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作 者:尤恬妮 YOU Tian-ni(Xiamen traditional Chinese Medicine Factory Co.,Ltd,Fujian,Xiamen 361000,China)
出 处:《海峡药学》2022年第12期182-187,共6页Strait Pharmaceutical Journal
摘 要:目的提高肾舒颗粒(无糖型)制粒工序生产制造能力。方法应用精益六西格玛DMAIC流程开展项目,通过收集内部顾客之声以确定度量指标及指标基线,使用微观流程图、Pareto图、树图识别出影响度量指标的影响因子,运用双样本T检验、DOE试验设计确定关键因子,最后使用响应优化器进行因子优化并实施改进和效果验证。结果确定了Y1(每服制粒时间)、Y2(制粒工序得率)两个度量指标及指标基线,识别出10个影响Y1、Y2的影响因子,最后确定了6个关键因子,使用响应优化器输出因子的最优参数并实施改进,经过效果验证证明Y1由平均236.4 min降低到189.8 min,Y2由平均94.0%提高到96.3%。结论肾舒颗粒(无糖型)等颗粒剂产品制粒时间、得率与粘合剂用量、进风温度、风量和蠕动泵转速密切相关,在生产过程中应进行有效控制。OBJECTIVE To improve the manufacturing capacity of the granulation process of ShenShu Granule(sugar-free type).METHODS The Lean Six Sigma DMAIC process was applied to carry out the project,internal customer voices were collected to determine the metric index and index baseline,the micro flow chart,pareto diagram and tree diagram were used to identify the influence factors affecting the metric index,two-sample T-test and DOE test design were used to determine the key factors,and finally the response optimizer was used to perform the factor optimization and improvement and effect verification.RESULTS Two metrics and index baselines of Y1(granulation time per serving)and Y2(yield rate of granulation process)were determined,10 influence factors affecting Y1 and Y2 were identified and 6 key factors were finally determined,the optimal parameters of factors were outputed by using the response optimizer and improvement was implemented.Through effect verification,Y1 decreased from 236.4 min to 189.8 min,and Y2 increased from an average of 94.0%to 96.3%.CONCLUSION The granulation time and yield rate of granules such of ShenShu granules(sugar-free type)and other granule products are closely related to the amount of adhesive,air inlet temperature,air volume and peristaltic pump speed,which should be effectively controlled in the production process.
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