| Objective： To establish a determination for the excipients mannitol injection ofbreviscapine,and explore the different content of mannitol injection Breviscapine on thecompatibility of the solution stability.Methods: To determination of the content of the excipients mannitol injection Breviscapineby using the iodometric method,UV spectrophotometry and evaporative light scattering-highperformance liquid chromatography (HPLC-ELSD).Comparisons of several differentdetection methods to find the most suitable for the determination of excipients mannitol.Take different amounts of mannitol,respectively,compatible with the10mg Breviscapine,Freeze-dried,respecitively,0.9%Nacl and5%glucose solution dissolved,test thecompatibility of stability within8h (just like clarity,pH value,the number ofparticles,osmotic molar concentration).Results: By using Iodimetry,UV-visible spectrophotometry,evaporative light scattering-highperformance liquid chromatography (HPLC-ELSD) to determination the content of the samebatch injection of Breviscapine excipients mannitol,Its content percentage respectively was96.3%,97.7%,99.6%.And the evaporative Light Scattering-high performance liquidchromatography (HPLC-ELSD) was the most suitable for determination of the content ofthe excipients mannitol injection breviscapine. Compatible Stability of experimental resultsshows that the number of particles in mannitol content and compatibility system,mannitolcontent for10mg compatibility system the number of particles at least.Conclusion（1）This topic established by HPLC-ELSD determination can be used to determine thecontent of the excipients mannitol injection breviscapine.The method issimple,fast,accurate,and is able to meet the requirements of the standard of quality ofpreparation.（2）Compatible Stability of experimental results shows that the number of particles inmannitol content and compatibility system,mannitol content for10mg compatibility systemthe number of particles at least. |
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