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目的:研究葡葡糖酸镁口服液的化学稳定性,探讨其内在质量。方法:依据化学动力学原理,以旋光法定量,采用经典恒温法,测定本品的降解速度常数(K),并由Arrhenius公式计算出有效期。结果:实验结果表明葡萄糖酸镁口服液的降解反应为一级反应,在室温25℃条件下T25℃0.9为25.4年。结论:葡萄糖酸镁口服液具有良好的化学稳定性,为新药生产、使用、贮存提供了理论依据。
Objective: To study the chemical stability of magnesium gluconate oral solution and to explore its intrinsic quality. Methods: According to the principle of chemical kinetics, quantify by polarimetry and determine the degradation rate constant (K) by classical thermostat method, and calculate the expiration date by Arrhenius formula. Results: The experimental results show that the degradation reaction of magnesium gluconate oral solution is first order reaction, T25 ℃ 0.9 is 25.4 years at room temperature 25 ℃. Conclusion: Magnesium gluconate oral liquid has good chemical stability, which provides a theoretical basis for the production, use and storage of new drugs.