复方β-环糊精莪术油栓的制备及质量检查

【研究目的】为了防止复方莪术油栓中有效成份的挥发，提高栓剂的溶解性，制备复方β-环糊精莪术油栓；【方法】采用饱和水溶液法制备莪术油β-环糊精包合物，将包合物和甲硝唑等以热熔法制成栓剂并依据兽药典进行质量检查；【结果】试验结果表明在薄层色谱图中，莪术油包合物与莪术油斑点一致，Rf值差异不显著。包合物中含油率为3.6％，油的收率为32.4％，包合物的收率为86.1％。栓剂重量在1.0g～3.0g之间者重量差异限度为±7.5％；栓剂均在30min内全部溶解；【结论】包合过程没有改变莪术油的化学成分，栓剂的质量符合2005版兽药典规定。

Study on suppository of compand of β-cyclodextrin inclusion compound and quality inspection

In order to prevent volatilization and raise solubility of the compound oil of zedoary turmeric suppositories,prepared a kind of compound oil of zedoary turmeric suppositories;prepared inclusion compound of oil of zedoary turmeric with β-cyclodextrin,adopted Saturated aqueous solution,prepared suppositories by way of fusion method with inclusion compound and metronidazole,and inspectied quality according to Veterinary Pharmacopoeia.The results showed that compound oil of zedoary turmeric and oil of zedoary turmeric with the same spots in the thin-layer chromatogram,Rf of the difference was not significant.The rate of oil in the inclusion compound was 3.6%,the rate of oil acquisition was 32.4% and the inclusion rate reaches 86.1%.the limitation of weight for the difference was 7.5%,between the weight 1.0 to 3.0 gram,all suppositories were dissolved in 30 minutes.Chemical composition of the oil of zedoary turmeric was not changed by inclused.Solubility of the suppositories was very good and meet the specification of Veterinary Pharmacopoeia of 2005 edition.