Studies On Preparation Technology For Pharyngeal Ann Buccal Tablets And Quality Standard

Objective:Preparation of a chinese medicinal compound with buccal tablets in treatment of chronic pharyngitis, and to control the quality of.Methods:(1)Consulting the documents and materials, by using single factor and multi- level and orthogonal test method, study on the extraction process of Radix Platycodonis, Momordica grosvenori and olives, find the best extraction process.(2)According to the characteristics of buccal tablets and extract preparation properties,screening of additives and appropriate dosage by the wet granulation, drying, tabletting,i.e..(3)TLC qualitative distinction were used to inspect each ingredients in the prescription. The content of total saponins of Platycodon grandiflorum was determined by UV and Momordica saponin V and gallic acid content were determined by HPLC.(4)Qualities control by HPLC fingerprint of pharyngeal Ann buccal tablets.The chromatographic conditions were: hypersil ODS2-C18 column, the flow rate of 0.5m L·min-1,detection wavelength of 210 nm,column temperatureof 30℃. The mobile phase:acetonitrile-0.05% phosphoric acid solution.Results:(1)Extraction technology of Platycodon grandiflorum was: with 6 times amount of 70% ethanol reflux extraction 2 times, each time 3h, filtering, extraction process of Momordica grosvenor and olive was: to extract with water decoction for 3 times. Each time l0 times water for 2 hour. Using 70 % ethyl alcohol for precipitation, clear supernatant liquid was obtained.(2)The product forming process recipe:extracts of each ingredients was condensed and arescented, and the eligible dosage of them optimized by the single factor and multi-level method: powder 20g/100 tables, mannitol 24g/100 tables, lactose 36g/100 tablets, with 10% starch slurry as the wetting agent for grain, by wet granulation and tabletting.(3)Study on quality standard: the qualitative analysis results show that the spot is clearly visible, no negative interference; content determination of main components of reliable data.(4)Study on HPLC fingerprint: the 10 batch of samples of each chromatographic peak was effectively separated, identified 18 common peaks, the peak 7 is gallic acid, peak 17 is Mogroside V, peak 18 is platycodin D.Conclusion: Through the study of pharyngeal Ann buccal tablets, the extraction process of all drugs in the prescription was reasonable, reliable data.The confectioning process improved the taste and the stability problem of pharyngeal Ann buccal tablets effectively. Pharyngeal Ann buccal tablets conformed to regulations of the tablet item in 2010 edition of Chinese Pharmacopoeia. Quality specification of pharyngeal Ann buccal tablets Was established. Assay method and experimental data was stable and reliable. Using HPLC fingerprinting technology to control pharyngeal Ann buccal tablets quality, achieve quality from the macro perspective of comprehensive control of buccal tablets and the HPLC fingerprinting provides a reference for the quality standards of Pharyngeal Ann buccal tablets.