CAJ | 학술논문

本研究选择柴胡提取物和氟尼辛葡甲胺为栓剂主药，采用半合成脂肪酸甘油酯和PEG混合物为基质制备复方柴胡提取物中空栓。以药物与基质的比例（A）、药液温度（B）及脱模时间（C）为考察因素，以外观质量和融变时限为考察指标，采用正交试验优选中空栓制备工艺并对栓剂进行质量控制。正交试验结果选取栓剂制备工艺为A2B2C2，即药粉与基质间比例为1：2，药液温度50℃，脱模时间25 min。验证试验结果表明，栓剂中柴胡总皂苷含量稳定，工艺可行，适合大生产。
본연구선택시호제취물화불니신포갑알위전제주약，채용반합성지방산감유지화PEG혼합물위기질제비복방시호제취물중공전。이약물여기질적비례（A）、약액온도（B）급탈모시간（C）위고찰인소，이외관질량화융변시한위고찰지표，채용정교시험우선중공전제비공예병대전제진행질량공제。정교시험결과선취전제제비공예위A2B2C2，즉약분여기질간비례위1：2，약액온도50℃，탈모시간25 min。험증시험결과표명，전제중시호총조감함량은정，공예가행，괄합대생산。
Compound Bupleurum extract hollow bolt was prepared from Radix Bupleuri Extract and Flunixin Meglumine which were used as main drug, and mixture of Semi-synthetic fatty acid alycer-ide and Polyethylene glycol were selected as ground substance. Hollow type suppository preparation was selected in the orthogonal experiment with the examined factors of the proportion of the drug and the ground substance(A), Liquid temperature(B), and Stripping time(C) and the indexes of out-ward appearance and melt time, and the quality was checked according to China Veterinary Pharmaco-poeia. The results show that the optimum preparation of suppository is A2B2C2, the optimum propor-tion of synthesis fatty acid is 1:2. the liquid temperature is 50℃, and the stripping time is 25 min. The total saikosaponins content is stable in suppository, the optimum preparation of supposi-tory is feasible, so the method is suitable to be used in large-scale production.