間質微粒控釋劑型在藥學界已廣泛地受到研究與討論，本研究乃
以微溶性之tamsulosin HCl為模式藥物，以自動化之流動床包覆來研
究探討利用不同高分子聚合物與陰離子性腸溶聚合物混合比例及包
覆厚薄的程度，並藉由不同pH溶媒的體外溶離試驗評估上述不同配
方變數對間質微粒控釋藥物釋放之影響及效應，並經由安定性試驗來
了解間質微粒控釋配方組成中塑化劑及界面活性劑，對間質微粒控釋
劑型藥物在長期儲存下之釋放影響效應。
由本研究之結果可得知高分子聚合物與陰離子性腸溶聚合物在
混合之比例及包覆之濃度均對藥物釋放有顯著影響。加入陰離子性聚
合物於間質及包衣中可降低其在低pH值環境中之藥物釋放速率，而
間質及包衣之高分子聚合物增加時，其藥物釋放速率將減緩。此外微
粒之安定性不受塑化劑添加濃度之影響，但界面活性劑添加方式則將
影響其藥物釋放之安定性。
本研究顯示高分子聚合物與陰離子性聚合物之種類，混合比例及
濃度均將對微溶性藥物之間質控釋劑型藥物釋放有顯著之影響。 Controlled drug release using matrix-based pellets has been widely
discussed in the pharmaceutical field. The present study used tamsulosin
HCl as a low solubility model drug to evaluate the effect polymer type,
polymer ratio and coating thickness on drug release from those matrix
and matrix-coated pellets in various pH medium. Fluidized bed system
was used in the coating process and the effect of rotor and bottom spray
on drug release was assessed. The stability of matrix pellets after curing
was also evaluated.
The results indicate that tamsulosin release was significantly affected by
the polymer type, polymer ratio and coating thickness of polymer. The
addition of anionic polymer in matrix as well as coating membrane may
decrease drug release rate in low pH environment. The addition of more
plasticizer and suspending of surfactant may not be able to stabilize drug
release after curing, however, the addition of soluble surfactant may
improve the stability of drug release after curing.
The present study clearly demonstrates that the type of polymer used, the
ratio of polymer used and the coating thickness can have significantly
affect drug release from matrix-based pellet.
