Pharmaceutical Research Of Qizhu Nasal Spray

Qizhu nasal spray is an experience prescription which come from the Teaching Hospital of Chengdu University of TCM.In the clinical,It is used for treating allergic rhinitis. The preparation process,quality standard and stability tests of the product have been studied in this paper.A、preparation technology researcha. Extraction processAccording to major functions and the chemical properties of main medicinal components of prescription,the extraction process was that Baizhu,Guizhi,Fangfeng and Danpi was extracted with water to collect aromatic water.And Huangqi and the dregs of Baizhu,etc. were extracted with water.TCL identification was adopted to optimize extraction technology of aqua aromatica.With orthogonal test was adopted,the content of calycosin separately glycosidase and total flavons was used as the indexes to optimize water extraction technology.The optimum extraction technology was as follows:Baizhu,etc. were distilled to extract aromatic water with 10 times water, collecting 50% of the total agents.And the dregs of Baizhu,etc. mixd with Huqi extracted three times with forteen times the amount of water, half an hour each time.b.Concentration processBy comparing the impact of index components of atmospheric and reduced pressure concentration,the atmospheric concentration was selected as the concentrated method.c. Purification processAccording to the results of different purification method,the macroporous resin was used to purify the liquid.And the related conditions were studied.The optimum purification technology was as follows:Water extraction liquid was concentrated and centrifuge (concentrated liquid relative density is 1.05 and the rate of the centrifuge was at 3000r/min). Then,centrifugate was diluted with water to 0.25g/ml and flow though the AB-8 macroporous resin column at of whith diameter-height ratio is 1:6,washed by 1BV water eeluted with 4BV 50% ethanol.d.The molding processThe paper optimized the variety and dosage of auxiliary materials used in the molding process.The molding process was determined as follows:polysorbate 80 was used as solubilizer and sorbic acid was chosen as Preservative.The arrange of PH was 6.0-7.0B、Quality standard and Accelerated stability studyTLC was used to identify Huangqi,Guizhii and Fangfeng and the content of calycosin separately glycosidase were determined by HPLC. We had established the determination methods and content limitation.According to the accelerated stability study results, under clinical drug packaging conditions, indicators were in line with the requirements in the accelerated test within 6 mont,It shows that stability of the agent were very good.So temporarily set the valid date as 12 months.