首页|星点设计-效应面法优化桦褐孔菌泡腾片的制备工艺及其质量评价

星点设计-效应面法优化桦褐孔菌泡腾片的制备工艺及其质量评价

扫码查看
目的:为生产既具备药理作用,同时又容易于崩解且健康美味的桦褐孔菌泡腾片,通过Design-expert 11.0.4 软件优化其生产工艺.方法:将桦褐孔菌结合现代压片技术,结合碳酸氢钠、甜橙香精、乳糖等药用辅料生产桦褐孔菌泡腾片,并对影响片剂质量的因素进行单因素考察.选取对片剂影响较大的3个因素进行3因素5水平的星点设计-效应面法实验,使用Design-expert 11.0.4软件进行组方优化,从而得出最优方案.并对优化后制得的桦褐孔菌泡腾片进行质量检查.结果:采用星点设计-效应面法实验优化后的最佳工艺为桦褐孔菌含量为60%,碳酸氢钠与酒石酸的质量比为1∶0.846,乳糖含量为7%,甘露醇含量为2%、PEG-6000含量为2%.结论:采用星点设计-效应面法对桦褐孔菌泡腾片进行了优化,制备出的桦褐孔菌泡腾片质量合格,符合2020版《中华人民共和国药典》要求.为桦褐孔菌保健食品的研发提供了必要的科学基础.
OBJECTIVE On the basis of the reported research review of Inonotus obliquus,to prepare effervescent tablets of Inonotus obliquus that have pharmacological effects,are easy to dissolve,and are healthy and delicious,and use Design-expert 11.0.4 software to prepare them the process is optimized.METHODS Combining Inonotus obliquus with modern tableting technology,combined with pharmaceutical excipients such as sodium bicarbonate,sweet orange flavor,lactose,etc.,to prepare effervescent tablets of Inonotus obliquus,and single-factor investigation of factors affecting the quality of tablets.Select three factors that have a greater impact on the tablet to conduct a 3-factor 5-level star point design-response surface method experiment,and use the Design-expert 11.0.4 software to optimize the formula to obtain the optimal plan.And conduct quality inspection on the optimized effervescent tablets.RESUITS The best process after optimization by star point design-response surface method is:the content of Inonotus obliquus is 30%,the content of is 30%,the mass ratio of sodium bicarbonate to tartaric acid is 1∶0.846,and the content of lactose is 7%,the content of mannitol and PEG-6000 is 2%.CONCLUSION The star point design response surface methodology was used to optimize the effervescent tablets of Inonotus obliquus,providing a necessary scientific basis for the development of Inonotus obliquus health food.The quality of the prepared Inonotus obliquus effervescent tablets is qualified and meets the requirements of the 2020 edition of the Pharmacopoeia of the People's Republic of China.

central composite design response surface methodInonotus obliquus effervescent tabletpreparation processquality evaluation

姜海波、秦国昭、刘雨薇、吕颖、廖威、李文晴、冯宇飞

展开 >

黑龙江中医药大学 黑龙江哈尔滨 150040

星点设计-效应面法 桦褐孔菌泡腾片 制备工艺 质量评价

黑龙江省博士后研究人员落户黑龙江科研启动资助项目(2020年)

2023

黑龙江中医药
黑龙江省中医研究院

黑龙江中医药

影响因子:0.425
ISSN:1000-9906
年,卷(期):2023.52(4)
  • 21