- 期刊
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神經戰劑預治用藥－Pyridostigmine控釋顆粒製備之研究（II）
The Study of Controlled Release Pellets of Pyridostigmine Bromide (II)
摘要
吡啶斯狄明（Pyridostigmine）為預治神經性化學毒劑之最佳藥物，本研究依已發展出之具穩定持續釋出效果之控釋顆粒處方組成及製程，重覆製備10批次，其製造均一性及再現性均極佳。本研究另以改變機械操作條件，探討量產製備時之影響因素，結果顯示氣體濕度為Pyridostigmine控釋顆粒製備過程中之最大影響因素，風門開口以50%之進風量較為適宜，噴液速率與配方之黏度、乾燥快慢有顯著關聯，於6ml/min之噴液速率，可得理想之單體控釋顆粒，轉盤速度於180-270rpm間，對製備Pyridostigmine 控釋顆粒無顯著影響。
並列摘要
Pyridostigmine bromide, a carbamate derivative, was a known anticholinesterase agent, and used to treat the myasthenia gravis. It has been developed as a pretreatment drug of nerval toxicity.The uniformity and recovery of granular properties of developed formulation of Pyridostingmine controlled release pellets were evaluated by repeating the preparation in 10 batches. All batches of Pyridostingmine controlled release pellets had excellent uniformity and recovery.The effects of operating variables on the preparation of Pyridostingmine controlled release pellets were also evaluated. The results indicated that the humidity of the fluidization air had more influence than any other examined variables on the characteristics of pellets. It was suitable for setting the fluidization air blower at 50%. The setting of spray rate was significantly dependent on the formulation viscosity and fluid-bed drying capacity. In addition, the ideal integral pellets were produced when the spray rate was set at 6 ml/min. Setting the rotor speed between 180 and 270 rpm did not have significantly effect on the preparation of Pyridostigmine hydrobromide sustained release pellets.