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目的:制备新型抗抑郁药LPM的单室渗透泵片,并考察其体外释放。方法:采用包合技术提高LPM的溶解度,以聚氧乙烯(PEO)和氯化钠(NaCl)相结合作为渗透压促进剂,以醋酸纤维素为膜材,制备单室渗透泵片。以单因素考察和正交试验设计对处方组成进行优化。结果:采用包合技术,LPM在去离子水中的溶解度可达59.2 g·L-1。最优处方组成为:包合物50%,PEO17%,NaCl 17%,包衣厚度14%。该制剂可以达到12 h的零级释放,累积释放度达80%以上,药物的释放不受介质pH和转速的影响。结论:制备成LPM的单室渗透泵片,其药物释放完全,释药行为符合零级动力学方程。
OBJECTIVE: To prepare single-chamber osmotic pump tablets of new anti-depressant LPM and investigate its in vitro release. Methods: Inclusion technique was used to improve the solubility of LPM. Polyethylene oxide (PEO) and sodium chloride (NaCl) were used as the osmotic pressure enhancer and cellulose acetate as the membrane material to prepare single-chamber osmotic pump tablets. The formulation of prescription was optimized by single factor test and orthogonal design. Results: The solubility of LPM in deionized water was 59.2 g · L-1 by inclusion technique. The optimal prescription consisted of: inclusion compound 50%, PEO 17%, NaCl 17%, coating thickness 14%. The formulation can reach zero-order release for 12 h with a cumulative release of more than 80%. The drug release is independent of the pH and speed of the medium. Conclusion: LPM prepared single-chamber osmotic pump tablets, the drug release is complete, release behavior in line with zero-order kinetic equation.