- 學位論文
腸溶衣材料應用於口服劑型藥物之延遲釋放研究
Study of Coating Materials on Oral Enteric Drugs for Delayed Release
摘要
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。
並列摘要
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.