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| 題 名 | 中藥材殘留農藥背景值監測調查=Investigation and Monitoring of the Pesticide Residue Level in Chinese Herbal Medicine |
|---|---|
| 作 者 | 顏瑞泓; | 書刊名 | 中醫藥年報 |
| 卷 期 | 13 2024.10[民113.10] |
| 頁 次 | 頁(15)1-(15)39 |
| 分類號 | 414.3 |
| 關鍵詞 | 中藥材; 農藥; 殘留容許量; Herbal medicines; Pesticide; Maximum residue limits; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 本計畫評估中藥材栽培方式、生長特性、國內取食人口、取食方式及取食量,再藉 採集市售之中藥材樣品分析實際農藥殘留情形 (包含殘留農藥種類、殘留量及出現殘留 的頻度),建立各種中藥材農藥殘留之背景資料,同時亦蒐集各個農藥在國內於各農產品 上之殘留資料進行分析比對,最終研擬中藥材農藥殘留容許量之訂定策略供主管機關參 酌。及此,本計畫於 110 年度諮詢中醫師公會全聯會、台灣製藥工業同業公會、台灣中 藥工業同業公會及中藥商全聯會,自衛福部公告之「得供食品原料使用中藥材分類及品 項」(草案) 篩選出 15 項中藥材進行農藥殘留檢驗分析,分別為赤芍、龍眼肉、蛇床子、 玉竹、白茅根、廣藿香、刺五加、桂子、高良薑、萊菔子、女貞子、排草、伸筋草、佛 手柑和紅景天。每項中藥材各採集 20 件樣品進行基原鑑定,確認臺灣中藥典所記載之 藥材基原,再以衛福部公告之「食品中殘留農藥檢驗方法-多重殘留分析方法(五)」進 行農藥殘留分析。計畫執行期間舉辦三場專家會議,邀請國內與中藥材品質以及檢驗相 關之產、官、學界出席,共同研討三個主題,分別為「本年度中藥材品項之選擇及中藥 材殘留農藥檢驗方法標的農藥之選擇」、「中藥材中農藥殘留限量研訂階段規畫」及「得 105~109 年度之 75 種中藥材市售樣品監測結果統整」,以照顧國民健康與維持中藥材品 質為目標,為中藥材殘留農藥容許量訂定研擬相關策略並凝聚共識。同時整合歷年所調 查之中藥材農藥殘留的數據與結果,建置可供方便查詢的檔案格式,建立可立即與各殘 留農藥的資料庫相連之連結。 最後,依年度執行成果合併前期成果,將本年度選用之中藥材同時比對衛福部農藥殘留容許量以及前期成果建議之殘留容許量,提出下列建議:(1) 已有衛福部食藥署公 告標準的中藥材品項,與食藥署研商是否區分為鮮品及乾品 (例如: 山藥或枸杞);(2) 中 藥材來源為一般農產品生產所栽培之作物,該作物取食部位已訂有農藥殘留容許量標準 (例如:枇杷葉源自枇杷作物、萊菔子源自於蘿蔔),則考量加工因子及農藥衰退等因素, 採用鮮食部位或相近之取食部份的農藥殘留容許量 5 倍作為其農藥殘留容許量標準;(3) 其餘來源作物並未用於一般鮮食用農產品者的中藥材品項,依其取用部位區分後,將 26 項需關注之農藥參考相似作物或代表作物農藥殘留容許量標準並考量加工因子做為該 中藥材農藥殘留容許量標準;(4) 其他未定容許量之農藥,若有研訂中藥材農藥殘留檢 驗方法者,則採用定量極限。此外,因中藥材上的農藥殘留樣態會隨時間而有所更替, 在中藥材之農藥殘留管理上,建議採用滾動式的管理,其可分為三大方向: (1) 來源為衛 福部食藥署已訂有農藥殘留容許量標準之農作物的中藥材品項,定期檢討公告該公告增 刪之農藥殘留容許量標準;(2) 來源作物並未用於一般鮮食用農產品者的中藥材品項, 應藉由歷年中藥材殘留農藥背景值監測結果,重新對藥劑進行風險評分及排序,並考量 是否需更新或增列需關注農藥名單;(3) 關注國際上是否有農藥將被列為禁用之藥劑, 例如:陶斯松因其毒性可能會導致胎兒腦部缺陷,近期被廣泛討論是否應被禁用。另外 在本年度第三次專家會議討論到的 2-phenylphenol,因其可能產生於中藥材的炮製過程, 屬於外源性的殘留,專家一致建議往後不列入中藥材殘留農藥限量的規範中,亦檢附供 主管機關研參。 |
| 英文摘要 | The cultivation methods, growth characteristics, domestic feeding population, feeding patterns, and intake of Chinese medicines were evaluated in this study. Then background information on Chinese medicines was established by analyzing the pesticide residues of commercial samples (including the types and frequency of detected pesticide). Simultaneously, the pesticide residue data in domestic agricultural products was collected to be compare with the practical data. Finally, the strategies for determining the maximum residue limits (MRLs) of pesticides in Chinese medicines were formulated. In this regard, this study chose 15 items from “Classification and qualification of Chinese medicines for food raw materials” (Draft) by consulting with industry and authorities. These 15 items include red peony (PAEONIAE RUBRA RADIX) (赤芍), longan flesh (LONGANAE ARILLUS) (龍眼肉), common cnidium fruit (CNIDII FRUCTUS) (蛇床子), solomon's seal (POLYGONATI ODORATI RHIZOMA) (玉竹), imperata root (IMPERATAE RHIZOMA) (白茅根), patchouli (POGOSTEMONIS HERBA) (廣藿香), prickly anacthopanax (RADIX ACANTHOPANACIS SENTICOSL) (刺 五加), fruit of japanese cinnamon (CINNAMOMI RAMULUS) (桂子), galanga galangal (ALPINIAE OFFICINARUM RHIZOMA) (高良薑), radish seed (RAPHANI SEMEN ) (萊菔子), privet fruit (LIGUSTRI LUCIDI FRUCTUS) (女貞子), lysimachia foenum-graecum hance (LYCOPODII HERBA) (排草), common clubmoss herb (LYCOPODII HERBA ) (伸筋 草), fingered citron (CITRI SARCODACTYLIS FRUCTUS) (佛手柑), rhodiolae herba (RHODIOLAE CRENULATAE RADIX ET RHIZOMA) (紅景天), and twenty samples were collected for each item for pesticide residue analysis. The “Method of Testing for Pesticide Residues in Foods-Multi residue Analysis (5)” announced by the Taiwan Food and Drug Administration was used to determine the residues of 380 pesticides in all samples. Throughout the duration of this study, three meetings were held with relevant industrial, official, and academic experts in attendance to discuss the strategy of establishing pesticide MRLs in Chinese herbal medicine for ensuring the safety of people and the quality of Chinese herbal medicine supplied in Taiwan. Eventually, this study integrates all the data of pesticide residues in Chinese herbal medicines collected over the years and submits them to the Department of Chinese Medicine and Pharmacy as a reference to build up a standard of pesticide MRLs in Chinese herbal medicine. Based on the results of this year and the previous years, the following recommendations were proposed for the Ministry of Health and Welfare (MOHW): 1. For the Chinese herbal medicines whose MRLs has been announced by Taiwan Food and Drug Administration (TFDA) of MOHW, the competent authority should discuss with the TFDA whether to separate fresh and processed products (e.g. chinese yam or chinese wolfberry). 2. If the source of the Chinese herbal medicine is a crop cultivated for general agricultural production whose MRLs have been set for the edible part (e.g. loquat leaf from loquat, radish seed from radish), the MRLs of Chinese herbal medicine would be 5-time MRL of the fresh food (or equivalent ingested part) after being considered the factors such as processing factors and pesticide decline . 3. For the Chinese herbal medicines not from the source of general agricultural product, the 26 concerned pesticides are chosen to set the MRLs. These MRLs would be considered the processing factor. 4. For other pesticides with undetermined MRLs but including in method for pesticide residues analysis on Chinese medicine, limit of quantification (LOQ) were recommended as the standard of pesticides’ residues. In addition, since the pesticide residue on Chinese herbal medicines will change over time, it is recommended to adopt a rolling management of pesticide residues in Chinese herbal medicines, which can be divided into three major directions: 1. For the Chinese herbal medicines whose MRLs has been announced by TFDA of MOHW, review regularly to update MRLs with the latest standard. 2. For the Chinese herbal medicines not from the source of general agricultural product, reevaluate the risk score and ranking of the pesticide and consider whether to add other pesticides to the list of highly-concerned pesticides every year. 3. Focused on any pesticides which would be banned internationally. For example, chlorpyrifos has been discussed recently because of its toxicity which may cause brain defects in fetus. Finally, 2-phenylphenol which was discussed at the third expert meeting of this year is an exogenous residue because it may arise from the processing of Chinese herbal medicinal materials. The experts unanimously proposed 2-phenylphenol to be excluded from the regulation of pesticide residues in Chinese herbal medicines in the future. |
本系統中英文摘要資訊取自各篇刊載內容。