The Study On Preparation And Quality Standards Of Fufangjiubingying Effervescent Granules

The Study on Prepearation and Quality Stardards of Fufangjiubingying Effervescent granulesSpeciality:PharmaceuticsAuthor:Su YangyangTutor:Professor Cheng YiObjective:Fufangjiubiying which is based on local private prescription is the highly effective compound preparation for treatment of gastroenteritis, stomach cramps,diarrhea and so on.Its existing formulations is the capsules. However,the capsules is larger and need to take many times a day,so it is difficult to take for children,the elderly and the patients who has difficulty to swallowing capsules.Therefore,the study designed the effervescent granules of Fufangjiubiying,and established its quality standards.The Fufangjiubiying effervescent granules showed rapid effect,and easy to storage and carry,especially suitable for children,the elderly and patients with difficult to take capusules;and the product is sugar-free-type granules and also suitable for patients with diabetes,so the market prospect is broad.Methods:In this study,Chinese medicine theory was the guiding principle, and according to the functions of the prescription and the properties of active ingredients in the herbs,combined with the requirements of new drugs of traditional Chinese medicine,by modern pharmaceutial techniques.The research focused on the preparation of the Fufangjiubiying effervescent granules and the quality standards.In the appreciation of crude herbs,besides with TLC which it is the original standard to identify,the HPLC is used to the determination of syringin---the main active ingredient in the Holly Bark,so it is better to evaluate the quality of herbs.In the side of the preparation process,its extraction process and molding process were studied by single-factor and orthogonal experimental,and the merits of its technique was evaluated by measuring the content of syringin.In the Standardization of quality standards,not only was o the original TLC standard applied,but also was the method for the determination of syringin by HPLC established,so it was supplied a more scientific,standardized quality control system of Fufangjiubiying effervescent granules.Results:In the appreciation of crude herbs,we found it was significantly different in extract of Holly Bark from different places:the Holly Bark of highest extract was from Guangxi,the second from Guangdong,the third from Jiangxi.But on the contrary,the content of syringin was not the same,showed difference with the origin;Inspection of the results of extraction with water as solvent,reflux extraction twice and each time about 60 minutes;In the forming process of Fufangjiubiying effervescent granules,the formula was:the PVP K-30 as adhesive,mannitol as a filler and flavor,sodium bicarbonate: citric acid ratio of 1:1.3 as disintegrating agent.Conclusion:The preparation and quality standards of Fufangjiubiying effervescent granules is reasonable and suitable for industrial mass production.