贵州医科大学学报

2018, v.43;No.216(09) 1003-1006+1011

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腺苷蛋氨酸配伍美洛昔康肠溶制剂的制备工艺
Optimization on Formulation and Process of Compound Enteric Coated Capsule for Osteoarthritis

黄家宇;陈俊;刘兰;张敏;万立;李莉;
HUANG Jiayu;CHEN Jun;LIU Lan;ZHANG Min;WANG Li;LI Li;College of Pharmacy,Guizhou Medical University;

摘要(Abstract):

目的:研究腺苷蛋氨酸(SAMe)配伍美洛昔康(MLX)肠溶制剂的处方配比和制备工艺。方法:拟定9种处方成分,以流动性、成型性、粒径分布以及临界相对湿度(CRH)为指标,筛选优化复方制剂的最佳制备工艺。结果:处方2为复方肠溶制剂制备的最佳处方,以5%乙醇制软材,24目尼龙筛制粒并整粒,添加0. 3%的微粉硅胶助流,装入0号肠溶空心胶囊中,即得SAMe配伍MLX复方肠溶胶囊剂;该复方颗粒的流动性好、粒径分布均匀(355~850μm)、成型性好(97. 44%)、CHR为78. 5%。结论:选择处方2所得复发颗粒有良好的流动性和成型性、制备工艺简单可行、合理有效,适用于SAMe配伍MLX复方肠溶胶囊的制备。
Objective: To study the optimization on formulation and process of compound enteric coated capsule consisting of S-adenosy-L-methionine and Meloxicam. Methods: Designing 9 kinds of formulation for compound enteric coated capsule with compound particle movement,shape,particle size distribution and critical relative humidity( CRH) as the index to determine the preparation process of compound enteric coated capsules. Results: The second formulation was the best one for the preparation of compound enteric coated capsule. The soft material was made with 5% ethanol,the granule was made with 24-mesh nylon screen and the whole granule was added with 0. 3% micropowder silica gel to assist the flow,and then put into No. 0 enteric dissolving hollow capsule,and the SAMe compatible with MLX compound enteric dissolving capsule was obtained. The compound particles had good fluidity,uniform size distribution( 355 ~ 850 μm),good shaping( 97. 44%) and CHR was 78. 5%.Conclusion: The recurrent granule obtained from formulation 2 has good fluidity and formability,the preparation process is simple and feasible,reasonable and effective,and is suitable for the preparation of the SAMe compatible with MLX compound enteric capsule.

关键词(KeyWords): S-腺苷蛋氨酸;美洛昔康;骨关节炎;分析样品制备方法;药物制剂
S-adenosy-L-methionine;meloxicam;osteoarthritis;analytic sample preparation methods;compound preparation

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基金项目(Foundation): 贵州省科技厅中药现代化专项项目[黔科合中药字(2013)5025号];; 2015年贵州省教育厅大学生创新创业项目(20151066000S)

作者(Author): 黄家宇;陈俊;刘兰;张敏;万立;李莉;
HUANG Jiayu;CHEN Jun;LIU Lan;ZHANG Min;WANG Li;LI Li;College of Pharmacy,Guizhou Medical University;

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