The Pharmaceutical Research Of Shuanghuanlian Nasal Thermosensitive Gels

Modern research of the effective ingredients,pharmacodynamics,mechanism proved that Shuanghuanglian with broad-spectrum anti-viral,anti-inflammatory,antipyretic,antibacterial,it also can improve immunity and so on.In recent years,it has been made into many forms,Shuanghuanglian injection,Shuanghuanglian oral liquid,granules,tablets and suppositories.The topic envisaged Shuanghuanglian nasal thermosensitive gels,that can be used for rhinitis,sinusitis or the treatment after nasal irrigation.Thermosensitive in situ gels as a new dosage form were widely researched in the field of pharmacy and biotechnology.In vitro it has good mobility and in vivo with strong affinity to the mucosal tissue,the retention time is prolonged and the controlled drug release performance is good..The research was carried out from five aspects,Identification of raw medicinal herbs,Extraction technology,Moulding technics,Quality standard and stability.1 Study on the identification of raw medicinal herbs in Shuanghuanglian nasal thermosensitive gelsReference to 2015 edition of the Chinese pharmacopoeia for the inspection,dentification and content determination of raw materials.The results conformed to the requirements.2 Study on the extraction process of Shuanghuanglian nasal thermosensitive gelsReflux extraction was used to extract Lonicera japonica and Forsythia suspense,We adopted single factor binding orthogonal test,took the content of chlorogenic acid and extraction ratio as the index to choose optimum extraction.The best extraction program of Lonicera japonica and Forsythia suspense is after 12 times water immersion 24h,heated at reflux and extracted two times,each time 1h,filtered and combined filtrate,the filtrate was concentrated to the relative density of 1.15-1.20,Cooled to 40 ℃,alcohol precipitation,containing alcohol amounted to 60%,stir and standing for 12h,filtered,and combined the filtrate,recycling ethanol to no alcohol taste,concentrated into a thick paste.we choose ethanol as the extraction solvent,took baicalin and cream rate as index,adopt the single factor and orthogonal process to select optimum extraction technology of Scutellaria baicalensis Georgi.Finally determined the optimum extraction of Scutrllaria baicalensis Georgi:12 times the amount of 75%ethanol reflux extraction 2 times,each time 1.5h,filtration,combined filtrate,the filtrate recovery of ethanol,concentrated into a thick paste.3 Study on the molding process of Shuanghuanlian nasal thermosensitive gelsBy the research before prescription,investigated the effects of different substrates and accessories for the gelling temperature.We used temperature as the index to opt concentration ratio of materials and matrix,then ascertained the optimum molding process,The concentration of Poloxamer 407,Poloxamer 188,glycerol was 18%(w/w),4%(w/w)and 5%(w/w).The in vitro release rate of thermosensitive gels prepared by the optimum process was showed that Shuanghuanlian nasal thermosensitive gels had a slow release,the main release behavior in vitro was dissolution.4 Study on the quality standards of Shuanghuanlian nasal thermosensitive gelsWe made the identification for Lonicera japonica,Forsythia suspense and Scutellaria baicalensisGeorgi.The test and reference substance in the corresponding position were the same color spots and negative control without interference.pH value,loading and other tests are in accordance with "Chinese Pharmacopoeia" 2015 edition of an Appendix Ⅸ in a nasal formulation.we investigated spreadability,gelation time of thermosensitive gels,the results are consistent with the requirements.Refer to the Pharmacopoeia 2015 edition,we determined preliminarily,the content of baicalin in Shuanghuanglian nasal thermosensitive gels is 111.56mg/branch,the content of chlorogenic acid is 12.46mg/branch,the content of phillyrin is 4.25mg/branch.And the actual use according to clinical as a standard.5 Study on the preliminary stability studies of Shuanghuanglian nasal thermosensitive gelsBy influencing factor and preliminary stability tests,we researched on Shuanghuanglian nasal thermosensitive gels character,identification,pH,quantity of contents,content,gelling temperature and other key projects.The results showed that Shuanghuanglian nasal thermosensitive gels should be set closed,dark container in a cool place for storage.The preparation of Shuanghuanglian nasal thermosensitive gels process is reasonable,Shuanghuanglian nasal thermosensitive gels are stable.