Study On The Technology And Quality Standard Of Buckwheat Dispersible Tablets

Tracheitis is one of the most common diseases in the north of China.The disease affects the function of pulmonary alveolus and the ventilation and ventilation function of the lung,which seriously affects the health and working ability of the people.It is serious when the lung function is damaged and life is endangered.The Golden buckwheat dispersible tablet is derived from the change of the state basic drug Golden buckwheat tablet,which is composed of the extract of Golden buckwheat.It is used for the treatment of chronic tracheitis,asthmatic chronic bronchitis,acute tracheitis and other diseases.The Golden buckwheat dispersible tablet is novel and easy to use,and is especially suitable for elderly patients,infants and patients with dysphagia.Compared with Golden buckwheat tablets,it has the advantages of fast dispersion,good absorption and high bioavailability.Objective:By optimizing the extraction technology of Golden buckwheat extract,screening the prescription and preparation process of the dispersible tablets,determining the optimum technological parameters and studying the scale of the pilot scale.By establishing the quality standard of the Golden buckwheat dispersible tablets and investigating the stability of the products,the feasibility of the preparation of the Golden buckwheat dispersible tablets and the stability of the products are clearly defined,a new dosage form of Fagopyrum has been prepared.Method:The optimum extraction process was determined through single factor investigation and orthogonal test.The formulation and process of dispersible tablets were established through prescription investigation and process parameter test.The quality standard of Golden buckwheat dispersible tablets was established by detailed quality methodology.The stability test of the pilot scale sample was carried out based on the guideline of stability test in the four part of Chinese Pharmacopoeia 2015,to verify the quality of the Golden buckwheat dispersible tablets.Result:With the optimum design of single factor test and orthogonal test,the optimum extraction process of Golden buckwheat extract was to extract 3 times with 8 times the amount of 50%ethanol and 2 hours each time,and the highest detection content of catechin was found.In the study of prescription technology,through the screening of disintegration agent,filling agent,adhesive and lubricant,the formulation ratio and production process of the buckwheat dispersible tablets were determined,and the key technological parameters were clarification,and the production efficiency was improved.Through the study of quality standards,the contents of characters,identification,inspection and content determination are studied in detail,and the quality standard for the quality test of the Golden buckwheat dispersible tablets is established,and the test method is accurate,feasible,stable and controllable.The stability test of the stability test,accelerated test and long-term test proved the stability of the product.The validity period of the provisional product is 24 months,and the long-term test is still continuing.Conclusion:The stability of the three batch of pilot products proved that the quality of the Golden buckwheat dispersible tablets is stable,the prescription is reasonable,the process flow is controllable,the quality inspection method is scientific,and the quality standard can reflect the internal quality of the product.By studying the preparation technology and quality standard of the Golden buckwheat dispersible tablets,the scientific basis was provided for the industrial production of the Golden buckwheat dispersible tablets,which laid a good experimental foundation for the clinical development of the new form of the Golden buckwheat,and provided a reference for the modernization of the traditional Chinese medicine preparation.