| 引用本文: | 阮昊,徐东海,陈悦,潘芳芳,洪利娅,孙楠.激光衍射法测定对乙酰氨基酚粒度分布的方法研究[J].中国现代应用药学,2023,40(2):213-218. |
| RUAN Hao,XU Donghai,CHEN Yue,PAN Fangfang,HONG Liya,SUN Nan.Methodological Study on Particle Size Distribution of Paracetamol by Laser Particle Analyzer[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(2):213-218. |
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| 激光衍射法测定对乙酰氨基酚粒度分布的方法研究 |
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阮昊1,2, 徐东海1, 陈悦2, 潘芳芳2, 洪利娅2, 孙楠1
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1.浙江工业大学, 杭州 310014;2.浙江省食品药品检验研究院, 浙江省药品接触材料质量控制研究重点实验室, 国家药品监督管理局仿制药评价关键技术重点实验室, 杭州 310052
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| 摘要: |
| 目的 利用激光衍射法建立对乙酰氨基酚粒度与粒度分布的测定方法。方法 采用马尔文Mastersizer 2000激光粒度分析仪，湿法测定对乙酰氨基酚的粒度与粒度分布。样品采用含0.1%大豆卵磷脂的正己烷溶液，样品折射率1.70，样品吸收率0.1，遮光度范围10%~20%，超声20 s，泵转速2000 r·min-1。结果 激光衍射法可以测定对乙酰氨基酚的粒度及其分布，由体积平均粒径D[4,3]可以直观表征对乙酰氨基酚粒度的大小差异。d(0.5)值的RSD<3%，d(0.1)和d(0.9)值的RSD均<5%，方法重复性较好。结论 本法快速、简便、重复性好，可用于对乙酰氨基酚粒度及粒度分布的测定。 |
| 关键词: 对乙酰氨基酚 粒度与粒度分布 湿法测定 激光衍射法 |
| DOI：10.13748/j.cnki.issn1007-7693.2023.02.009 |
| 分类号:R917 |
| 基金项目:浙江省基础公益研究计划(LGC22H300003)；浙江省药品监督管理局科技计划项目(2020006，2021012) |
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| Methodological Study on Particle Size Distribution of Paracetamol by Laser Particle Analyzer |
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RUAN Hao1,2, XU Donghai1, CHEN Yue2, PAN Fangfang2, HONG Liya2, SUN Nan1
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1.Zhejiang University of Technology, Hangzhou 310014, China;2.Zhejiang Institute for Food and Drug Control, Key Laboratory of Drug Contacting Materials Quality Control of Zhejiang Province, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China
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| Abstract: |
| OBJECTIVE To establish a method for determination of the particle size and particle size distribution of paracetamol by laser diffraction method. METHODS The Malvern Mastersizer 2000 laser size analyzer was used to test particle size and particle size distribution of paracetamol by the wet measurement. The n-hexane containing 0.1% of soybean lecithin was used for the dispersion, the sample refractive index was 1.70, the sample absorption rate was 0.1 and the shading rate was 10%-20%. Determine the samples after sonicating for 20s at the pump speed of 2000 r·min-1. RESULTS A variety of paracetamol products could be analyzed by laser diffraction method. The D[4,3] could show the size difference between different products. The RSD of d(0.5) was less than 3%, and the RSDs of d(0.1) and d(0.9) were both less than 5%. The method had good repeatability. CONCLUSION The method is fast, simple, accurate and producible, which is suitable for the particle size control of paracetamol. |
| Key words: paracetamol particle size and particle size distribution wet determination laser diffraction method |
