参红咀嚼片成型工艺及质量标准的研究

The Study of Shenhong chewable tablet molding technology and quality standards

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 the health food and Shenhong Chewable Tablet and ensure the clinical curative effect of the preparation, we take ginseng,radix ophiopogonis, rhodiola as the main raw material to prepare Shenhong Chewable Tablet. We initially develop the quality standards for the preparation. Methods We inspect eorrigent, filler, wetting agent and lubricants espectively with the method of single factor analysis. Then we select the best preparation technology. We measure the characters of Shenhong Chewable Tablet, thin layer identifieation（TLC） for ginseng, check under preparation and the content of ginseng total saponin. We formulate the quality standard. Results Determine the molding process Take herbs extracts,according to extract powder - anhydrous lactose - citric acid - aspartarne （333：167：10：1） and mixed with 95% ethanol, granulating,drying under 55~C, whole grain, adding magnesium stearate is fight amount, tabletting; And Ginseng to identify medicinal spots were clear and the negative without interference in Shenhong chewable tablet;And ginseng total saponins shall not be less than 64mg. Conclusion This method is accurate, simple and rapid operation. It is suitable for the quality control of Shenhong Chewable Tablet.