【摘要】 目的对乙酰半胱氨酸胶囊的处方进行筛选,制备乙酰半胱氨酸胶囊,测定其含量。方法对乙酰半胱氨酸胶囊的处方进行筛选,高效液相色谱法测定含量,流动相:0.68%磷酸氢二钾溶液(用磷酸调节pH值至3.0)-甲醇=95∶5;检测波长为214 nm,进样量:10μL。结果乙酰半胱氨酸200 g、微晶纤维素50 g,0.5%羟丙基甲基纤维素(75%乙醇溶)为最佳处方。乙酰半胱氨酸在0.1274~0.4248 mg/mL之间呈良好的线性关系(r=0.9996,n=5),平均回收率为99.53%,RSD%为1.60%(n=9)。结论该制剂制备工艺合理可行,含量测定方法准确可靠。更多还原

【Abstract】 Objective To screen the prescription of acetylcysteine capsules, and to prepare the acetylcysteine capsules and to determine of its content. Method To screen the prescription of acetylcysteine capsules. The analysis was performed by HPLC, a mobile phase of 0.2mol/L buffer stock solution(pH=3.0)–methanol(95∶5)with a flow rate at 1 mL/min. The UV detective wavelength was 214 nm. Results Prescription was made up by 200g acetylcysteine, 50 g Microcrystalline cellulose and 0.5% HPMC. Acetylcysteine was linear in the range of 0.1274~0.4248 mg/mL(r=0.9996, n=5).The average recovery was 99.53%(RSD 1.60%, n=9). Conclusion Method for the preparation and quality control of acetylcysteine capsules is reliable.更多还原