中藥材重金屬之限量標準係中藥材品質管制之重要規範之一,故本計畫委託經評估核可之實驗室利用氣相層析儀/電子捕捉偵測器法(GC-ECD)針對主要價購於藥廠之浙貝母、防風、薏苡仁、白芷、山梔子、連翹、菊花、鉤藤、丁香、懷牛膝、益母草、黃芩、薑黃、玄參、鬱金等15種中藥材,各20件;十全大補湯、人參養榮湯、八珍湯、小柴胡湯、獨活寄生湯、炙甘草湯、歸脾湯、補中益氣湯、六君子湯、天王補心丹等10種含人參中藥製劑,各10件,合計400件檢體,進行α-BHC、β-BHC、γ-BHC、δ-BHC、o,p'-DDE、p,p'-DDE、o,p'-DDT、p,p'-DDT、Aldrin、Dieldrin、Endrin、PCNB、Chlordane、Hexachlorobenzene、Heptachlor等15種有機氯劑農藥之背景值調查,結果上述400件檢體,均未檢出上述15種有機氯劑農藥,本計劃結果提供行政管理單位作為制定管制標準之參考依據。
The limitation of organochlorine pesticide in raw materials of traditional Chinese medicine (TCM) is an important regulation issue for the implementation of GMP in Chinese pharmaceuticals. A certified laboratory was commissioned by this project to investigate the background values of the following fifteen organochlorine pesticides: α-BHC, β-BHC, γ-BHC, δ-BHC, o,p'-DDE, p,p'-DDE, o,p'-DDT, p,p'-DDT, Aldrin, Dieldrin, Endrin, PCNB, Chlordane, Hexachlorobenzene, and Heptachlor, contained in 20 samples each of 15 selected Chinese herbs and 10 samples each 10 kinds of pharmaceutical products. Total of 400 samples were used for this project by GC/ECD and were conformed by GC/MS method. Mostly purchasing from Chinese pharmaceuticals, fifteen raw materials of TCM included Fritillariae Thunbergii Bulbus, Saposhnikoviae Radix, Coicis Semen, Angelicae Dahuricae Radix, Gardeniae Fructus, Forsythiae Fructus, Chrysanthemi Flos, Uncariae Ramulus Cumuncus, Caryophylli Flos, Achyranthis Bidentatae Radix, Leonuri Herba, Scutellariae Radix, Curcumae Longae Rhizoma, Scrophulariae Radix, and Curcumae Radix. The 10 kinds of phamaceuticl products were Shyh-Chyuan-Daa-Buu Tang(十全大補湯), Ren-Shen-Yeang-Rong Tang(人參養榮湯), Ba-Jen Tang(八珍湯), Sheau-Chair-Hwu Tang(小柴胡湯), Liow-Jiun-Tzyy Tang(六君子湯), Tian-Wang-Buu-Shin Tang(天王補心丹), Zih Gan-Cao Tang(炙甘草湯), Buu-Jong-Yih-Chih Tang(補中益氣湯), Guei-Pi Tang(歸脾湯), and Dwu-Hwo-Jih-Sheng Tang(獨活寄生湯). No pesticide residue was in the samples. The results could provide limitation assessment of organochlorine pesticide residue in TCM for the regulatory authority.