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目的为了有效控制保健食品参红咀嚼片的质量,研究参红咀嚼片成型工艺,初步制定该制剂的质量标准。方法采用单因素分析法分别对矫味剂、填充剂、润湿剂、润滑剂进行考察,优选最佳制剂成型工艺;通过对参红咀嚼片性状、人参薄层鉴别、制剂项下检查、人参总皂苷含量等测定,制定质量标准。结果确定参红咀嚼片的成型工艺:取药材提取物,按提取物粉末-无水乳糖-柠檬酸-阿斯巴甜(333:167:10:1)加入辅料,混匀,以95%乙醇制颗粒,55℃下干燥,整粒,加入硬脂酸镁适量,压片,即得;参红咀嚼片中人参药材薄层鉴别斑点清晰,阴性无干扰;并确定其含人参总皂苷不得少于64mg。结论参红咀嚼片成型工艺合理,质量稳定可控,适合工业大生产。
Objective In order to effectively control the quality of health food ginseng chewable tablets, research the ginseng chewable tablet forming process and preliminarily formulate the quality standard of the preparation. Methods The single factor analysis method was used to investigate flavoring agents, fillers, wetting agents and lubricants, respectively, and the optimal preparation process was optimized. Through the analysis of the properties of ginseng chewable tablets, identification of thin layer of ginseng, Determination of total saponin content, the development of quality standards. Results Confirm the forming process of ginseng chewable tablet: Take medicinal extract, add the excipient powder - anhydrous lactose - citric acid - aspartame (333: 167: 10: 1) Granules, dried at 55 ℃, the whole grain, add the amount of magnesium stearate, tablet, that was; ginseng red ginseng tablets clear identification of thin spots, negative non-interference; and determine its containing not less ginseng total saponins At 64mg. Conclusion Ginseng chewable tablet forming process is reasonable, stable and controllable quality, suitable for industrial production.