The Research On Preparation And Quality Control For Fufang Jinfeizhisou Granula

Fufang Jinfeizhisou Granula derived from a famous doctor namesd Jiang Erxun’s clinical experience. It is mainly used to treat chronic cough caused by wind-cold assault lung, defieiency of Qi in lung and spleen, Lung-Yin deficient, Kidney-Qi deficient, as well as the accompanied symptoms and signs of Gasping, throat distress, hoarse voiee, Dry cough or few sputum and so on.According to the the physiochemical property of the effective components, we designed a systemative technological process in preparation procedure. The results suggest the preparation procedure of the Granula is reasonable and practical. Morever, the results of quality control study show that quality of the Granula is controllable, and property is stable.The processes and results are as follows:1Technology explorationThe herbs in this prescription were divided into two groups according to the physiochemical property of the effective components. Aster tataricus L. f. and Stemona sessilifolia were fall in alcohol extraction, shionone was used to control all these researches in this process; Inula Britannica L., Paeonia lactiflora Pall., Schizonepeta tenuifolia Briq., Cryptotympana pustulata Fabricius, Platycodon grandif lorum, Cynanchum glaucescens and glycyrrhiza were fall in water extraction, paeoniflorin and total flavones was the quality through these study.2Preparation technologyUsing single factor and orthogonal design to optimize the alcohol extraction technology. The optimum conditions for the alcohol extraction were as follows:adding10times of80%alcohol, the extracting tempruture is90℃, and extracting for1h each time, totally extracting two times. The optimum conditions for the water extraction were as follows:adding12times of water, and extracting for1.0h each time, totally extracting three times. The influence of concentration on the retention rates of shionone, paeoniflorin and total flavones was studied. The optimum conditions for concentration were as follows:film vacuum evaporation was used for concentration of alcohol extraction and water extraction, the temperature was controlled in80℃, and the relative density of concentrate was about1.33and1.2. The metastasis rates of shionone, paeoniflorin and total flavones were more than80%in this process.The influence of concentration on the drying, vacuum drying, vacuum microwave drying rates of shionone, paeoniflorin and total flavones was studied. The optimum conditions for vacuum microwave drying were as follows: the limit temperature of alcohol extraction and water extraction were90℃, the point of drying end was decided by observing the extract not foam after ten minutes. The metastasis rates of shionone, paeoniflorin and total flavones were more than85%in this process.When it comes to molding process, the influence of dosage, wetting agent concentration were studied, as well as the critical relative humidity and the angle of repose were measured. The optimum conditions were the use of dextrin, dosage is1.5times compared by the dry extract powder,75%alcohol for wetting agent. The measurement of granula in the critical relative humidity of58.7%and the angle of repose of32.94°3. Quality controlThe methods of TLC identification for Inula Britannica L.、 Paeonia lactiflora Pall.、Aster、Stemona sessilifolia and glycyrrhiza in the preparation were established. The methodology of HPLC determining shionone and paeoniflorin content of the preparation was investigated systematically. These methods were easily oprated, and were good at specificity and repeatability. The qualities for Fufang Jinfeizhisou Granula were conformed as follow:the shionone content in granula should be more than0.20mg;the paeoniflorin content in suppository should be more than5. Omg.