乳消康胶囊的制备工艺及质量标准研究

Study on preparation technology and quality standards of Ruxiaokang Capsules

目的优化乳消康胶囊的制备工艺,提升乳消康胶囊的质量标准。方法采用正交实验法考察优化乳消康胶囊的水提取工艺;在显微镜下观察香附和枳壳的显微特征;采用TLC法对青皮、香附、丹参、当归、川芎、枳壳和甘草进行研究;采用HPLC法同时测定青皮和枳壳中主要成分柚皮苷和橙皮苷的含量。结果优化后的制备工艺简单可行,香附和枳壳显微特征明显,青皮、香附、丹参、当归、川芎、枳壳和甘草的TLC斑点清晰,阴性对照无干扰。柚皮苷和橙皮苷的质量浓度分别在4.89~97.8和16.8~168μg·mL-1范围内与峰面积呈良好的线性关系(r=0.999 8)。柚皮苷和橙皮苷的平均回收率分别为99.56%和99.50%,RSD值分别为1.58%和0.79%(n=9)。结论制备工艺科学合理,质量标准方法易于操作、专属性强、重复性好,所建立的质量标准可用于该制剂的质量控制。

To optimize the preparation technology of Ruxiaokang Capsules and promote the quality standards of Ruxiaokang Capsules.The preparation process was optimized by an orthogonal test.The microscopic characteristics of Cyperus rotundus and Fructus aurantii was observed by microscope;TLC was used to identify the green tangerine peel Cyperus rotundus,Salvia miltiorrhiza,Angelica sinensis,Ligusticum wallichii,Fructus aurantii and Liquorice;and HPLC was used to quantitatively measure naringin and hesperidin.The optimized preparation process is simple and feasible;the TLC spots were clear,and no interference was observed;the calibration curves of naringin and hesperidin were linear over the range of 4.89-97.8 and 16.8168μg.mL H r=O.999 8),the average recoveries were 99.56%and 99.5 0%,and RSD was 1.58%and 0.79%(n=9)respectively.The optimized preparation technology is reasonable,and the quality standard is easy to operate with high specificity and good repeatability.The established quality standards can be used for Ruxiaokang Capsules quality control.