Study On Preparation And Quality Standard Of Jianjingshu Praing-film

Jianjingshu spraying-film agent is a new type of transdermal preparation made from more than ten traditional Chinese medicines including Ligusticum chuanxiong,Chinese angelica,safflower,and folium artemisiae argyi.It has the effects of activating blood and removing stasis,warming and activating meridian,ispelling cold and removing dampness,relieve swelling and pain.It is used for cervical spondylosis(neural root type)stasis blood stasis,cold dampness collateral card.Its prescription is derived from the Tongluoqutong Adhesive Plaster that was published in the 2015 edition of the Chinese Pharmacopoeia.the Tongluoqutong Adhesive Plaster is effective and widely used in clinical practice.However,the adhesive plaster has poor air permeability,is easy to adhere to the skin,has a large irritating effect,easily leads to skin allergies,and the production process is complicated and backward,and the quality is difficult to control.Based on the original prescription,this study developed the original adhesive plaster design into a spraying-film.Combining with the actual production requirements,this study has optimized the extraction process and preparation process of the Jianjingshu spraying-film.The preparation has the characteristics of long working time,good air permeability,excellent skin adaptability,and stable and controllable quality.This subject adopts the single factor-orthogonal design test to evaluate the volatile oil extraction rate,the factors with the volume of water,soaking time,extraction time,optimized the preparation of compound extraction technology of volatile oil;The single factor test was used to examine the rate of ethanol percolation in the compound.The content of hydroxysafflor yellow A in the prescription was used as an index to optimize the optimal percolation extraction process.The single factor-star design-response surface method test was used to examine the spray effect,film formation time,and film formation efficiency.Polyvinyl alcohol 1788(PVA 1788)and polyvinyl pyrrolidone K30(PVP K30)were used.1,2-Propanediol addition as inspection factor to study the best prescription forming process.In order to control the quality standard of preparation,Ligusticum chuanxiong,Chinese angelica,Pepper,piper longum,and Rhubarb in the preparations was performed by thin layer chromatography(TLC).Gas Chromatography-Mass Spectrometry(GC-MS)was used to analyze the composition of volatile oils in the preparations;The contents of ferulic acid,hydroxysafflor yellow A,and piperine in the preparation were determined by reversed-phase high performance liquid chromatography(RP-HPLC).In order to stabilize the quality of the preparation,this topic examines the preliminary stability of the Jianjingshu spraying-film,preparation of high temperature test,strong light test and accelerated test.The results showed that the qualitative and content determinations of the Jianjingshu spraying-film and all inspection indexes were in compliance with the regulations.This paper drew up the quality standard draft of Jianjingshu spraying-film,laid the foundation of product development for the Jianjingshu spraying-film.