膝骨痹康胶囊的提取工艺研究

目的研究影响膝骨痹康胶囊提取工艺的因素并确定其最佳提取工艺。方法用正交试验法,以提取液中淫羊藿苷的含量以及总固体得率为指标,综合评分优选药材的提取工艺。并通过考察成型颗粒的制粒条件、流动性、堆密度、吸湿百分率、临界相对湿度来进一步验证该制剂的流动性是否能满足生产过程的要求,通过上述参数来确定该制剂的最佳生产环境及贮藏条件。结果药材较优的提取工艺为加水煎煮两次,第一次加10倍量水煎3 h,第二次加8倍量水煎2 h。颗粒的休止角为30.6°,堆密度（d）为0.42 g.cm-3,48 h后吸湿百分率为14.92%,临界相对湿度为62%。结论优选的工艺各活性部位提取率较高,操作比较简便,也很适用于医院制剂的生产;颗粒的流动性、堆密度、吸湿百分率、临界相对湿度的考察为生产该制剂提供了充足的参考依据。

Extraction Process Research of Xigubikang Capsules

Objective To study the impact factors of the extraction process of xigubikang capsules and determine the optimal extraction process.Methods The orthogonal test was adopted.The content of icariin and the total solid yield in the extracting solution were taken as the indicators.The extraction process of the medicinal materials was optimized by comprehensive assessment.By investigating the pelletizing condition,flowability,bulk density,moisture absorption percentage and critical relative humidity of the capsules,the flowability of this preparation was further verified to meet the requirement of productive process.The above-mentioned parameters were used to determine the best conditions of production and storage.Results For the optimal extraction process,the medicinal materials were decocted twice with water,in which,the materials were decocted for 3 h with water of 10-times amount as the materials in the first time,and were for 2 h with water of 8-times amount in the second time.The angle of repose of the granules was 30.6°,the bulk density was 0.42 g·cm-3,the moisture absorption percentage was 14.92% in 48 h and the critical relative humidity was 62%.Conclusion In the optimal process,the extracting rate in each active site is quite high,the operation is simple and applicable in the production of hospital preparation.The investigation of the granule flowability,bulk density,moisture absorption percentage and critical relative humidity provides the adequate reference evidences for the preparation production.