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清毒消瘀颗粒的粉体学性质及制粒工艺考察

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目的:比较辅料(糊精、可溶性淀粉、甘露醇、微晶纤维素)种类及其不同配比对清毒消瘀颗粒粉体学性质的影响,并优选该制剂的制粒工艺.方法:以颗粒吸湿性、溶化性、成型性、流动性为指标,采用粉体学的研究方法筛选最佳辅料及其配比,在此基础上,采用正交试验考察清毒消瘀方浸膏粉与辅料的配比、乙醇体积分数及用量对清毒消瘀颗粒制粒工艺的影响.结果:选择糊精-甘露醇(1∶1)为混合辅料,清毒消瘀方浸膏粉与混合辅料的配比1∶2,乙醇体积分数85%,乙醇用量13%;清毒消瘀颗粒的成型率、休止角、平衡吸湿率、溶解率分别为94.01%,33.72度,3.562%和97.3%,RSD依次为0.6%,1.6%,1.7%,1.9%.结论:甘露醇的阻湿效果好,与糊精联合使用后制成的清毒消瘀颗粒成型率高、吸湿率低、流动性好、溶解率高,且甘露醇可有效改善颗粒的口感.优选的制粒工艺条件稳定可靠、重复性好,适合工业化生产.
Investigation of Powder Properties of Qingdu Xiaoyu Granules and Optimization of Its Granulating Process
Objective:To compare the effects of several pharmaceutic adjuvants (dextrine,amylum solubila,mannitol,microcrystalline cellulose) and their different proportions on the powder properties of Qingdu Xiaoyu granules,and to screen optimum granulating process of this granules.Method:Taking hygroscopicity,mobility,formability and dissolubility as indexes,powder research method was used to screen optimum pharmaceutic adjuvants and their proportions,on this basis,orthogonal test was used to optimize granulating process.Result:The optimum granulating process was mixing the extract with mixed pharmaceutic adjuvants of dextrine-mannitol (1 ∶ 1) at 1 ∶ 2,injecting 85% ethanol into the mixture with the amount of 13%.Under these conditions,the forming rate,angle of repose,equilibrium moisture absorption rate and dissolution rate of Qingdu Xiaoyu granules were 94.01%,33.72 degree,3.562% and 97.3% with RSD of 0.6%,1.6%,1.7% and 1.9%,respectively.Conclusion:The moisture blocking effect of mannitol is excellent,and the granules prepared by dextrine and mannitol has high mobility,high formability,high dissolubility and low hygroscopicity.In addition,mannitol can effectively improve the taste of the granules.The optimum granulating process is feasible,stable and suitable for industrial production.

Qingdu Xiaoyu prescriptiongranulespower propertiespharmaceutic adjuvantsmannitolgranulating processdextrine

王姗姗、施崇精、刘小妹、程中琴、袁强华、宋英

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成都中医药大学,成都 610075

成都中医药大学附属医院,成都 610072

清毒消瘀方 颗粒剂 粉体学性质 药用辅料 甘露醇 制粒工艺 糊精

四川省科技计划项目

2014SZ0140

2018

中国实验方剂学杂志
中国中医科学院中药研究所 中国中西医结合学会中药专业委员会

中国实验方剂学杂志

CSTPCDCSCD北大核心
影响因子:1.62
ISSN:1005-9903
年,卷(期):2018.24(6)
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