Studies On Preparing Of Sustained-release Patches Of Duliang And Establishing The Draft Of Quality Standard

Objective：To prepare and establish the draft of quality standard ofsustained-release patches of Duliang.Methods: Based on L9(34) orthogonal experimental design,theextraction process of Angelica dahurica(Fisch.ex Hoffm.)Benth.et Hook.f.and Ligusticum chuanxiong Hort. was optimized by the ultrasonicextraction technology in the sustained-release patches of Duliang,thetransfer rate of imperatorin and ferulic acid,dry extract yield were regardedas a comprehensive evaluation index to achieve the purpose,the content ofimperatorin of the release rate and transdermal osmolality in vitro wereregarded as evaluation indexes to optimize the matrix and permeationenhancer of patches with the use of Drug dissolution tester and Franzdiffusion cell,then prepare the sustained-release patches of Duliang.And toestablish HPLC content determination method to determine the content ofthe imperatorin and ferulic acid,to establish the draft of quality standard.Atlast,investigate the safety of the preparation simply. Results：The results indicated that the optimal extraction process wasobtained as follows:8times the amount of80%ethanol under ultrasoundfor2times,40min each of sustained-release patches of Duliang, the bestprescription of sustained-release patch of Duliang was: the qualitypercentage content of the starch, sodium carboxymethyl cellulose, glycerin,azone, propylene glycol, PEG400were6%,2%,30%,1%,15%,2.5%respectively. The release behavior of sustained-release patches of Duliangtallied with Higuchi equation and the effect of sustained-release wasapparent.Preliminary experiments of the stability test and safety test showthat,the stability and safety preparations are qualified and no skinirritation.Finally establish the draft of quality standard.Conclusion：The preparation process of the sustained-release patchesof Duliang is reasonable and practicable.The results of the release rate andtransdermal osmolality in vitro tests show that the sustained-release effect ofthe patches well.the stability and safety test, the draft of quality standard ofthe preparations conform to the requirement of the Chinese pharmacopoeia.