不同厂家的阿莫西林胶囊实时溶出度考察

Observation of the Real-time Dissolution of Amoxicillin Capsules from Different Manufacturers

目的考察不同厂家及同厂家不同批号的阿莫西林胶囊的体外溶出过程。方法用光纤药物溶出度实时测定仪,采用《中国药典》2005年版中阿莫西林胶囊溶出度测定条件,对7个不同厂家的阿莫西林胶囊进行了实时溶出度测定。结果7个厂家的阿莫西林胶囊体外溶出度均符合《中国药典》2005版的规定,但从实时溶出曲线比较来看,7个厂家产品间的实时溶出曲线存在较大差异;部分同厂家同批号的6粒产品也表现出不同的溶出曲线。结论对药物进行实时溶出度测定,既能有效地测定药物的体外溶出度,又能显示药物溶出的全过程,对改进制剂工艺、加强药品的内在质量控制提供了有效参考。

Aim To observe the dissolving-out process of Amoxicillin Capsules of different batch numbers from one manufacturer and those from different manufacturers and detect the inherent quality difference of the products.Methods The fiber-optic real time dissolution test was used and conditions for dissolution test were adopted in accordance with ＇Chinese Pharmacopoeia＇,2005 edition.The results of real-time dissolution tests of Amoxicillin Capsules from 7 different manufacturers were compared.Results Experimental results of those Amoxicillin Capsules from 7 different manufacturers conform to the provisions in ＇Chinese Pharmacopoeia＇,2005 edition.However,the real time dissolution curve of those 7 products varies a lot.Moreover,6 randomly selected pills of Amoxicillin Capsules of the same batch number from a manufactuer still possess different real-time dissolution curves.Conclusion The test of real time dissolution of drugs is efficient for testing dissolution of drugs in vitro as well as displaying the entire process of dissolution of drugs.This provides references for improving preparation process and the control of the inherent quality of drugs.