莫匹罗星软膏体外释放研究及评价
Study and Evaluation of Mupirocin Ointment in Vitro Release
路丽华 1常祎卓 2王立新 2崇小萌 2许卉 3宁保明2
作者信息
- 1. 烟台大学,山东烟台 264003;中国食品药品检定研究院,北京 102629
- 2. 中国食品药品检定研究院,北京 102629
- 3. 烟台大学,山东烟台 264003
- 折叠
摘要
目的 根据国内外软膏类制剂质量研究及仿制药技术指导原则,建立莫匹罗星软膏体外释放评价方法.方法 采用扩散池法,释放膜为聚醚砜膜,接收介质为pH 7.4的磷酸二氢钠缓冲液,转速为600 r·min-1,上样量为300 mg;采用高效液相色谱(HPLC)法测定不同时间点接收液中莫匹罗星的浓度,计算累积释放量及释放速率.采用粒度粒型仪对不同厂家莫匹罗星软膏粒子形态及粒度分布进行测定.采用流变仪对不同厂家制剂黏度进行测定.结果 建立了莫匹罗星软膏体外释放测定方法,此方法精密度、耐用性及区分力均较好,并对不同厂家制剂做了一致性评价.不同厂家制剂之间粒度分布及黏度存在较大不同.结论 不同厂家制剂之间粒度分布存在差异反映出制剂生产工艺的不同,黏度的差异反映出制剂处方的不同,二者可共同影响莫匹罗星软膏体外释放速率.
Abstract
OBJECTIVE To establish an evaluation method for the release of mupirocin ointment in vitro,according to the quali-ty research of ointment preparations at home and abroad and the technical guidelines for generic drugs.METHODS The diffusion cell method was adopted,the release membrane was polyethersulfone membrane,the receiving medium was sodium dihydrogen phos-phate buffer solution with pH 7.4,the rotation speed was 600 r·min-1,and the sample size was 300 mg.The concentration of mupirocin in the receiving solution at different time points was determined by HPLC method,and the cumulative release and release rate were calculated.The particle size morphology and particle size distribution of mupirocin ointment from different manufacturers were determined by particle size analyzer.The viscosity of preparations from different manufacturers was determined by rheometer.RESULTS The determination method for the release of mupirocin ointment in vitro was established,and the precision,durability and discrimination of this method were good,and the consistency evaluation was made for preparations from different manufacturers.There were great differences in particle size distribution and viscosity between different manufacturers.CONCLUSION The differences in particle size distribution between different manufacturers reflect the differences in preparation production process,and the differences in viscosity reflect the differences in preparation prescription,both of them can affect the release rate of mupirocin ointment in vitro.
关键词
莫匹罗星软膏/扩散池/体外释放/粒度分布Key words
mupirocin ointment/diffusion cell/in vitro release/particle size distribution引用本文复制引用
出版年
2024
NETL
NSTL
万方数据