The Study on Preparation and Quality Standards of Fufangjiubingying Effervescent Granules
|School||Guangzhou University of Traditional Chinese Medicine|
|Keywords||Will be saved Effervescent granules Preparation Process Quality standards|
Objective: The compound will be saved based on private prescription verification by the hospital clinical treatment of gastroenteritis, gastrointestinal cramps, diarrhea and other fruitful compound preparation. Existing dosage form of capsules, commonly used drugs for the treatment of abdominal pain, diarrhea. Capsules bulky or time required to service multiple tablets, to the old, young and dysphagia patients bring trouble. Therefore, the subject will be developed into an effervescent granules, and the establishment of its quality standards. This product is made effervescent granules, rapid onset, storage, easy to carry, especially suitable for children, the elderly, and patients who have difficulty taking pills, and the product is sugar-free granules, and also for diabetes patients taking broad market prospect. Methods: The study of Chinese medicine theory as the guiding principle, combined with the relevant requirements of the traditional Chinese medicine drug research, according to the nature of the active ingredients of the prescription Attending functions and Drug use of preparations modern technologies, research to determine the compound to rescue the preparation process and quality standards will be . In the evaluation of the quality of the raw herbs, in addition to the original TLC identification Fang Zhongjun drug to save one of the main active ingredient Bing - syringin content determination in order to more scientific evaluation of the quality of medicine. In the preparation process of the party, using a single factor and orthogonal experiment method of combining its extraction process and the molding process, and syringin indicators to measure the pros and cons of the process. In the study of standardization of quality standards, in addition to the original formulation quality standards, that TLC identification, but also to establish a high performance liquid chromatography to determine the content the syringin preparations for the compound to save Bing effervescent granules more scientific, standardized quality control system. Results: conducting quality evaluation of medicinal herbs, found different origin will be saved extract yield differences, to Guiping highest, Jiangxi of Pingyuan followed Guangdong Yingde lowest but syringin content contrary to Yingde, Guangdong has the highest difference of origin. Water extraction process study results solvent reflux extraction twice, 60 minutes each; Compound Holly should be the effervescent granules molding process as election PVP K-30 do adhesives, mannitol as a filler and Chief flavoring agents; compound Holly the optimum molding process of the effervescent granules: Select PVP K-30 to do the binder and mannitol as a filler of sweetener, sodium bicarbonate: citric acid ratio of 1:1.3 . Conclusion: Compound effervescent granules preparation process is reasonable, the quality of the finished product is stable, controllable quality standards, and is suitable for industrial production.