摘要
目的探明沉降篮对2种头孢呋辛酯(cefuroxime axetil,CEF)胶囊体外溶出度的区分能力。方法采用2015年版中国药典(四部)中第二法(桨法),分别以蒸馏水、pH=1.0的盐酸溶液、pH=4.0的醋酸盐缓冲液、pH=6.8的磷酸盐缓冲液为溶出介质,转速为50 r·min^(-1),分别测定并比较2种CEF胶囊在使用与不使用沉降篮条件下,两者累积溶出百分率的差异。结果在上述4种不同溶出介质中,使用沉降篮后,市售CEF胶囊的累积溶出百分率约减小25%~50%,而自制CEF胶囊的溶出行为几乎不受影响。结论溶出度测定中,使用沉降篮可较好地区分不同厂家CEF胶囊的溶出度差异。
Objective To investigate the differentiation of the in vitro dissolution of two cefuroxime axetil （CEF） capsules by basket sinker. Methods The paddle method for dissolution test （second method in Chinese Pharmacopoeia, 2015 edition, volume IV） was adopted to determine the in vitro dissolution of two CEF capsules in 4 dissolution media （distilled water, pH = 1.0 hydrochloric acid solution, pH = 4.0 acetate buffer solution, and pH = 6.8 phosphate buffer solution） at the rotation speed of 50 r - rain- x with or without the basket sinker. Results The cumulative dissolution of the marketed CEF capsules was reduced by about 25% -- 50% in the above 4 dissolution media when basket sinker was used, but under the same test conditions, the dissolution behaviors of the self-prepared CEF capsules were hardly affected. Conclusion Basket sinker used in dissolution determination may differentiate the in vitro quality difference of CEF capsules by different manufacturers.
出处
《中南药学》
CAS
2017年第10期1372-1374,共3页
Central South Pharmacy
