Rapid Analysis

Methodological study on particle size distribution of flunarizine hydrochloride by laser diffraction*

  • 耿晓婷 ,
  • 司徒子靖 ,
  • 徐东海 ,
  • 陈爽 ,
  • 陈世友 ,
  • 张育乐 ,
  • 阮昊
Expand
  • 1. Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Biopharmaceutical Contact Materials, NMPA Key Laboratory for Core Technology of Generic Drug Evaluation, Hangzhou 310052, China;
    2. China Pharmaceutical University, School of Pharmacy, Nanjing 211198, China;
    3. Institute of Chiatai Qingchunbao Pharmacetutical Co., Ltd., Hangzhou 310023, China;
    4. Zhejiang University of Technology, Hangzhou 310014, China

Received date: 2024-10-27

  Online published: 2025-11-13

Abstract

Objective: To establish a method for determination of the particle size distribution of flunarizine hydrochloride by laser diffraction. Methods: The Malvern Mastersizer 2000 laser size analyzer was used to test particle size distribution of flunarizine hydrochloride by the wet measurement. The n-hexane containing 2.5% of soybean lecithin was used for the dispersion, the sample refractive index was 1.80, the sample absorption rate was 0.1 and the shading rate was 10%-20%. Samples were tested after sonicating for 5 min at the pump speed of 2 500 r · min-1. Results: A flunarizine hydrochloride products could be analyzed by laser diffraction method. The D[4,3] could show the size differences between different products. The RSDs of d(0.1), d(0.5) and d(0.9) were not more than 7.6%. The method had good reproducibility. Conclusion: The method is simple, accurate and reproducible, which is suitable for the particle size control of flunarizine hydrochloride.

Cite this article

耿晓婷 , 司徒子靖 , 徐东海 , 陈爽 , 陈世友 , 张育乐 , 阮昊 . Methodological study on particle size distribution of flunarizine hydrochloride by laser diffraction*[J]. Chinese Journal of Pharmaceutical Analysis, 2025 , 45(6) : 1013 -1020 . DOI: 10.16155/j.0254-1793.2024-1227

References

[1] 王清清,刘玉敏,林晓,等.盐酸氟桂利嗪干预硝酸甘油致偏头痛大鼠的代谢组学研究[J].中国药学杂志,2019,54(3):193
WANG QQ,LIU YM,LIN X,et al.Metabolomics in the nitroglycerin-induced migraine rats intervened by flunarizine[J].Chin Pharm J,2019,54(3):193
[2] 代嫚嫚,马群,张慧敏,等.盐酸氟桂利嗪经眼部给药后在大鼠脑内的递送[J].中南大学学报(医学版),2020,45(11):1308
DAI MM,MA Q,ZHANG HM,et al.Drug delivery for intracerebral of flunarizine hydrochloride after intraocular administration in rats[J].J Cent South Univ(Med Sci),2020,45(11):1308
[3] 李青翠,解钰,高平.盐酸氟桂利嗪原料及其胶囊有关物质检查方法研究[J].药物分析杂志,2019,39(9):1635
LI QC,XIE Y,GAO P.Study on the determination method of related substances in flunarizine hydrochloride and its capsules[J].Chin J Pharm Anal,2019,39(9):1635
[4] ZHANG K,QIAN S,LIU Z,et al.Specific surface area of mannitol rather than particle size dominant the dissolution rate of poorly water-soluble drug tablets:a study of binary mixture[J].Int J Pharm,2024,660:124280
[5] JUNG JY,IL SHIN K,LEE M,et al.Enhanced solubility through particle size control,modification of crystal behavior,and crystalline form changes in solid dispersion of nifedipine[J].Biotechnol Bioprocess Eng,2022,27(1):105
[6] 郭金秀,曾令高,高梓真,等.处方工艺对阿普唑仑片混合均匀度及含量均匀度的影响[J].中国药业,2023,32(23):18
GUO JX,ZENG LG,GAO ZZ,et al.Effect of formulation technology on the blend uniformity and content uniformity of alprazolam tablets[J].China Pharm,2023,32(23):18
[7] PATEL K,KEVLANI V,SHAH S.A novel posaconazole oral formulation using spray dried solid dispersion technology:in-vitro and in-vivo study[J].Drug Delivery Transl Res,2024,14(5):1253
[8] 姜学美,肖波,邹玉明,等.复方倍他米松注射液粒度及粒度分布测定方法研究[J].中国药业,2021,30(10):68
JIANG XM,XIAO B,ZOU YM,et al.Determination method of particle size and particle size distribution of compound betamethasone injection[J].China Pharm,2021,30(10):68
[9] 王琳,吴斌,孙毅,等.注射用盐酸甲氯芬酯粒度分布与装量差异相关性研究[J].中国新药杂志,2021,30(3):226
WANG L,WU B,SUN Y,et al.Study on the correlation between the particle size distribution of meclofenoxate hydrochloride for injection and the weight variation[J].Chin J New Drugs,2021,30(3):226
[10] 徐登. 激光粒度仪测定盐酸吗啡粒度分布的应用研究[J].海峡药学,2021,33(2):53
XU D.Application of the laser particle analyzer to determine the particle size distribution of morphine hydrochloride[J].Strait Pharm J,2021,33(2):53
[11] 郭宁子,刘丽,岳瑞齐,等.激光衍射法测定西格列他钠粒径分布[J].中国药物警戒,2024,21(2):147
GUO NZ,LIU L,YUE RQ,et al.Determination of particle size distribution of chiglitazar sodium by laser diffraction Method[J].Chin J Pharmacov,2024,21(2):147
[12] 王越,吴松,薛丹,等.激光衍射法测定盐酸溴己新粒度分布的方法学研究[J].药物分析杂志,2021,41(8):1448
WANG Y,WU S,XUE D,et al.Methodological study of particle size distribution of bromhexine hydrochloride by laser diffraction method[J].Chin J Pharm Anal,2021,41(8):1448
[13] 肖艳,高永坚,梁标志,等.硝苯地平缓释片中间产品颗粒粒度的分布研究及对溶出度的影响[J].海峡药学,2024,36(5):38
XIAO Y,GAO YJ,LIANG BZ,et al.Particle size distribution study of nifedipine prolonged-release tablets intermediate products and its effect on dissolution[J].Strait Pharm J,2024,36(5):38
[14] 罗淑青,章燕,曹琳,等.苯磺酸氨氯地平片省级抽检质量考察分析[J].中国药师,2020,23(9):1843
LUO SQ,ZHANG Y,CAO L,et al.Quality analysis of amlodipine besilate tablets in provincial sampling inspection[J].China Pharm,2020,23(9):1843
[15] 薛雨晨,苏菊,姜丰,等.灯盏花乙素缓释微球的制备及药剂学性能考察[J].中国实验方剂学杂志,2017,23(6):7
XUE YC,SU J,JIANG F,et al.Preparation of scutellarin sustained-release microspheres and study on its pharmaceutical properties[J].Chin J Exp Tradit,2017,23(6):7
[16] 何驰宇,朱雪萍,胡玉玺.口服固体制剂粒度和粒度分布相关问题探讨[J].药学研究,2023,42(11):884
HE CY,ZHU XP,HU YX.Discussion on issues related to particle size and its distribution of oral solid preparation[J].J Pharm Res,2023,42(11):884
[17] DONG Y,PANG H.The co-solvency and thermodynamic properties calculation of flunarizine hydrochloride in mixtures of(acetonitrile/ethyl acetate+ isopropanol)[J].J Chem Thermodyn,2022,165:106645
[18] 中华人民共和国药典2020年版.二部[S].2020:1241
ChP 2020.Vol Ⅱ[S].2020:1241
[19] EP 10.0P 10.0[S].2019:2659
[20] BP 2020.Ⅰ[S].2020:1067
[21] 中华人民共和国药典2020年版.四部[S].2020:145
ChP 2020.Vol Ⅳ[S].2020:145
[22] KUMAR R,THAKUR AK,CHAUDHARI P,et al.Particle size reduction techniques of pharmaceutical compounds for the enhancement of their dissolution rate and bioavailability[J].J Pharm Innovation,2022,17(2):333
[23] BELSARKAR AS,PATIL RN,PAREKAR PB,et al.A brief review on solubility enhancement techniques with drug and polymer[J].Int J Cur Sci Res Rev,2022,5(12):4647
[24] 季轩. 激光衍射法测试超高分子量聚乙烯粒度分布的影响因素研究[J].合成技术及应用,2023,38(1):58
JI X.Study on impact factors of UHMWPE particle size distribution tested by laser diffraction method[J].Synth Technol Appl,2023,38(1):58
Outlines

/