中藥摻加西藥成分檢驗研究之回顧與展望

Review and Prospect of the Analysis of Synthetic Therapeutic Substances Adulterated in Traditional Chinese Medicines

顧祐瑞(Yoe-Ray Ku) ； 林哲輝(Jer-Huei Lin) ； 溫國慶(Kuo-Ching Wen) ； 何禮剛(Li-Kang Ho) ； 廖俊亨(Chun-Heng Liao)

《藥物食品檢驗局調查研究年報》 19號 (2001/09) Pp. 94-105

https://doi.org/10.6946/ASRNL.200109.0094

摘要

行政院衛生署為保護國民之用藥安全，不准許中醫師處方使用西藥，為配合行政管理取締非法，中藥摻加西藥之檢驗，一向為藥物食品檢驗局之重點工作。從早期篩檢方法之開發探討，建立薄層層析法及紫外光分光光度計之確認方法，也透過市售調查了解某種類別之製劑或某種提供藥品來源之違法摻加情形，近年來進一步開發建立高效液相層析、毛細管電泳層析或氣相層析質譜儀之定性定量方法，可同時分析多種西藥成分，對於篩檢該類製劑則更趨迅速、精準，並對部分檢體檢出之西藥成分加以定量，俾以瞭解其摻加劑量之情形。在美、日、澳、加等工業發達之國家，亦曾針對中草藥中摻加之西藥成分，所造成之後遺症，及對這些西藥成分所進行之分析發表論文。未來建立一種固相萃取作西藥成分之前處理方法，以系統性的分析篩檢酸性、中性及鹼性西藥成分，應屬可行。此外液相層析質譜儀作為此類檢體之篩檢，具有實用化及簡單化之價值。

關鍵字

中藥摻加西藥成分檢驗 ； 薄層層析 ； 高效液相層析 ； 毛細管電泳層析 ； 氣相層析質譜儀

並列摘要

The adulterations of synthetic therapeutic substances in traditional Chinese medicines (TCM) have been reported in many occasions and have been a public health concern in Taiwan over the past years. The term ”adulteration” refers to TCM tested and found to contain chemical substances not prescribed or labeled as part of the intended use. The adulterations of synthetic therapeutic substances in TCM were banned by the health authorities in Taiwan for public safety. Prescription by Chinese medicine practitioner is also prohibited.
The National Laboratories of Foods and Drugs (NLFD) functions as the gatekeeper in TCM analysis in Taiwan since the 1970s. In the early years, the thin-layer chromatographic method and spectrophotometer were developed for monitoring adulterants in TCM. The result of adulterants found in TCM using these methods was also reported by NLFD. Recently, solid-phase extractions (SPE), high-performance liquid chromatography, capillary adulterants were performed. Similar analytic methods of adulterants in TCM have also been established in several industrialized countries.
At the moment, SPE procedure in the systematic analysis for screening the adulterants should be standardized. In the future, liquid chromatography/mass spectrometry as a general and valuable analytical tool for the first line drug screening system should also be considered.

並列關鍵字

pharmaceutical analysis ； adulterant ； HPLC ； HPCE ； GC/MS