- 學位論文
Chlorzoxazone口腔快速崩散錠之處方研究
A Study on Formulation of Orally Rapidly Disintegrating Chlorzoxazone Tablets
摘要
Chlorzoxazone是中樞作用的肌肉鬆弛劑，它可用來治療腰痛、肩酸、神經痛，降低因運動後之肌肉酸痛、痙攣及強直。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chlorzoxazone口腔快速崩散錠的處方。本實驗採用23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chlorzoxazone與賦型劑之間的交互關係。 試驗設計法證明崩散劑濃度及打錠壓力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chlorzoxazone-HP?毧D成功被製備，chlorzoxazone口腔溶解錠之賦形劑間沒有相互作用的影響，由最佳化的處方可得到最短的崩散時間為8.3秒。
並列摘要
Chlorzoxazone is a muscle relaxant of central nervous system. It is used in the treatment of lumbago, shoulder ache, nerve ache, reduction the symptom of muscle ache, muscle convulsion and muscle tetanus after sports. 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 chlorzoxazone tablets. A 23 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 chlorzoxazone 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 and compression force had significant effect on the disintegration time. The results of DSC and FTIR spectra indicated that chlorzoxazone-HP?毧D was prepared successfully and no interaction between chlorzoxazone and excipients. An optimum formulation showed a shortest disintegrating time of 8.3 s.