广州化工
廣州化工
엄주화공
Guangzhou Chemical Industry
2015年
18期
116-118
,共3页
复方α-酮酸片%溶出度%全溶曲线
複方α-酮痠片%溶齣度%全溶麯線
복방α-동산편%용출도%전용곡선
compound α-ketoacid tablets%dissolubility%dissolution curves
采用原子吸收分光光度法建立了复方α-酮酸片溶出度的测定方法，采用桨法，以990 mL浓度为0.1 mol/L的盐酸为溶出介质，在转速为100 rpm的条件下，对市售和自制复方α-酮酸片的全溶曲线进行了测定，比较分析了市售参比制剂与自制样品制剂、自制制剂同一样品内、自制制剂样品间溶出行为的相似性，实验结果表明自制样品制剂与市售参比制剂体外溶出行为无明显差异、且自制样品制剂均一性良好。
採用原子吸收分光光度法建立瞭複方α-酮痠片溶齣度的測定方法，採用槳法，以990 mL濃度為0.1 mol/L的鹽痠為溶齣介質，在轉速為100 rpm的條件下，對市售和自製複方α-酮痠片的全溶麯線進行瞭測定，比較分析瞭市售參比製劑與自製樣品製劑、自製製劑同一樣品內、自製製劑樣品間溶齣行為的相似性，實驗結果錶明自製樣品製劑與市售參比製劑體外溶齣行為無明顯差異、且自製樣品製劑均一性良好。
채용원자흡수분광광도법건립료복방α-동산편용출도적측정방법，채용장법，이990 mL농도위0.1 mol/L적염산위용출개질，재전속위100 rpm적조건하，대시수화자제복방α-동산편적전용곡선진행료측정，비교분석료시수삼비제제여자제양품제제、자제제제동일양품내、자제제제양품간용출행위적상사성，실험결과표명자제양품제제여시수삼비제제체외용출행위무명현차이、차자제양품제제균일성량호。
A method to determine the dissolution of compound α-ketoacid tablets was established using atomic absorption spectrometry. The dissolution curves of commercial and home-made compound α-ketoacid tablets were detected using paddle method with the dissolution medium of 990 mL HCl (0. 1 mol/L) and the rotating speed of 100 r/min. The similarities of dissolution curves between commercial tablets and home-made tablets, dissolution curves among the same lots and dissolution curves between different lots were analyzed. The results showed that the dissolution curves between commercial tablets and home-made tablets had no significant difference and the homogeneity of home-made tablets was good.
