通便功能芦荟胶囊的研制

目的研制有通便功能的芦荟胶囊，建立产品质量标准。方法通过研究制剂成型性优化筛选富莱欣牌芦荟胶囊配方，设计生产工艺，评价产品稳定性、安全性以及通便功能。结果确定芦荟胶囊所用芦荟冻干粉每天最佳用量折合芦荟（以干品计）约1．5g／d，确定大豆膳食纤维最佳用量区间为90～100mg／d，玉米淀粉最佳用量区间为1200-1400mg／d，二氧化硅最佳添加量为3．8～4．1mg／d。连续3批产品质量稳定，功效成分及理化指标在3个月（38±1）℃和相对湿度75％的环境中有很好的稳定性。未见明显毒副作用、排便状况和粪便性状明显改善（P〈0．05）。结论该胶囊生产工艺可行，证明具有明显的通便功能，且各项质量指标稳定性良好。

Development of Aloe Capsule with Defaecation Function

Objective To develop aloe capsule with defaecation function and establish the quality standard of the product. Methods The formula of aloe capsule was screened by the preparation research. The production process was designed and the safety, stability and the defaecation function were assessed for aloe capsule. Results The optimum formula was as follows： aloe freeze-dried powder（ on dried basis） about 1.5g/d, soy dietary fiber 90-100 mg/d, corn starch 1200-1400 mg/d, silicon dioxide 3.8-4.1 mg/d. Three consecutive batches were stable in quality, and the functional composition, physical and chemical indices presented good stability for three months at 38±1 ℃ and 75% RH. No marked toxic effect was observed. The defaecation and characteristics of feces had obvious improvement （P〈0.05） . Conclusion The production process can be feasible for aloe capsule. The aloe capsule has defaecation function and good stability.