中国处方药
中國處方藥
중국처방약
CHINA PRESCRIPTION DRUG
2014年
6期
23-25
,共3页
解毒浓缩丸%含量测定%黄芩苷%高效液相色谱法%提取工艺
解毒濃縮汍%含量測定%黃芩苷%高效液相色譜法%提取工藝
해독농축환%함량측정%황금감%고효액상색보법%제취공예
Detoxification concentrated pill%Content determination%Baicalin%HPLC%Extraction process
目的：制定解毒浓缩丸中黄芩苷的含量测定方法及制备工艺的研究。方法用高效液相色谱法测定。色谱柱：十八烷基硅烷键合硅胶柱，流动相：甲烷-水-0.2%磷酸溶液（43：57：0.2），流速（0.9 mL/min）,检测波长315 nm，柱温：27℃。采用正交实验设计，以黄芩苷含量为指标优化提取工艺。结果线性范围：0.2142～0.4998μg。稳定性：RSD＝0.94%，n＝5。精密度：RSD＝0.97%，n＝6。重复性：RSD＝0.74%，n＝5。回收率：98.26%，RSD＝0.47%，n＝5。样品含量测定数据：不得少于26.0 mg。最佳提取工艺为ABCD，即每次加水10倍量，煎煮2次，每次0.5 h，提取温度60℃。结论本法简便、准确、专属性强，可用于解毒浓缩丸的含量测定。经过优化后制备的解毒浓缩丸各项指标符合药典规定，工艺重复性好，适于规模化生产。
目的：製定解毒濃縮汍中黃芩苷的含量測定方法及製備工藝的研究。方法用高效液相色譜法測定。色譜柱：十八烷基硅烷鍵閤硅膠柱，流動相：甲烷-水-0.2%燐痠溶液（43：57：0.2），流速（0.9 mL/min）,檢測波長315 nm，柱溫：27℃。採用正交實驗設計，以黃芩苷含量為指標優化提取工藝。結果線性範圍：0.2142～0.4998μg。穩定性：RSD＝0.94%，n＝5。精密度：RSD＝0.97%，n＝6。重複性：RSD＝0.74%，n＝5。迴收率：98.26%，RSD＝0.47%，n＝5。樣品含量測定數據：不得少于26.0 mg。最佳提取工藝為ABCD，即每次加水10倍量，煎煮2次，每次0.5 h，提取溫度60℃。結論本法簡便、準確、專屬性彊，可用于解毒濃縮汍的含量測定。經過優化後製備的解毒濃縮汍各項指標符閤藥典規定，工藝重複性好，適于規模化生產。
목적：제정해독농축환중황금감적함량측정방법급제비공예적연구。방법용고효액상색보법측정。색보주：십팔완기규완건합규효주，류동상：갑완-수-0.2%린산용액（43：57：0.2），류속（0.9 mL/min）,검측파장315 nm，주온：27℃。채용정교실험설계，이황금감함량위지표우화제취공예。결과선성범위：0.2142～0.4998μg。은정성：RSD＝0.94%，n＝5。정밀도：RSD＝0.97%，n＝6。중복성：RSD＝0.74%，n＝5。회수솔：98.26%，RSD＝0.47%，n＝5。양품함량측정수거：불득소우26.0 mg。최가제취공예위ABCD，즉매차가수10배량，전자2차，매차0.5 h，제취온도60℃。결론본법간편、준학、전속성강，가용우해독농축환적함량측정。경과우화후제비적해독농축환각항지표부합약전규정，공예중복성호，괄우규모화생산。
Objective Study on preparation method and determination of baicalin content of detoxification concentrated pill. Methods The analysis was used with a C18 column and a mobile phase of methanol-water-phosphoric acid(43:57:0.2)by HPLC.The flow rate was 0.9 mL/min and column temperature was 27℃. The detection wavelength was set at 315 nm.Through the orthogonal experimental design, the extraction process was optimized by using the content of baicalin as index.Results The linear range:0.214 2 ~ 0.499 8μg. Stability:RSD = 0.94%, n= 5. Precision:RSD = 0.97%, n= 6. Repeatability:RSD = 0.74%, the recovery rate:98.26%, RSD = 0.47%, n= 5. The content of the sample:not less than 26.0 mg. The best extraction process is ABCD, which means 10 times amount of water, decocting for 2 times, each time 0.5h, extraction temperature 60 ℃ . Conclusion The method is simple, accurate, reproducible, and can be used for the determination of detoxification concentrated pill. After optimization of detoxification concentrated pill, every index conform to Pharmacopoeia.The method is repeatable, and is suitable for large-scale production.
