烟酸微丸离心造粒工艺研究

目的制备烟酸微丸并考察其溶出度：方法采用离心造粒法，以微丸产率、休止角、堆密度、脆碎度等为指标考察影响微丸成型过程的处方因素和工艺因素，并采用紫外分光光度法测定溶出度。结果成丸的优化处方和工艺参数是，烟酸与微晶纤维素（MCC）的比例为10：1（w／w），黏合剂为3％羟丙基甲基纤维素（HPMC，5mPa·s）的20％乙醇溶液，主机转速为251 r／min，风机转速为476r／min，喷气压力为0、01～0．04MPa，喷浆泵频率为5、00～10．00Hz，供粉机转速为15．00～20、00r／min。结论在优化条件下采用离心造粒法可制备出表面光滑、圆整度好的烟酸微丸，18～24目微丸收率可达90．8％，溶出度符合2005年版《中国药典（二部）》要求。

Preparation of Nicotinic Acid Micropellet by Centrifugal Granulation Technology

Objective To prepare nicotinic acid mieropellet and to research the release rate. Methods Nicotinic acid micropellet were prepared by using centrifugal granulator. The composition and process factors were optimized by adopting several indices such as yield, repose angle, bulk density and friability. Results The optimal process parameters were as follows： nicotinic acid and MCC was l 0：1（w/w）, binder solvent was 3% HPMC 20% ethanol solution, rotor rotation speed was 251 r/min, slit air flow rate was 476 r/min, spray air rate was 0.01-0.04 MPa, spay binder rate was 5.00-10.00 Hz and feed powder rate was 15-20 r/min. Conclusion Under the optimal conditions, the miropellet prepared by using the centrifugal granulator have prefect shape and surface characteristics, the yields of nicotinic acid micropellet are 90.8%,and the release rate meets the requirements of the Chinese Pharmacopoeia （editon 2005）.