Design-Expert响应面法优选无糖型乳康颗粒成型工艺

Optimization of Forming Process of Sugar-Free Rukang Granules by the Design-Expert Response Surface Method

目的优选无糖型乳康颗粒的成型工艺。方法以干膏粉与辅料用量配比、乙醇体积分数、乙醇用量为考察因素,以颗粒成型性、溶化性、吸湿性、流动性为评价指标,采用Design-Expert响应面法优选无糖型乳康颗粒的成型工艺。结果无糖型乳康颗粒的最佳成型工艺为乳糖与甘露醇配比1∶1,干膏粉与辅料用量配比1∶1.5,乙醇体积分数70.94%,乙醇用量为混合药粉的12.94%。结论优化后的工艺稳定、可靠,所制得的颗粒外观粒度及流动性均较好,吸湿性小,溶化性佳,可用于无糖型乳康颗粒的生产。

Objective To optimize the forming process of sugar-free Rukang Granules.Methods The forming process of sugar-free Rukang Granules was optimized by the Design-Expert response surface method with the dosage ratio of dry paste powder and excipients,ethanol volume fraction and ethanol dosage as the investigation factors and with the formability,solubility,hygroscopicity and fluidity of granules as the evaluation indexes.Results The optimum forming process of sugar-free Rukang Granules was as follows:the ratio of lactose to mannitol was 1∶1,the ratio of dry paste powder to excipient was 1∶1.5,the volume fraction of ethanol was 70.94%,and the dosage of ethanol was 12.94%of the mixed powder.Conclusion The optimized process is stable and reliable.The granules prepared by this process have good appearance,particle size and fluidity,low hygroscopicity and good solubility.It can be used in the production of sugar-free Rukang Granules.