尼群地平固体分散体体外溶出度研究

目的:选择尼群地平固体分散体适宜的体外溶出介质。方法:测定尼群地平在多种溶出介质中的溶解度，通过体外溶出度试验比较尼群地平固体分散体在不同溶出介质中的溶出行为。结果:溶出介质1.0%和0.5%的十二烷基硫酸钠(SDS)水溶液可以满足“漏槽”条件，但药物释放较快，固体分散体间的溶出行为差异不明显；0.3%的SDS水溶液可以保证药物的全部溶出，且可以明显区别各固体分散体之间的溶出差异。结论:选用0.3%的SDS水溶液作为溶出介质，便于通过溶出度试验来筛选固体分散体处方。

Studies on Dissolution of Nitrendipine Solid Dispersions

Objective: To select preferable dissolution medium for dissolution test of nitrendipine solid dispersions. Methods: Nitrendipine solubilities in several media were determined, and dissolution tests of nitrendipine solid dispersions were carried out in different dissolution media. Results: The drug release rate from four kinds of nitrendipine solid dispersions was quite faster in 1.0% or 0.5% SDS solutions than in 0.3% SDS solution. The drug dissolution could be full in 0.3% SDS solution, and differences of the dissolution rate for the 4 kind of solid dispersions could be well displayed, although sink conditions could be achieved in 1.0% or 0.5% SDS solutions. Conclusion: Formulation of nitrendipine solid dispersion could be well evaluated through dissolution tests if 0.3% SDS solution was selected as dissolution medium.