不同溶出介质中利福昔明片体外溶出行为比较

Comparison of Rifaximin Tablets In-vitro Dissolution Behavior in Different Dissolution Media

目的考察利福昔明片自研制剂与原研制剂在不同溶出介质中体外溶出行为的相似性。方法以国外上市的利福昔明片作为参比制剂,采用桨法进行溶出试验。溶出介质分别为p H=1.2盐酸溶液[含1.0%十二烷基硫酸钠溶液(SDS)]、p H=4.5醋酸-醋酸钠缓冲液(含1.0%SDS)、p H=6.8磷酸盐缓冲液(含1.0%SDS)和水(含1.0%SDS),采用紫外分光光度法检测含量,以相似因子(f2)法对溶出曲线的相似性进行评价。结果在不同p H的溶出介质中,自研制剂与参比制剂比较,f2均大于50。结论自研制剂和参比制剂在不同溶出介质中的体外溶出行为相似。

Objective To investigate the similarity of the dissolution behavior of self- made rifaximin preparation and original rifaximin preparation in different dissolution media. Methods The paddle method was used to perform the dissolution experiment with abroad listed Rifaximin Tablets as the reference preparation. The dissolution media were p H = 1. 2 hydrochloric acid solution（ containing 1. 0% SDS）,p H = 4. 5 acetic acid- sodium acetate buffer solution（ containing 1. 0% SDS）,p H = 6. 8 phosphate buffer solution（ containing 1. 0% SDS）and water（ containing 1. 0% SDS）. The UV spectrophotometry was used to determine the rifaximin content. The similarity factor（ f2）method was adopted to evaluate the similarity of dissolution curves. Results In different dissolution media,f2 of rifaximin from the self- prepared preparation and the reference preparation were all more than 50. Conclusion The dissolution behaviors in vitro of the self- prepared preparation and the reference preparation are similar in different dissolution media.