光纤药物溶出度法测定盐酸环丙沙星片及胶囊的溶出度

目的用光纤溶出度法测定和分析不同生产厂家和批号的盐酸环丙沙星片及胶囊溶出度,以此为例,探索固体制剂药物溶出过程的评价方法。方法采用光纤溶出度实时测定和《中国药典》规定的药物溶出度测定方法,比较2种方法测得的溶出百分率与药物相对标示量的百分含量之间的差异;提取FODT测定该制剂的溶出曲线,以及开始、中间及终末溶出3个阶段4项参数,并比较这些曲线和参数;考察相似因子（f2因子）及A值评价药物溶出过程的方法;同时观察该制剂在不同溶出介质中的溶出行为。结果 FODT 30min溶出百分率高出《中国药典》约4%,更接近药物相对百分含量;该制剂溶出曲线总体分为＂厂＂型和＂S＂型,2种溶出曲线类型的4项溶出参数有所不同;相对试验结果：f2与A值评定结果不一;盐酸环丙沙星片在磷酸盐缓冲液中几乎没有溶出。结论本试验结果表明：不同生产厂家批号的盐酸环丙沙星片及胶囊的药物溶出过程差异较大,应当建立简单实用的固体制剂溶出度的评价方法。

Studies with Fiber-Optic in Situ Dissolution Testing Equipment on the Dissolution Rate of Ciprofloxacin Hydrochloride Tablets and Capsules

Objective With fiber-optic in situ dissolution testing（FODT） equipment,to determine and analyze the dissolution rate of ciprofloxacin hydrochloride tablets and capsules of the different producers and their lot No.To probe into the evaluation methods of the drug dissolution rate for the solid preparations.Methods By means of two ways of FODT and Chinese pharmacopoeia,2005 section Ⅱ,the differentiation of the following targets was compared,the drug dissolution percentage with the drug content determined by Ch.P rules.With FODT,the dissolution curves and four dissolution parameters at the phases of start,median and ending of the drug dissolution proceeding were examined and judged.The methods of similar factor（f2 factor）and A value for evaluation of the drug dissolution proceeding were investigated.Meanwhile,the preparations′dissolution actions in different dissolution medium were observed.Results FODT′s dissolution percentages for 30min are closer to the relative per cent content of the drugs and high about 4% to Ch.P.The figures of the preparation′s dissolution curves are generally classified the types of ＂厂＂and ＂S＂.Four dissolution parameters of two types are not same.The results of the relative comparing trials were that f2 factors and A values of the preparations investigated were different.The tablets of ciprofloxacin hydrochloride were almost not dissoluble in the buffer of phosphate.Conclusion The trials are shown that in different producers and their lot No.,the dissolution proceeding of the tablets and capsules of ciprofloxacin hydrochloride is very different.The evaluation methods about the dissolution rate of solid preparation should be simple and practical.