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Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics
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Yan TANG1, 2, Yuan-zhi HE1, 2, Li WU2, Liu ZHANG2, Tao GUO2, Wen-ting WU1, Guang-hui JING3, Xian-zhen YIN2, 3, Wei-feng ZHU1, *, Ji-wen ZHANG1, 2, *
Acta Pharmaceutica Sinica | 2018, 53(9) : 1545 - 1550
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Acta Pharmaceutica Sinica | 2018, 53(9): 1545-1550
• ORIGINAL ARTICLES •
Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics
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Yan TANG1, 2, Yuan-zhi HE1, 2, Li WU2, Liu ZHANG2, Tao GUO2, Wen-ting WU1, Guang-hui JING3, Xian-zhen YIN2, 3, Wei-feng ZHU1, *, Ji-wen ZHANG1, 2, *
Affiliations
  • 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
Published: 2018-09-12 doi: 10.16438/j.0513-4870.2018-0419
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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.

melting characteristics  /  mixed powder  /  particle size distribution  /  microscopic image  /  consistent evaluation
Yan TANG, Yuan-zhi HE, Li WU, Liu ZHANG, Tao GUO, Wen-ting WU, Guang-hui JING, Xian-zhen YIN, Wei-feng ZHU, Ji-wen ZHANG. Determination of particle size and particle size distribution of selected component in mixed powders by its melting characteristics[J]. Acta Pharmaceutica Sinica, 2018 , 53 (9) : 1545 -1550 . DOI: 10.16438/j.0513-4870.2018-0419
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Article Info
doi: 10.16438/j.0513-4870.2018-0419
  • Receive Date：2018-05-07
  • Online Date：2026-01-15
  • Published：2018-09-12
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History
  • Received：2018-05-07
  • Revised：2018-06-05
Funding
Affiliations
    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
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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