臺灣博碩士論文加值系統

腸溶衣材料包覆之藥物控制釋放技術被廣泛應用於固體藥物上，來延遲藥物於胃中的釋放，使其在小腸中釋放。使用腸溶衣包覆藥物有三種主要因素:
(一)防止活性物質在酸性環境胃中的降解
(二)避免藥物與胃壁接觸，造成胃出血及胃潰瘍等現象，妨礙胃的消化功能
(三)控制藥物於腸中釋放，達到有效吸收
本實驗是使用包覆機(coating pan)作為在處方藥上覆膜的機器，將腸溶衣材料與預包覆藥物，先行混合成包覆溶液，再利用噴槍噴灑於糖粒表面，完成包覆之後接著使用熱空氣烘乾，就會形成膜狀的包覆藥物，再進行篩析，以獲得適當大小表面積的粒子。
將已獲得在8號與10號標準篩網之間的腸溶衣材料控釋劑型多層藥物，分別秤取適當的質量，對照不同pH值(人工胃液：pH=1.2，人工腸液：pH=6.8，二次去離子水)的緩衝液，進行3組體外的溶離延遲釋放測試，最後利用UV量測此圓粒控釋劑型的藥物釋放情形。


由實驗結果可以得知:
I. 微粒包衣控制釋放製劑(pellets)及其以羥丙基纖維素(hydroxypropyl cellulose; HPC)及乙基纖維素(ethyl cellulose; EC)等為膜衣包覆後對於藥品釋出的影響。
II. 膜衣包覆的影響因素:
(1) 包覆膜衣溶液的組成
(2) 包覆缽的轉速、包覆液噴灑量
(3) 包覆過程
III. 在本研究中發現，對於不同控制釋放劑型的機制及原理之間或許有差異，但是最後都能藉由配方的調配而達到控制藥品穩定釋出，並使藥品達到長期釋放的效果。

The enteric coating material coated drug controlled release technology is widely used in solid pharmaceutical, and to delay the release of drugs in the stomach so that it is released in the small intestine. Drugs coated with an enteric coating, there are three main factors:
(1) Prevent the active substance in the acidic environment of the stomach degradation
(2) To avoid contact with drugs and stomach, causing stomach bleeding and ulcers and other phenomena, prevent stomach digestive function
(3) Controlling drug release in the intestine, to achieve effective absorption
This experiment is to use the Coating pan coated on prescription drugs as the machines that will pre-coated with an enteric coating materials and medicines, first mixed into a coating solution is sprayed on the sugar pills use spray gun surface coated finish is followed by drying with hot air, it will form a film coating of pharmaceutical, during sieving to obtain adequate particle size, surface area.
Received in the 8th and the 10th standard sieve material between the controlled release dosage form enteric coating multiple layers drugs, respectively, weighed appropriate quality control different pH values (artificial gastric juice: pH = 1.2, simulated intestinal fluid: pH = 6.8 , distilled water) buffer, for three groups delayed release in vitro dissolution test, and finally the use of UV measurements controlled release dosage form of this drug release pellets situation.

The experimental results show that:
I. particles coated controlled release formulations (pellets) and Hydroxypropyl cellulose
(Hydroxypropyl cellulose; HPC) and ethyl cellulose (Ethyl cellulose; EC) such as
film-coated release after coating for pharmaceuticals effects.
II. Film-coated coated factors:
(1) The composition of the solution film coated
(2) coated with a bowl speed, the amount of coating liquid spray
(3) coating process
III. In the present study found that, for different controlled release dosage form, or
mechanism, and there are differences between the principle, but in the end be able to
achieve through the deployment of controlled prescription drugs stable release, and
to achieve long-term release of drugs effects.

摘 要 i
ABSTRACT iii
誌 謝 v
目 錄 vi
表目錄 viii
圖目錄 x
第一章 緒論 1
1.1 前言 1
1.2 研究動機和目的 2
第二章 文獻回顧與相關原理 3
2.1 蟲膠(Shellac)之簡介 3
2.2 高分子材料之簡介 3
2.2.1乙基纖維素(Ethylcellulose, EC) 3
2.2.2 羥丙基纖維素(Hydroxypropyl cellulose, HPC) 4
2.3 功能性高分子材料之簡介 4
2.3.1 釋放類型介紹和原理 7
2.3.2 改良釋放劑型與遞藥系統 9
2.4 藥物控制釋放之簡介與分類 10
2.4.1 長效型製劑 10
2.4.2 腸溶型製劑 11
2.5 藥物釋放動力學 13
2.5.1 圓粒控釋劑型半徑與膜衣時間的關係 13
2.5.2 動力學模式 14
2.6 處方藥物 17
第三章 實驗方法 18
3.1 實驗藥品 18
3.2 實驗儀器 21
3.3 實驗方法 26
3.3.1多層圓形劑粒控釋膜衣之藥物包覆 26
3.3.2實驗流程圖 28
3.3.3包覆藥物溶離試驗 30
3.3.4 UV紫外光-分光光度計 31
第四章 結果與討論 32
4.1 產物分析 32
4.2 測試分析 33
4.2.1檢量線製作 33
4.2.2處方藥物波長掃描 35
4.2.3緩衝溶液電導度測量 36
4.2.4溶離藥物濃度殘留值 36
4.3 UV測量 37
4.3.1單層膜衣高濃度蟲膠與乙基纖維素合成膜衣之動力學 討論 39
4.3.2多層膜衣 44
4.3.2.1高濃度蟲膠與乙基纖維素合成膜衣之釋放動力學 討論 44
4.3.2.2低濃度蟲膠與乙基纖維素合成膜衣之釋放動力學 討論 53
4.3.2.3高濃度蟲膠與羥丙基纖維素合成膜衣之釋放動力學討論 62
4.3.2.4低濃度蟲膠與羥丙基纖維素合成膜衣之釋放動力學討論 71
4.4討論 80
第五章 結論 83
第六章 參考文獻 84

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