摘要
目的评价国内不同企业生产的莫匹罗星软膏的质量。方法按照现行质量标准检验结合探索性研究,包括对产品的有关物质、聚乙二醇含量、黏度、粒度、酸碱度、透皮吸收等的考察,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127批样品,按国家标准检验合格率为100.0%。探索性研究结果表明,酸碱度测定结果均近中性;6个生产企业样品杂质种类和水平相近;但黏度、粒度、透皮吸收等存在差异。结论目前莫匹罗星软膏总体质量较好;现行标准需进一步完善,建议增/修订有关物质检测方法;建议企业对莫匹罗星软膏剂的处方、工艺进行再评价。
Objective To evaluate the quality of mupirocin ointment from different manufactures. Methods The quality and standard controllability of mupirocin ointment was evaluated comprehensively by researching on the original standard and the exploratory experiments, including the determination of related substances and two kinds of polyethylene glycol in ointment, the investigation of viscosity, particle size, acidity and alkalinity, and transdermal absorption. Results The qualified rate was 100.0% for the 127 batches of samples extracted according to the original standard. The results of exploratory research showed that the results of acidity and alkalinity of different samples were all nearly neutral and the impurity types and levels of samples from six manufacturing enterprises were similar. However, the differences existed in viscosity, particle size, transdermal absorption, and so on. Conclusion The quality of mupirocin ointment was good at present and the current standard should be further improved and unified. It was proposed that the related substance method should be added or revised. It was proposed that the prescription and the production process should be reevaluated further.
作者
王小亮
梁亚伟
衷红梅
张秉华
席志芳
赵蒲中
绳金房
Wang Xiao-liang;Liang Ya-wei;Zhong Hong-mei;Zhang Bing-hua;Xi Zhi-fang;Zhao Pu-zhong;Sheng Jin-fang(Shaanxi Institute for Food and Drug Control,Xi’an 710065)
出处
《中国抗生素杂志》
CAS
CSCD
2020年第3期252-258,共7页
Chinese Journal of Antibiotics
关键词
莫匹罗星软膏
质量评价
药品标准
有关物质
透皮吸收
Mupirocin ointment
Quality evaluation
Drug standard
Related substance
Transdermal absorption
