| 摘要: | 由於永續觀念的重要性逐漸興起，製藥領域也希望可將此觀念帶入其行業中發展。為了有助於了解那些模式的轉變，提出了一系列從開發產品至最終產品皆採用永續性方法的範例研究。
在範例一中，介紹了在開發(R,S)-(±)-ibuprofen的手性分析範例中，藉由漿料反應結晶來回收過量的試劑及溶劑。拆分劑(56.8至77.5 mol%)及廢液(75.8至87.9 wt%)的回收所得到液體會在後續批次中重複使用，結果顯示可得到純度為 70.2 至 90.0% 的(S)-(+)-ibuprofen。
在製造過程中，廢物處理是不可避免的。因此，在範例二中，介紹一種在生產含砷的化療針劑過程中所產生的含砷廢水。為了從此廢水中去除砷，開發了一種砷吸附劑由洋菜膠與水合氧化鐵製成。將含有250 μg的As(III) / L的As(III)廢水通過裝有砷吸附劑的管柱，As(III)的濃度可以降低到10 μg的As(III) / L，符合WHO規定的標準。
最後，製藥工程的汙染不會只發生在製造過程中。汙染可能產生在處理過期的藥物之中，因此在範例三中發展出回收未使用的acetaminophen藥錠、 (R,S)-(±)-ibuprofen和As2O3針劑，將從過期的藥物中回收其含有的活性藥物成分。利用固液萃取方法acetaminophen藥錠、 (R,S)-(±)-ibuprofen的回收率分別達到58.7% 及67.6%，而對於隨者蒸發結晶法的發展，As2O3針劑的回收率可達到65.2%至79.9%。 所有回收的產品都是具有穩定的晶形以及符合經HPLC所測定的純度標準。
;Due to the ever-increasing awareness of the importance of sustainability, pharmaceutical sector is expected to adopt a sustainable mindset as well. As a means to contribute to those paradigm shift, a series of case studies concerning about developing a sustainable process from the beginning to the end product are presented. In Case I, a method to recycle the spent excess reagent and solvent by slurry reactive crystallization was developed in the chiral resolution of (R,S)-(±)-ibuprofen. The recycle of the resolving agent (56.8 to 77.5 mol%) and spent mother liquor (75.8 to 87.9 wt%) were resulted and reused in subsequent batches, while at the same time, the enriched (S)-(+)-ibuprofen with enantiopurity of 70.2 to 90.0% was produced. However, in reality, waste disposal will be inevitable at some point in a manufacturing process. Therefore, in Case II, an arsenic-containing wastewater produced from the production of an arsenic-based chemotherapeutic agent was presented. To remove arsenic from this wastewater, an arsenic adsorbent made of hydrous ferric oxide impregnated in agarose beads was developed. By passing the wastewater containing 250 μg of As(III) / L of As(III) through a column packed with the adsorbent, the concentration of As(III) could be reduced to 10 μg of As(III) / L of As(III), which was in conformity with the WHO recommended limit. Lastly, pharmaceutical pollution may also happen outside the manufacturing facility. Some of the finished pharmaceutical products may end up being unused, in which its disposal would be problematic. Therefore, in Case III, processes were developed to recycle unused acetaminophen tablets, (R,S)-(±)-ibuprofen tablets, and As2O3 injectables for chemotherapy by salvaging the valuable active pharmaceutical ingredients from those unused drug products. Utilizing a process based on solid-liquid extraction, acetaminophen and (R,S)-(±)-ibuprofen could be recovered with the yield of 58.7 wt% and 67.6 wt%, respectively. For the As2O3 injectables, evaporative crystallization-based protocol was developed, which could recover 65.2 to 79.9 wt% of As2O3. All of those recovered products were recovered in the desired stable crystal form, and were in conformity with the purity standard based on HPLC assay. |
