气相色谱法研究赋形剂对苯唑青霉素钠稳定性的影响

INVESTIGATION OF THE INFLUENCE OF EXCIPIENTS ON THE STABILITY OF SODIUM OXACILLIN BY PYROLYSIS GAS CHROMATOGRAPHY

采用程序裂解-气相色谱(GC)检测系统,配合红外光谱等手段,研究常用赋形剂如硬脂酸、硬脂酸镁、淀粉、滑石粉和碳酸钙等对苯唑青霉素钠和氨苄青霉素稳定性的影响。实验结果表明,硬脂酸和苯唑青霉素钠有固相反应发生,不宜作苯唑青霉素钠固体制剂的赋形剂,其它赋形剂在相同条件下无此现象。这与差热分析的结果一致。

The influence of the common excipients, such as stearic acid, magnesium stearate, starch, talc powder and calcium carbonate etc. on the stability of sodium oxacillin and ampicillin trihydrate was studied by programmed pyrolysis gas chromatography and infrared spectroscopy. Experimental results showed that there is solid state reaction between sodium oxacillin and stearic acid. So it's not suitable for them to be used as excipients with sodium oxacillin. No reactions happened between the sodium oxacillin and other excipients. The same results were obtained by using DTA method.