摘要
目的:研究托西酸舒他西林明胶微球颗粒的制备与质量控制.方法:用适宜的辅料将托西酸舒他西林明胶微球制成颗粒,样品用0.1 mol·L-1盐酸溶液超声提取,采用高效液相色谱(HPLC)法,Dioney Kromasil ODS1(250 mm×4.6 mm,5 μm)分析柱,0.02 mol·L-1磷酸二氢钠-乙腈(85:15)为流动相,流速1.0 mL·min-1,检测波长218 nm.结果:颗粒外观呈类白色,味甜,其他检查项目符合标准要求.色谱分离托西酸舒他西林保留时间约为6 min,与邻近峰的分离度大于1.5,线性范围为0.128～0.642 g·L-1.得高、中、低3个浓度的平均回收率(n=3)分别为101.3%,100.8%,100.3%,RSD分别为0.18%,0.35%,0.33%.结论:本品可有效掩盖托西酸舒他西林本身具有的苦味,适于儿童服用,定量分析方法简便、准确、可靠,可用作该制剂的质控方法.
OBJECTIVE To study the preparation of sultamicillin tosilate gelatin microspheres granules and its quality control. METHODS Sultamicillin tosilate gelatin microspheres granules were prepared by mixing sultamicillin tosilate gelatin microspheres with appropriate excipients. The sample was extracted with 0. 1 mol·L^-1 hydrochloride solution by ultrasonication. RP-HPLC was used for the determination of sultamicillin tosilate in sultamicillin tosilate gelatin microspheres granules. The chromatographic procedure was carried out using Dionex Kromasil ODS1 （250 mm×4. 6 mm,5μm） as an analytical column and a mixture of 85 volume of 0. 02 mol·L^-1 sodium dihydrogen phosphate solution and 15 volume of acetonitrile （ the pH was adjusted to 4. 4 with phosphoric acid） as mobile phase. The detection wavelength was 218 nm. RESULTS The granules was a almost white powder and sweet. Other tests conformed to the requirements. The retention time of Sultamicillin Tosilate was about 6 minutes and the resolution was more than 1.5. Tt＇s linear ranges were between 0. 128-0. 642 mg·mL^-1. The average recoveries （n = 3） of high, middle, low three concentrations were 101.3%,100.8%,100.3%;RSDs were 0. 18%,0.35%,0.33%. CONCLUSION This preparation can completly remove the bitter taste of sultamicillin tosilate, and is suitable for children. The quantitati on method is simple, accurate, reliable, and can be used as the quality control of this preparation.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2005年第10期935-937,共3页
Chinese Journal of Hospital Pharmacy
