芊玖舒胶囊产业化稳定性提升关键技术研究

Study on Key Technologies of Stability Improvement in the Industrialization of Qishu Capsule

为改善芊玖舒胶囊内容物吸湿稳定性,对大生产干燥工艺进行优化。采用新技术稠膏预混辅料减压干燥法,结合酒精制粒,分别对半成品颗粒流动性、吸湿曲线、十天影响因素试验、产品加速稳定性进行对比考察,以水分、崩解、葛根素、总黄酮和卫生学等指标为评价标准。工艺优化后颗粒流动性和性状改善,休止角降低2°,吸湿临界湿度为:64.3%,吸湿稳定性增强。结果表明,总黄酮含量指标下降率控制在于0.25%~12.26%,葛根素含量指标下降率控制在于0.61%~14.77%,其他指标符合标准,与原工艺无异。大生产工艺中预混辅料干燥及酒精制粒技术能有效提高产品的吸湿稳定性,可更好保障产品质量稳定性,可作为大生产工艺的重要参考。

In order to improve the hygroscopic stability of the content of Qianjiushu Capsule,this paper optimizes the large-scale production drying process and achieves better results.The new technology thick paste premixed auxiliary material decompression drying method combined with alcohol granulation,respectively,the semi-finished granule fluidity,moisture absorption curve,ten-day influencing factor test,product acceleration stability comparison,water,disintegration,puerarin,Indicators such as total flavonoids and hygiene are evaluation criteria.After the process optimization,the fluidity and properties of the particles were improved,the angle of repose was reduced by 2 degrees,the critical humidity of moisture absorption was 64.3%,and the hygroscopic stability was enhanced.The results of stability test showed that the control rate of total flavonoids was between 0.25 and 12.26%,and the control rate of puerarin was between 0.61 and 14.77%.Other indicators met the standard and were no different from the original process.The premixed auxiliary material drying and alcohol granulation technology in the large production process can effectively improve the moisture absorption stability of the product,and can better guarantee the product quality stability,and can be used as an important reference for the large production process.