Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics
10.16438/j.0513-4870.2018-0419
- VernacularTitle:利用热熔特征检出混合粉体中目标成分粒径及其分布
- Author:
Yan TANG
1
;
Yuan-zhi HE
1
;
Li WU
2
;
Liu ZHANG
2
;
Tao GUO
2
;
Wen-ting WU
1
;
Guang-hui JING
3
;
Xian-zhen YIN
2
;
Wei-feng ZHU
1
;
Ji-wen ZHANG
1
Author Information
1. Key Laboratory of Modern Preparation of TCM, Ministry of Education, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China
2. Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China
3. Disha Pharmaceutical Co., Ltd., Weihai 264200, China
- Publication Type:ORIGINAL ARTICLES
- Keywords:
melting characteristics;
mixed powder;
particle size distribution;
microscopic image;
consistent evaluation
- From:
Acta Pharmaceutica Sinica
2018;53(9):1545-1550
- CountryChina
- Language:Chinese
-
Abstract:
The particle diameters of active pharmaceutical ingredient (API) and excipients are important factors to the quality of preparations and have great significances in the reverse engineering to brand products and the consistent evaluation of generic drugs. In this study, a novel method was established for particle size determination to identify the selected component and eliminate other interferential particles by comparing the microscopic images before and after fusion caused by controllable heating. Stearic acid (SA) particles in irregular and spherical shape were selected as a typical excipient to demonstrate the methodology, which were identified from the mixed particles based upon its melting characteristics to detect their particle sizes as well as the size distributions. In the same approach, the morphology and particle size of fenofibrate particles as API in tablets were analyzed. The results illustrated that the particle diameters and particle size distributions of the selected components in the mixture of particles can be detected via the hot-melting characteristics under the prerequisite of proper pretreatment to separate selected components from other particles in microscopic field. In conclusion, this research provides a practical approach for the reverse engineering purpose to brand products and the consistent evaluation of generic drugs.
