论文部分内容阅读
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 investigate the extraction process of flavored granule and its preparation process. Methods: The ethanol concentration, the amount of ethanol, the extraction time and the extraction temperature were investigated by single factor to determine the optimal conditions. L9 (34) orthogonal test was used to optimize the extraction of estrogen and stilbene glycosides The optimum combination of materials was determined by comparing the effects of the excipient differences on the granules. The angle of repose was measured, the fluidity of the granules was examined, and the critical relative humidity (CRH) of the granules was measured. Results: The optimum conditions for the extraction process of Jiawei Erzhi granule were as follows: 15 times the amount of 60% ethanol and refluxed for 3 h at 100 ℃. Forming process: 2.5 times the amount of excipients (lactose: CMC-Na = 9: 1), the critical relative humidity of 66%. The particles produced in line with the “People’s Republic of China Pharmacopoeia” under the quality requirements of granules. Conclusion: The extraction process of Jiawei Erzhi granule is reasonable and stable, and it is simple and easy to operate. It is suitable for the actual production. The appearance of the granule obtained by the selected process is better, the granulation process has less loss and the granules are even.