Study On Quality Analysis And Comparison Of Maqin Jizhi Patch With Kechuan Plaster

Objective:Through the analytical methods including thin layer chromatography, content determination on the effective ingredients in Maqin jizhi Patch and compared with the Original Black Plaster from thin layer chromatography, content determination, release rate, vitro percutaneous rate, which has confirmed the reason of the clinical curative effect of Maqin jizhi Patch is better than that of Original Black Plaster form the material base of drug, release speed of drug ingredients and the vitro percutaneous rate. It has confirmed the formulations reform of the Original Black Plaster is reasonable and necessary.Methods:1 Quality analysis research:①Thin layer chromatography:TLC was used to identify Ephedra,Scutellaria baicalensis Leorgi,Leguminosae,Cleditsia sinensis Lam,Platycodon grandiflorum,Diascorea Nipponica Mak Borneol,Ardisia japonica in Maqin jizhi Patch.②The limited amount of Aristolochic Acid A in the Herba Asari was determinated by TLC.③The contents of Ephedrine Hydrochloride and baicalin in Maqin jizhi Patch was determined by HPLC, in which the chromatography conditions were that the Agilent Extend C18 (4.6mm×250mm,5μm) column was used, the mobile phase was composed of methanol-0.1%phosphoric acid (5:95), the flow rate 1.0mL·min-1, the wavelength of detection 262 nanometer and the column temperature 25℃; the Agilent TC-C18 (4.6mm×250mm,5μm) column was used, the mobile phase was composed of methanol-0.1% phosphoric acid (47:53), the flow rate 1.0mL·min-1, the wavelength of detection 207 nanometer and the column temperature 25℃, respectively.2 Comparative study of Maqin Jizhi Patch and Original Black Plaster:①The comparison of preparation technology:to demonstrate the advantages and disadvantages of Maqin jizhi Patch and Original Black Plaster though comparative study.②The comparison of thin layer chromatography:to compare the Ephedra,Scutellaria baicalensis Leorgi,Leguminosae,Cleditsia sinensis Lam,Platycodon grandiflorum,Diascorea Nipponica Mak Borneol,Ardisia japonica in Maqin jizhi Patch and Original Black Plaster though thin layer chromatography.③The comparison of vitro percutaneous rate of effective ingredients in Maqin jizhi Patch and Original Black Plaster:to compare the vitro percutaneous rate of effective ingredients including Ephedrine Hydrochloride and baicalin in Maqin jizhi Patch and Original Black Plaster.④The release rate research:the release rate instrument was used to carry out the release rate experiment, in which the content of Ephedrine Hydrochloride and baicalin in accepting medium was detected by HPLC, so as to calculate the release rate of Ephedrine Hydrochloride and baicalin in Maqin jizhi Patch.Results:1 Study on Quality Analysis of Maqin Jizhi Patch:①The methods to identify Ephedra,Scutellaria baicalensis Leorgi,Leguminosae,Cleditsia sinensis Lam,Platycodon grandiflorum,Diascorea Nipponica Mak,Borneol,Ardisia japonica in Maqin jizhi Patch by TLC was simpl,the spots were clear on the TLC pictures, the negative contrasts were not disturbed. on the limited amount of Aristolochic Acid A had shown that there is not the same spot of Aristolochic Acid A on the TLC picture of the Maqin jizhi Patch and the medicinal materials. The minimum detectable level of Aristolochic Acid A was 0.03μg. (3)The detections of Ephedrine Hydrochloride showed that their linear rang were 0.0493μg～0.4930μg (r=0.9999) and 0.054μg～0.54μg (r=0.9997) precision (RSD) were 0.96% and 1.48%; average contents of Ephedrine Hydrochloride were 0.0790% (RSD=1.58%) and 0.8352%(RSD=2.12%) in the reproducibility experiments;average recovery were 99.05%(RSD=2.51%) and 98.12% (RSD=1.55%);respectively.The contents of Ephedrine Hydrochloride in three batches were 2.976mg,3.200mg,2.940mg and 33.40mg,32.00mg, 33.40mg per patch, respectively.2 Study on Comparison of Maqin Jizhi Patch with Kechuan Plaster:①The comparison of manufacturing technology:The extraction technology, solvent of extraction and proportion of the base material of Maqin Jizhi Patch are better than that of Kechuan Plaster.②The comparison of TLC:The methods to identify Ephedra,Scutellaria baicalensis Leorgi,Leguminosae,Cleditsia sinensis Lam,Platycodon grandiflorum,Diascorea Nipponica Mak,Borneol,Ardisia japonica in Maqin jizhi Patch by TLC, Which has the same spots on the TLC pictures with standard medicinal materials, the negative contrasts were not disturbed. But the spot of Ephedra,Scutellaria baicalensis Leorgi,Leguminosae,Cleditsia sinensis Lam Platycodon grandiflorum,Diascorea Nipponica Mak,Borneol,Ardisia japonica in Original Black Plaster is not clear or even can not be seen. (3)The release rate research:The release rate in the water within 150 minutes of Ephedrine Hydrochloride and baicalin in Maqin jizhi Patch was 45.58% and 27.51%.④The comparison of permeation rate:The cumulative permeation rate of Ephedrine Hydrochloride and baicalin in Maqin jizhi Patch within 48 hours was 20.7% and 5.2% respectively.Conclusions:Through the comparative study of preparation technology, Thin layer chromatography of effective ingredients ,Content determination and vitro percutaneous rate of effective ingredients of Maqin jizhi Patch and Original Black Plaster. we confirmed that Maqin jizhi Patch is better than Original Black Plaster and the formulations reform is reasonable and feasible.