正交试验优化银翘败毒片的干法制粒工艺

发布时间：2018-01-18 04:12

本文关键词：正交试验优化银翘败毒片的干法制粒工艺　出处：《中国药房》2017年25期 　论文类型：期刊论文

【摘要】：目的:优化银翘败毒片干法制粒的工艺条件。方法:以制粒难易程度和崩解时限等为考察指标,对银翘败毒片中辅料微晶纤维素和可压性淀粉的配比、用量及喷干粉的含水量进行筛选;以颗粒得率和休止角为指标,采用L9(34)正交试验对干法制粒工艺中压轮压力、转速及送料速度等条件进行优化并进行验证试验。结果:微晶纤维素与可压性淀粉的比例为7∶3(m/m),二者与(喷干粉+包合物)的混合比例为1∶5;控制喷干粉含水量在1%~2%之间。干法制粒最优工艺参数为压轮压力3.5 MPa、压轮转速4 r/min、送料速度10 r/min。验证试验中颗粒平均得率为69.2%,平均休止角为31.5°,绿原酸转移率达92%以上,且各指标RSD均在2.53%以下(n=3)。结论:按优化辅料处方和工艺制备的颗粒各项指标均具有较好的重现性和可行性,且工艺稳定,适合工业生产。
[Abstract]:Objective: to optimize the technological conditions of dry granulation of Yinqiao Baiduu tablets. Methods: the ratio of microcrystalline cellulose and compressible starch in Yinqiao Baiduu tablets was studied by taking the degree of granulation difficulty and disintegration time as the index. The dosage and moisture content of dry powder were screened. Based on the particle yield and angle of repose, the pressure of dry granulation process was studied by using L9 / 34) orthogonal test. The results showed that the ratio of microcrystalline cellulose to compressible starch was 7: 3 m / m). The mixing ratio of the two to (spray powder inclusion compound) is 1: 5; The water content of dry powder was controlled in the range of 1% and 2%. The optimum parameters of dry granulation were as follows: wheel pressure 3.5 MPA, wheel speed 4 rmin. The average particle yield was 69.2, the average angle of repose was 31.5 掳, and the transfer rate of Lv Yuan acid was more than 92%. The RSD of each index is less than 2.53%. Conclusion: the parameters of the granules prepared by optimizing the prescription of excipients and the preparation of the process have good reproducibility and feasibility, and the process is stable. Suitable for industrial production.
【作者单位】：江苏联合职业技术学院连云港中医药分院;江苏康缘药业股份有限公司中药制药过程新技术国家重点实验室;
【基金】：国家重大新药创制项目-现代中药创新集群与数字制药技术平台基金资助项目(No.2013ZX09402203)
【分类号】：R283.6
【正文快照】： 银翘败毒片是用于治疗风热感冒的国家级新药。其制备方法是先提取方中金银花、连翘、薄荷等药材的挥发油,再将挥发油经β-环糊精包合,其他药材经水提取、采用喷雾干燥方法制颗粒,二者加辅料均匀混合,干法制粒、压制成片即得。由于提取物中含有较多的多糖及皂苷类成分,制成的喷

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