本文關(guān)鍵詞：玄芪化瘀丸（濃縮丸）制備工藝及質(zhì)量標(biāo)準(zhǔn)的研究　出處：《新疆醫(yī)科大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 玄芪化瘀濃縮丸 星點(diǎn)設(shè)計(jì)-效應(yīng)面法 制備工藝 質(zhì)量標(biāo)準(zhǔn)

【摘要】：目的:研究玄芪化瘀濃縮丸的制備工藝,并建立其質(zhì)量標(biāo)準(zhǔn)。方法:(1)采用單因素試驗(yàn)結(jié)合星點(diǎn)設(shè)計(jì)-效應(yīng)面的方法,以黃芪甲苷含量、哈巴俄苷含量、總多糖含量及浸膏得率為評(píng)價(jià)指標(biāo),對(duì)提取次數(shù)、提取時(shí)間及加水倍數(shù)進(jìn)行考察,優(yōu)選黃芪等藥材水提的工藝參數(shù);(2)研究玄芪化瘀濃縮丸的最佳成型工藝;(3)采用薄層色譜法對(duì)玄芪化瘀濃縮丸中全方藥材進(jìn)行鑒別。(4)采用高效液相色譜法測(cè)定玄芪化瘀濃縮丸中黃芪甲苷、哈巴俄苷和丹酚酸B的含量并進(jìn)行方法學(xué)的考察,制定質(zhì)量標(biāo)準(zhǔn)。結(jié)果:(1)玄芪化瘀濃縮丸的最佳提取工藝為13倍量水連續(xù)回流提取2次,每次130 min。(2)玄芪化瘀濃縮丸的最佳成型工藝為取丹參、三七粉碎成細(xì)粉,備用。水提液濃縮至相對(duì)密度為1.35~1.40(60℃)的稠膏,取1/3的稠膏備用,其余稠膏60℃減壓干燥,粉碎成細(xì)粉,與藥材細(xì)粉混勻,加入稠膏中,混合均勻,制成丸粒,干燥,即得。(3)建立玄芪化瘀濃縮丸中黃芪、三七、玄參、丹參的薄層色譜鑒別方法。(4)采用高效液相色譜法測(cè)定玄芪化瘀濃縮丸中黃芪甲苷、哈巴俄苷、丹酚酸B的含量。黃芪甲苷色譜條件為:流動(dòng)相為乙腈-水(33:67),檢測(cè)器為蒸發(fā)光散射檢測(cè)器,氮?dú)鈮毫?0 psl,漂移管溫度為60℃,流速為1.0 mL/min;哈巴俄苷和丹酚酸B色譜條件為:流動(dòng)相為甲醇-1%甲酸(45:55),紫外檢測(cè)器的檢測(cè)波長分別為278 nm和286 nm,柱溫為30℃,流速為1.0 mL/min。結(jié)論:玄芪化瘀濃縮丸制備工藝合理、可行;制訂的質(zhì)量標(biāo)準(zhǔn)簡(jiǎn)便、可靠、穩(wěn)定,能有效控制制劑的質(zhì)量。
[Abstract]:Objective: To study the preparation technology of Qi Xuan Huayu pill, and establish its quality standard. Methods: (1) by using single factor test method combined with the central composite design, with the content of astragaloside, harpagoside content, total polysaccharide content and extract yield as the evaluation index, the extraction times. The extraction time and the amount of water were investigated. The optimum parameters of water extraction of Radix Astragali etc.; (2) the best molding process of Xuan Qi Huayu pill; (3) were identified by TLC on the Xuan Qi stasis pill in medicine. (4) determined by Xuan Qi Huayu pill in Huangqi a method by high performance liquid chromatography, and the content of harpagoside and salvianolic acid B on methodology, set up quality standard. Results: (1) the best extraction process of Xuan Qi stasis pill for 13 times the amount of water for extracting 2 times, every time 130 min. (2) Xuan Qi stasis the best concentrated pill 鎴愬瀷宸ヨ壓涓哄彇涓瑰弬,涓変竷綺夌鎴愮粏綺，

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