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目的:制备姜黄素与胡椒碱复方自乳化给药系统,并对其质量进行评价。方法:测定药物在不同油相、乳化剂、助乳化剂中的溶解度,通过配伍相容性实验研究不同油相、乳化剂、助乳化剂对自乳化效率的影响,并结合假三元相图,筛选出复方自乳化制剂的处方。通过观察微乳的外观及测定、粒径、电位和稳定性对其进行评价。结果:自乳化处方为Labrafil M 1944CS-Transcutol HP-Solutol HS15(10∶40∶50);所形成的微乳外观清澈、透明,粒径为(19.0±3.1)nm,ξ电位为-7.27mv,稳定性研究表明其载药量为姜黄素10 mg·g-1,胡椒碱0.2 mg·g-1。结论:自乳化给药系统可以提高难溶性药物的溶解度。
Objective: To prepare curcumin and piperine compound self-emulsifying drug delivery system, and evaluate its quality. Methods: The solubility of drug in different oil phase, emulsifier and co-emulsifier was determined. The effect of different oil phase, emulsifier and co-emulsifier on self-emulsifying efficiency was studied by compatible compatibility experiment. Combined with the pseudo-ternary phase diagram , Screening out prescription self-emulsifying formulations. By observing the appearance and determination of microemulsion, particle size, potential and stability of its evaluation. Results: The self-emulsifying prescription was Labrafil M 1944CS-Transcutol HP-Solutol HS15 (10:40:50). The formed microemulsion had a clear and transparent appearance with a diameter of (19.0 ± 3.1) nm and a zeta potential of -7.27mv Stability studies showed that the drug loading of curcumin 10 mg · g-1, piperine 0.2 mg · g-1. Conclusion: Self-emulsifying drug delivery system can improve the solubility of insoluble drugs.