蒜氨酸/蒜酶肠溶片质量控制方法研究  

Study on quality control of alliin /allinase enteric-coated tablets

作　　者：张海波[1] 李新霞[1] 赵东升[1,2] 宋百灵 谢丽婷 陈坚[1,3] 

机构地区：[1]新疆医科大学,乌鲁木齐830011 [2]新疆比尔兄弟生物技术有限公司,乌鲁木齐830011 [3]新疆埃乐欣药业有限公司,乌鲁木齐830011 [4]库车县人民医院,阿克苏842000

出　　处：《中国新药杂志》2014年第7期829-832,838,共5页Chinese Journal of New Drugs

基　　金：国家自然科学基金(81260486);新疆研究生科研创新项目(XJGRI2013085)

摘　　要：目的:建立一种新型片剂蒜氨酸/蒜酶肠溶片有效的质量控制方法。方法:采用TLC法对蒜氨酸/蒜酶肠溶片中的蒜氨酸、潜在大蒜辣素进行定性鉴别;采用HPLC法对制剂中的蒜氨酸、潜在大蒜辣素进行含量测定。结果:薄层色谱中蒜氨酸、潜在大蒜辣素特征斑点清晰;3批样品中蒜氨酸含量分别为55.24,49.60,54.90 mg/片,大蒜辣素含量分别为21.08,22.10,23.20 mg/片。辅料在整个研究中不干扰测定。结论:所建立质量控制方法可用于蒜氨酸/蒜酶肠溶片的质量控制。Objective：To establish an effective quality control method of alliin/allinase enteric-coated tablets（a new type of tablets）. Methods：Alliin and potential allicin were identified by TLC. The contents of alliin and potential allicin were determined by HPLC. Results：The spots of alliin and allicin in TLC were clear. The contents of alliin per tablet in three batches of samples were 55.24,49.60 and 54.90 mg,and those of allicin were 21.08,22.10 and 23.20 mg,respectively. No interference from excipients was found throughout the study. Conclusion：This method can be used for the quality control of alliin/allinase enteric-coated tablets.

关 键 词：蒜氨酸 蒜酶 肠溶片 潜在大蒜辣素 TLC HPLC 含量测定 

分 类 号：R943.3[医药卫生—药剂学]