摘要
目的:考察苏州辖区内生产及流通的不同厂家、不同剂型的盐酸左氧氟沙星产品的安全性、有效性和质量可控性。方法:抽取盐酸左氧氟沙星不同生产厂家的3种剂型15批次(胶囊7批次、片剂4批次、注射液4批次)产品,按《中国药典:2015版》法定标准及相关国家标准检验,比较各批次中有关物质、含量和溶出度的差异。结果:抽验的盐酸左氧氟沙星产品3种剂型(胶囊剂7批次、片剂4批次、注射液4批次)15批次中,按法定标准检验结果均符合规定,合格率为100.00%;不同生产厂家执行的"药品质量标准"经与《中国药典》标准比较,发现存在限度不统一、《中国药典》收载品种缺失等问题,15批次产品的含量极差为11%,其中胶囊极差为6.8%、片剂极差为2.2%、注射液极差为10.5%。结论:抽验的3种剂型15批次盐酸左氧氟沙星产品,其质量状况较好,企业生产其工艺成熟,质量较为稳定,但仍然有提高的空间。
Objective:To analyze and evaluate the safety, effectiveness and quality of levofloxacin hydrochloride on different manufacturers and dosage forms in Suzhou area. Methods:15 batches(7 batches for capsules, 4 batches for tablets and 4 batches for injection) of 3 kinds of dosage forms from different manufacturers of levofloxacin hydrochloride were sampled and tested according to the Chinese Pharmacopoeia(2015 Edition) and relevant legal standards. The differences of relevant substances, contents and dissolution of each batch were compared. Results:Among the 15 batches of the three dosage forms(7 batches of capsule, 4 batches of tablet and 4 batches of injection), all results met the requirements according to the legal standards;the qualified rate was 100%. Comparing the pharmacopoeia standard with the non pharmacopoeia standard implemented by manufacturers, there is still improving room for the standard. For example, the Pharmacopoeia could not cover all the dosage forms. The content range of 15 batches was 11%, including 6.8%for capsule, 2.2% for tablet and 10.5% for injection. Conclusion:The quality of 15 batches levofloxacin hydrochloride is in good condition. The production process of the manufacturers is stable, but there is still room for improvement.
作者
王思渊
朱乃军
陈蓉
郭彬
许丹
郝刚
WANG Si-yuan;ZHU Nai-jun;CHEN Rong;GUO Bin;XU Dan;HAO Gang(Suzhou Institute for Drug Control,Suzhou Jiangsu 215104,China)
出处
《抗感染药学》
2020年第9期1245-1247,共3页
Anti-infection Pharmacy
关键词
盐酸左氧氟沙星
不同厂家
产品质量
质量标准
levofloxacin hydrochloride
different manufacturers
product quality
quality standard
