补肾健骨片水煎药材的提取、纯化及制剂工艺研究

Study on the Extraction,Purification and Preparation of Kidney-good Tablets Water Decoction

研究了补肾健骨片水煎煮药材的提取、纯化及制剂工艺。采用正交设计法以淫羊藿苷含量、醇浸出物量为指标对提取工艺条件进行优化,采用离心法和醇沉法对除杂工艺进行比较,在制剂成型工艺中,对辅料进行筛选并确定用量。最佳提取工艺为药材加10倍量的水,浸泡1.0 h,回流提取2次,每次1.0 h,采用离心法除去杂质,每个处方的辅料用量为:1倍量的碳酸钙,质量分数为10%的糊精、0.5%的微晶纤维素和0.3%的硬脂酸镁。该工艺可以用于制备补肾健骨片。

The extraction, purification and preparation of kidney-good tablets water decoction were studied. Using the content of icariin and alcohol extract as the screening index, we obtained the optimal extracting conditions by orthogonal experimental design. The optimum conditions were as follows： soaking the medicine in a state of hot reflux with ten times of water for 1.0 h, and extracting it for 1.0 h and two times in all. By using centrifugation to impurity elimination, we determined the dosage of supplemental material in the formulation of the tablets as follows： 1 time calcium carbonate, dextrin 10% （mass fraction）, microcrystalline celluloses 0. 5%（mass fraction）, and magnesium stearate 0.3% （mass fraction）. The proposed technology can be used for the preparation of kidney-ood tablets.