nanomaterials using the EpiOcular?eye irritation test and the bovine corneal opacity and permeability assay[J].Part Fib Toxicol,2016,13:18.
[2]万山红,万晓红.妥布霉素的药理及药代动力学特点[J].黑龙江医药,1997,10(02):99-100.
[3]李家斌,赵风培.硫酸妥布霉素治疗急性细菌性痢疾[J].中国抗生素杂志,1997,22(2):159-160.
[4]肖玉坤,谢玉琼,李芚,等.用荧光免疫法对健康人妥布霉素药物动力学的研究[J].中国医院药学杂志,1984,14(7):3-5.
[5]吴兵,黄雁,彭隽.妥布霉素不良反应[J].中国误诊学杂志,2010,10(24):6033-6033.
[6]刘诗通.妥布霉素[J].国外医药抗生素分册,1987,8(5):346-354.
[7]Reconstructed human Cornea-like Epithelium(RhCE)testmethod for identifying chemicals not requiring classificationand labelling for eye irritation or serious eye damage,OECD Guidelines for the Testing of Chemicals,Section 4 Health Effects No.492[S].2015.
[8]Susanne N K,Ursula G S,Maria C R,et al.Eye irritationtesting of nanomaterials using the EpiOcular?eye irritation test and the bovine corneal opacity and permeability assay[J].Part Fib Toxicol,2016,13:18.