阿膠等市售中藥材化學規格測定及污穢物質之檢測

Study on the Chemical Specifications of Corii Asini Colla and other Chinese Crude Drugs and the Detection of Contaminants

謝州凱(Chou-kai Hsieh)

指導教授 ： 詹旭川 ； 張永勳

中臺科技大學/健康科學院/藥物科技研究所/碩士(2011年)

摘要

行政院衛生署中醫藥委員會於2004年公佈之第一版中華中藥典中收載中藥品項僅200種。因此，需於中華中藥典再版中增加品項。本研究，以臺灣全民健保用藥分析，選出常用方劑之組成藥物及單味濃縮藥但中華中藥典未收載之中藥材品項，進行化學規格背景值之研究。 本研究選擇阿膠等26種藥材，每種藥材收集20家檢品，進行乾燥減重、灰分、酸不溶性灰分、稀醇抽提、水抽提之五項試驗測試，並進行二氧化硫含量檢測以及農藥殘留篩檢。本實驗也選擇於易添加重粉藥材中黃連、通草、白朮、草豆蔻、百部、黃芩、百鮮皮、升麻、木香、威靈仙、射干、蒼朮、丹參、白豆蔻、金銀花、豬苓、紅花、紫河車、防風等19種挑選檢品進行硫酸鎂之檢測，了解臺灣市售藥材添加加重粉情況，再選擇使用感應耦合電漿質譜儀(ICP-MS)做重金屬殘留研究。另外並選擇牛蒡子、菊花、虎杖、半枝蓮、忍冬藤、升麻等6種藥材進行指標成分之定量分析，探討6種中藥材指標成分之分析方法並進行含量分析。 除了本實驗所得之實驗數據之外，也收集並參考各國藥典對於上述藥材之各項數據，並與行政院衛生署藥檢局及國內主要GMP中藥廠代表進行座談，討論其相關數據之可行性，及對藥材之基原做一探討，以作為中華中藥典再版編輯之依據。

關鍵字

高效液相層析法 ； 氣相層析法 ； 農藥殘留 ； 應耦和電漿質譜儀 ； 硫酸鎂 ； 加重粉 ； 二氧化硫 ； 水抽提 ； 酸不溶性灰分 ； 稀醇抽提 ； 總灰分 ； 乾燥減重

並列摘要

The Committee on Chinese Medicine and Pharmacy (CCMP), Department of Health, promulgated the completion of the first version of the Taiwan Herbal Pharmacopeia in 2004. The first edition of the Taiwan Herbal Pharmacopeia contained only about 200 Chinese crude drug species. The items were too few in comparison with the PRC Pharmacopeia or the Japanese Pharmacopeia. Therefore it was necessary to include more items in the upcoming revised version. The chemical specifications of these new items also needed to be established.
This study was conducted based on data from the National Health Insurance (NHI) of Taiwan. Crude drug items in commonly used formulae and single herb granules used in the NHI system but not already included in the Chinese Herbal Pharmacopeia were targeted. Furthermore, items that had already been examined from 2005 to 2008 were deducted as well. In the end, a total of 26 crude drugs items such as Asini Colla Corii were selected. For each crude drug, 20 samples were collected from different parts of Taiwan to conduct five experiments on, including loss on drying, total ash, acid-insoluble ash, diluted ethanol extractive and water soluble extraction.Sulfur dioxidne residue and chlorinated pesticide residue were also examined. Furthermore, this experiment also selected nineteen crude drugs commonly found with heavy magnesium sulfate feedstock (Coptidis Rhizoma, Tetrapanacis Medulla, Atractylodis Macrocephaiae Rhizoma, Alpiniae Semen, Stemonae Radix, Scutellariae Radix, Dictamni Cortex, Cimicifugae Rhizoma, Aucklandiae Radix, Clematidis Radix, Belamcandae Rhizoma, Atractylodisa Rhizoma, Salviae Militiorrhizae Radix, Amomi Rotundus Fructus, Lonicerae Flos, Polyporus, Carthami Flos, Hominis Placenta and Saposhnikoviae Radix). Through experiments on total ash and acid-insoluble ash, as well as detection on magnesium sulfate, we were able to have an understanding of the prevalence of weight gaining powder in the Chinese medicine market in Taiwan. Additionally, 6 crude drugs including Arctii Fructus, Chrysanthemi Flso, Polygoni Cuspidati Rhizoma, Scutellariae Barbatae Herba, and Cimicifugae Rhizoma were selected for the quantitative and qualitative analyses of their marker constituents. Discussions on the analytical methods for the 6 crude drugs were made and quantitative analyses for the marker constituents were conducted.
Besides the data obtained in this study, we have also collected information on the above mentioned crude drugs from pharmacopeias of different countries. Additionally, panel discussions were held in which officials from the Bureau of Drug and Food Analysis and representatives from GMP pharmaceuticals were invited to discuss the feasibility of these data, as well as the origins of these crude drugs. The results can be used as a reference in editing the of newer editions of Taiwan Herbal Pharmacopeia in the future.

並列關鍵字

HPLC ； GC ； Weight gaining powder ； ICP-MS ； Magnesium sulfate ； Water-soluble extraction ； Pesticide residues ； Diluted ethanol-soluble extractive ； Loss on drying ； Total ash ； Acid-insoluble ash

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