芊玖舒胶囊的吸湿稳定性研究

Study on the stability of Qianjiushu capsule

目的为提高芊玖舒胶囊在大生产中的吸湿稳定性,优化浸膏干燥技术及颗粒制备参数。方法采用浸膏预混辅料新技术,以95%乙醇作为润湿剂制粒,以水分、葛根素、总黄酮、灰分、崩解时限、性状等为主要考察指标,考察产品的影响因素、加速稳定性及长期稳定性。结果颗粒剂流动性改善良好,休止角达到33. 3度,相对临界湿度为80. 2%,高湿环境是影响稳定性的重要因素; 3批产品加速、长期稳定性符合规定。结论大生产工艺中采用浸膏预混淀粉干燥分散新技术及95%乙醇制粒工艺能有效提高产品吸湿的稳定性,可为药物制剂工艺在保健食品大生产中的应用提供参考。

OBJECTIVE To improve the hygroscopic stability of Qianjiushu capsule in large production,the drying technology of extract and the particle preparation parameters were optimized.METHODS Premixing excipients was used to granulate with95%ethanol as a wetting agent.The main indicators such as water,puerarin,total flavonoids,ash,disintegration time limit and traits were investigated,and the influencing factors,accelerated stability and long-term stability of the products were investigated.RESULTS The fluidity of the preparation particles improved well,the particle angle of repose reached 33.3 degrees.The relative critical humidity was 80.2%.CONCLUSION The new technology of drying and dispersing extract premixed starch and the 95%ethanol granulation process can improve the moisture absorption stability of the product effectively.