曲安奈德新霉素贴膏的质量评价

目的评价国内不同企业生产的曲安奈德新霉素贴膏的质量。方法按照现行质量标准检验结合探索性研究,包括醋酸曲安奈德及硫酸新霉素鉴别方法的改进、醋酸曲安奈德和硫酸新霉素的含量测定方法的建立、含量均匀度的测定、残留溶剂的考察等,综合评价产品质量及现行质量标准对产品质量的可控性。结果抽取的267批样品,按现行国家标准检验合格率为98.9%。探索性研究结果表明,改进的鉴别方法专属性及可操作性均较高,能更好的鉴别两个主成分;不同厂家的曲安奈德新霉素贴膏两个主成分含量水平存在较大差异,抽取6个厂家的样品中有5个厂家硫酸新霉素含量不合格且均一性较差;1个厂家溶剂残留量超出规定范围。结论目前曲安奈德新霉素贴膏总体质量一般;现行标准不能很好控制产品质量,需进一步提高,建议现行标准改进两个主成分醋酸曲安奈德及硫酸新霉素的鉴别方法,增加含量测定项目;建议企业进一步优化生产工艺,控制样品含量均匀性及溶剂残留量,以提高产品质量。

Quality assessment of triamcinolone acetonide and neomycin paste

Objective To evaluate the quality of triamcinolone acetonide and neomycin paste from different manufactures. Methods The quality and the standard controllability of triamcinolone acetonide and neomycin paste were evaluated by researching on the original standard and the exploratory experiments including the improvement of the identification method of triamcinolone acetonide acetate and neomycin sulfate, assay of triamcinolone acetonide acetate and neomycin sulfate, and the determination of the content uniformity and the residual solvents. Results The qualified rate was 98.9% for the 267 batches of samples extracted according to the original standard. The results of exploratory research showed that the improved identification method was specific, accurate, and well operated, which could identify the two principal components well. There were big differences for the assay results amongdifferent manufacturers, where five were unqualified among the six manufactures and the homogeneity were poor meanwhile; the residual solvents exceeded the specified limit for one of the manufacturers. Conclusion The quality of triamcinolone acetonide and neomycin paste was generally not bad and the current standard should be further improved. It was proposed that the identification methods for the two principal components should be improved and the method for the assay of triamcinolone acetonide and neomycin sulfate should be added. However, it was necessary to optimize the production process, control the uniformity of the content of the product and the residual solvents for better quality