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醋氯芬酸肠溶胶囊为非甾体抗炎药,具有抗炎、镇痛作用,在临床上用于骨关节炎、类风湿性关节炎和强直性脊椎炎等引起的疼痛和炎症的症状治疗。其质量标准目前《中国药典》与国外药典均未收载,国家药品监督管理局标准(试行)YBH08642003(以下简称标准)为现行标准[1],在对该药品进行评价抽验的过程中,发现现行标准中有关物质的检测规定有值得探讨之处,标准规定记录供试品溶液的色谱图至主峰保留时间的两倍,而有三个杂质峰(杂质C、D、E)保留时间超过了主峰保留时间的两倍,易造成漏判;另外,在检查有关物质的过
Aceclofenac enteric-coated capsules are non-steroidal anti-inflammatory drugs with anti-inflammatory and analgesic effects and are clinically used in the treatment of symptoms of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis treatment. The quality standards at present, “Chinese Pharmacopoeia” and foreign Pharmacopoeia were not included, the State Drug Administration standards (Trial) YBH08642003 (hereinafter referred to as the standard) as the current standard [1], in the evaluation of the drug testing process, found that The existing standards for the detection of substances have worth exploring, the standard records for the test solution chromatogram to the main peak retention time twice, and three impurity peaks (impurities C, D, E) retention time exceeds the main peak Double the retention time, easily lead to leakage of judgment; In addition, the inspection of the material over