Study On The Preparation Technology And Quality Standard Of Shipixiao Hydrogel Plaste

Objective:The formula of Shipi Xiaoshui is a clinical experience prescription of China-Japan Friendship Hospital,which used to be a Extract dosage forms.This subject is guided by Traditional Chinese Medicine theory,in order to overcome the inconvenience of using extracts,with a application of modern technology,we carry on a Secondary development to make it become better and better.The extraction technolo gy of the prescription and its preparation are optimized.We not only examine the in vitro release behavior but also develop a preliminary quality standards.The research in this thesis will provide more effective,safe and easily acceptable for patients with advanced cancer.Methods:(1)Study on the extraction technology of Shipi Xiaoshui Cataplasm prescription:①The process of volatile oil extraction:We use the single factor test method to optimize the extraction process parameters of volatile oil by degree of crushing,the amount of water and extraction time as evaluation indicators.②The water extraction process of plant medicine:with transfer rate of Astra galoside and Geniposide acid as the evaluation indexes,the amount of water,extracting time,extraction times on the effects of water extraction process conditions.③The alcohol precipitation process of water extraction liquid:with the content of Astra galoside and Geniposide acid as index,the influencing factors including the concentration of alcohol precipitation on alcohol precipitation were considered in alcohol precipitation technique.(2)Study on the forming process of Shipi Xiaoshui Cataplasm:①Screen the species of moisturizer with the index of cumulative water loss rate.② With the appearance properties of the gel patch,a single factor test was conducted to examine the amount of each material in the matrix.③To optimize the composition of cataplasma by D-optimal mixture design,using maximum initial tack,maximum peel strength and minimum tack strength as evaluating indicators.(3)Study on the release properties in vitro of Shipi Xiaoshui Cataplasm:Modified Franz diffusion cell method were used to study the in vitro release performance by using the cumulative release rate of Geniposide acid for 24 hours.(4)Study on the preliminary quality standard of Shipi Xiaoshui Cataplasm:TLC identification research:The method of TLC was used to identify Rstragali Radix,Plantaginis Semen,Cinnamomi Ramulus,Curcumae Rhizoma,Carthami Flos,Polyporus,Akebiae Fructus,a HPLC method for the determination of Geniposide acid and a LC/MS method for the determination of Astra galoside,then conduct a methodological study.To perform the routine inspection,including the content of ointment,shaped nature and adhesion according to the Phamcopoeia of People’s Republic of China of 2015 edition.Results:(1)Study on the extraction technolo gy of Shipi Xiaoshui Cataplasm prescription:Cinnamomi Ramulus and Curcumae Rhizoma smashed and passed 10 mesh screen,added 6 times the amount of water to extract 8 hours in the way of refluxing;then the residue and the rest of prescription were mixed as prescribed proportion,added 10 times per volume of water added,boiled 3 times and 1.5h each time,filtered then spared;Ethanol was recovered and concentrated to a relative density of about 1.05(60℃),ethanol was added to adjust the alcohol concentration to 60%,and concentrated to 2.5 g crude drug·mL-1 of liquid extract.(2)The forming process of Shipi Xiaoshuui Cataplasm:①The matrix formulation of XC was as follows:NP700:5.00 g,aluminum glycinate:0.30 g,tartaric acid:0.30 g,glycerin:35.00 g,PVPK90:5.00 g,water:36.40 g,and Shipi Xiaoshui liquid extract:18 g.②The preparation of Shipi Xiaoshui Cataplasm:Disperse volatile oil,NP700 and dihydroxyaluminum aminoacetate evenly in glycerinum as phase A;Dissolve PVPK90 and tartaric acid by water fully as phase B.Then add phase B,orneol dissolved in ethanol and Shipi Xiaoshui liquid extract into phase A.At last,spread the system on cloth until it become uniformity.The cataplasm was done when the crosslink structure was formed.(3)Study on the release and transdermal absorption properties in vitro of Shipi Xiaoshui Cataplasm:In vitro release characteriistics of Geniposide acid in Shipi XiaoShui Cataplasm conformed to the first dynamicalequation,the equation is ln(1-Q)=-0.0647t-0.1825,and the Cumulative release rate of it was(79.40±1.4)%.(4)The preliminary quality standards of Shipi Xiaoshui Cataplasm:Rstragali Radix,Plantaginis Semen,Cinnamomi Ramulus,Curcumae Rhizoma,Carthami Flos,Polyporus and Akebiae Fructus could be detected by TLC.The content of Geniposide acid in each patch should not be lower than 3.255 mg by HPLC;the content of Astra galoside in each patch should not be lower than 188.437 μg by LC-MS method.Conclusion:The preparation of Shipi Xiaoshui Cataplasm is simple,the process is stable and feasible,while it has been shown to be with high efficient dru g release.The quality control method is accurate,high specificity,and can effectively control the quality of preparation,which can lay the the foundation for further development of the prescription.