丹参多酚酸口腔崩解片的质量标准研究.docVIP

丹参多酚酸口腔崩解片的质量标准研究 作者：周毅生，孟江，咸银库，廖华卫，刘林，段芳 【摘要】 　　目的 建立丹参多酚酸口腔崩解片的质量标准。方法 采用薄层色谱法鉴别丹参多酚酸口腔崩解片中主要成分丹酚酸B，采用高效液相色谱法及紫外可见分光光度法分别测定丹参多酚酸口腔崩解片中的丹酚酸B及丹参总酚酸的含量，并测定其崩解时限和片重差异。结果 丹参多酚酸口腔崩解片平均崩解时限为23.5 s，且片重差异符合规定；丹酚酸B在41.04～205.2 μg·mL-1范围内色谱峰面积与进样量间线性关系良好，r=0.999 6，平均回收率为99.96％，RSD为0.55％；原儿茶醛在41.36～248.16 μg·mL-1范围内色谱峰面积与进样量间线性关系良好， r=0.999 6， 平均回收率为96.67％， RSD为1.54％。 结论 建立了该制剂的质量标准，其鉴别与含量测定方法简便、可靠，可作为该制剂的质量控制指标。 【关键词】 丹参多酚酸 丹参酚酸B 口腔崩解片 质量标准 　　Abstract:Objective To establish the quality standard of orally disintegrating tablets of salvianolic acids. Methods The main ingredient of the tablets, salvianolic acid B, was identified by TLC. The contents of salvianolic acid B and total salvianolic acids in the orally disintegrating tablets of salvianolic acid were measured by HPLC and UV. The disintegration time and tablet weight were determined．Results The tablets of salvianolic acids disintegrated in 26.5 seconds, and the tablet weight was fit for the criterion．A good linearity of salvianolic acid B was obtained within the range of 41.04-205.2 μg·mL-1 with the correlation coefficient 0.9996．The recovery was 99.96 ％ and RSD 0.55 ％．A good linearity of protocatechuic aldehyde was obtained within the range of 41.36-248.16 μg·mL-1 with the correlation coefficient 0.9996．The recovery was 96.67％ and RSD 1.54％．Conclusion The method for identifying and determining salvianolic acids is useful for the quality control of orally disintegrating tablets of salvianolic acids. 　　Key words:salvianolic acids B; salvianolic acid ; orally disintegrating tablets; quality standard 　　丹参多酚酸是中药丹参中的水溶性成分，具有显著的抗心肌缺血作用，降低心脏耗氧量，并能对抗诱导的血小板聚集和抑制血栓的形成。临床试验研究表明，丹参多酚酸对于冠心病、心绞痛，疗效显著、确切，病人使用安全［1］，其中丹酚酸B具有较高的生物活性。口腔崩解片是近年来国内外研究开发的一种速释新剂型，不需用水或只需少量水，亦无需咀嚼，而只需将药物置于舌面上，遇唾液迅速崩解后，随吞咽动作入胃起效，方便老人、儿童、吞咽困难或特殊环境下的患者用药［2］。本研究通过对丹参多酚酸口腔崩解片的质量标准研究，为该制剂的质量控制提供依据。 　　1 仪器与试药 　　1.1 试剂与试药 　　丹参多酚酸口腔崩解片(自制,规格:0.25 g/片)；丹酚酸B对照品(中国药品生物制品检定所，批号：111562200605)；原儿茶醛对照品(中国药品生物制品检定所，批号：1