Object:To establish the best preparation process and a reliable quality standards for fractures liniment, and to investigate its pharmacodynamics.Method:1.Preparation technology research:On the premise of fixed extraction solvent amount, the orthogonal experiment was the four factors (ethanol concentration, extraction time,extraction frequency and medicinal material granularity)and three levels of L9 (34). The indexes are evalued by eugenol content, extract and comprehensive scores.Optimal extraction process for Rhizoma Et Radix Notopterygii,Angelicae Pubescentis Radix,Zanthoxyli Pericarpium,Kaempferiae Rhizoma,Caryophylli Flos,Cinnamomi Cortex,Olibanum,Myrrha,Resina Draconis were determined by the combination of single index and integrated scoring intuitive analysis and variance analysis;The orthogonal test was the four factors extraction solvent,solvent amount, extraction time and extraction times and three levels of L9 (34).The kaempferide in the Safflower were selected as the evaluation index.By the intuitive analysis of test,we can know the medicinal materials reasonable extraction technology conditions including Chuanxiong Rhizoma,Carthami Flos,Angelicae Sinensis Radix,Croci Stigma,Arnebiae Radix,Litseae Fructus,Corydalis Rhizoma.2.Quality standard research:6 kinds of medicinal materials,which were Chuanxiong Rhizoma,Corydalis Rhizoma,Angelicae Pubescentis Radix,Caryophylli Flos,Caryophylli Flos, Born eolum Syntheticum of the fractures liniment were distinguished by TLC;The content of eugenol in fractures liniment was investigated by gas chromatography,the concentration of alcohol,total solids,microorganism project of the fractures liniment was studied and set the qualified standard.3. Pharmacodynamic studies:The analgesic effect of the fractures liniment were investigated by observing the number of twist body of pain induced by acetic acid and hot plate in mice pain threshold value. The anti-inflammatory effect of the fractures liniment was examined by observing the fractures liniment on blood capillary permeability of the abdominal,auricle swelling in mice and rat foot swelling and cotton ball granuloma of rats.The influence of the fractures liniment of soft tissue injuries was examined by observing their hematoma of rat and rabbit. The influence of the fractures liniment for promoting blood circulation to remove blood stasis was examined by observing the blood stasis model rats hemorrheology and rat foot microcirculation.Result:1.Preparation technology of the fractures liniment:Notopterygii Rhizoma Et Radix, Angelicae Pubescentis Radix,Zanthoxyli Pericarpium, Kaempferiae Rhizoma, Cinnamomi Cortex were crushed into the coarsest powders and combined with Caryophylli Flos,Olibanum,Myrrha, Resina Draconis,and then 400mL 85% EtOH was added into them and refluxed 2 times,1.5hours each time.The extract was combined and collected in another device statandby.Corydalis Rhizoma were crushed into the coarse powders and combined with Chuanxiong Rhizoma,Angelicae Sinensis Radix,Arnebiae Radix,Litseae Fructus.Carthami Flos.Croci Stigma 600mL 60%EtOH was added into them and refluxed 1.5 hours.The extract was combined and collected in another device standby.1200mL 60%ETOH was added into the dregs of a decoction and refluxed 1.5 hours.The extract was reduced pressure recovery of ethanol and reduced to 1:1(g/ml) extract(density ratio 1.09~1.10,80℃).The extract of 60%EtOH and 85%EtOH that collected in another device was added in turn in the mix and stewing 8 hours.The extract was filtrated standby. Borneolum Syntheticum was dissolved to a little ETOH and added to the solution above.60% EtOH was added into it to make it 1000mL, stewing 12 hours and filtrated.The extract was filled in the bottle to get the finished product.2.The TLC analysis of Chuanxiong Rhizoma,Corydalis Rhizoma Angelicae Pubescentis Radix,Caryophylli Flos, Cinnamomi Cortex,Borneolum Syntheticum was specific and the spots were clear.The eugenol content was measured by GC with a good linear relation in the rags of 0.05mg/ml~1.00mg/ml(r=0.9992).The average recovery rate was 99.08%,RSD was 1.02%(n=5).RSD of reproducbility test was 1.56%(n=5).3.The fractures liniment has good effects of analgesic, anti-inflammatory swelling, activating blood circulation to dissipate blood stasis, especially the biological activities of exudative inflammation and the treatment of soft tissue injuryis.Conclusion:1.Using the orthogonal experiment design,optimization of fractures liniment preparation technology is reasonable and feasible.2.Quality standards that have been set up can effectively control the preparation quality.3.The effect of fractures liniment is clear, curative effect is distinct, safe and reliable. |