液相層質譜儀(LC/MS)與製藥工業－－原料藥(API)分析、生體可用率與生體相等性(BA/BE)評估

Liquid Chromatography Mass Spectrometry (LC/MS) and Pharmaceutical Industry － API Analysis and BAIBE Evaluation

王慶雄(Chin-Hsiung Wang) ； 謝建台(Jen-Taie Shiea)

《化學》 60卷2期 (2002/06) Pp. 241-251

https://doi.org/10.6623/chem.2002024

摘要

「時間就是金錢」是目前高科技工業成功的關鍵，在藥物工業上也不例外。隨著各種科學與技術的進步，藥廠也以縮短新藥物研發所需的時間以及加速藥物上市的時間為主要工作。新藥物篩選的技術包含了組合化學(combinational chemistry)、蛋白體學(proteomics)及各式自動平行合成平台等。這些技術可以在短時間內製造出數千種不同的預選藥物((candidate drug)，或是在數千個物種中找出可以做為預選藥物的化合物。而這些大量的預選藥和必須找出其藥物活性以及安全性之臨界值，因此更快速以及更準確的分析技術已變成目前製藥工業重要自古課題。分析技術必須具備以下特點才能滿足製藥工業的需求高靈敏度、高選擇性或特異性(good selectivity or specificity) 分析速度快主及高樣品通量(High throughput)，此外若能具備混合物種分析能力更好。液相層析串聯式質譜分析技術(LC/MS/MS)結合液相層析分離法可以作微量混合物的分析，而質譜分析技術因具備速度快，靈敏度高等特點，符合製藥工業的要求，而成為目前製藥工業最倚重的分析方法。

關鍵字

液相層析串聯式質譜分析法 ； 串聯式質譜儀 ； 藥物動力學 ； 藥物分析 ； 質譜

並列摘要

＂Time is Money＂ is now a key to success of high tech enterprise and no longer a slogan. There is no exception for pharmaceutical industry. Base on the progress in science and teclmology, a pharmaceutical corporation can speed up the new drug development procedure and direct a new drug into market. New drug screening technology include combinational chemistry, proteomic, automated synthetic plate-form etc. could produce or find out thousands of candidate drug in a short time. More candidate drug needs more analysis capacity to determine or define the critical factor to be a safely active drug. It is now that faster and more precise analysis process has become an important issue of pharmaceutical industry. The analysis capacity should be increased to handle a great quantity of candidate drug. To provide fast and high quality analysis service, an analytical instrument should provide with high sensitivity, good selectivity or specificity, speed, high throughput, and if possible, capable of analyze trace mixture. With possessed previous character, the LC/MS/MS has become more and more popular in each stage of the drug discovery. To be a powerful analytical tool in pharmaceutical industry, the use of LC/MS/MS is the need instead of choice.

並列關鍵字

liquid chromatography mass/mass spectrometry ； mass/mass spectrometry ； pharmacokinetic ； drug analysis ； mass spectrometry