Preparation And Clinical Study Of Xiaoyin Capsule

Objective: To study the basic theory of traditional Chinese medicine and modernmedicine pharmacology guidance, the optimum Xiaoyin capsule preparation bychemical tests on completion of Xiaoyin capsule; quality standard test. At the sametime, to observe the clinical effect of Xiaoyin capsule of blood-heat syndrome ofpsoriasis vulgaris, and to compare with Xiaoyin decoction, compound Qingdaicapsule treatment, mental status, recurrence rate, the incidence rate of adversereaction and health economics.Methods:（1）L₉（3⁴）orthogonal design experiment, the content of salvianolic acidB as the index, the content was determined by HPLC, study the optimum waterextraction conditions of the solvent quantity, decoction time, decoction timesexperiment; safflower, Radix Arnebiae, raw Huaihua, small red ginseng by ethanolrefluxing extraction, the rutin content as the index, the content was determined byHPLC, the best experimental conditions of alcohol extract of alcohol concentration,solvent volume, extraction time and extraction times.（2） According to the preparation process of try out, in three batches, each batch ofpreparation are ten prescriptions. Then the research of these preparations werequalitatively identified by TLC, HPLC method for determination of the content oftaking the drug in Paris polyphylla saponin I chromatography, to work out the draftquality standards, control the quality.（3） According to the inclusion criteria for the selection of vulgaris psoriasis ofblood-heat syndrome patients105cases, randomly divided into Xiaoyin capsulegroup, Xiaoyin Decoction group and Qingdai capsule group,35cases in each group,treatment for8weeks. Changes of PASI score were observed before and aftertreatment. Results:（1） The optimum water extraction process conditions:14times of water,decocting0.5h and extracting2times; the best technological conditions of extractionwere: ethanol concentration80%, solvent amount, extraction time is12times2times60min, extraction. Medicinal extract and water buffalo horn, Rhizoma Paridis powdermixed evenly, made into capsule.（2） Xiaoyin capsule by TLC, HPLC, moisture, disintegration time, content andheavy metal test results are in line with the "Chinese Pharmacopoeia" provisions.（3） After8weeks of treatment, all their PASI scores before and after treatment, thepaired sample t test, P=0.000<0.05, significant differences, both PASI integral changebefore and after treatment; after treatment in three groups by analysis of variance,PASI integral, P=0.010<0.05integral, the three groups have significant difference,three groups of patients after PASI integration is not the same. The three groups werecompared after two two treatment of PASI integral, by LSD-t test, Xiaoyin capsulegroup and Xiaoyin Decoction group P=0.991>0.05, no significant difference; Xiaoyincapsule group and Qingdai capsule group P=0.012<0.05, with significant difference;Xiaoyin Decoction group and Qingdai capsule group P=0.012<0.05, with significantdifference. Three groups of patients with the total effective rate were87.88%,90.63%and79.41%, the Kruskal-Wallis H rank sum test to compare=12.951, H,P=0.002<0.05, the clinical efficacy of the three groups had significant difference. TheMann-Whitney U rank sum test to compare, Xiaoyin capsule group and XiaoyinDecoction group U=494.50, P>0.05, no significant difference; Xiaoyin capsule groupand Qingdai capsule group U=355.00, P<0.05, with a significant difference; XiaoyinDecoction group and Qingdai capsule group U=299.00, P<0.05, significantdifference. Each of their DLQI scores before and after treatment, the paired sample ttest, P=0.000<0.05, significant differences of psychological test, change the integralof each group before and after treatment; after treatment in three groups by analysis ofvariance, DLQI integral, P=0.001<0.05integral, the three groups have significantdifference, three groups of patients after psychological test points are not the same.The three groups were compared after two two treatment of DLQI integral, by LSD-ttest, Xiaoyin capsule group and Xiaoyin Decoction group P=0.208>0.05, nosignificant difference; Xiaoyin capsule group and Qingdai capsule group P=0.000<0.05, with significant difference; Xiaoyin Decoction group and Qingdaicapsule group P=0.023<0.05, with significant difference. The three groups of patientsrelapse rates were24.14%,17.24%and18.52%, the x2test P=0.785>0.05, threegroups of patients with no difference in recurrence rate. Loss. Three groups ofpatients with adverse reaction rates were12.12%,18.75%and8.82%, the x2testP=0.471>0.05, three groups of patients the incidence of adverse reactions was nosignificant difference in. Xiaoyin capsule by CEA=30.81; Xiaoyin Decoction byCEA=68.79.Conclusion: Through the chemical experiment to find the best technology andXiaoyin capsule, illustrate the high content of the effective components of thepreparation; clinical study showed that the treatment of psoriasis vulgaris, eliminationof blood-heat syndrome type silver capsule, clinical curative effect is satisfactory, andthe good quality of life of patients, has a certain effect of Xiaoyin capsule, easy tocarry, safety and health, affordable, convenient taking, with indicators of healtheconomics, the future in clinical application.