| Objective1.This project aims to study the development of a microneedle patch by the famous prescription(Wentonggao Prescription),and to evaluate the related characteristics of the prepared microneedle patch and transdermal release in vitro.2.Qualitative identification of the extracted and purified Wentong cream by thin-layer chromatography,and quantitative determination of the effective chemical constituents in the Wentong cream by high performance liquid chromatography(HPLC).The content of the ingredients is controlled to control its quality and provide relevant experimental evidence for subsequent in vitro release and transdermal tests.3.Screening different concentrations of excipients,preparing micro-needle needle layers of fast-dissolving polymer,and examining its various properties,and finally obtaining the optimal prescription for preparing micro-needle needle layer.4.Screened the auxiliary materials of the drug-loading layer withdifferent concentrations,in order to reducing the influence of Wentonggao Prescription on the micro-needle layer,and providing the best prescription and process for preparing the thermo-paste square micro-needle patch.5.Investigated the preparation in vitro release properties and transdermal properties of Wentonggao Prescription microneedle patch,and mastered its in vitro release behavior and transdermal ability.Methods1.The TLC identification study of the extract of Junchen and large dose in the Wentonggao Prescription after extraction and purification was carried out.Establish a high performance liquid phase analysis method for active ingredients in Junchen medicine.2.Using Polydimethylsiloxane(PDMS)as a negative mold,micro-needle patch was prepared by centrifugal casting method.The prepared microneedles were screened and optimized by microscopic observation and pressure change performance experiments.The skin puncture performance and in vitro dissolution properties of the finally obtained microneedles were investigated.3.Different concentrations of polyvinylpyrrolidone(PVP)and polyvinyl alcohol(PVA)were used as drug-loading layers in different proportions,and added into the prepareci needle layer to investigate the effect of drug-loaded layer on the needle layer.The ratio of the matrix.4.Using the modified Franz diffusion pool,the release behavior of the Wentonggao Prescription microneedle patch in different receptors was investigated.The in vitro release properties and transdermal properties of Wentong cream prescription micro-needle patch Zhongchuan saponins VI,psoralen and isopsoralen were studied.Results1.Extracting the purified Wentong cream retains most of the active ingredients.The HPLC method was used to quantitatively determine the main active constituents of Wentong Ointment,including saponins VI,psoralen and isopsoralen.The results showed good precision and good repeatability.The method was stable and reliable.2.When the ratio of excipients is 10%Dextran 40(Dex)and 10%Anylopectin(AP)1:2,the micro-needle layer has the best physical and compressive properties when it is dried at room temperature.It penetrates the skin of isolated rat and dissolves quickly in the skin.3.33%of PVP and 40%of PVA were mixed in a ratio of 1:1.The prepared drug-loading layer could have a certain thickness,and the ratio of matrix to drug solution was 3:1.4.The saponins ?,psoralen and isopsoralen have the highest fitness in the receiving solution of physiological saline containing 20%ethanol,and the fitting curves of the three components have the same trend in 24 hours.The average release rate of Wentong cream prescription micro-needle patch Zhongchuan saponins ?,psoralen and isopsoralen was 4.6727?g·h-1·cm-2,8.6342?g·h-1?cm-2,7.5171?g·h-1?cm-2,and the average transdermal rate was 1.534?g·h-1·cm-2,respectively.2.9465?g·h-1?cm-2,2.3973?g·h-1?cm-2,the three chemical components were respectively smaller than the average rate of in vitro release.The cumulative release rates of 24 were 51.26%,34.98%,and 30.62%,respectively.The cumulative transdermal rate at 24h was 11.44%,9.40%,and 6.17%,respectively.The transdermal cumulative release at 24 h was also less than the cumulative release in vitro.Conclusion1.After the extract of Wentonggao Prescription was extracted by ethyl acetate and n-butanol,the original active ingredient was retained,which can increase the concentration of the drug and lay a foundation for the preparation of microneedles.2.The obtained polymer microneedle patch has simple process and good performance,and can be quickly dissolved after puncture the skin,which provides a new idea for the development of the traditional Chinese medicine microneedle patch.3.The prepared Wentonggao Prescription micro-needle has better performance and contains more medicine,that can provide clinical value for the development of traditional Chinese medicine micro-needle patch.4.Wentonggao Prescription prescription micro-needle patoh can release the drug more slowly and uniformly within 24 hours,and achieve the requirements of sustained-release preparation,which provides experimental basis for the in vitro release behavior of Wentonggao Prescription micro-needle patch. |
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