Sancai Dectoction derived from Wen Bing Tiao Bian Volume three, which is made from three traditional Chinese medicines including Ginseng Radix, Rehmanniae Radix and Asparagi Radix. It is effective in supplementing Qi, nourishing Yin and promoting production of body fluid, can be used in long summer febrile disease, sleep easily disturbed, loss of appetite, impairment of vitality and body fluid. Because of the formulation of Sancai Dectoction has the disadvantages including high dose, poor taste and difficult to storage. Therefore, in order to exert good curative effect and better market performance, a systematic study was carried out to investigate the preparation technology and quality evaluation of Sancai concentrated pills. Under the prescription of Sancai concentrated pills, virtue of theories of pharmaceutical technology design and characteristics of these three Chinese medicines with its preparation technology were studied and optimized with modern methods. In the preparation experiments, Rehmanniae Radix extraction process was firstly optimized by response surface methodology (RSM) using central composite design (CCD), followed by drying Rehmanniae Radix concentration using spray dryer with the yield ~90%. After mixing, soft material preparation, pelletizing, drying and polishing, the concentrated pills were obtained. The Sancai concentrated pills has passed the preparation tests, including appearance tests, moisture content test, disintegration test and weight variation test required by Chinese Pharmacopoeia (2010). In the experiment of quality evaluation, two medicinal materials, Ginseng Radix and Rehmanniae Radix, have been identified by TLC. The content of Sancai concentrated pills were determined by HPLC-DAD method. The method of switching wavelengths was established for simultaneously quantification of the Ginsenoside Rb1 and Ginsenoside Rg1 from Ginseng Radix, and Catalpol and Acteoside from Rehmanniae Radix. In summary, the prepared Sancai concentrated pills has fulfilled the requirement of Chinese Pharmacopoeia.

三才湯源於《溫病條辨》卷三，由人參、地黃、天門冬三味中藥組成，具 有益氣養陰生津之功效，主治暑溫日久，寢臥不安，不思飲食，元氣陰液兩傷 等症。由於湯劑存在著服藥量大、口感差、不易於保存等缺點，而濃縮丸具有 服藥量少，外形美觀，便於運輸，利於攜帶且容易保存等優點，使患者易於接 受。因此，對三才湯進行劑型改造必將會對臨床應用開闢新的前景。本論文就 三才濃縮丸製備工藝和品質標準進行了系統的研究。 根據三才濃縮丸的處方和藥材的性質設計製劑工藝，運用現代研究方法， 優化三才濃縮丸的製備工藝。採用星點設計對地黃的提取工藝進行優化，并將 得到的地黃提取液進行濃縮及噴霧乾燥。通過工藝的優化，地黃提取液噴霧乾 燥后收率達到 90%。地黃噴霧乾燥粉末與人參、天門冬的 100 目生藥粉混勻， 制軟材，制丸，乾燥，拋光，最後得到三才濃縮丸。經過製劑檢查得知，該濃縮丸符合 2010 版《中國藥典》制定的水分不超過 9.0%、2 小時之內溶散、重量 差異不超過 12.0%的要求。 品質標準研究中，建立了人參、地黃的薄層鑒別方法。同時利用高效液相 色譜法對三才丸進行含量測定，採用波長切換的方法對人參中的人參皂苷 Rb1 和人參皂苷 Rg1，地黃中的梓醇和毛蕊花糖苷進行同時測定，為三才丸以後的 開發、應用及品質評價提供方法。結果，本品的製備工藝合理穩定，所建立的 薄層色譜鑒定方法簡便，穩定且重現性好；高效液相色譜法同時測定三才丸中 的 4 個指標性成份，其分離度均高於 1.5，且通過方法學考察的各項要求，具 有簡便、準確、分離效果好、重複性好等優點。 關鍵字：三才濃縮丸；製劑工藝；品質標準；薄層色譜法；高效液相色譜 法