复方党参胶囊的制备及质量标准研究

Preparation of a compound Codonopsis capsule and study of its quality standards

目的为了将具有抗疲劳作用的临床经方'复方党参方'开发成方便携带和服用的现代中药制剂,优选提取工艺及制剂工艺,研究定性定量质控方法。方法以出膏率、总多糖含量、总皂苷含量为综合指标,正交设计法优选提取工艺;采用湿法制粒进行制剂工艺研究;参照《中华人民共和国药典》相关药材的薄层鉴定方法和食品安全国家标准——食品中还原糖的测定方法以及《保健食品检验与评价技术规范》(2003年版)中'保健食品中总皂苷的测定'进行质量控制研究。结果优选的提取工艺:分别以8、6、6倍量水煎煮提取3次,1 h/次,提取液减压浓缩得干膏粉;制剂工艺m(干膏粉)∶m(辅料(m(微晶纤维素)∶m(糊精)=1∶3))=1.5∶1.0混合,60%乙醇润湿,制粒,80°C干燥,过筛,装入囊壳。制剂中当归、枸杞子、大黄可用薄层色谱法鉴定,3批制剂中还原糖的平均含量为232.00 mg/g,总皂苷的平均含量为12.00 mg/g。结论通过出膏率、总多糖含量以及总皂苷含量多指标优选的提取工艺操作简单,有利于活性成分的转移。制得的囊心物颗粒性状良好,符合《中华人民共和国药典》胶囊剂项下有关规定。薄层色谱定性方法和还原糖含量及总皂苷含量的测定方法可用于复方党参胶囊剂的质量控制。

Objective In order to develop the clinical prescription'Compound Codonopsis Formula'with anti-fatigue effect into a modern Chinese medicine preparation that is convenient to carry and take,its preferred extraction process and preparation process and qualitative and quantitative control methods were studied.Methods The extraction rate,total polysaccharide,total saponin content were taken as the comprehensive indicators.The orthogonal design method was used to optimize the extraction process.The wet granulation was used for the formulation process.Pharmacopoeia related medicinal materials were used for the thin layer chromatogphy identification method and the national food safety standards-recovery in food.Also referred to was the method for the determination of sugar and the quality control study of'Determination of Total Saponins in Health Foods'in'Technical Specifications for Testing and Evaluation of Health Food(2003 Edition)'.Results The preferred extraction process 8,6,6 times the amount of water was decocted and extracted 3 times;each time for 1 hour the extract was concentrated under reduced pressure to obtain a dry powdered powder;the preparation process:the ratio of the quality of dry cream powder to the quality of auxiliary materials(the ratio of the quality of microcrystalline cellulose to the quality of dextrin was 1∶3)was 1.5∶1.0,were wetted with 60%ethanol,granulated,dried at 80°C,sieved through mesh and filled in capsule shell.Identification of Angelica,Chinese wolfberry and Rhubarb by thin layer chromatogphy.The average content of reducing sugars in the three batches of preparations was 232.00 mg/g,and the total saponin content was 12.00 mg/g.Conclusion The extraction process optimized was simple and was beneficial to the transfer of active ingredients.The granule properties of the obtained capsules were good and in compliance with the relevant regulations under the Chinese Pharmacopoeia capsules.Thin layar chromatogphy qualitative method and the determination method of reducing sugar and total saponin can be used for quality control of compound Codonopsis capsules.