CCMP97-RD-004
〝中藥濃縮製劑〞是國內中(草)藥之主要劑型之一，主要將藥草經選材、清洗、飲片加工、炮製，再經加熱、萃取、濃縮，並常添加澱粉、食用膠、乳糖作為賦型劑，賦型劑能提供藥效、香氣保存及溶解性、成型性之改善，更成為造粒之關鍵技術。許多中(草)藥業者常因萃取時，指標成分過低及再現性不穩定，常添加生藥粉末以提昇其穩定性及效果；另許多含澱粉、膠質成分高之中藥材，其在熬煮、萃取過程中，易因糊化及黏度過高，容易影響其萃取率及乾燥；〝生藥粉末〞常是業者添加之賦型劑以提高其製作方便性及藥效。如何評估生藥粉末之添加量及其對品質、藥效、再現性、安定性等之影響，十分值得重視及相投入相關之研究。本年度(97)衛生署中醫藥委員會的〝推動傳統藥材生技研發類〞委託研究計畫研究重點項目－－研究重點2-2：中草藥品質之確保研究；將中藥製劑品質再現性與安定性及製程與檢驗技術之確效研究作為研究重點。
本計畫〝中(草)藥添加生藥粉末之品質(指標)量化及確效研究〞擬將研究項目分為三項主題進行：(一)生藥粉末添加對其品質指標檢測及量化評估；包括：粗纖維含量、纖維組成分(半纖維素、纖維素及木質素)、纖維單醣組成(rhamnose、fructose、arabinose、xylose、mannose、galactose、glucose、allose)、澱粉含量、粒徑大小、十字偏光、色澤、膨潤力、沉降速率。(二)生藥粉末添加之確效評估：利用液相層析儀分析麻黃湯之指標成分Ephedrine、pseudophedrine、Amygdalin、cinnamic acid、glycyrrhizin及生理活性成分：總多酚類含量、類黃酮、單寧含量。(三)生藥粉末添加對造粒機制及品質影響之評估：探討傳統(澱粉、乳糖、CMC)及生藥粉末添加對造粒機制、顆粒大小、外觀、溶解性及微細構造觀察，並評估其對品質之影響。
關鍵字：生藥粉末、粗纖維、賦形劑、中(草)藥、造粒
CCMP97-RD-004
“Chinese herbal concentrated medicine” is one of the main product types of Taiwan’s medicinal herbs. The medicinal herb is mainly selected, cleansed, decoction processed, packaged and then heated, extracted, concentrated, and added with starch, edible gum, and lactose to produce excipients. The excipients can provide curative effect, maintenance of aroma, improvement of formation and solubility, thereby, becoming a key technology of granulization. Owing to the low index composition and reproducibility instability, during extraction, many medicinal herb producers often add raw medicine powder to improve the stability and effectiveness. Moreover, the raw materials of many medicinal herbs that include high content of starch and pectin cause the medicinal herbs to be easily affected during extraction and drying because of gelatinization and high degree of viscosity. “Raw medicine powder” is the excipient, producers mostly add to the medicinal herbs so as to improve the processing convenience and curative effect. The process of estimating the quantity of raw medicine powder added to the medicinal herb and its effect on quality, curative effect, reproducibility, stability, is worthy to be valued and invested in related researches.
關鍵字：raw medicine powder, crude fiber, excipient, Chinese herbal medicine, granulization
