Study On Prepration Process And Quality Control Method Of The Jiedu Qingyan Buccal Tablet

Objective:To study the extraction process, preparation process, quality control method and preliminary stability of Jiedu Qingyan Buccal Tablets with the theory and the method of modern pharmaceutics under the guide of the theory of traditional Chinese Medicine. They will lay foundations for developing Jiedu Qingyan Buccal Tablets that process is reasonable and quality is controllable.Methods:1. Orthogonal test was used to study the preparation process. Screened the optimum process by ethanol extraction of Lonicera Japonica and the optimum process by water of Sarcandra glabra etc.2. The Thin Layer Chromatograph (TLC) identification of Natural Indigo, Forsythia suspensa and Balloon Flower was established in the study of quality control method. High performance Layer Chromatograph (HPLC) was used to test the content of isofraxidin and rosmarinic acid in preparation. And developed the quality control method of Jiedu Qingyan Buccal Tablets on this basis. In the meantime, observe them for three months in the light of each test items of the method of quality control.Results:1.The optimum preparation process was confirmed as follows:weighed proper Lonicera Japonica, extracted twice with 15 times the amount of 50% ethanol and 0.5 hour for each time and mixed the filtrate. Mixed the Sarcandra glabra. Forsythia suspensa and Balloon Flower and extracted three times with 7 times the amount of water and 1 hour for each time and mixed the filtrate. Mixed the two kind of filtrate above, then condensed them to thick extract under vacuum condition (pressure:-0.09MPa; temperature:55℃, density: 1.36-1.42). then they were dryed in vacuum drying oven for 4 hours (pressure:-0.09MPa; temperature:40℃). Smashed the dry extract and mixed with Natural Indigo as the amount in prescription. Next, added aspartame. citric acid, sorbitol dextrin and proper 95% ethanol into them. And granulated by 14 meshes dryed them for 4 hour at 60 ℃, and then granulated by 12 meshes. Additionally, added 0.5% magnesium stearate with the amount in prescription. Lastly, compressed them into tablets.2. Establishing the TLC method of Natural Indigo, Forsythia suspensa and Balloon Flower, and the determination method to isofraxidin and rosemarinic acid, simultaneously. All examination were consistent with the requirements of tablet under the edition of 2015 "Chinese Pharmacopoeia". The quality control method is simple, specific, and reproducible.3. Through the preliminary stability test of three arrays of samples, all expeditions were qualified and the result showed strong stability.Conclusion:The preparation of Jiedu Qingyan Buccal Tablets was reasonable and practicable. The quality of tablets were controlled and had strong stability, established the foundation of the development to Jiedu Qingyan Buccal Tablets.