Study On The TDD System Of Compound Danggui Anti-dysmenorrhea Cataplasm

Objective: To optimize the extraction and preparation technology for the compound Danggui anti-dysmenorrhea cataplasm, and to establish the quality standard.Methods: The TLC identification method of Angelica sinensis(Oliv.) Diel, Ligusticum chuanxiong Hort., Ramulus Cirmamoim, Paeonia lactiflora Pall and Rhizoma corydals were carried out; Oxytoein(OT) was used to induce uterine coniraction and to build the organ models in vitro.,and the optimal conditions are investigated. Twisting reaction test and isolated uterus smooth muscle in non-pregnant mices by biological signailing system were used to confirm the effective part of the compand Danggui anti--dysmenorrhea cataplasm (extraction A, B and C); Single-factor selecting method was uesd to selecting the parameters of supercritical CO2 fluid extraction(SFE) such as temperature and pressure, using extraction yield and the contents of ferulic acid(FA) and cinnamaldehyde from Angelica sinensis(Oliv.) Diel, Ligusticum chuanxiong Hort. by HPLC as index, was applied to determine the optimized prccess;the same method was employed for selecting the optimum of extraction technology of percolate by the indices of the contents of Paeoniflorin and dl-tetrahydropalmatine from Paeonia lactiflora Pall, Rhizoma corydals;Optimum matrix excipients were selected by investigating and comparing the outcomes of action; Their amounts were selected through orthogonal experimental design in which general grades (viscosity and mouldability) were major indices; Process technology (order of mixing, drying time) was established by the method of single-factor optimization using mould ability as major index; Quality evaluation (qualitative identification and quantitative assay included)was performed as stipulated in the Chinese Pharmacopoeia and some research reports, accordingly a related standards was drafted. Results: The chromatographic spots of samples showed the same colors with those of control agents. The color spectrum was clear without interference of impurity nearby. Supercritical extract of dysmenorrhea prescription obviously essened the pain induced by acetic acid and dysmenorrhea model ,and strikingly inhibited the contraction of isolated uteri both in normal and sensijzed by oxytocin mice;The optimized process parameters of SFE were 30MPa of extraction pressure, 60℃of extraction temperature, 8 Mpa of resolu pressureⅠ, 6 MPa of resolu pressureⅡ, 50℃of resolu temperatureⅠ, 55℃of resolu temperatureⅡand 2.5h of extraction time. And the extracta sicca were sieved through 10mesh.The optimized process parameters of percolate were using 8-fold 70%(v/v) ethanol.Extracta sicca of Paeonia lactiflora Pall and Corydalis yanhusuo W.T.Wang were porphyrizated, sieved through 20~40mesh,mixed together, and impregnate for 24 hours.According to optimized formula (adhensive agent (Carbopol:NP700=1:3):humectant (glycerol:PEG400=2:1): cross-linker (dihydroxyaluminum aminoacetate)=5:30:0.2), NP 700 is stired into Carbopol solution to form phase A. Dissolve cross-linker in the mixture of humectants,then add in extracta sicca and volatile oils to form phase B. Stir A into B, grind, stet to obtain the poultice. Spread the poultice uniformly onto cloth(6cm×12cm),dry at 75℃for 2 hours, package.Quality evaluation was performed in line with provisions of cataplasma as designated in Chinese Pharmacopoeia; besides, qualitative and quantitative method was established based on which a quality standard proposal was drafted(≥16mg peoniflorin/per cataplasma).Conclusion: The preparation precedure of compound Danggui anti-dysmenorrheal Cataplasm was feasible, stable and well mouldable, and the quality of the sample was steady as well.The research is successful in achieving its objectives.