以单因素试验为基础，采用正交实验设计优化制备朝鲜蓟(Cynara scolymus)提取物颗粒剂的最佳工艺条件。以原料与辅料配比、原料药比例、乙醇浓度及干燥温度为考察因素，以颗粒合格率、溶化时间作为评价指标，采用L9(34)正交试验分别对颗粒合格率、溶化时间进行直观分析及方差分析。结果表明，最佳成型工艺为乳糖:糊精=3:1，乙醇浓度60%，原料药比例7.0%，干燥温度50 ℃。按此方案进行验证实验，颗粒性状良好，颗粒合格率为91.45%，含水量4.90%，减失重量不超过2.0%，溶解时间85.67 s，均符合2020年中国药典有关规定。通过正交试验优选的颗粒剂制备工艺稳定、简便易行，为朝鲜蓟提取物的剂型开发及工业化生产颗粒剂提供理论依据。
To optimize the preparation conditions of artichoke extract granules by orthogonal design based on single factor experiment, the ratio of raw materials and excipients, the ratio of raw materials, the concentration of ethanol and the drying temperature were taken as the investigation factors, the particle pass rate and dissolution time were taken as the evaluation indexes, and the orthogonal test of L9(34) was used to analyze the particle pass rate and dissolution time directly and anova respectively. The best molding process: lactose:dextrin=3:1, ethanol concentration was 60%, raw material ratio was 7.0%, and drying temperature was 50 ℃. According to the verification experiment of this scheme, the particle properties were good, the qualified rate of the particles was 91.45%, the water content was 4.90%, the weight loss didn’t exceed 2.0%, and the dissolution time was 85.67 s, which all met the Chinese Pharmacopoeia(2020) specifications. The preparation process of granules optimized by orthogonal test was proved to be stable and simple, which provided a theoretical basis for the research and development of dosage form of artichoke extract and mass production of granules in industry.
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