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Sodium, potassium, calcium lactobionates, and lactobionic acid from Zymomonas mobilis: A novel approach about stability and stress tests.
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2019-05-27 , DOI: 10.1016/j.jpba.2019.05.060 Maria Gabriele Delagustin 1 , Eduarda Gonçalves 2 , Sabrina Carra 1 , Thiago Barcellos 2 , Valquiria Link Bassani 3 , Mauricio Moura da Silveira 2 , Eloane Malvessi 2
Journal of Pharmaceutical and Biomedical Analysis ( IF 3.1 ) Pub Date : 2019-05-27 , DOI: 10.1016/j.jpba.2019.05.060 Maria Gabriele Delagustin 1 , Eduarda Gonçalves 2 , Sabrina Carra 1 , Thiago Barcellos 2 , Valquiria Link Bassani 3 , Mauricio Moura da Silveira 2 , Eloane Malvessi 2
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The bioproduction of lactobionic acid and its salts can be performed by enzymatic complex glucose-fructose oxidoreductase (GFOR) and glucono-δ-lactonase (GL) of Zymomonas mobilis. Considering the applicability of these compounds in pharmaceutical area, the aim of this study was to assess the accelerated and long-term stability studies of sodium, potassium, calcium lactobionate, and lactobionic acid. Furthermore, stress tests were performed to evaluate the stability against pH, temperature and oxidation. The samples submitted to degradation tests were analyzed by high-performance liquid chromatography (HPLC) and high-resolution mass spectrometry analysis (HRMS-ESI-QTOF). Sodium, potassium, and calcium lactobionate were stable for six months of analyses considering the accelerated (40 °C and 75% RH) and long-term (30 °C and 75% RH) stability studies. The presence of lactobiono-δ-lactone and a significant increase in moisture were observed for both biosynthesized and commercially available lactobionic acid samples. Against the forced degradation tests, all the lactobionate salts and lactobionic acid showed to be stable upon alkaline and acid pH conditions, at 60 and 80 °C, and also against UV light exposition. Furthermore, the presence of lactobiono-δ-lactone form was observed in lactobionic acid samples. However, the degradation of both lactobionic acid and lactobionate salts was evident in the presence of hydrogen peroxide. This degradation kinetic profile suggests, that lactobionate salts follows a zero-order reaction model and lactobionic acid follows a second-order kinetic. The MS analysis of the main degradation product suggests a molecular formula C11H20O10 resulting from the oxidative decarboxylation. This report brings an amount of results as contribution to the scarce information regarding the chemical and physical-chemical stability of sodium, potassium, calcium lactobionate, and lactobionic acid. These data may be useful and serve as reference, in view of the multipurpose applications of the cited compounds.
中文翻译：
运动发酵单胞菌的钠，钾，乳糖酸钙和乳糖酸：关于稳定性和压力测试的新方法。
乳酸原酸及其盐的生物生产可以通过运动发酵单胞菌的酶复合葡萄糖-果糖氧化还原酶（GFOR）和葡萄糖酸-δ-内酰胺酶（GL）来进行。考虑到这些化合物在医药领域中的适用性，本研究的目的是评估钠，钾，乳糖酸钙和乳糖酸的加速和长期稳定性研究。此外，进行了压力测试以评估其对pH，温度和氧化的稳定性。进行降解测试的样品通过高效液相色谱（HPLC）和高分辨率质谱分析（HRMS-ESI-QTOF）进行分析。考虑到加速（40°C和75％RH）和长期（30°C和75％RH）稳定性研究，乳酸钠，钾和乳酸钙在六个月的分析中稳定。对于生物合成的和市售的乳糖酸样品，都观察到了乳酸菌-δ-内酯的存在和水分的显着增加。在强制降解测试中，所有乳糖酸盐和乳糖酸在碱性和酸性pH条件下（60和80°C）均表现出稳定的特性，并且还可以抵抗紫外线的照射。此外，在乳糖酸样品中观察到了乳酸-δ-内酯形式的存在。然而，在过氧化氢的存在下，乳酸酸和乳酸酸盐的降解都是明显的。该降解动力学曲线表明，乳酸酯盐遵循零级反应模型，而乳酸酯酸遵循二级动力学模型。主要降解产物的MS分析表明，由氧化脱羧产生的分子式为C11H20O10。该报告带来了大量的结果，为对钠，钾，乳糖酸钙和乳糖酸的化学和物理化学稳定性的稀缺信息做出了贡献。考虑到所引用化合物的多用途，这些数据可能是有用的，并可以作为参考。
更新日期：2019-05-27
中文翻译：
运动发酵单胞菌的钠，钾，乳糖酸钙和乳糖酸：关于稳定性和压力测试的新方法。
乳酸原酸及其盐的生物生产可以通过运动发酵单胞菌的酶复合葡萄糖-果糖氧化还原酶（GFOR）和葡萄糖酸-δ-内酰胺酶（GL）来进行。考虑到这些化合物在医药领域中的适用性，本研究的目的是评估钠，钾，乳糖酸钙和乳糖酸的加速和长期稳定性研究。此外，进行了压力测试以评估其对pH，温度和氧化的稳定性。进行降解测试的样品通过高效液相色谱（HPLC）和高分辨率质谱分析（HRMS-ESI-QTOF）进行分析。考虑到加速（40°C和75％RH）和长期（30°C和75％RH）稳定性研究，乳酸钠，钾和乳酸钙在六个月的分析中稳定。对于生物合成的和市售的乳糖酸样品，都观察到了乳酸菌-δ-内酯的存在和水分的显着增加。在强制降解测试中，所有乳糖酸盐和乳糖酸在碱性和酸性pH条件下（60和80°C）均表现出稳定的特性，并且还可以抵抗紫外线的照射。此外，在乳糖酸样品中观察到了乳酸-δ-内酯形式的存在。然而，在过氧化氢的存在下，乳酸酸和乳酸酸盐的降解都是明显的。该降解动力学曲线表明，乳酸酯盐遵循零级反应模型，而乳酸酯酸遵循二级动力学模型。主要降解产物的MS分析表明，由氧化脱羧产生的分子式为C11H20O10。该报告带来了大量的结果，为对钠，钾，乳糖酸钙和乳糖酸的化学和物理化学稳定性的稀缺信息做出了贡献。考虑到所引用化合物的多用途，这些数据可能是有用的，并可以作为参考。
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