摘要
目的:探讨加味二至颗粒提取工艺及制剂成型工艺。方法:对乙醇浓度、乙醇用量、提取时间、提取温度进行单因素考察,确定最佳条件;采用L9(34)正交实验,以特女贞苷及二苯乙烯苷含量为评价指标,优化提取工艺;通过比较辅料差异对颗粒剂的影响,确定最佳辅料组合;测定休止角,考察颗粒流动性,并测定颗粒临界相对湿度(CRH)。结果:加味二至颗粒提取工艺优选条件为:15倍量60%乙醇,100℃水浴回流提取3 h。成型工艺为:2.5倍量辅料(乳糖:CMC-Na=9∶1),临界相对湿度66%。所制得的颗粒符合《中华人民共和国药典》项下颗粒剂质量要求。结论:加味二至颗粒提取工艺合理稳定,且简便易行,适于生产实际,所选工艺制得的颗粒外观较好,制粒过程损失较少,颗粒均匀。
Objective： To explore the extraction and moulding technology of Additional Erzhi Grains. Methods： By investigating the single factors of the concentration of ethanol,ethanol consumption,extraction time and extraction temperature,we determined the best conditions. In order to optimize the extraction technology,use orthogonal table L9（ 34） to arrange the experiment with the content of glossy privet fruit glucosides and as the evaluation index. By comparing the impact of differences in materials with the grains,we determined the best material combination,inspected the liquidity of the grains by determining the angle of repose and determined the critical relative humidity（ CRH）. Results： The extraction technology of additional erzhi grains was as follows： 15 times volume 60% ethanol,3 h reflux extraction at 100 ℃. The best moulding technology of Additional Erzhi Grains was as follows： 2. 5 times of auxiliary materials（ lactose ∶ CMC- Na = 9 ∶ 1）. Its fluidity was good and the critical relative humidity was 66%. The Additional Erzhi Grains were compliance to requirements of the quality requirements of grains in pharmacopoeia. Conclusion： The experiment showed that extraction process was not only stable,reasonable,simple,but also suitable for actual production. The appearance of the grains which were gained by the selected process was good,and the loss was relatively small in the granulating process. More over,the grains were quite uniformed.
出处
《中华中医药学刊》
CAS
北大核心
2015年第6期1287-1292,共6页
Chinese Archives of Traditional Chinese Medicine
基金
浙江省卫生高层次创新人才培养项目(浙卫发[2008]134)
关键词
加味二至颗粒
提取工艺
制剂工艺
Additional Erzhi Grains
extraction technology
preparation process
