Radix Astragali (Huangqi) injection (RAI), a well-known traditional Chinese medicine formula, is extracted from Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., which is a highly valued and important Chinese medicinal herb. It is commonly and widely employed to tonify Qi for strengthening the body, invigorate the spleen for damp elimination, treat viral myocarditis and protect the liver function. Due to the increasing of adverse reaction reporting, the safety is much more important. However, the markers for quality control of Radix Astragali injection were only calycosin-7-O-β-D-glucoside and astragaloside IV, which cannot effectively control the quality of RAI. It is necessary to know the other components in RAI to ensure its safety. The dissertation consists of three chapters. Chapter 1 reviewed the chemical components in Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., as well as the quality control and pharmacological activities of RAI. In Chapter 2, the total solids content of RAI was firstly detected using freezing dryer system and the solids amount varied significantly among the products from different companies, which suggested that the determination of total solids would be helpful to control the quality of RAI. Meanwhile, UPLC coupled with photo-diode array (PDA) and evaporative light scattering detection (ELSD) were developed for simultaneous determination of four flavonoids (calycosin-7-O-β-D-glucoside, ononin, calycosin, formononetin) and five saponins (astragaloside I, astragaloside II, astragaloside III, astragaloside IV, isoastragaloside I) in RAI from different pharmaceutical companies. The established method was fully validated with respect to linearity, precision, repeatability, and accuracy. In Chapter 3, to explore the other main components in RAI, the types and contents of carbohydrates were investigated and quantitatively determined. The result showed RAI mainly contained fructose, glucose and sucrose and their total amount occupied up to 60.8 - 68.4%. In a word, carbohydrates are major constituents in RAI. Moreover, the HPLC-ELSD method is simple，accurate and reliable, which is helpful to evaluate the quality of RAI and also provides method for quantitative determination of carbohydrates in traditional Chinese medicine injections.

黃芪注射液為豆科植物蒙古黃芪 Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao 或膜莢黃芪 Astragalus membranaceus (Fisch.) Bge.的乾 燥根經提取製成的滅菌水溶液。具有益氣養元，扶正祛邪，養心通脈，健脾利濕 之功效，用於心氣虛損，血脈瘀阻之病毒性心肌炎、心功能不全及脾虛濕困之肝 炎。中藥注射液因具有定向給藥等優勢而廣泛應用於臨床上，但因中藥本身成分 的複雜性，其不良反應也較多，因此其安全性尤為重要。現行黃芪注射液的質量 控制手段只是測定毛蕊異黃酮葡萄糖苷和黃芪甲苷兩個指標性成分的含量，無法 全面反映黃芪注射液的內在質量。因此，瞭解黃芪注射液總固形物主要化學成分， 對完善黃芪注射液的基礎物質研究以及黃芪注射液的質量再評價均具有重要意 義。 全文共分為三章，第一章分別對黃芪注射液原料藥材即蒙古黃芪和膜莢黃芪 的化學成分研究進展，黃芪注射液的質量研究現狀以及其藥理作用和不良反應進 行綜述。第二章對黃芪注射液總固形物及黃酮皂苷類成分進行分析。首先採用真 空冷凍乾燥的方法對黃芪注射液總固形物的含量進行測定，發現不同廠家黃芪注 射液總固形物含量差異較大，提示增加總固形物的測定有助於黃芪注射液的質量 控制。其次針對黃芪注射液總固形物化學成分的兩個已知重要組成部分黃酮及皂 苷 類 成 分 ，建立了超高效液相色譜 - 紫 外 - 蒸發光檢測器聯用技術 (UPLC-PDA-ELSD)測定 4 種黃酮(毛蕊異黃酮葡萄糖苷、芒柄花苷、芒柄花素和 毛蕊異黃酮)和 5 種皂苷成分(黃芪甲苷、黃芪皂苷 III、黃芪皂苷 II、黃芪皂苷 I 及異黃芪皂苷 I)的含量，該方法線性良好，快速準確。第三章探索黃芪注射液總固形物中其他大類成分，採用 HPLC-ELSD 的方法首次對黃芪注射液中所含糖類 化合物（低聚糖和單糖）的種類及其各自含量進行測定，結果糖類成分主要為果 糖、葡萄糖和蔗糖，且其總量占總固形物比例高達 60.8% ~ 68.4%，因此黃芪注 射液總固形物中糖類化合物是其主要成分之一。此外，该方法操作简便，结果准 确可靠，可為黃芪注射液質量再評價提供參考，也可為中藥注射液糖類成分的測 定提供方法和手段。