ZHANG Zhuoyu,LI Jinghui,WANG Xin,et al.Study on optimization of fluidized bed granulation process for Anti⁃Hashimoto’s Thyroiditis Formula Granules and preparation quality evaluation[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(04):52-58.
ZHANG Zhuoyu,LI Jinghui,WANG Xin,et al.Study on optimization of fluidized bed granulation process for Anti⁃Hashimoto’s Thyroiditis Formula Granules and preparation quality evaluation[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(04):52-58. DOI: 10.16306/j.1008-861x.2022.04.008.
Study on optimization of fluidized bed granulation process for Anti⁃Hashimoto’s Thyroiditis Formula Granules and preparation quality evaluation
Objective: The fluidized bed granulation process of anti-Hashimoto’s thyroiditis Formula Granules was optimized to improve the drug loading capacity of the formulation, and then the quality evaluation of the obtained granules was carried out accordingly.,Methods,2,Taking preparation feasibility, forming rate, particle size and fluidity of granules as evaluation indexes, the initial material temperature, inlet air temperature and concentrated solution density of fluidized bed granulation were investigated by single factor experiment. HPLC method was established for content determination of calycosin-7-,O,-β-,D,-glucoside and rosmarinic acid in the granules, and the moisture, particle size and solubility of the granules were examined by ,Chinese Pharmacopoeia’s, methods.,Results,2,The optimized granulation parameters were as follows: initial material temperature (38±1)℃, air inlet temperature 70℃, concentrated liquid density was 1.24~1.26 g/cm,3, (25 ℃). The drug loading of the obtained granules was 72%, which was about 50% higher than that before optimization. The contents of calycosin-7-,O,-β-,D,-glucoside and rosmarinic acid in the obtained preparation were 0.298 3 mg/g and 0.989 5 mg/g, respectively. Meanwhile, its moisture, particle size and solubility and other inspection items all met the requirements of ,Chinese Pharmacopoeia,.,Conclusion,2,The preparation process obtained in this study is stable and feasible, and the drug loading capacity is high. The related quality research can lay a foundation for further formulation of quality standard of the preparation.
关键词
抗甲方流化床工艺优化颗粒剂毛蕊异黄酮苷迷迭香酸含量测定
Keywords
Anti-Hashimoto’s Thyroiditis Formula Granulesfluidized bed process optimizationgranulacalycosin-7-O-β-D-glucosiderosmarinic acidcontent determination
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The State Administration of Traditional Chinese Medicine Key Laboratory for New Resources and Quality Evaluation of Chinese Medicine, The Ministry of Education (MOE) Key Laboratory for Standardization of Chinese Medicines, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai R&D Center for Standardization of Chinese Medicines
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