腎病患者末期常見有尿毒性搔癢症症狀，常嚴重影響病患的生活品質。迄今對於搔癢症的病理機轉尚未明確被掌握，目前治療尿毒性搔癢症的藥物主要是日本上市的Nalfurafine之錠劑，雖然有其他仿單核准適應症外使用(off-lable-use)的藥品，但其治療效果不佳或是療效未被驗證。此外還有新藥CR845被開發出來，目前尚在臨床階段。由於治療尿毒性搔癢症的需求市場大，因此抗尿毒性搔癢的藥品是目前仍有高度需求的藥品，而外用的抗搔癢軟膏開發將會符合病患的需求。
LT016是目前順天醫藥積極研發抗搔癢藥物，而本論文研究則以開發新軟膏劑型為目的，並探討於與部分賦形劑之組成合宜性和分析方法的開發。本研究分析儀器為UPLC，透過分析條件的調整，包含移動相之比例調整等，尋求較合適的分析條件，之後進行精密度、線性和準確性等之驗證，研究結果顯示分析方法的靈敏度和準確度皆可符合規範。
Patients with nephropathy often have uremic pruritus symptoms, which seriously affect the quality of life of patients. So far, the pathological mechanism for pruritus has not been clear. Recently, Nalfurafine tablet is primary drug for treatment of urinary pruritus marketed in Japan. Although there are other drugs as off-lable-use for urinary pruritus, those are not effective or the efficacy has not been verified. In addition, the new drug CR845 has been still developed in clinical stage. Because of the large market demand for uremic pruritus, anti-urinative itching drugs are still highly demanding drugs, and the development of topical anti-itch ointment will meet the needs of patients.
LT016 is currently development as anti-itch drug by Lumosa therapeutics. The purpose of this thesis is to develop new ointment dosage forms, and then explore the suitability and analytical methods for the composition of excipients. In this study, UPLC was used as analytical instrument. By the adjustment of the analysis conditions, such as the proportional of the mobile phase. The appropriate analysis conditions are verified by precision, linearity and accuracy. The results show the sensitivity and accuracy of the analysis method met the guideline.
