【论文】甘草酸二铵肠溶胶囊的制备与质量控制.docxVIP

目 录摘要 ……………………………………………………………………1第1章 绪论 ……………………………………………………………2第2章 甘草酸二铵肠溶胶囊的制备与质量控制 ……………………………31仪器与试药 …………………………………………………………………31.1 仪器 …………………………………………………………………3 1.2 试药 …………………………………………………………………32方法 ……………………………………………………………………32.1 载药微丸的制备 ………………………………………………………32.2 隔离微丸的制备 ………………………………………………………32.3肠溶颗粒的制备 ………………………………………………………42.4 耐酸力与释放度测定 …………………………………………………42.5 肠溶微丸处方优化 ……………………………………………………53?结果 ……………………………………………………………………53.1?肠溶微丸处方优化结果 ………………………………………………53.2?肠溶微丸溶出度测定结果 ……………………………………………63.3 肠溶微丸含量及耐酸力考察结果?………………………………………64 讨论 ……………………………………………………………………65参考文献…………………………………………………………………7甘草酸二铵肠溶胶囊的制备及其质量控制摘要目的 研究甘草酸二铵肠溶胶囊的制备和质量控制方法。方法 采用挤出滚圆法制备微丸，进行流化床包衣，并采用正交实验法进行处方筛选，以溶出度、耐酸力等指标进行质量研究。结果 高效液相色谱法测定耐酸力和缓冲液中释放度，在10-500μg·ml-1浓度范围内，甘草酸二铵线性方程Y＝0.305X+170.69,R2=0.9994，样品耐酸力和缓冲液中释放度均达到质量要求。最终确定了甘草酸二铵肠溶胶囊的处方和工艺，产品释放符合要求。结论 本制备工艺合理可行，质量控制方法重现性好，能有效地控制该制剂的质量。关键词 ? 甘草酸二铵 ；肠溶胶囊；制剂工艺 AbstractObjectives To study the preparation and quality control methods of diammonium glycyrrhizinate enteric-coated capsules.Methods Pellets were prepared by extrusion spheronization and fluidized bed coating, orthogonal experimental method was used for the prescription screening and quality study was carried on by dissolution, acid force,and so on. Results HPLC determination of acid strength and buffer release rate in the 10-500μg · ml-1 concentration range, the glycyrrhizic acid diammonium linear equation Y = 0.305X +170.69, R2 = 0.9994, samples of acid strength and buffer release in the liquid met the quality requirements.The prescription and preparation of diammonium glycyrrhizinate enteric-coated capsules were determined and the release of product met the requirements finally. Conclusion The preparation method was feasible, and the good reproducibility of quality control methods can effectively control the quality of the preparations.Key words glycyrrhizic acid diammonium, enteric-coated capsules, preparation process 第一章绪论甘草来源于豆科多年生草本植物甘草G．uralensin．Fisch．胀果甘草G．inflataBat．或光果甘草G．glabral