积雪苷口腔崩解片的研制及质量控制

    Preparation and Quality Control of Asiaticoside Orally Disintegrating Tablets

    • 摘要: 目的 研制积雪苷口腔崩解片。方法 以积雪苷为主药,内加淀粉为崩解剂,建立性状、崩解时限、含量测定等质控方法。结果 制备的口腔崩解片符合工艺要求。以高效液相色谱法测定积雪苷口腔崩解片中积雪草苷的含量,平均回收率为100.7%,RSD=1.01%(n=9)。结论 该制剂制备工艺可行,测定方法简便、准确。

       

      Abstract: OBJECTIVE Preparation and formulation investigation of asiaticoside orally disintegrating tablets. METHODS Prepare the tablets by using asiaticoside as principal drug and starch as disintegrating agent; establish the quality control method including character, disintegration, assay etc. RESULTS The asiaticoside orally disintegrating tablets prepared met technology requirements. The assay of asiaticoside was determined by HPLC, average recovery rate and RSD were 100.7% and 1.01% (n=9) respectively. CONCLUSION The preparation technology is feasible and testing method is convenient and accurate.

       

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