[关键词]
[摘要]
目的 对加味脑乐静合剂的稳定性进行研究,探讨pH值的变化与微量沉淀形成的关系,确保本品安全有效使用。方法 样品室温下存放,对其pH、沉淀形成及化学成分进行为期2年的跟踪检测。化学成分的定性用TLC和HPLC法,葛根素含量测定采用HPLC法,外标法定量(mg/mL)。结果 获得了沉淀和液体部分各自的TLC和HPLC特征图谱。在薄层上可以清楚地检识出甘草和葛根的斑点,在HPLC谱中可以清楚地检识出葛根素的特征峰;随着贮存时间的延长,沉淀的量稍有增加,而pH值略有下降。结论 该液体制剂在贮存期间基本稳定,所获实验数据可为本品的进一步研究提供参考。
[Key word]
[Abstract]
Object<\b> To study the stability of JIAWEI NAOLEJING ORAL LIQUOR and to find the relationship between pH and sedimentation in the ORAL LIQUOR, so as to ensure its safety and efficacy.Methods<\b> The chemical costituents of the ORAL LIQUOR which have been stored for 24 months at room temperature were qualitatively determined by TLC and HPLC, the puerarin was quantitatively determined by HPLC with external standard and expressed in mg/mL Results<\b> Characteristic TLC and HPLC spectrum of the sediment and the liquid was obtained Spots of Radix glycyrrhizae and Radix Puerariae were clearly distinguished on the plate HPLC peaks of puerarin were clearly exhibited The content of sediment in the ORAL LIQUOR increased slowly accompanying time prolonging, but the pH value reduced slowly Qualitative analysis proved that the sediment contained no active ingredients, such as puerarin and glycyrrhizin Puerarin hadn't reduced during storage for 24 months at room temperature Conclusion<\b> This ORAL LIQUOR is stable during storage for 24 months These data obtained from the experiment may be useful for further studies on the ORAL LIQUOR.
[中图分类号]
[基金项目]
卫生部科技计划;湖南省科委重点项目(98ssy1002)