| Lishen Capsules is consists of Equisetum,Curcuma,,Anemarrhena, Rhizoma Belamcandae and many other Chinese herbs,with the functions of clearing away heat and toxic materials, tonifying the kidney. It was used in the treatment of Kidney disease with infection. In this paper, traditional Chinese medicine bitter carry taking inconvenience, based on the prescription of herbs physicochemical and pharmacological research, combined with traditional Chinese medicine theory and actual production, prepared into capsules, and study the quality standards forclinical preparation of high efficacy, portable easy to take new drugs, to facilitate the promotion of new Chinese medicine.According to the physicochemical properties of the prescription drug, prescription drug by orthogonal test extraction and purification, concentration process and molding process to filter, to finalize the process route:Equisetum diffusa, barbata6times the amount of60%ethanol was extracted3times, each time1h, filtered liquid reserve. Shegan, Curcuma cordata, adding8times the amount of water, boiling2times, each time for1h, filtered, the filtrate and ethanol extract were combined, ethanol recovery, concentration, drying, grinding, adding an appropriate amount of dextrin and lactose, dried, granulated,60℃dried, whole, into capsules made of1000.Determined by single factor method, molding rateã€the percentage of moisture and particulate mobility as an indicator result the best molding process; Smell the other side of the thin-layer chromatography qualitative identification; carried out using high performance liquid chromatography herbs active ingredientscontent determination, in accordance with the provisions of the2010edition of the "Chinese Pharmacopoeia" a capsule under the inspection of the finished product, the initial development of the Lishen capsules quality standards.The preliminary stability research is made at room temperature for3months. The results showed that three batches of samples of the indicators are in line with the quality standards of the Chinese Pharmacopoeia provides preliminary indication of the preparation process is viable, stable quality. |