| Objective:Selecting evodia rutaecarpa as a representative drug that can guide fire back to the original place. And improved traditional dosage form of evodia rutaecarpa, developed new dosage forms of the effective, convenient and safe which is conductive to the elderly. Then using new dosage forms of evodia rutaecarpa to stick yongquan cave treatment of senile insomnia patients with different syndromes, comparing the clinical curative effect of syndrome if there is a difference, as to provide theoretical basis for method of guiding fire back to the original place.Methods:First. Using the method of water titration and test of the conductivity to determine the phase transition point, and using software map pseudo ternary diagram, investigating the variety and dosage of surface active agent, surfactant, and oil phase, to optimized formula of evodia rutaecarpa oil-in-water microemulsion. Then using orthogonal test method to optimize oil-in-water microemulsion cataplasm formula, selecting microemulsion, glycerin, hydroxy aluminium, PVP as examine factors of Papua agent that had a greater influence on the quality, with cohesion, adhesion force, follow sex skin, apply malleable, uniformity and other comprehensive score as an index.Evodia rutaecarpa microemulsion Papua agent formula is determined, by the method of in vitro proliferation pool to investigates characteristics in vitro transdermal of evodia rutaecarpa microemulsion Papua agent, conventional Papua agent and traditional dosage form, to collect receptor fluid of three dosage forms in 2,4,6,8,12,24 h, testing receiving liquid content of Evodiamine and Rutecarpine in each time point by high performance liquid chromatography (HPLC), and calculate the accumulative osmotic quantity per unit area of each point in time. Comparing three kinds of dosage form in vitro transdermal absorption, and to determine clinical dose of the evodia rutaecarpa in the oil-in-water microemulsion Papua agent, at the same time proving oil-in-water microemulsion Papua agent absorption effect is better than the conventional Papua agent and traditional dosage forms.According to the preparation technology and formula ratio of evodia rutaecarpa oil-in-water microemulsion Papua agent to produce 1000 copies of thickness 1 mm size,10 cm long and 5 cm wide Papua agent with the cloth coating machine. Then selecting Yin deficiency fire flourishing syndrome group, spleen and kidney Yang deficiency syndrome group, heart and gallbladder qi deficiency syndrome group, deficiency both heart and spleen syndrome group, liver depression phlegm heat syndrome group according to diagnostic criteria of clinical insomnia syndrome classification from elderly insomnia patients of the nursing home,10 cases each group. Before treatment stop taking sleeping pills, every day will be a piece of evodia rutaecarpa oil-in-water microemulsion Papua agent to symmetric cut in half and tear protective film, heated with blower, respectively Conduct yongquan point application in feet before going to bed, take off until the next day morning, for 14 consecutive days, and respectively fill in the Pittsburgh sleep quality index (PSQI) scale and TCM syndrome scale before and after therapy. Using SPSS statistical software to analyze the clinical efficiency and compare the method of guiding fire back to the original place for the clinical curative effect of different syndromes of elderly patients with insomnia.Results:The best prescription of Evodia rutaecarpa oil-in-water microemulsion is for:Tween80:C040:propyleneglycol:oleicacid:water:Evodia rutaecarpa extracts=3.2:3.2:3.2:0.5:18:0.5. The best ratio of Evodia rutaecarpa oil-in-ater microemulsion Papua agent formula is NP-800:glycerol: aminoacetate gump:water:PVPk90:tartaric acid:1% carbomer 940:microemulsion =2:13:0.08:10:3:0.05:18.Evodia rutaecarpa oil-in-water microemulsion Papua agent in Evodiamine Q24h, were regular Papua agent, traditional dosage forms of 1.88,2.16 times, and Rutecarpine Q24h were regular Papua agent, dosage forms of 1.47 1.91 times.Clinical results are as follows:Using the standard of western medicine to evaluate the curative effect for the elderly insomnia. Result display, Yin deficiency fire flourishing syndrome group, spleen and kidney Yang deficiency syndrome group, heart and gallbladder qi deficiency syndrome group, deficiency both heart and spleen syndrome group, liver depression phlegm heat syndrome group respectively were 80%,70%,40%,30%,30%. Using the standard of TCM syndrome to evaluate curative effect. Result display, Yin deficiency fire flourishing syndrome group, spleen and kidney Yang deficiency syndrome group, heart and gallbladder qi deficiency syndrome group, deficiency of both heart and spleen syndrome group, liver depression phlegm heat syndrome group respectively were 70%,60%,20%,20%,30%. By using multiple sets of unidirectional orderly data Ridit analysis of these two kinds of evaluation method analysis found that the results between groups of five syndrome overall efficacy had significant difference (P< 0.05). Yin deficiency fire flourishing syndrome group and spleen and kidney Yang deficiency syndrome group was significantly better than heart and gallbladder qi deficiency syndrome group, deficiency both heart and spleen syndrome group, liver depression phlegm heat syndrome group (P< 0.05). By group curative effect between the two comparison, finding Yin deficiency fire flourishing syndrome group and spleen and kidney that had no significant difference between the two groups (P> 0.05), and the other three groups is not obvious (P> 0.05) by comparing curative effect between any two groups.Conclusion:Using microemulsion technology combined with conventional Papua agent formulation and preparation process of evodia rutaecarpa microemulsion Papua agent can meet the demands of pharmacopoeia quality standards, and the surface is smooth and moisturizing effect is strong, cohesion and adhesion force, at the beginning of the skin to follow are better, simple production technology, the method is suitable for industrialized production.Transdermal absorption characteristics of the experimental results show that:the microemulsion technology can improve release of the fat-soluble constituents in evodia rutaecarpa microemulsion Papua agent, which is superior to conventional Papua agent and traditional dosage form, this technology is suitable for new dosage forms of evodia rutaecarpa treatment of senile insomnia.Clinical research results show that:in evodia rutaecarpa oil-in-water microemulsion Papua agent drugs, as a representative of the method of guide fire back to the original place to stick the yongquan point to treat different syndromes of elderly patients with insomnia, to the curative effect of Yin deficiency fire hyperactivity and spleen kidney Yang deficiency syndrome is good, heart and gallbladder qi deficiency syndrome group, deficiency both heart and spleen syndrome group, liver depression phlegm heat syndrome group is poorer, therefore, by using the method of guide fire back to the originalplace to treat different syndromes of elderly patients with insomnia,the clinical curative effect are different. Treatment of senile insomnia should based on syndrome differentiation by using the method of guide fire back to the original place, and traditional Chinese medicine external treatment to treat insomnia, should according to the differences of each type of syndrome pathogenesis to choose suitable drugs and acupuncture points, so as to improve the clinical curative effect. |
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