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目的了解市售国内外生产厂家生产的复方对乙酰氨基酚片的质量差别,为合理选择复方对乙酰氨基酚片提供依据。方法选择对临床有影响的药剂学指标,对国内外每个生产厂家的三个批次样品进行质量比较。结果各厂家复方对乙酰氨基酚片的性状、溶出度、有关物质、含量均匀度、碎脆度和含量测定均符合规定。结论国内外厂家复方对乙酰氨基酚片均能达到《中国药典》和《国家药品标准》的要求。
Objective To understand the quality differences of acetaminophen tablets produced by domestic and foreign manufacturers in the market and provide the basis for the rational choice of acetaminophen tablets. Methods The pharmacy indexes influencing the clinic were selected, and the quality comparison of three batches samples of each manufacturer at home and abroad was carried out. Results The properties, dissolution, related substances, evenness, fragility and content of paracetamol tablets of all manufacturers were in accordance with the regulations. Conclusion Both domestic and foreign manufacturers of acetaminophen tablets can meet the requirements of “Chinese Pharmacopoeia” and “National Drug Standards”.