摘要：目的 制备SC胶囊并对其质量进行检测。方法 以溶出度、装量差异为指标，通过多处方筛选，确定SC胶囊的处方组成，并对其SC溶出介质中含量测定方法学进行考察，实验通过取出不同时间点下的溶出介质进行紫外分光光度法的测定。在线性范围内0.2μg∙mL-1~0.85μg∙mL-1,r=0.9999，线性关系良好。在其范围内稳定性、精密度和专属性均良好，符合标准。此法简便 、易行、结果准确。结果 按确定的处方制备的SC胶囊以及质量检测，各项质量指标均符合国家标准要求。结论 制备的SC胶囊质量达到标准要求。7793
关键词：SC胶囊；质量检测；紫外分光光度计；溶出度
The preparation and quality control of SC capsule
Abstract: Objective Preparation of SC capsules and inspect quality. Methods Dssolution and weight deviation were taken as the target to screen SC capsules formula and content determination of content in dissolution medium was carried out. This experiment with the determination of the SC content of in different time of dissolution medium by UV spectrophotometry. Within the linear range 0.2 μg∙mL-1~0.85 μg∙mL-1,r=0.9999. The linear relation was good. The lineat between stability,accuracy and specificity was good. It is standard in such experiments.themethod is simple, efficient, sensitive and selective. This approach enjoy broad prospect. Results The quality of SC capsules manufactured according to the formula met the requirements. Conclusion The capsule prescription is reasonable, and the method for quality control is reliable.
Keywords: SC capsules; quality detection; UV spectrophotometer; solubility
目 录
1.绪论 7
1.1简介 7
1.2 SC的市场前景 7
2.文献综述 8
2.1 SC的的合成工艺与纯化 8
2.1.1 合成路 8
2.1.2 SC的纯化 8
2.2 SC的研究进展 9
2.2.1 药理作用[16] 9
2.2.2作用机制 9
2.2.3 SC的治疗关节炎的作用机理 9
2.3 SC及其有关物质的质量检测 10
2.3.1对胶囊一般的检测方法 10
2.3.2 RP-HPLC法测定SC的含量及有关物质 10
2.4 SC的常见的剂型 10
2.5 SC在临床上的应用及不良反应 11
2.5.1临床应用 11
2.5.2不良反应 11
2.5.3 SC在临床应用上的总结 12
3.SC胶囊的处方研究及考察 13
3.1仪器与试剂 13
3.1.1实验仪器 13
3.1.2药品与试剂 13
3.2 胶囊制备工艺及常用辅料 13
3.2.1常见胶囊的制备工艺 14
3.2.2胶囊剂制备处方组成 15
3.2.3填充剂或稀释剂的种类及性质 15
3.2.4粘合剂的种类与性质 16
3.2.5崩解剂的种类及性质 16
3.2.6润滑剂的种类及性质 17
3.2.7润湿剂的种类与性质 18
3.3 SC原料药性质的考察 18
3.3.1溶解度 18
3.3.2原料流动性的考察 19
3.3.3 粒度的考察 19
3.3.4 SC原料药堆密度的考察 20
3.4处方筛选 20
3.4.1粘合剂的筛选 20
3.4.2 制备工艺 20
3.4.3 颗粒堆密度的测定 21
3.4.4 颗粒休止角的测定 21
3.4.3得率计算 21 SC胶囊的制备及质量检查+文献综述:http://www.751com.cn/yixue/lunwen_5872.html