Study Of Preparation Process And Quality Standard Of Shaqing Granules

Shaqing Granule is the clinical experienced prescription, and composed of Adenophorae, Scutellaria, Ephedra and many other herbs. with the functions of Clearing the Heat in the Lung and Nourishing Yin, Moisturizing Dryness and Relieving Cough, It was used in the treatment of Phlegm-heat type cough.the main research work of the subject is the preparation technology, quality standard and preliminary stability of Shaqing GranuleAccording to the physical-chemical properties of the herbs, The reasonable technological line are established. The conditions of extraction, purification, concentration and molding are optimized by using the orthogonal experiment method and the single factor experiment method. The optimum conditions are that extract Ephedra, Peucedanum praeruptorum 3 times, with 6-fold volume of 60% of ethanol, 1 hours each time, then filtering and combining the extractive solutions; Extract the other herbs 2 times with 8-fold volume of water,the first extracted time is 1.5 hours,the second extracted time is 1 hour, then filtering, combining the extractive solutions and concentrating to certain density, add ethanol and make the ethanol concentration reached to 60%, blend, static placing and precipitate, take out and cool to room temperature, filter impurities, combine the filtrate and the Ethanol-extraction liquid, decompress and reclaim the ethanol, dry it in vacuum and break it up. Blend the medicinal powder with dextrin and MCC according to the proportion, Evenly spray into 85% ethanol and granulating, dry it at 60℃, and 1000g granule is made finally.In the study of the quality standard, the characters of the products are drafted according to 3 batches of pilot experiment. TLC is used to identify all the herbs in the prescription. Meanwhile, TLC of Scutellaria, Ephedra, Peucedanum praeruptorum, Loquat leaf, South adenophora are taken as the quality standard of the subject. The research about the moisture content, weight deviation, granularity, the dissolubility are made. The content of the Baicalin is taken as the inherent index of the product by HPLC, and we make a systematic study on methodology on the Analysis Method. The Baicalin limitation is made according to the mensuration result of some samples, the temporary content of Baicalin is no less than 20mg/g.The preliminary stability research is made in ordinary temperature as long as 3 months. The result shows that Character, identification, inspection, the content determination are consistent with the quality standard.Result:This preparation process is reasonable and practical; the quality of the sample is stable and controllable.