Study On The Extraction Process And Quality Standard Of Hospital Hospital Preparation From Ganghuo Kanggan Granules

ObjectiveGanghuo Kanggan Granules in the clinical treatment of influenza experience"Ganghuo anti-Influenza prescriptions" on the basis of the group to make their own system of traditional Chinese medicine medical institutions preparations,is no supply varieties on the market at present.Previous studies have shown that Ganghuo Kanggan Decoction can significantly improve the main symptoms of influenza,shorten the time to fever,but in the peak epidemic of influenza,influenza cases are greatly increased,and the hospital human resources are limited.There will be a lot of inconveniences with the native medicine,will delay the patient's treatment time,so that the condition will be increased.Therefore,the research group will be the development of its decoction into Ganghuo Kanggan Granules hospital preparations,both are convenient and effective and timely to meet the clinical needs of patients with medication.And when the hospital preparation preparation to declare,we need to submit the preparation process research materials and preparation quality standards related to the study.Therefore,this paper focuses on the selection and optimization of the extraction process of Ganghuo Kanggan Granules,and establishes the quality standard of Ganghuo Kanggan Granules.Which including the water extraction process research,preparation of Thin layer identification(TLC),content determination,the Fingerprints of High Performance Liquid Chromatography(HPLC).Methods1.The water extraction process of Ganghuo Kanggan Granules raw material medicine:Three factors and three levels of orthogonal experiment were used to study the effects of adding water,extraction time and extraction times on the two indexes of total amount of phyllostachin and extract yield in the prescription,which to determine the optimal extraction parameters;And then look at the immersion time of raw materials on the impact of the above indicators,and ultimately determine the best extraction process parameters and process validation.2.In this paper,a thin layer identification method of Radix et Caulis Ilicis Asprellae,Notopterygium,Divaricate saposhnikovia root and Atractylodes was established by using thin layer identification method,and the chromatographic conditions were determined and the treatment method was given.3.In this paper,high performance liquid chromatography(HPLC)was used to establish the method for the determination of Prim-O-glucosylcimifugin and Forsythin in Ganghuo Kanggan Granules,and the preparation method(extraction method,extraction solvent,extraction time)and chromatographic conditions(mobile phase,column temperature,flow rate,detection wavelength)were optimized,and the system adaptability and methodological study were carried out.4.In this paper,the fingerprints of Ganghuo Kanggan Granules were studied by high performance liquid chromatography(HPLC)with reference to the requirements of Technical Requirements for Fingerprints of Traditional Chinese Medicine Injection(Temporary)",including the screening of the preparation method(extraction method,extraction solvent,Extraction time)and fingerprint chromatographic conditions(mobile phase,column temperature,flow rate,detection wavelength);The selection of the reference material and the establishment of the pattern of fingerprints were carried out;A similar evaluation was made on the fingerprint map of ten batches of Ganghuo Kanggan Granules.Results1.The optimum extraction conditions were as follows:extraction 2 times,the first increase of 8 times the amount of water,extraction 1.5h,the second plus 6 times the amount of water,extraction 1h,no need to immerse before extraction.2.Radix et Caulis Ilicis Asprellae,Notopterygium,Divaricate saposhnikovia root and Atractylodes for the thin-layer chromatography,and the corresponding reference substance and control herbs were the same color or fluorescent spots,and negative control without interference,with the strongly specificityand good reproducibility.3.The determination method of HPLC content of Ganghuo Kanggan Granules.The content of Prim-O-glucosylcimifugin and forsythin in the product in each bag Is tentatively fixed at no less than 1.62 mg and 3.06mg respectively.4.In this paper,the HPLC fingerprints of Ganghuo Kanggan Granules were established.The similarity evaluation results showed that the similarities of fingerprints of ten batches Ganghuo Kanggan Granules wereabove 0.90.The fitting of the common fingerprints may represent the common characteristics of the Ganghuo Kanggan Granules.conclusionIn this experiment,the optimized extraction conditions are simple,feasible and time-saving,it is suitable for large-scale production.The quality standard of Chinese medicine for Ganghuo Kanggan Granules of hospital preparation was established,which provided scientific and feasible basis for the quality control and the establishment of standards.