氯己定碘溶液的制备与初步稳定性研究

Study on Preparation and Preliminary Stability of Chlorhexidine-iodine Solution

目的制备氯己定碘溶液并考察其初步稳定性。方法合成氯己定碘,以非离子表面活性剂为增溶剂,以小分子有机溶剂为潜溶剂,采用单因素法优化氯己定碘溶液处方;并对优化处方进行低温实验和冻融实验。结果增溶剂Cremophor EL、ELP、RH 40、Solutol HS 15与潜溶剂乙醇合用时,对氯己定碘的增溶效果最佳。0.5%氯己定碘溶液剂的优化处方为:10%Cremophor RH 40+1%乙醇,昙点为100℃,低温和冻融实验未见制剂性状、含量、昙点等发生变化。结论采用增溶原理可制备性质稳定的氯己定碘溶液。

Objective To prepare chlorhexidine-iodine solution and to investigate its preliminary stablilty.Methods Hlorhexidine-iodine was synthesized.Single-factor method was used to optimize the prescription of chlorhexidine-iodine solution using non-ionic surfactants as solubilizer and a small molecule organic solvent as potential solvent.Low temperature experiment and freeze thawing test were designed to detect the stability of the optimized prescription.Results Chlorhexidine-iodine possessed the best dissolubility when such solubilizers as Cremophor EL,ELP,RH40,Solutol 15 combined with the potential solvent ethanol were used to solubilize chlorhexidine-iodine.The optimized prescription of 0.5% chlorhexidine-iodine solution was as follows： 10% Cremophor RH40 ＋ 1% ethanol.Its cloud point was 100 ℃.No such changes as preparation characteristics,content and cloud point were found in low temperature test and freeze thawing test.Conclusion The stable chlorhexidine-iodine solution can be prepared successfully using the solubilization principle.