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出 处:《中国药房》2012年第27期2519-2521,共3页China Pharmacy
基 金:江苏省中医药科研课题专项项目(LZ09055)
摘 要:目的:研究甲花片处方及制粒工艺。方法:以颗粒外观、制粒难易程度、颗粒成型率为指标,采用单因素试验考察流化床制粒工艺;以原料粒度、黏合剂浓度、黏合剂用量为指标,以粒度、休止角、颗粒强度、硬度、脆碎度、崩解时限的综合评分为指标,采用正交试验优选甲花片处方。结果:流化床制粒的最佳工艺为物料温度49~53℃、喷雾压力0.10~0.12MPa、蠕动泵转速度30~38r·min-1;甲花片最佳处方为干膏粉粒度80目、黏合剂浓度3%、黏合剂用量为干膏粉重量的180%~200%。结论:采用流化床制粒法并对处方和工艺进行定量化控制,可以得到质量合格的制剂。OBJECTIVE: To study the prescription and granulation process for Jiahua tablet. METHODS: Fluid-bed granulation process was investigated by single factor test with appearance of granules, degree of difficulty and ratio of briquetting; the prescrip- tion of Jiahua tablet was optimized orthogonal design test with granularity of raw material, concentration and amount of adhesives as index using granularity, angle of repose, intensity, rigidity and friability of granules and disintegration time limit as index. RE- SULTS: The optimal fluid-bed granulation process was as follows: material temperature of 49-53 ℃, pressure spray of 0.10- 0.12 MPa, speed of peristaltic pump of 30-38 r. min^-1. The optimal prescription was as follows: granularity of dry extract power of 80 mesh, adhesives concentration of 3%, amount of adhesives was 180%-200% of the weight of dry extract power. CONCLU- SION: By fluid-bed granulation method, prescription and process have been controlled quantitatively to obtain qualified tablet.
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