中草藥安全性之研究

1. 中草藥安全性之研究 • 在西醫藥發達的現代，在台灣地區大多數民眾仍沿襲傳統，習慣使用中草藥進行疾病治療或食療以保健身體，然而民眾卻常因服用不明藥物或食品造成中毒現象，如1995年之減肥菜─守宮木事件，因此衛生署制定了「健康食品管理法」，對長期食用及製造加工考量其安全性，將雖列為食品者仍須進行毒性試驗，因此在本論文中將針對一些與生活息息相關的農產品及中藥進行毒性檢測，包含急性毒性檢測及重金屬檢測。 • 本論文進行天然物安全性之檢測，包含中藥方劑之動物毒性檢測及農產品、礦物類藥材之重金屬含有測定，論文中以具有免疫提升作用，或消炎清熱作用為主之中藥進行動物毒性作用，農作物之重金屬元素定量分析，則選擇桃園縣十三個鄉鎮市種植之97個蔬果樣品進行重金屬鎘、鉛、汞測定，在1996年針對35種常用中藥材之礦物質含量分析報告中發現礦物類中藥材含有高含量之重金屬成分，礦物類中藥材因地質構成關係，成分不相同，如雄黃之硫化砷、朱砂之硫化汞等，但未經炮製或炮製方法不當時，雄黃易有氧化砷、朱砂有鉛、砷、鎘等金屬元素污染，因此宜採用中藥炮製法中之水飛加以改變，故就近年來頻傳重金屬中毒事件之朱砂進行炮製，及重金屬元素分析，以建立一安全、正確之”朱砂炮製方法”，植物之種源鑑定是中藥使用安全性之首要因素，因此在第二部分將利用T.L.C.指紋圖譜及分子生物技術RAPD的模式建立，使近緣不易區別之新鮮近緣藥材之鑑定法藥材能方便且快速的鑑別。 • 結果顯示(1)中藥方劑龜鹿二仙膏、消痔丸及加味消痔丸在連續口服兩週之後，實驗組與對照組相比較皆呈無意義之改變，(2)桃園縣採樣區內之農作物未發現有鎘、鉛、汞之污染，(3)朱砂重金屬含量除口米砂外，任何水飛法均可除去大部分重金屬，(4)T.L.C.指紋圖譜及RAPD技術可使藥用植物之種源鑑定快速且方便。 • 本研究結果將可提供國內農政單位、藥政單位及中藥從業人員對中藥方劑之毒性作用、蔬果、礦物類藥材之重金屬元素含量參考，毒性試驗模式的建立是中藥安全性維護的不二法門，而環境的污染是須長期的監測，因此毒性試驗模式及重金屬之測定是必要性且持續性的繼續進行，建議應列為政策性推行，尤其對中藥材炮製更須加以謹慎處理，尤其是礦物類藥材，才不致發生重金屬中毒情況，中藥材的基源不同，而T.L.C.指紋圖譜及RAPD分析的方法為一可輕便且快速的應用途徑。

2. Safety Studies on Chinese Medicine and Angriculture • The western medicine develop at present the most people carry on as before tradition on Taiwan, that is used to treat disease with Chinese herb or take good sare of one’s health with food, but that happened toxic event because of that used unknow herbs or foods, example 1995 the weight reducing vegetable-Sauropus androgynus event, so The Department of Health rules “HEALTH FOOD CONTROL ACT” , and the food belong to long term feeding or producing that must think about its safety. Although belong to food, it must still proceed toxic test. • This paper would do nature products safety test, that included the toxic test in animal of Chinese medicine and the heavy metal test of the agriculture and mineral drug. The potency immunology action and anti-inflammation action were selected from Chinese prescription, that were “Guei-Luh-Ell-Shian-Jiau” and “Shian-Jyh-Wan”, the acute toxic test was in progress. The heavy metals analysis of agriculture was selected from Taur-Yuan County’s 13 towns, and would analysis from 97 samples of vegetables and fruits, it included Cd, Hg, and Pb. We found mineral drug which had high content of heavy metals from common use of Chinese drugs in 1996. Mineral drugs component is different from geology factor, example As2S3 of Realgar, HgS of Cinnabar etc., but the drug is unprepared or use wrong preparation method, it would be contaminated example As2O3 of Realgar, Pb, As, Cd of Cinnabar so we must use Chinese drug preparation method by connon processing of refined powder. Recently many heavy metals poison cases of Chinese medicinal products accidents were reported of cinnabar, therefore, how to selected the standardization of the raw material and processing procedure are important works to the pharmaceutical industry on the quality and safety control. The plant original identify is important factor of Chinese medicine, so we would inquire into relative classify that was difficulty of the medicinal herb. And the part II we would use T.L.C. fingerprint and molecule biological technique of RAPD moder that could identify the plant original fast and convenience. • The result showed (1) Guei-Luh-Ell-Shian-Jiau and Shiau-Jyh-Wan weren’t toxicity in oral continue 14 days, (2) that wasn‘t pollution from Cd, Hg and Pb in the Taur-Yuan County, (3) that Cinnabar could remove the heavy metal of As, Cd, Pb by common processing method of refined powder except Koou-Mii Cinnabar, (4) the T.L.C. fingerprint and RAPD method results matched to identify the plant original different of Lycium chinense Mill. and Lycium barbarum L. • The result showed it must continue and expand region to analysis the toxic test from health food, and control heavy metals pollution condition, that is used a feel at ease agricultural products of consumers. And it will give the government a reference of safety re-evaluation Cinnabar in the future.