神昌注射液稳定性影响因素的考察

Stability of Shenchang Injection

目的:考察影响神昌注射液(石菖蒲、冰片)稳定性的因素及最佳稳定性条件。方法:用RP-HPLC法测定神昌注射液在高温、光线、氧气以及pH值等因素的影响下β-细辛醚的含量变化;并用GC-MS法测定其中化学组成的变化;以β-细辛醚的含量为指标,采用L9(34)正交试验优选神昌注射液稳定性条件。结果:温度、光线、空气以及酸碱度等对神昌注射液的稳定性都有一定的影响,其中光线是神昌注射液稳定性的最主要影响因素。结论:神昌注射液最佳稳定性条件是:pH为6.5,避光生产、贮存,不需加抗氧化剂。

AIM： To inspect the stability factors and the storage condition for Shenchang Injection （Rhizoma aeori tatarinowii; Borneolum syntheticum）. METHODS：The concentrations of β-asarone in Shenchang Injection under the condition of heat,light, oxygen and pH value were determined by RP-HPLC. To mensurate the transformation of chemistry composing by GC-MS. To study the best condition of the stability of Shenchang Injection by L9 （34） orthogonal design and to use the content of β-asarone as the index. RESULTS： There existed influence on temperature,light, air and pH, but the light was the one of the most important factors in the stability of Shenchang Injection. CONCLUSION ： The optimal condition of the stability for Shenchang Injection adopts pH as 6.5 ; storage keeps from light and has no need of antioxident.