Study On Preparation Technology And Quality Standard Of Dieda Huoluo Cataplasm

The prototype of Dieda Huoluo Cataplasm is Dieda Huoluo oil,which is a famous traditional Chinese medicine,lt is consist of Radix Angelicae Dahuricae,Rhizoma Chuanxiong,Fructus Cnidii,peppermint oil,camphor oil and so on more than 80 kind of herbal medicine.It has the function of hemostasia,acesodyne,diminish inflammation and detumescence,lt is a ordinary family standing-by medicine and commonly used in the treatment of the injuries from falls,scalds and strain in the clinic.Because this product is a traditional liniment,its preparation technology and quality standard and so on still has many insufficiencies until now.This topic through the experimental study,utilized the new technology and preparation to carried on the improvement to the original product.Utilizes supercritical CO₂ fluid extraction(SFE-CO₂)to carries on the extraction of herbal medicine part in the prescription,substitutes for the old extract technology.Through the research on the SFE extraction pressure,the extraction temperature,and the extraction time,inspect the extracts receives rate under dissimilar condition,and after the preliminary pharmacological experimentation,obtains the best extraction technology as the follows:the extraction pressure is 30Mpa,the separation pressure is 5MPa,the extraction temperature is 50℃,the separation temperature is 40℃,the extraction time is 2 hours,the flux is 26-32kg/h.Takes the evaluation by the result of tackiness and peeling test,through the matrix screening pre-experiment,The preliminary determination base polymer is composed by the varying degree of neutralized polyacrylate(VISCOMATE NP-700),polyvinylpyrrolidone(PVP K-90)and the glycerine,then carries on optimized screening through the orthogonal experiment,obtains the final matrix medicine allocated proportion as the follows:VISCOMATE NP-700:PVP K-90:Glycerin:PVPP XL-10:Tartaric acid:Aluminum hydroxide=5:2:30:2:0.2:0.2.After the duplicated experiment, finally indicates this matrix medicine allocated proportion effectively feasible.Because the original liniment has not stipulated the amount used, therefore refers to the original liniment once has done in pharmacodynamics experiment project design as well as the market similar product specification, the hypothesis specification of Dieda Huoluo cataplasm for 6×10cm,the weight of cataplasm is 10g,carries the dose is 1%,selects the adhesive-bonded cloth as the backing liner material,selects the transparent polypropylene membrane (CPP)as the covering liner material.The result of production of Dieda Huoluo cataplasm indicated the preparation process stable feasible.Because the original quality standard was only controlled by gas chromatography analysis of borneol,camphor oil and peppermint oil,then the content of volatile oil was determined by the volatile oil measuring method. New methods were offered in controlling the cataplasm's quality by TLC analysis of Rhizoma Chuanxiong,Radix Angelicae Dahuricae and GC analysis of the wintergreen oil.The content of osthole was determined by HPLC method.The experimental result indicated,in each piece of cataplasm,the content of osthole is about 0.1071mg,the content of volatile oil is about 0.426ml, therefore stipulation the content of osthole can not less than 0.070mg in each piece of cataplasm and the content of volatile oil can not less than 0.30ml in each piece of cataplasm.Small amount of production of Dieda Huoluo cataplasm showed that the preparation process was reasonable and practical,the quality was controllable,and the quality of the end product was stable.The study afforded a best basis of the quality standardization research of Dieda Huoluo cataplasm.