参藻籽胶囊的提取和制剂工艺研究

Study on Extraction and Preparation Process on Shenzaozi Capsule

对参藻籽胶囊的提取工艺和制剂工艺进行研究,以干膏重及人参皂苷、虾青素和白藜芦醇含量为指标,采用正交实验分别研究人参、红球藻和葡萄籽的提取工艺,并分析不同辅料和不同浓度润湿剂的制粒效果并装胶囊。最佳制剂工艺为人参采用50%乙醇,6倍料液比,提取3次;红球藻采用70%乙醇,提取温度65℃,提取4.0 h;葡萄籽采用80%乙醇,15倍料液比,提取2 h;最佳辅料为CMC-Na,70%乙醇做润湿剂,填装0号胶囊壳。本制剂工艺可行性较强,科学合理,颗粒成药性良好。

Shenzaozi Capsule is mainly used for the treatment of cardiovascular and cerebrovascular diseases.The extraction technology and preparation method were studied.With the dry paste weight and the contents of ginsenoside,astaxanthin and resveratrol as indexes,the influencing factors and main active components of radix ginseng,red algae and grape seed were analyzed by orthogonal experiment,respectively.In the extraction process,the effect of ethanol concentration,solid-liquid ratio,extraction duration,extraction temperature,and extraction times was analyzed.Then,wet compression granulation method was investigated through selection of different excipients,different concentration of wetting agent and capsule type.For radix ginseng,the optimum extraction technology was 50%of ethanol concentration,6 of liquid ratio and 3 extraction times.For red algae,it was 70%of ethanol concentration,65℃of extraction temperature and 4.0 h of extraction duration.For grape seed,it was 80%of ethanol concentration,15 of liquid ratio and 2 h of extraction duration.The best excipient was CMC-Na with 70%ethanol as wetting agent.At last,the granule was filled in No.0 capsule shell.This extraction and preparation process were stable,scientific and reasonable.