复方灵通胶囊稳定性试验中吴茱萸碱和吴茱萸次碱的含量变化  

Content changes of evodiamine and rutaecarpine in Compound Lingtong Capsule in stability testing

作　　者：史万忠[1] 李世芳[1] 刘瑾[1] 刘力[1] 徐德生[1] 

机构地区：[1]上海中医药大学附属曙光医院,上海200021

出　　处：《中成药》2011年第8期1356-1360,共5页Chinese Traditional Patent Medicine

基　　金：上海市科委新药基金项目(03DZ19508)

摘　　要：目的考察复方灵通胶囊稳定性试验中吴茱萸碱和吴茱萸次碱的含量变化。方法建立复方灵通胶囊中吴茱萸碱和吴茱萸次碱的HPLC测定方法;分别采用加速稳定性试验和长期稳定性试验,测定加速试验条件下0、1、2、3、6个月及长期稳定性条件下03、6、、9、12个月取样点时样品中吴茱萸碱和吴茱萸次碱的量;比较长期稳定性条件下12个月样品与0个月样品的液相色谱图中吴茱萸碱和吴茱萸次碱的峰面积的比例。结果加速稳定性试验与长期稳定性试验中吴茱萸碱下降幅度较大,而吴茱萸次碱较为稳定。12个月样品的吴茱萸碱与吴茱萸次碱的峰面积比值与0个月样品相比,明显下降。结论对含有吴茱萸药材的制剂,特别是质量标准中有吴茱萸生物碱含量或指纹图谱项目的,需要注意相关测定中吴茱萸碱的含量下降而造成的对含量限度或指纹图谱相似度的影响,应关注中药稳定性与药效相关性的评价问题。AIM To study the content changes of evodiamine and rutaecarpine in Compound Lingtong Capsule in stability testing. METHODS The HPLC method of contents determination was established, and the contents were determined in the samples under the accelerated and long-term storage conditions, at time points 0, 1, 2, 3, 6 months and 0, 3, 6, 9, 12 months respectively. The ratio of peak area in its chromatogram of evodiamine to rutaecarpine from the 12 months＇ sample was compared with that from the 0 month＇ s sample under the long-term storage condition. RESULTS The contents of evodiamine were decreased significantly in the samples under both the accelerated and the long-term storage conditions, while the contents of rutaecarpine were relatively stable. The ratio of peak area of evodiamine to rutaecarpine in the sample under final time point （12 months） was decreased re- markably compared with that in the sample at initial time point （0 month）. CONCLUSION The influence to the contents limitation and similarity of fingerprint chromatography should be paid attention to, which caused by the de- cline of the evodiamine content in the preparation containing Euodiae Fructus, and especially for those with the con- tent determination and fingerprint chromatography in their quality control standards. The relationship of chemical components stability with pharmacological effects should be considered.

关 键 词：灵通胶囊 稳定性 吴茱萸 吴茱萸碱 吴茱萸次碱 

分 类 号：R927.11[医药卫生—药学]