濃縮中藥之倍數標示問題探討(2-1)

張朝霖
台灣區中藥工業同業公會
本計畫擬針對目前中藥基準方200方，分兩年達成第一年100方，第二年100方，制定標準統一規範，並且對這類濃縮製劑的檢驗規格，提出是否應明定那些項目等提供背景資料以供行政管理參考，進而提供中醫藥委員會未來藥品的正確標示建議。
樣品將由市場採購(第一年100方，第二年100方，每方三種市售品)與自行試製。研究分成兩部分，第一部分研訂濃縮製劑真實合理之濃縮倍數，針對市售品與自行試製樣品，進行水抽提物測試，由水抽提物推定各濃縮製劑之濃縮倍數。考察市售品與標籤之濃縮倍數是否相符。並提出濃縮倍數之合理定義與範圍，同時提出濃縮中藥之倍數標示問題之解決對策。第二部分，研訂濃縮製劑含微生物、重金屬、農藥殘留之限量標準，針對濃縮製劑樣品進行微生物、重金屬與農藥殘留檢驗。作為藥品查驗登記審查準則第86條建議，提供未來藥品的正確標示建議
關鍵字：濃縮倍數、標示、基準方

Evaluate the labeled concentrated ratio of the concentrated herbal medicine(2-1)

The 200 CHM standard prescriptions (CHMSPs) will be study in two years.The main purpose of this plan wanna to make an uniform specification of the CHMSPs and consider that some items of the test specification of concentrated preparations should be issued as background for government manage reference or not. And then, provide the CCMP that correct labeling suggestions in the future. 
The 80 CHMPs samples come from the three brands in the market and DIY. Firstly, we wanna to know the true and rationable concentrated ratio for the products from market and DIY. Water extractions have been tested and evalutated the concentrated ratio of the concentrated preparations. Inspecting the concentrated ratio on label is match to products from market or not. Submit a rationable definition and range, suggest a right policy for the label how to contain concentrated ratio.
Secondly, research to analysis and conclude the limitation of microorganism, heavy metal and survive of pesticide. The results will be suggestion for license application rule 86, for make a correct label for the future medicine.
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