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目的:优选膝悦颗粒的提取及纯化工艺。方法:采用HPLC-ELSD测定黄芪甲苷含量,流动相乙腈-水(35∶65);采用HPLC测定龙胆苦苷含量,流动相甲醇-水(27∶73),流速0.8 mL·min-1,检测波长271 nm。以黄芪甲苷和龙胆苦苷含量的综合评分为指标,选择加水量、提取时间、提取次数为考察因素,采用正交试验优选膝悦颗粒的提取工艺;以黄芪甲苷、龙胆苦苷含量及出膏率为评价指标,通过单因素试验筛选膝悦颗粒的纯化工艺。结果:最佳提取工艺为加10倍量水煎煮3次,每次1 h;黄芪甲苷、龙胆苦苷质量分别为4.34,43.7 mg。采用醇沉法,使含醇量达50%;黄芪甲苷21.30 mg(保留率85.61%),龙胆苦苷216.32 mg(保留率97.74%),出膏率22.13%。结论:优选的提取及纯化工艺稳定可行,为膝悦颗粒的工业化生产提供参考。
OBJECTIVE: To optimize the extraction and purification of Keye granule. Methods: The content of astragaloside was determined by HPLC-ELSD. The mobile phase was acetonitrile-water (35:65). The content of gentiopicroside was determined by HPLC. The mobile phase consisted of methanol and water (27:73), the flow rate was 0.8 mL · min- , Detection wavelength 271 nm. Taking the comprehensive score of astragaloside Ⅳ and gentiopicroside as the index, choosing the amount of water, the extraction time and the number of extraction as the investigation factors, the orthogonal experiment was used to optimize the extraction process of the Koyue granules. With astragaloside, gentiopicroside Content and the rate of a paste for the evaluation of indicators, through a single factor screening Knee Yue particles purification process. Results: The best extraction process was adding 10 times the amount of boiling water three times, each time 1 h; Astragaloside, gentiopicroside quality were 4.34,43.7 mg. Alcohol precipitation method was used to make the alcohol content reach 50%; Astragaloside 21.30 mg (retention rate 85.61%); gentiopicroside 216.32 mg (retention rate 97.74%); Conclusion: The optimized extraction and purification process is stable and feasible, which provides a reference for the industrial production of KA Yue particles.