- 學位論文
Ramipril口腔快速崩散錠之處方研究
A Study on Formulation of Orally Rapidly Disintegrating Ramipril Tablets
摘要
Ramipril是一種強力且長效的血管收縮素轉化酶抑制劑，它可用來治療高血壓、心衰竭，降低因心血管疾病導致的心肌梗塞中風及死亡的危險。口腔快速崩散錠是一種在口腔內就可快速崩散完成的固體劑型，可以減少錠劑吞嚥的困難。將錠劑放入口腔中，唾液可以快速地滲透到錠劑孔洞裡，而使錠劑崩解。 本實驗利用複因子試驗設計法來找出最適合ramipril口腔快速崩散錠的處方。本實驗採用32試驗設計法以口腔快速崩散錠的崩散時間為依據，接著使用ANOVA來分析變因。探討其物性包括崩散時間、硬度、脆度、含量均一度以及體外溶離等實驗。再利用示差掃描熱分析儀(DSC)及傅立葉轉換式紅外線光譜儀(FT-IR)來探討Ramipril與賦型劑之間的交互關係。 試驗設計法證明崩散劑濃度對口腔快速崩散錠崩散時間有顯著影響。DSC及FT-IR分析結果指出ramipril與賦形劑有相互作用的影響，由最佳化的處方可得到最短的崩散時間為21.5秒。
並列摘要
Ramipril is a strong and longterm angiotensin converting enzyme inhibitor. It is used in the treatment of hypertension, heart failure, myocardial infarction, reduction the dangerous of stroke and death. Orally rapidly disintegrating tablets are solid dosage forms that disintegrate in the oral cavity leaving an easy-to-swallow residue. A statistical factorial experimental design was used to optimize the formulation of orally rapidly disintegrating ramipril tablets. A 32 experimental design was employed to evaluate the disintegration of the orally rapidly disintegrating tablets; subsequent data was compared using analysis of variance (ANOVA). The characterization of the orally rapidly disintegrating tablets were studied, such as disintegration time, hardness, friability, uniformity content of the tablets, and in-vitro release test of the orally rapidly disintegrating ramipril tablets. Host-guest interactions were studied in the solid state by differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR). The experimental design study illustrated that the concentration of disintegrants had significant effect on the disintegration time. The results of DSC and FTIR spectra indicated that some interaction between ramipril and excipients. An optimum formulation showed a shortest disintegrating time of 21.5 s.