2种晶型利福平制剂之间溶出曲线的差异

目的: 比较不同晶型制剂之间利福平溶出度的差异。 方法: 采用中国药典溶出度桨法装置测定溶出曲线,3种不同pH的溶出介质体积为900 mL,溶出介质温度为37 ℃,桨转速为75 r·min^-1;使用适当的HPLC方法对利福平的溶出度进行测定。 结果: 大多数Ⅰ晶型制剂比作为参比的Ⅱ晶型制剂所得到的溶出度结果相似或较高。 结论: 排除制剂工艺的影响后,Ⅰ晶型制剂与作为参比的Ⅱ晶型在溶出度结果上相似或更优。

Objective: To compare the differences of the dissolution profiles of two crystalline types of the fixed dose combinations(FDCs)of rifampin. Methods: Three dissolution profiles in media(900 mL)with different pH were obtained using the dissolution determination apparatus of paddle method in ChP.The temperature of the media was 37 ℃ and the rotation speed was 75 r·min^-1.A proper HPLC method was selected and used to determine the dissolution. Results: Most dissolution results of the FDCs made by crystalline type Ⅰ were similar to or higher than those reference substances made by crystalline type Ⅱ. Conclusion: It indicates that Rifampin of crystalline typeⅠ has the similar or better dissolubility compared with the type Ⅱ,excluding the influence of pharmaceutical technologies.

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