Preparation Technology And Quality Standard Xylaria Nigripes Dropping Pills

Objective Xylaria nigripes can regulate the nervous and enhance immune function for patients, and it has been widely confirmed in clinic. There are many reports about external application of Xylaria nigripes in the folk and the effect is satisfying. In this project, the Xylaria nigripes were transformed to dropping pills, the systematic study including preformulation study, formulation screening and preparation craft, quality standard, preliminary stability study.Methods Preformulation study, investigate the physicochemical properties of Xylaria nigripes, hin layer chromatography (TLC) was used to study the adenosine. UV spectrometery (UV) methods for determination of polysaccharide and a high performance liquid chromatography (HPLC) method for determination of adenosine. Preparation of the extraction, compared boil ing water, water back two extraction methods and choose water back extraction, three influencing factors (temperature, time, times) and three levels, and the concentration of polysaccharide was as the target of the experiment to screen the best extraction process. Purification study, Four types of macroporous resin were selected to compare their adsorbing and desorbing performances for adenosine from Xylaria nigripes, and good behaviors will be selected. Further studies macroporous resin aqueous extract adenosine dynamic adsorption and desorption process, get the best conditions. In the preparation of studies, inspected the type of the matrix and coolant. In the shaping process, orthogonal test was used for the choice of proportion of drug and matrix, the temperature of condensate, the dropping distance, the temperature of melting liquid, and determine the Xylaria nigripes dropping pills of the prescription process. The quality specification of Xylaria nigripes dropping pills, such as character, TLC identification, check and the determination of research for polysaccharide and adenosine. The preliminary stability study, the influence factors and speed up the trial were studied, and we know the basic understanding of the quality characteristics of dropping pills and changes in laws.Results The result of pre formulation study demonstrated that in medicine and the control by the appropriate location on the spot in the same color, with the reference substance by the corresponding position, In the same shallow dark dot, the negative control without interference. The results of methodology tests prove that these methods are all accurate, stable and reliable. The process of extraction and purification ofXylaria nigripes involved in this paper is as follow:extracted with10double times water circumfluence for2times and2hours each time. Precipitation with4double times ethanol for2times and24hours each times. This paper using macroreticular resin purify Pyrola extractum and optimize purification process. The type of macroreticular resin is AB-8, the concentration of crude extract solution was0.5g Xylaria nigripes·mL-1, the adsorption flow rate was3BV·h-1, the loading quantity of crude extract solution was2BV, eluted with1BV water to remove impurities, and then eluted with1.5BV50%ethanol. In the preparat ion of studies, using PEG2000/PEG4000=2:1as matrix, extractum/matrix=1:1.5. The melting temperature is80℃, the dropping distance is10cm, the condensate is silicon oil, the temperature of condensate tube inlet is30℃. The established qualitative and quantitative methods were investigated by the methodology, results show that they meet the requirements and can control the quality of preparation. The result of preliminary stability study showed that the dropping pills sample placed on three months of the test results compare with "0" month, there is no significant change.Conclusion This paper finished the entire contents of Xylaria nigripes dropping pills preparation craft study、 quality standard study, preliminary stability study, and supplied reliable quality control methods. It established firm theoretical basis for the development of preliminary pharmacodynamics study and industrialization study in the future.