| The main ingredient of Zushima Gaoyao(Z62020522) produced in gansu province is extract powder from the bark of rhizome and stems of Daphne giraldii Nitsche(Thymelaeaceae), in which main chemical components are coumarins,flavonoids, lignin, terpenoids and so on. Zushima Gaoyao have effects of expel wind-evil and remove wetness, promoting blood circulation to arrest pain,which is used for treating rheumatoid arthritis(wind-cold-wetness bype of arthralgia, blood stasis stagnating collaterals syndrome). Zushima Gaoyao as traditional plaster have defects of inconvenience for use, poor effect of transdermal absorption, easy contaminated clothing, low level of production process automation and so on. In order to overcome defects of traditional plaster, re-develop of Zushima Gaoyao and develop of Zushima cataplasm. In this thesis,the proportion of matrix recipe, forming process,pharmacological effects of Zushima cataplasm is studied.1. Preparation of Zushima cataplasm1.1 Optimization of blank matrix formulation of Zushima cataplasmBased on the single factor experiments to the optimal ratio of blank matrix of Zushima cataplasm, The comprehensive scores of the sensory evaluation, tacking strength, holding strength, and peeling strength as evaluation indicators.The Box-Behnken test design were used to optimize 4 factors, which were the dosage of viscomate NP-700, Carbopol 940,aluminum glycinate and glycerol.The response surface methodology was used to optimize the blank matrix recipe of Zushima cataplasm. Results shows the best ratio of blank matrix prescription was as follows:viscomate NP-700-Carbopol 940-aluminum glycinate-glycerol-kaolin-citric acid(2.0:0.30:0.10:10.0:0.5:0.10).The preparation process of blank matrix of Zushima Cataplasm was optimized by L9(34) orthogonal test method, with stiring speed,refining temperatur and stiring time as the indicators. The best preparation process blank matrix of Zushima Cataplasm was stiring time for 5 min,refining temperature of 40℃,stirring speed of 100 r·min-1.1.2 Study on forming process of Zushima CataplasmIn order to confirm the best recipe proportion and forming process of Zushima cataplasm,adding drug order and adding dosage was explored by the single factor experiments,and the process parameters was optimized by L9(34)orthogonal experiment, with stiring speed, refining temperatur, stiring time and adding drug order as the indicators. The results shows that the best recipe proportion of Zushima cataplasm were drug powder:viscomate NP-700:Carbopol 940:aluminum glycinate:glycerol:kaolin:citric acid: azone:water=7.0:2.0:0.30:0.10:10.0: 0.5:0.10:0.28:20. and the best forming process of Zushima cataplasm was as follows: drug powder(7.0 g) was dispersed in glycerol(10.0 g), then added kaolin(0.5g) and azone(0.28g), well mixed, regarded as A phase. Carbopol 940(0.3g) was dissolved in15 mL of water, and full swelled at 50℃water bath, regarded as B phase. Aluminum glycinate(0.10g) and citric acid(0.10g) were dissolved in 5mL of water, regarded as C phase. Under stirring constantly,A phase and C phase were well mixed at 40℃,then added to B phase at 100r·min-1 stiring speed, well mixed, and then evenly coated on the non-woven fabric to dry at room temperature,cover polyethylene film.2. Evaluation of main pharmacological effects of Zushima cataplasmBoth the writhing test and hot plate test were conducted to assess the antinociceptive effect of Zushima cataplasm and Xylene-induced mouse ear edema was conducted to assess the anti-inflammatory effect of Zushima cataplasm. Results:compared to the matrix control group, Zushima cataplasm in low,intermediate and high dose, all could increase the pain threshold at different time(P < 0.05 or P < 0.01),moreover, the effect of intermediate and high dose is stronger than that of Zushima plaster(P < 0.05); compared with the matrix control group, Zushima cataplasm in low,intermediate and high dose, all could prolong the latency after being daubed and reduce the number of writhing response(P < 0.05 or P < 0.01), moreover, high dose was less than the writhing of Zushima plaster group(P < 0.05), Compared with Votalin group; compared with the matrix control group, Zushima cataplasm in intermediate and high dose,could reduce the ear swelling of mice(P < 0.05 or P <0.01), moreover,large dose swelling inhibition rate is higher than Zushima plaster group(P < 0.05).Every dose group of Zushima cataplasm compared with Votalingroup,no statistical significance(p>0.05). Zushima cataplasm have obvious effects of anti-nociceptive and anti-inflammatory.suggesting it may be worth funther investigation. |
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