Preparation Technology And Quality Standard

Objective:The external formula of cold hypochondrium protrusion is a clinical experience prescription of China-Japan Friendship Hospital, which used to be a fumigation and washing dosage forms. Under the guidance of the theory of Traditional Chinese Medicine, the original formulation will be developed into Hanbishu Cataplasm, a transdermal therapeutic systems of Chinese medicine compound, according to the clinical requirements.Methods:(1)Study on the extraction technology of Hanbishu Cataplasm prescription:With orthogonal test, the extraction technology of Hanbishu cataplasma was optimized with the index of transfer rate of osthole and asperosaponin VI and solid extracts rate.(2)Study on the forming process of Hanbishu Cataplasm:①Screen the species of matrix excipients according to its properties and functions.②With single factor experiment, the range of excipients was optimized with the index of Comprehensive sensory score.③ To optimize the composition of cataplasma by D-optimal mixture design, using initial bonding strength, endurance bonding strength, and gel strength as evaluating indicators.(3)Study on the transdermal absorption of Hanbishu Cataplasm:Modified Franz diffusion cells were used to study the in vitro release and transdermal absorption of Hanbishu Cataplasm, with the indexs of accumulative release rate and accumulative penetration quantity per unit area of Osthole in 24h.(4)Study on the quality standards of Hanbishu Cataplasm:To establish the TLC identification methods of Pubescent Angelica, Dipsacales, Caulis Sinomenii, Angelica Sinensis, Radix saposhnikoviae and achyranthes root, a HPLC method for the determination of Osthole. To perform the routine inspection, including the content of ointment, shaped nature, adhesion and weight difference, according to the Phamcopoeia of People’s Republic of China of 2010 edition.Results:(1)The extraction technology of Hanbishu Cataplasm prescription:The optimum extraction conditions were extracting 2 times with 10-fold of 70% alcohol,2 h for each time.(2)The forming process of Hanbishu Cataplasm:① The matrix formulation of HC was as follows:NP700:6.97g, aluminum glycinate:0.30g, tartaric acid:0.25g, glycerin:35.00g, PVPK90:3.87g, water:43.61g, and Hanbishu liquid extract:1 0g.② The preparation of Hanbishu Cataplasm:Disperse NP700 and dihydroxyaluminum aminoacetate evenly in glycerinum as phase A; Dissolve PVPK90 and Tartaric acid by water as phase B. which was added into phase A. then add Hanbishu liquid extract into the mixture. then spread the system on cloth until it become uniformity. The cataplasm was done when the crosslink structure was formed.(3)The transdermal absorption of Hanbishu Cataplasm:In vitro release characteriistics of Osthole in Hanbishu Cataplasm conformed to the first dynamicalequation, the equation is ln(1-Q)=-0.0395t +4.5958, and the Cumulative release rate of it was (63.30±0.05)%. The results of in viro transdermal experiments show that Osthole in Hanbishu Cataplasm is best correlation with zero dynamical equation, the equation is Q= 0.1579t-0.2167, and the 24 h permeated amount was (3.61±0.32) μg/cm2.(4)The quality standards of Hanbishu Cataplasm:Pubescent Angelica, Dipsacales, Caulis Sinomenii, Angelica Sinensis, Radix saposhnikoviae and achyranthes root could be detected by TLC. The Provisions of Osthole in each Piece of Hanbishu Cataplasm should not be less than 0.918mg, according to the results of HPLC.Conclusions:The preparation of Hanbishu Cataplasm is simple, the process is stable and feasible. The quality control method is accurate, high specificity, and can effectively control the quality of preparation.