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目的:研究盐酸地尔硫芯溶液在不同条件下的稳定性。方法:采用经典恒温法考察了盐酸地尔硫芯在不同pH值的磷酸盐缓冲液、相同pH值的不同缓冲盐溶液及多种有机溶剂中的稳定性。结果:盐酸地尔硫芯在pH4时最为稳定;枸橼酸盐缓冲液和酒石酸盐缓冲液能延缓其水解;其在乙醇和甲醇中较稳定。结论:盐酸地尔硫芯溶液在不同条件下稳定性不同,该结果为盐酸地尔硫芯的分析及相关制剂的研究提供了参考。
Objective: To study the stability of diltiazem hydrochloride hydrochloride solution under different conditions. Methods: The stability of diltiazem hydrochloride hydrochloride in phosphate buffer solution with different pH value, buffer solution with the same pH, and various organic solvents was investigated by classical thermostat method. RESULTS: Diltiazem hydrochloride was the most stable at pH 4; citrate buffer and tartrate buffer delayed its hydrolysis; it was more stable in ethanol and methanol. CONCLUSION: The stability of diltiazem hydrochloride is different under different conditions. This result provides a reference for the analysis of diltiazem hydrochloride and the related preparations.