紫金透骨喷雾剂的质量控制及稳定性考察  

Study on the quality control and the stability of Zijin Tougu sprays

作　　者：石凌云[1] 王永林[1] 郑林[1] 周雯[1] 王爱民[1] 黄勇[1] 

机构地区：[1]贵阳医学院药学院,贵州贵阳550004

出　　处：《中国医院药学杂志》2012年第19期1513-1516,共4页Chinese Journal of Hospital Pharmacy

基　　金：贵州省中药现代化科技产业研究开发基金项目(编号:黔科合社字[2008]5014号);贵阳市科技计划项目(编号:[2008]筑科农合同

摘　　要：目的:建立紫金透骨喷雾剂的质量控制方法并考察其在加速和室温条件下的稳定性。方法:采用薄层色谱法鉴别紫金透骨喷雾剂中的主要药材;采用气相色谱法测定冰片的含量;采用高效液相色谱法测定双[4-(β-D-吡喃葡萄糖氧)苄基-]2-异丁基苹果酸酯的含量。结果:所采用的薄层色谱法均检出了紫金透骨喷雾剂中的主要药材,冰片在0.135 7～0.814 1 mg·mL-1范围内线性良好(r=0.999 9),militarine在0.027 12～0.434 0 mg·mL-1范围内线性良好(r=0.999 9),且3批紫金透骨喷雾剂中试样品经加速试验3个月和长期试验6个月考察,各项指标均符合质量标准要求。结论:所采用的各项方法均能简单、准确的应用于紫金透骨喷雾剂的质量控制中,且本品稳定性良好。OBJECTIVE To establish the quality control method and study the stability of Zijin Tougu sprays at accelerated testing and room temperature.METHODS Major drug ingredients in sprays were identified by TLC.Borneol was determined by GC.Militarine was determined by HPLC.RESULTS Major drug ingredients in sprays all could be identified by TLC,the linear range for borneol and militarine was 0.135 7-0.814 1 mg·mL-1 and 0.027 12-0.434 0 mg·mL-1（r=0.999 9）respectively.In the influence factor testing,accelerated testing and the long-term testing,various indexes of 3 pilot test samples accorded with the quality standard of Zijin Tougu sprays.CONCLUSION The adopted various methods for quality control of Zijin Tougu sprays were simple and accurate,and Zijin Tougu sprays had excellent stability.

关 键 词：紫金透骨喷雾剂 稳定性 薄层色谱法 气相色谱法 高效液相色谱法 双[4-(β-D-吡喃葡萄糖氧)苄基-]2-异丁基苹果酸酯 

分 类 号：R944[医药卫生—药剂学]