Skullcap Dysmenorrhea Post Pharmaceutical Research

Objective:To lay a foundation for exploring a kind of class 5 new traditional Chinese medicine which can provide a certain cure for essential dysmenorrhea through the pharmaceutical research of the Huangqin Tongjing Patch.Methods:1 The research of the extraction technology Several extraction methods for Scutellaria baicalensis Georgi (water decoction, alcohol reflux(optimized by L₉(3⁴) orthogonaltest), alcohol Percolation(optimized by L₉(3⁴) orthogonal test), sohlex extraction, SCFE-CO₂) were compared with the evaluating criterias such as the extraction yield of the total flavone which was determined by UV, baicalin, wogonin which were determined by HPLC.2 The research of the purification technology The content and the yield of the total flavone , baicalin, wogoninwere used as the evaluating criterias. The total flavone was determined by UV, baicalin and wogonin were determined by HPLC. With these evaluating criterias we studied the technical process for the purification of the total flavone in Scutellaria Baicalensis Georgi by 5 different kinds of macroporous adsorption Resines, and the technical process of the acid-depositing purification methods. The purification efficiency of the two methods were compared.3 The study of the manufacturing technology for Huangqin Tongjing Patch and cataplasmata According to the preliminary test, we selected the matrixes and the range of their dosages for Huangqin Tongjing Patch and cataplasmata. With the matrixes and the range of their dosages we optimized manufacturing technology for Huangqin Tongjing Patch by L₉(3⁴) orthogonal design with the adhesion strength, degree of softness, uniformity and meltability as indexes, and optimized the procedures of the cataplasmata by L₁₆(4⁵) orthogonal design with the adhesive ability, spreading ability,appearance,layer residue as indexes.4 The study of the quality standards and preliminary stable property The baicalin and wogonin in the patch preparation were identified by TLC. And the contents of them were determined by HPLC. The chromatography conditions: Using ZORBAX SB-C18(4.6mm×250mm, 5μm )column with methanol-water-phosphoric acid(58:40:0.05) as mobile phase and UV detector at 278nm, the flow rate was 1mL·min^-1, and the column temperature was 35℃. The extraction,adhesive ability,heat resisting property and weight variation were determined. The preliminary stable property was studied with the investigation items such as characteristics,identification and the content of extraction,adhesive ability,the content of baicalin and wogonin.5 The study of the release rate and the percutaneous absorption The content of total flavone of both released and percutaneous absorbed from Huangqin Tongjing Patch and cataplasmata were determined by UV. The content of baicalin, wogonin of both released and percutaneous absorbed from nuangqin Tongjing Patch and cataplasmata were determined by HPLC.6 Study on the chemical constituents of Scutellaria baicalensis Georgi Silica Gel chromatographic technique and recrystallization method were used to separate and purify the constituents.Results:1 The optimized extraction and purification technology was as follows: The coarse powder of the Scutellaria baicalensis Georgi was extracted by percolation method after being soaked 36 hours with 70% alcohol, 30 times 70% alcohol as solvent, and the flow rate was 5mL/min/kg. The alcohol was reclaimed under reduced pressure, added sufficient water, adjusted pH to 1.0-2.0 with HCl, incubated 1 hour at 80℃, stood 24 hours, then filtered, the deposition was scrubbed with water until the pHwas equal to 7.0, dried the deposition under reduced pressure. The yield of the total flavone,baicalin,wogoninwas 8.02%,6.01%,0.47% respectively, and the content of the flavone,baicalin,wogonin in the extraction was 97.61%,38.36%,4.15% respectively.2 The optimized manufacturing technology for Huangqin Tongjing Patch was as follows: extracta sicca (0.4g), sodium dodecylsulfate(SDS) 0.1g, glycerol 0.4g, glyceryl monostearate 0.3g, paraffin wax 0.3g, vaseline 0.4g, the patch was prepared by melted method. The optimized ingredients of the matrix of the cataplasmata were 70%PANA:PVP K-30:D- glucitol: glycerol: gelatin:PEG-400: extracta sicca=4:3:1:4:2:1:4.7.3 The results of the quality standards:â‘ The identification methods of the baicalin, wogonin in the patch preparation by TLC were simple, the spots on the TLC picture were clear.â‘¡Study on the determination had shown that the liner rang was 0.44μg～2.2μg(r=0.9999) for baicalin, 0.0128μg～0.2048μg (r=0.9999) for wogonin; the precision (RSD) was 1.83% forbaicalin, 0.84% forwogonin; the average recovery was 96.5% with RSD 0.99% for baicalin, 101.9% with RSD 1.26% for wogonin; the average content of the baicalin was 7.32% with RSD 1.95%, and the average content of thewogoninwas 0.65% withRSD 1.90%. The contents of the baicalin,wogonin in the patch preparations were used as quality control indexes, and the contents of baicalin andwogonin in each piece of the patches were not lower than 100mg andl0mg respectively. The content of theextraction,theadhesiveability,theheat resisting property and the weight variation of the patch preparation were right to the regulation.4 The release rate of the total flavone,baicalin,wogonin from Huangqin Tongjing patch in the water was 37.41%,13.23%,30.10% in 200 minutes respectively and the cumulative permeation rate within 36 hours was 1.00%, 0.61%, 1.02% respectively. The release rate of the total flavone,baicalin,wogonin from cataplasmata in the water was 99.91%,99.99%,100% in 200 minutes respectively and the cumulative permeation rate within 36 hours was 1.00%,0.61%,1.02% respectively.5 Six compounds were isolated and purified, their melting range were determined. Their structures will be identified and their pharmacodynamics will be verified in the future.Conclusions:The contents of this article include the manufacturing technology for Huangqin Tongjing Patch, the comparison of the release rate and the cumulative permeation rate of Huangqin Tongjing Patch and cataplasmata, the study of the quality standards and preliminary stable property. All these researching contents lay a foundation for deeply studying of the new traditional Chinese medicine——Huangqin Tongjing Patch.