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bce ›› 2018, Vol. 52 ›› Issue (5): 25-30.doi: 10.3969/j.issn.1673-5854.2018.05.005

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Preparation and Properties of 1-Deoxynojirimycin Controlled-release Pellets

SUN Zhaoying1, YUAN Shujie2, ZHAO Huanan3, DING Hui3, LIU Zhiming1   

  1. 1. College of Material Science and Engineering, Northeast Foresty University, Harbin 150040, China;
    2. College of Chemistry and Chemical Engineering, Harbin Institute of Technology, Harbin 150020, China;
    3. Harbin Pharmaceutical Group Technology Center, Harbin 150020, China
  • Received:2017-06-08 Online:2018-09-30 Published:2018-10-15

Abstract: Fluidized bed coater was employed to prepare controlled-release pellet core with 1-deoxynojirimycin as raw material and hydroxypropyl methely cellulose phthalate as coating material. Blank pellet core was prepared with microcrystalline cellulose. Hydroxypropyl methyl cellulose was used as adhesives to administer medicines. The prepared pellets were packed into capsule. In the dissolution test, it was found that 1-deoxynojirimycin pellets exhibited controlled release effect. SEM analysis showed that the controlled-release pellets were nearly ball shape,the surface was smooth,uniform and compact,and the pellet core,durg layer and controlled-release layer were clearly and had uniform thichness,which indicated that the coating teachnology was stable.The capsules had the uniform content of 1-deoxynojirimycin and the impurities accorded with the regulation.The drug releases of the 1-deoxynojirimycin controlled-release pellets in medias with pH value of 1.2, 4.5 and 6.8 were studied. Compared controlled-release pellets with immediate-release tablets, there was significant difference in the mean cumulative drug concentration profile in different media evaluation. The results indicated that drug release profiles from 1 to 12 hours showed excellent zero-order release character in vitro.Exposed on the conditions of RH 92.5%, strong light (4500±500)lx and high temperature 60℃, respectively, the product was stable.

Key words: 1-deoxynojirimycin, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, controlled-release pellets, fluidized bed

CLC Number: