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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。
OBJECTIVE: To optimize the dry granulation technology conditions for Yinqiao baidu tablet. METHODS: Using granulating difficulty degree and disintegration time as investigation indexes, ratio and amount of accessories microcrystalline cellulose and compressible starch in Yinqiao baidu tablet, moisture content of the sprayed powder were screened. Using yield of particle and angle of repose as indexes, L9(34) orthogonal test was used to optimize the wheel pressure, rotating speed and feeding speed in dry granulation technology, and verification test was conducted. RESULTS: The ratio of microcrystalline cellulose and compressible starch was 7 ∶ 3, and mixing ratio of the two with spray powder+inclusion compound was 1 ∶ 5. The moisture content of spray powder was controlled in 1%-2%. The optimal technology was as follow as wheel pressure of 3.5 MPa, roller speed of 4 r/min and feeding speed of 10 r/min. In verification test, average yield of particle was 69.2% and angle of repose was 31.5 °. Transfer rate of chlorogenic acid had reached over 92%, and RSD of each index was below 2.53% (n=3). CONCLUSIONS: Each index of particle prepared by optimized accessories formulation and technology shows good reproducibility and feasibility, and the technology is stable and suitable for production.
银翘败毒片干法制粒正交试验颗粒得率休止角转移率绿原酸
Yinqiao baidu tabletDry granulationOrthogonal testYield of particleAngle of reposeTransfer rateChlorogenic acid
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