夏黄颗粒提取浸膏粉粉体学和稳定性研究.PDFVIP

现代药物与临床 Drugs Clinic 第 29 卷 第 4 期 2014 年 4 月 ·363 · 夏黄颗粒提取浸膏粉的粉体学和稳定性研究 肖瑞颖1, 2, 3，廖茂梁2, 3 ，张铁军2, 3* ，胡 乔 1, 2, 3 1. 天津中医药大学，天津 300193 2. 天津药物研究院 释药技术与药物代谢动力学国家重点实验室，天津 300193 3. 天津药物研究院 中药现代制剂与中药质量控制技术国家和地方工程实验室，天津 300193 摘 要：目的 对夏黄颗粒提取浸膏粉进行处方前粉体学和稳定性研究，为设计优良的颗粒制剂处方提供参考。方法 考察 夏黄颗粒提取浸膏粉的主要粉体学参数，如堆密度、休止角、溶化性、pH 值、吸湿性、临界相对湿度。以主要活性成分芦 荟苷为指标，考察高温、高湿和强光照射的影响。结果 夏黄颗粒提取浸膏粉流动性较差，休止角大于 45° ，水溶性较好， 呈弱酸性，临界相对湿度为 72% ；不耐高温，易吸湿，不耐光照。结论 夏黄颗粒提取浸膏粉应在密封、避光、干燥 处储存。 关键词：夏黄颗粒提取浸膏粉；粉体学；稳定性 中图分类号：R283.6 文献标志码：A 文章编号：1674 - 5515(2014)04 - 0363 - 04 DOI: 10.7501/j.issn.1674-5515.2014.04.008 Micromeritic and stability studies on Xiahuang Granule extracts XIAO Rui-ying1, 2, 3, LIAO Mao-liang2, 3, ZHANG Tie-jun2, 3, HU Qiao1, 2, 3 1. Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2. State Key Laboratory of Drug Delivery Technologies and Drug Metabolism, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China 3. The National and Local Engineering Laboratory of the Modernized Chinese Medicine and Chinese Medicine Quality Control Techniques, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China Abstract: Objective To evaluate the preformulation studies, such as micromeritic and stability studies on Xiahuang Granule extracts and to provide a reference for the design of fine particle formulation of design. Methods Powder micromeritics major parameters of Xiahuang Granule extracts, such as bulk density, angle of repose, dissolve resistance, pH value, moisture absorption, and critical relative humidity were studied. Aloin as the main active ingredient in the prescription was determined to compare the effects of high temperature, high humidity, and strong light on Xiahuang Granule ext