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

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.