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Stability studies of lincomycin hydrochloride in aqueous solution and intravenous infusion fluids

机译:盐酸林可霉素在水溶液和静脉输液中的稳定性研究

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Purpose: The purpose of this study was to evaluate the chemical stability of Lincocin? (lincomycin hydrochloride) in commonly used intravenous fluids at room temperature (25°C), at accelerated-degradation temperatures and in selected buffer solutions. Materials and methods: The stability of Lincocin? injection (containing lincomycin 600?mg/2?mL as the hydrochloride) stored at 25°C±0.1°C in sodium lactate (Hartmann’s), 0.9% sodium chloride, 5% glucose, and 10% glucose solutions was investigated over 31 days. Forced degradation of Lincocin? in hydrochloric acid, sodium hydroxide, and hydrogen peroxide was performed at 60°C. The effect of pH on the degradation rate of lincomycin hydrochloride stored at 80°C was determined. Results: Lincomycin hydrochloride was found to maintain its shelf life at 25°C in sodium lactate (Hartmann’s) solution, 0.9% sodium chloride solution, 5% glucose solution, and 10% glucose solution, with less than 5% lincomycin degradation occurring in all intravenous solutions over a 31-day period. Lincomycin hydrochloride showed less rapid degradation at 60°C in acid than in basic solution, but degraded rapidly in hydrogen peroxide. At all pH values tested, lincomycin followed first-order kinetics. It had the greatest stability near pH 4 when stored at 80°C (calculated shelf life of 4.59 days), and was least stable at pH 2 (calculated shelf life of 0.38 days). Conclusion: Lincocin? injection was chemically found to have a shelf life of at least 31 days at 25°C when added to sodium lactate (Hartmann’s) solution, 0.9% sodium chloride solution, 5% glucose solution, and 10% glucose solution. Solutions prepared at approximately pH 4 are likely to have optimum stability.
机译:目的:本研究的目的是评估室温下(25°C),加速降解温度和所选缓冲液中常用林肯霉素(盐酸林可霉素)的化学稳定性。解决方案。材料和方法:林可霉素?注射液(含有林可霉素600?mg / 2?mL作为盐酸盐)在25°C±0.1°C的乳酸钠(Hartmann's),0.9%的钠中储存的稳定性。在31天内研究了氯化物,5%葡萄糖和10%葡萄糖溶液。在60℃下,在盐酸,氢氧化钠和过氧化氢中强制降解林可霉素α。确定了pH对储存在80°C的盐酸林可霉素降解速率的影响。结果:发现盐酸林可霉素在乳酸钠(Hartmann's)溶液,0.9%氯化钠溶液,5%葡萄糖溶液和10%葡萄糖溶液中在25°C时能保持其货架期,而在所有情况下,林可霉素的降解均低于5%在31天的时间内静脉注射溶液。盐酸林可霉素在60°C的酸中降解不如在碱性溶液中快,但在过氧化氢中迅速降解。在所有测试的pH值下,林可霉素均遵循一级动力学。当在80°C下储存时,它在pH 4附近具有最大的稳定性(计算的货架期为4.59天),在pH 2下则最不稳定(计算的货架期为0.38天)。结论:从化学角度看,加入乳酸钠(Hartmann's)溶液,0.9%氯化钠溶液,5%葡萄糖溶液,Lincocin ?注射液在25°C下的保质期至少为31天。和10%葡萄糖溶液。在大约pH 4下制备的溶液可能具有最佳稳定性。

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