摘要
目的利用六通道光纤药物溶出度测定仪,建立实时、在位监测格列齐特片Ⅱ体外溶出度的测定方法,并比较测定不同厂家共7批格列齐特片Ⅱ的体外溶出参数。方法采用FODT-601检测了格列齐特片Ⅱ的溶出度,并与《中国药典》药品标准溶出度测定结果进行了比较,无显著性差异(P>0.05)。溶出度测定条件为:测定波长240nm、基线校正波长290nm、温度37℃、转速150r/min、数据采集间隔120s、监测时间180min、溶出介质为磷酸盐缓冲液pH(8.60±0.05)、溶出体积1000ml、转篮法、光纤探头2mm。结果共测定了两个厂家不同批次的格列齐特片Ⅱ在60、180min的溶出度及溶出曲线,其中一个厂家的格列齐特片Ⅱ符合《中国药典》规定,另一个厂家的格列齐特片Ⅱ在180min的溶出度不符合《中国药典》规定。两个厂家的格列齐特片Ⅱ溶出曲线存在非常显著性差异。结论光纤药物溶出度实时测定仪原位、准确、连续、定量地反映了药物的溶出过程,可比较出不同厂家之间同种药品的溶出过程差异。
Aim To demonstrate the dissolution behavior of Gliclazide tablets Ⅱ using the fiber-optical pharmaceutic dissolution process monitor （FODM） and to study the parameters for dissolution tests of seven batches from two different manufacturers. Methods Gliclazide tablet Ⅱ was monitored with 2 mm fiber optic probe. The dissolution conditions were ： 1 000 ml of phosphate buffer at pH （8.60±0.05） ,basket at 150 r/min. The fiber optic unit was configured to calculate the amount of drug dissolved by substracting the baseline measurement at 240nm against the reference wavelength at 290nm. Dissolution data were colleted and plotted as %- dissolved every 120 seconds during 180minutes. The results of cumulative dissolution by FODT had no difference with those by the methods pecificed in ClaP 2005（ P 〉0.05）. Results The dissolutions of Gliclazide tablet Ⅱfrom one manufacturer were all below 50% at 60 and above 75% at 180. Those of the other manufacturer were all below 50% at 60 and above 75% at 180. The dissolution curve did not differ significantly between the two manufacturers （ P 〈0.01 ）. Conclusion The procession analysis can quantitatively monitor the cumulative dissolution at real-time ,and can be used to compare the difference of dissolution curves from different manufacturers.
出处
《解放军药学学报》
CAS
2008年第6期544-546,共3页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
南京军区卫生专业人才培养122工程资助项目
No.07M109
关键词
格列齐特片Ⅱ
溶出度
Gliclazide tablets Ⅱ
Dissolution
