| 引用本文: | 朱培曦,魏炜,陆静娴,陶巧凤.去痛片溶出度测定方法的研究[J].中国现代应用药学,2017,34(2):272-275. |
| ZHU Peixi,WEI Wei,LU Jingxian,TAO Qiaofeng.Study of Method for Dissolution Test of Compound Aminopyrine Phenacetin Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(2):272-275. |
|
| 摘要: |
| 目的 建立去痛片中氨基比林、非那西丁、咖啡因和苯巴比妥的溶出度测定方法。方法 采用浆法，以0.1 mol·L-1盐酸溶液900 mL为溶出介质，转速为50 r·min-1。应用高效液相色谱法，色谱柱为Kromasil C18柱（250 mm×4.6 mm，5 μm），磷酸二氢钾溶液-甲醇（60：40）为流动相，检测波长为215 nm，测定去痛片的溶出量。结果 不同厂家去痛片的溶出曲线存在明显差异。结论 所建方法可为提高去痛片的质量标准，建立合理的溶出度测定方法提供依据。 |
| 关键词: 去痛片 溶出度测定 高效液相色谱法 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.02.026 |
| 分类号: |
| 基金项目: |
|
| Study of Method for Dissolution Test of Compound Aminopyrine Phenacetin Tablets |
|
ZHU Peixi1, WEI Wei2, LU Jingxian1, TAO Qiaofeng3
|
|
1.Zhejiang Institute for Food and Drug Control, Hangzhou 310000, China;2.College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou 310014, China;3.Zhejiang Center for Drug and Cosmetic Evaluation, Hangzhou 310012, China
|
| Abstract: |
| OBJECTIVE To establish the dissolution test method for the compound aminopyrine phenacetin tablets.METHODS The established dissolution was the paddle method. 900 mL 0.1 mol·L-1 hydrochloride acid was used as the dissolution medium, the rotation speed was 50 r·min-1. HPLC was used for detection. A Kromasil C18 column (250 mm×4.6 mm, 5 μm) was used. Mobile phase consisted of a mixture of monopotassium phosphate solution-methanol (60:40), and UV detection wavelength was 215 nm.RESULTS Obvious difference of dissolution curves between different companies was observed.CONCLUSION The developed method provided a scientific basis for improving the quality control standards, and establishing a reasonable dissolution test method for compound aminopyrine phenacetin tablets. |
| Key words: compound aminopyrine phenacetin tablets dissolution test HPLC |
