Study On Preparation Technology And Quality Analysis Of Fufangjiaotai Cataplasmate

Objective:To study on preparation technology and quality analysis of Fufangjiaotai Cataplasmate, attempt to develop one kind of cataplasmate which can be adhered on the acupoint to treat insomnia auxiliarily.Methods:1 The extraction technology research:①The extraction technology research of volatile oil in Cinnamomi Cortex:To optimize the conditions of extraction technology of volatile oil by wet distillation method, the L9 (34) orthogonal design experiments were carried out, in which four influence factors such as soaking time, amount of water, the size of Cinnamomi Cortex and the time of extraction were selected, and the rate of volatile oil extracted was regarded as the evaluating indices.②To optimize the extraction conditions of the ethanol reflux extraction for Coptis, the L9 (34) orthogonal design experiments were carried out, in which four influence factors such as concentration of alcohol, volume of solvent,time for extraction,number of times for extraction were selected, and the extracted yield of berberine alkaloids determined by UV was regarded as the evaluating indices.③contrast research of different extraction technology for Coptis and Cinnamomi Cortex: to select appropriate extraction technology,a comparative research was carried out among the reflux extraction the ethanol reflux extraction,extraction apart and extraction together for Coptis or Cinnamomi Cortex, in which the extracted yield of berberine alkaloids or the rate of volatile oil was regarded as the evaluating indices.2 The preparation technology research of Fufangjiaotai Cataplasmate: according to the results of preliminary test and large amounts of data,the kinds and dosages rang of excipients were determind, the proportion of the base material was optimized by the L48 (37) orthogonal design experiments, in which appearance, prelimilary adhesion and residual amount on the polyethylene membrane were as their evaluating indices.3 The quality analysis research of Fufangjiaotai Cataplasmate:It was identified for Cinnamon by TLC. According to related regulations in China Pharmacopoeia, mastic amount, adhesive ability,weight difference,bestows on the shape and heat resisting property was detected.Draft a method how the contents of Berberine in preparation was detected by HPLC.The chromatography conditions of determination were that the ZORBAX SB-C18 (4.6mm×250mm,5μm)column was used,the mobile phase was composed of acetonitrile- 0.05mol/L Potassium dihydrogen phosphate (0.4g sodium lauryl sulfate Per 100ml,adjust the PH to 4.0 with phosphoric acid solution) (35:65), the wavelength of detection is 345 nanometer, the flow rate is 1.0mL·min-1.Results:1 The extraction technology research:①The optimum conditions for the extraction technology of volatile oil for Cinnamomi cortex were that the size of medicinal material was between 10 mu and 30 mu, the amount of water was 8 times of medicinal materials, the soaking time was 2 hours, and extraction time was 4 hours.②The optimum technological conditions of the ethanol reflux extraction for Coptis,were that the medicinal materials were extracted with 4 times of 50% alcohol for three times, every time for 2 hours. The average extraction rate of berberine alkaloids in 3 batches of samples was 8.4 %.③Contrast research results of different extraction technology for Coptis and Cinnamomi:extract volatile oil from Cinnamomi apart by wet distillation method,then collect the solution extracted by water, while Coptis and Margaritiferaconcha was extracted together by the ethanol of 50%.2 The optimum proportion of the base material of the Fufangjiaotai Cataplasmata were:the mastic amount - sodium polyacrylate - glycerin-aluminium hydroxide - microcrystalline cellulose -citric acid-distilled water was 0.9:1.5:5:0.05:1:0.2:20.3 The quality analysis research of Fufangjiaotai Cataplasmate:It was very simple to identify Cinnamomi cortex in Fufangjiaotai Cataplasmate by TLC, the spots were clear, the negative contrasts were not disturbed.The mastic amount,Adhesion, bestows on the shape, heat resisting property and weight difference were in accordance with the regulations of China Pharmacopoeia.The detection of berberine alkaloids showed that their linear rang were 0.02μg～0.2μg (r=0.9998), stability (RSD) were 0.87%, average content of berberine alkaloids were 0.7252%(RSD 1.53%) in the reproducibility experiments, average recovery were 97.31%(RSD1.26%).The contents of berberine alkaloids in three batches of were 39.52mg,38.80mg,40.25mg, per patch, respectively.Conclusions:by studying on the extraction technology, preparation technology, quality analysis research, a good foundation had been laid for the further development of Fufangjiaotai Cataplasmate.