Study On Modified Excipient â…¡ And Its Sustained-release Properties

Objective: To study the sustained release performance of Modified Excipients II and toseek excellent sustained release excipients for balanced releaseof compoundtraditionalChinese preparation.Method:â‘ Using of dilatometry, viscometer, pH meter, fourier transform infraredspectroscopy detect modified excipient II about degree of swelling, viscosity, pH,functional groups, etc.â‘¡With the degree of difficulty of granulating, roundnessand identities of the particle,particle compressibility and the solution time of tablet as index,research the change of the compatibility with other excipients,mading the tablet.â‘¢Theassay method ofreleasing in vitro of modified excipient IIsustained-releasingChuanpingtablets is established by the methods of UV spectrophotometry and HPLC.â‘£How do theway of dissolution, rotational speeds, release media,ionic strength exercise influences onthe degree of release in vitro of ephedrine, pseudoephedrine and scopolamine contained inmodified excipient IIsustained-releasingChuanping tabletswill betested, and these threeindexes are tried to be integrated into zero-order model, first-order model, Higuchi model,Ritger-Peppas model, Baker-Lonsdale model, Hixon-Crowell model.Results:â‘ Modified excipient II was translucent yellow irregular block or granular solid,soluble in water, slightly soluble in glycerol, nearly soluble in propylene glycol, insolublein methanol, ethanol.It contained Saccharide and only beta glycosidic bond inpolysaccharide,without tannic acid,the PH was9.33of5%aqueous solution,which was anon Newtonian fluid. The dry weight loss was9.075%, the swelling degree was5.2, waterholding capacity was10.73.â‘¡With appropriate ethanol aswetting agent,1%magnesiumstearate as lubricants, dextrin or MCC as filler,the tablet could be the best drugprescription.Sustained release matrix tablets were formulated using Modified excipient II,HPMC-K15or HPMC-K100,which had excellent sustained release excipients for balancedreleaseof compound traditionalChinese preparation.â‘¢It is practical and feasible to test the results of indexes of the modified excipient II sustained-releasing Chuanping tablets withthe help of UV and HPLC.â‘£The modified excipient II sustained-releasing Chuanpingtablets are insensitive to the way ofdissolution,rotational speeds,release media, the changesof ionic strength. And three indexes areintegrated best into Higuchi model, Ritger-Peppasmodel and Hixon-Crowell model, whose correlative coefficients R2are larger than0.99.Their diffusion indexes result in Ritger-Peppas model is between0.45and0.89,andtheir correlative coefficients R2in Higuchi model are higher than those in Hixon-Crowellmodel.Conclusion: Modified excipient II could control drug release,and be excellent sustainedrelease excipients for balanced releaseof compound traditionalChinese preparation. Themethod and results about finding excipients for balanced releaseof compoundtraditionalChinese preparation as a reference.