黑藥九中摻加未標示處方西藥之分析   全文下載

Determination of Undeclared Prescription Drugs in Black Pearl Products

黑藥丸為一傳統中國草藥產品，通常標榜治風濕與背痛流通於美國市場。美國“食品與藥物管理局”雖早在1970年代已禁止其進口，但此類產品仍然以郵購方式或在特定店銷售。其受關注的主因在於某些產品含有處方藥。本研究以GC ／ MS 與HPLC方法分析黑藥丸的甲醇／乙醚萃取液，發現摻加下列處方藥：diazepam, diclofenac, hydrochlorothiazide,　indomethacin與mefenamic acid。分析結果並顯示所含處方藥的種類與含量即使在同一廠商的成品中亦不一致，其種類亦因不同包裝而異。因其含管制的處方藥物與缺乏固定成份的管制，促使“食品與藥物管理局”致力制止其銷售與使用。"

Black Pearls are a type of Chinese herbal preparation generally marketed to American consumers suffering from arthritis and back pain. Their importation and sale in the United States has been banned by the Food and Drug Administration since the 1970s. However, they are still available by mail order and occasionally in specialty shops. The FDA is concerned over the use of black pearls because some products have been adulterated with undeclared prescription drugs. Using a combination of GC/MS and HPLC to analyze methanol/ether extracts of black pearl products, we have detected the following prescription drugs: diazepam, diclofenac, hydrochlorothiazide, indomethacin and mefenamic acid. The levels and combinations of drugs present varied significantly, even within the same manufacturer and the presence or absence of the drugs was not consistent within different packages of the same product. Because of the adulteration and lack of control in the contents of these products, the FDA is actively trying to stop the sale and use of black pearls in the United States. 黑藥丸為一傳統中國草藥產品，通常標榜治風濕與背痛流通於美國市場。美國“食品與藥物管理局”雖早在1970年代已禁止其進口，但此類產品仍然以郵購方式或在特定店銷售。其受關注的主因在於某些產品含有處方藥。本研究以GC ／ MS 與HPLC方法分析黑藥丸的甲醇／乙醚萃取液，發現摻加下列處方藥：diazepam, diclofenac, hydrochlorothiazide,　indomethacin與mefenamic acid。分析結果並顯示所含處方藥的種類與含量即使在同一廠商的成品中亦不一致，其種類亦因不同包裝而異。因其含管制的處方藥物與缺乏固定成份的管制，促使“食品與藥物管理局”致力制止其銷售與使用。