中国药房2013，Vol.24Issue(5)：438-440,3.DOI:10.6039/j.issn.1001-0408.2013.05.19
氨咖黄敏胶囊中2种组分质量控制方法的建立及9厂家产品质量评价
Establishment of Quality Control Methods for 2 Components in Anka Huangmin Capsules and Quality Evaluation of the Products from 9 Manufacturers
丁苏苏 1王威 2王玉 1李倚云 2闻琍毓3
作者信息
- 1. 江苏省扬州药品检验所,江苏扬州225009
- 2. 中国药科大学,南京210009
- 3. 江苏省药品检验所,南京210008
- 折叠
摘要
Abstract
OBJECTIVE: To establish a method for the content and in vitro dissolution determination of acetaminophen and caffeine in Anka huangmin capsules, and to evaluate the quality of the products from 9 manufacturers. METHODS: HPLC method was adopted. Gemini-da column was used with mobile phase consisted of phosphate buffer solution-acetonitrile (82 : 18, VIV) at wavelength of 262 nm. Dissolution test was conducted by rotating basket method using water as dissolution medium at rotation speed of 100 r/min. Accumulative dissolution percentages of each component were calculated at different time, and then the similarity of dissolution curves were compared by similarity factor (f2). RESULTS: The linear ranges of acetaminophen and caffeine were 0.100 2-0.500 8 mg/ml and 6.332-63.320 μg/ml (all r=0.999 9); average recoveries were 100.81% (RSD=1.4% h 101.10% (RSD=0.7% ) ,n=9. Statistical test P value of acetaminophen and caffeine in 95 batches of samples from 9 manufacturers were less than 0.05, and 60% and 56% off, of them were lower than 50, compared with original manufacturers. CONCLUSIONS: The content and dissolution of 2 components are different in samples from different manufacturers. It is necessary to establish dissolution determination in the standard in order to control the quality of the preparation completely.关键词
氨咖黄敏胶囊/高效液相色谱法/溶出/对乙酰氨基酚/咖啡因/含量测定Key words
Anka huangmin capsules/ HPLC/ Dissolution/ Acetaminophen/ Caffeine/ Content determination分类
医药卫生引用本文复制引用
丁苏苏,王威,王玉,李倚云,闻琍毓..氨咖黄敏胶囊中2种组分质量控制方法的建立及9厂家产品质量评价[J].中国药房,2013,24(5):438-440,3.
