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目的:以丹参普通片为参比制剂,研究Beagle犬口服丹参多组分渗透泵片后药物在血浆中的浓度变化,评价丹参多组分渗透泵片的缓释行为。方法:采用HPLC测定,日本岛津ODS-SP色谱柱(4.6 mm×150 mm,5μm),流速1 mL.min-1,柱温30℃。丹参酮ⅡA和丹酚酸B的血浆样品分别以乙酸乙酯萃取和丙酮沉淀的方法除去蛋白,根据测定结果求算药代动力学参数。结果:2种极性不同的成分的方法学考察均符合要求,与丹参普通片相比,Beagle犬口服丹参多组分渗透泵片后,Cmax降低,Tmax延长。结论:与丹参普通片相比,丹参多组分渗透泵片具有良好的缓释效果。
OBJECTIVE: To study the change of plasma concentration of Salvia miltiorrhiza multi-component osmotic pump tablets in Salvia miltiorrhiza Bunge with Salvia miltiorrhiza tablet as reference preparation and to evaluate the sustained-release behavior of Salvia miltiorrhiza multi-component osmotic pump tablets. Methods: The chromatographic column of Shimadzu ODS-SP (4.6 mm × 150 mm, 5 μm) was used in HPLC. The flow rate was 1 mL.min-1 and the column temperature was 30 ℃. Plasma samples of tanshinone IIA and salvianolic acid B were removed by ethyl acetate extraction and acetone precipitation, respectively, and the pharmacokinetic parameters were calculated from the results. Results: The methodological investigation of two components with different polarities met the requirements. Compared with the common tablets of Salvia miltiorrhiza, the Cmax decreased and the Tmax prolonged after oral administration of the Salvia miltiorrhiza multi-component osmotic pump tablets. Conclusion: Salvia miltiorrhiza multi-component osmotic pump tablet has good sustained-release effect compared with common tablet of Salvia miltiorrhiza.