尿石颗粒的成型性工艺研究
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摘要
目的优选尿石颗粒的成型工艺条件。方法根据制粒难易程度初步优选出颗粒剂的最优辅料,再以辅料的成型性、吸湿性、休止角为考察指标,采用正交试验法优化辅料加入量、乙醇体积分数及辅料比例的工艺参数,并对制得的颗粒进行临界相对湿度考察。结果最佳成型工艺条件为浸膏粉与糊精配比为1∶0.9,乙醇的体积分数为90%,糊精与淀粉比为3.5∶1。为减少水分对药物性质及稳定性的影响,环境相对湿度应控制在72%以下。结论优选出的尿石颗粒成型工艺简单可行,为进一步工业化生产提供参考。
Objective To optimize the forming technology of Urolite granules. Methods According to the difficulty of granulation, the optimum excipients of granules are selected preliminarily. The orthogonal test is used to optimize the technological parameters of excipients addition, ethanol volume fraction and the proportion of excipients, and the critical relative humidity of the prepared granules is investigated. Results The optimum technological conditions are as follows: the ratio of extract powder to dextrin is 1∶0.9, the volume fraction of ethanol is 90 %, and the ratio of dextrin to starch is 3.5∶1. To reduce the influence of water on the properties and stability of drugs, the relative humidity of environment should be controlled below 72 %.Conclusion The optimized moulding process of Urolite granules is simple and feasible, and can provide reference for further industrialized production.
Objective To optimize the forming technology of Urolite granules. Methods According to the difficulty of granulation, the optimum excipients of granules are selected preliminarily. The orthogonal test is used to optimize the technological parameters of excipients addition, ethanol volume fraction and the proportion of excipients, and the critical relative humidity of the prepared granules is investigated. Results The optimum technological conditions are as follows: the ratio of extract powder to dextrin is 1∶0.9, the volume fraction of ethanol is 90 %, and the ratio of dextrin to starch is 3.5∶1. To reduce the influence of water on the properties and stability of drugs, the relative humidity of environment should be controlled below 72 %.Conclusion The optimized moulding process of Urolite granules is simple and feasible, and can provide reference for further industrialized production.
引文
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[2]宋开蓉,刘雄,高建德,等.中药颗粒剂研究现状及展望[J].甘肃中医药大学学报,2017,34(3):79-82.
[3]谢岱,易艳东,马威.归芪补肾颗粒成型工艺及其质量控制[J].中国医院药学杂志,2015,35(21):1928-1934.
[4]国家药典委员会.中华人民共和国药典(四部)[S].北京:中国医药科技出版社,2015:通则0104.
[5]许有瑞,高雅,张可锋,等.狗肝菜多糖颗粒剂成型工艺的优选[J].中国医院药学杂志,2016,36(24):2141-2144.
[6]李茜,黄莹,李伟.丹苓颗粒的成型工艺[J].中华中医药杂志,2017,32(11):5193-5195.
[7]付亭亭,韩天燕,左文宝,等.黑果枸杞颗粒成型工艺研究[J].中国新药杂志,2018,27(13):1560-1564.
[8]郭小红,冷静,徐冲,等.柔肝宝颗粒剂的成型性工艺[J].中国医院药学杂志,2018,38(1):46-49.
[9]蔡霈,肖作奇,王哲明,等.盆炎灵颗粒剂成型工艺及辅料筛选的研究[J].解放军药学学报,2018,34(2):131-133.
[10]王佩,刘晓昱,徐红.复方芪苓无糖颗粒剂成型工艺的研究[J].中华中医药学刊,2014,32(2):354-356.
[11]刘易陇,童荣生,李晋奇.虎杖解毒无糖颗粒成型工艺的优选研究[J].中国医院药学杂志,2016,36(20):1759-1763.
[12]汪铜芳,张咏梅,李姗姗,等.心脑苏颗粒成型工艺优选[J].世界中医药,2017,12(2):411-413.
[13]付美丽,严铭铭,邵帅,等.新扶正除疫颗粒剂的成型性工艺[J].中成药,2016,38(3):692-694.
[14]岳国超,严霞,赵映波.湿法制粒工艺参数对颗粒成型性的影响[J].中南药学,2015,13(6):587-590.