Studies On Preparation Technology And Quality Control Of Bushenjiannao Granules

Bushenjiannao granules is a kind of preparation prepared by five herbs and mainly used for curing attention deficit hyperactivity disorder(ADHD).The five herbs are cistanche,polygala tenuifolia,acorus graminus,achyranthes and tortoiseshell.This dissertation optimized extraction and preparation technology of Bushjiannao granules on the basis of consulting a large number of related references.Thin layer chromatography and ultra performance convergence chromatography were used to control the quality and quantity of Bushenjiannao granules.A scientific and reasonable technology was worked out for extraction as well as preparation of the sample.Furthermore,reliable quality control methods were established to guarantee good quality of this preparation.This article contains the following sections:Review:An overview of ADHD,causes and treatment methods was described according to the abundant references.The overview of research status of each herb was summarized.The basis and significance of the study was also introduced in this part.Chapter one:Study on extraction technology of Bushenjiannao granules To optimize the extraction parameters with single-factor experiment and L9(33)orthogonal experiment.The yield of dry extract and the content of P-ecdysterone were selected as the index and the amount of water,extraction times as well as extraction time were tested.The optimized process was as follows:the herbs were extracted with 12 times amount of water for 3 times for 1 hour each time.The three batches of validation experiments showed that the preferred process was simple and reliable.Chapter two:Study on preparation technology of Bushenjiannao granules To determine the best preparation process.The influence of drying methods,temperature,amount of excipients,ethonal concentration and sieve mesh number on preparation were tested.The extracting solution was concentrated to extractum and two kinds of drying methods(conventional drying and vaccum drying)were experimented to determine the method of drying.The extractum was smashed and filterd through a 100 mesh sieve after it was dried.Prescription proportion of tortoise shell was homogeneously blended into the dry matter.The pass rate and angle of repose of the granules were selected as the index to determine parameters of preparation.The optimized preparation process of Bushenjiannao granules was as follows:The prescription amount of cistanche,polygala tenuifolia,acorus graminus and achyranthes were extracted by 12 times amount of water for 3 times for 1 hour each time.The filtrate was combined and concentrated to extractum.The extractum was dried under the temperature of 60?.Then it was smashed and filterd through a 100 mesh sieve.Prescription proportion of tortoise shell was homogeneously blended into the dry matter.An appropriate amount of microcrystalline cellulose was added and mixed.Then the granules were made by 60%ethanol with a 16 mesh sieve and dried under the temperature of 60 ?.Chapter three:Thin layer chromatography study of Bushenjiannao granules To establish an effective TLC method for quality control of Bushenjiannao granules.The reference crude herb of cistanche and polygala tenuifolia were used as control and TLC method was carried out to identify cistanche and polygala tenuifolia in Bushenjiannao granules.The result showed that the relevant spot was clear and the negative control had no interference.Chapter four:Qualitative and Quantitative Analysis of Bushen Jiannao Grains by UPC2 A method was developed for the quantitative and qualitative analysis of bushen jiannao grains using ultra performance convergence chromatography(UPC2).Samples were extracted with ethanol and then analyzed by ultra performance convergence chromatography.The analytical column was Waters ACQUITY UPC2TM BEH(100 mm x 3.00 mm,1.7 ?m)and the mobile phases were super-critical CO2 and 0.05%phosphoric acid methanol.The injection volume was 1 ?L and the column temperature was 40 ?.Under the optimal conditions,good separation and linear relationships were obtained.By retention time and UV spectrum,the 15 main peaks in the fingerprint of bushen jiannao grains were correctly attributed.The 12th peak was ?-ecdysterone with the content of 380 ?g/g and the 15th peak was echinacoside with the content of 9.562 mg/g.The method was simple,rapid,accurate and reliable compared with HPLC and UPLC.Chapter five:Conclusion and prospects...