The Research On The Quality Standard Of Shebingchang Micro-emulsion Spray

The musk,the borneol,the acoprus tatarinowii sehott for clinical commonly used awakes the brain to straighten out the Chinese native medicine,three often must for use,to have the coordination synergize the function,to lacks the courage and uprightness brain damage curative effect to be accurate.Lacks the blood heavy sickness patient to the brain to say that,develops one stability well,the safe convenience preparation is extremely essential.The musk,the borneol,the acoprus tatarinowii sehott mainly contains the fat-soluble volatility ingredient such as the muskone,the camphor,the thin dioctyl ether, the elemene and so on.these ingredients can penetrate the blood brain barrier display to awake the brain to straighten out the function.The difficult soluble volatile oil ingredient solubility to be small in the liquid preparation,for enable it not to gather and have the better physical stability in the preparation,is guarantees this spray quality control guideline.According to the musk,the borneol,the acoprus tatarinowii sehott physics and chemistry nature and the function characteristic,this topic develops it contains the volatile oil micro emulsion the Shebingchang spray solution.To increases the micro emulsion in the Chinese native medicine compound preparation through,and to enhances the Chinese native medicine compound liquid preparation the stability,has provided a shortcut for the volatile oil to stable and divergence.The topic completes the solution preparation craft and quality specification of the Shebingchang spray,and will develop the new medicine to lay the foundation.Aim:To study the preparation technics of nose uses spray named the Shebingchang spray contains the volatile oil micro emulsion,and develop the formulation preparation preparation craft.To investigate the four pre-treatment methods about the determination of synthetic borneol in microemulsions before GC.To establish the quality examination standard of Shebingchang micro-emulsion spray.Methods:Volatile oil from the acoprus tatarinowii sehott as the oil phase,tween-80 was used as emulsifiers,absolute alcohol as assistant emulsifiers,the proportion between the emulsifier and append-emulsifier was established by triangular phase diagram,and to filtrate the best technics by a serials of experiments.Four methods—distillation, acidolysis by HCl,demulsification by freezing and extraction by chloroform were used to release the synthetic borneol which was enclosed,inserted,and absorbed in the oil phase of mi-croemulsions.Examine the content of borneol in the volatile component of Shebingchang micro- emulsion spray through GC,in the condition of supposing FID detector and dimethyl polysiloxane(SE-30)as solid phases,the column temperature as 140℃and Eugenol as internal standard.Use GC-MS Gas mass Spetrometry to establish dactylogram atlas,mass detector and quartz capillary chromatogram column (30m×0.25m)of Shebingchang micro-emulsion spray.Results:filtrate the best technics of tween-80 to the absolute ethyl alcohol load ratio respectively is 3:1,the prescription quantity volatile oil forms the micro emulsion,stably disperses in the preparation.Screens the best preparation Shebingchang spray solution craft:After grinds the earthen bowl grinds uniform musk and absolute ethyl alcohol, supersonic withdraws 30 minutes,is accepted after passing an examination the serum to filter with the pore filter diaphragm,after joins the borneol dissolution,then joins to tween-80,the volatile oil of the acoprus tatarinowii sehott,after fast mixes uniform mixes uniform,adds water,mixture is uniform the buff color to clarify,to be transparent,and has the fragrance of the musk,the borneol,the acoprus tatarinowii sehott,the fluid good liquid, namely Shebingchang spray.The recoveries of four methods(distillation,acidolysis, demulsification and extraction)were 91.06%～95.65%,80.59%～87.99%,52.36%～63.41%and 43.36%～53.93%;and the RSDs were:2.46%,3.70%,5.56%and 5.44% respectively according to above sequence.Take ten batch Shebingchang micro-emulsion spray for examinating,then use the data gain before to chose 8 chromatogram peaks as the dactylogram pink.Conclusions:The study of micro—emulsions of volatile oil in compound liquid preparation of traditional Chinese medicine by triangular phase diagram offered a short—cut for resolving its stability.The experiment also suggested that the micro-emulsions could increase solubility of insoluble volatile oil from TCM.Among the four methods,the result of pretreated by distillation was the most accurate,and the recovery was the highest.The pre-treatment through distillation was a convenient,simple, rapid and least sample-consumed method.What is more,it had little influence on the stability of synthetic borneol in microemulsions.GC is convenient,quick and exact to examine the content of borneol by using Gas chromatography,so it can be used as one of the quality control guideline for this medicine.And dactylogram atlas can be used as differentiation and quality control standard for the content of Shebingchang micro-emulsion spray.