摘要
目的筛选美洛昔康温敏性水凝胶的最佳处方和制备工艺，并建立其含量测定方法。方法以正交实验法筛选基质最佳处方，根据测得数据设计最佳处方，用紫外分光光度法测定美洛昔康的含量。结果正交设计优选的最佳处方为：泊洛沙姆P407：P188为15g：15g，7％氢氧化钠（NaOH）溶液20mL，月桂氮革酮4mL，聚乙二醇400为8g。美洛昔康在1．984～19．840mg·L^-1（r=0．9996）浓度范围内呈良好线性关系。平均加样回收率98．65％，相对标准差（RSD）2．40％。结论该处方设计合理，制备工艺简单，质量稳定可控。
Objective To screen an optimal formulation and the preparation process of the thermo-reversible meloxicam gel and establish its determination method . Methods Orthogonal design was used to observe the change of gelation temperature and gel strength. The content of meloxicam in thermo-reversible meloxieam gel was determined by UV. Results The formulation of the thermo-reversible meloxieam gel was composed of P407/P188 with 15 g/15 g,7% sodium hydrate 20 mL, azone 4 mL and polyethylene glycol 400 8 g. Viscosity of the gel was proper and its stability was high. The liner response range was 1. 984 - 19. 840 mg · L^-1 （ r = 0. 999 6 ）. The mean recoveries was 98.65% （ RSD 2.40% ）. Conclusion The formulation is reasonable,and the preparation process was simple and easy to control with stable quality .
出处
《医药导报》
CAS
2008年第12期1494-1496,共3页
Herald of Medicine
关键词
美洛昔康
水凝胶
温敏性
正交设计
泊洛沙姆
Meloxicam
Thermo-reversible quidgel
Orthogonal design
Poloxamer
