摘要
目的：建立用紫外分光光度法测定辛伐他汀渗透泵型控释片体外释放度的方法。方法：以5．0g/L十二烷基硫酸钠水溶液为释放递质，转速100r／min；递质温度37℃。根据《中华人民共和国药典））2005版二部附录XC转篮法操作，分别于0．5，1．0，1．5，2．0，3．0，4．0，6．0，8．0，12．0，24．0h取样10ml，及时补加同温度、同体积的相应递质。取续滤液稀释适当倍数，按照《中华人民共和国药典））2005版二部附录ⅣA分光光度法，在238nm波长处测定吸光度，根据标准曲线计算不同时间样品液浓度，计算药物的累积释放百分率Q。结果：浓度在2．048～16．384μg/ml时，辛伐他汀-5．0g/L十二烷基硫酸钠溶液的浓度与吸收度线性关系良好：c=16．5910A-0．0383（r=0．9998），回收率与精密度良好。结论：紫外分光光度法可准确地测定辛伐他汀渗透泵型控释片的体外释放度。
Objective： To establish a method for the determination of in vitro release behaviors of Simvastatin osmotic pump controlled release tablets by ultraviolet spectrophotometry. Methods：A solution of 0.5 g/L sodium do-decyl sulfate was employed for the release medium, the speed was 100 r/min, and the medium temperature was 37℃. According to the second Department of Chinese Pharmacopoeia 2005 Edition appendix XC basket method, ten milliliter samples were taken in 0.5,1.0,1.5, 2.0,3.0,4.0,6.0,8.0,12.0,24.0 h and promptly supplemented with the same temperature and the same volume medium. The appropriately diluted filtrate was taken in accordance with the second Department of Chinese Pharmacopoeia 2005 Edition appendix IVA spectrophotometry, the ab-sorbance was measured at the wavelength of 238 nm. The concentration of different times was calculated according to the standard curve sample, and the drug cumulative percentage of the release was computed also. Results： There was a good linear relationship between the content and the peak absorption when the content of simvastatin-5.0 g/L SDS was in the range of 2. 048 - 16. 384 μg/ml. The regression equation was c = 16. 591 0 A - 0.038 3 （ r = 0. 999 8 ）, and the recovery rate and the degree of precision were good. Conclusion ： Ultraviolet spectrophotometry can exactly determine the in vitro release of simvastatin osmotic pump controlled release tablets.
出处
《安徽中医学院学报》
CAS
2007年第4期39-41,共3页
Journal of Anhui Traditional Chinese Medical College
关键词
辛伐他汀
渗透泵
紫外分光光度法
释放度
Simvastatin
Osmotic pump
Ultraviolet spectrophotometry
In vitro release
