Objective：To establish a laser light diffraction method for determination of the particle size and particle size distribution of bromhexine hydrochloride, and to explore the effect of the particle size of active pharmaceutical ingredient (API) on the dissolution in vitro. Methods：The Malvern Mastersizer 3000 laser particle size analyzer with AERO S dry sampler was used. The determination conditions were as follows：background measurement time：10 s, sample measurement time：15 s, obscuration：0.50%-5%, particle RI∶1.626, particle AI∶0.1, analysis model：general, fine dry powder model, pressure：350 kPa, sampling velocity：40%, hopper gap：2.0 mm, sample weight：200 mg. Results：The laser diffraction method could be used to determine the particle size of bromhexine hydrochloride. The relative standard deviation values (RSD%) of methodology validation and sample measurement were less than 5%. The particle size distribution values of 4 batches of self-made samples were 30.05, 40.60, 48.60 and 82.20 μm, respectively. The larger the particle size of the API, the slower the dissolution rate of the granules. Conclusion：The method is suitable for the particle size and its distribution determination of bromhexine hydrochloride. And the particle size distribution of bromhexine hydrochloride has significant influence on the release of granules, therefore it is very important to control the particle size in the production process of pharmaceutical preparation.
WANG Yue, WU Song, XUE Dan, ZHANG Kun, SHAO Hui-hui, XU Wei-guo, ZHANG Dui-liang, ZHANG Song, YANG Qing-yun
. Methodological study of particle size distribution of bromhexine hydrochloride by laser diffraction method*[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(8)
: 1448
-1453
.
DOI: 10.16155/j.0254-1793.2021.08.20
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