血塞通泡腾片的处方工艺研究及稳定性考察

Investigation on formulation technology and stability of xuesaitong effervescent tablets

目的:探讨制备血塞通泡腾片并考察其稳定性。方法:以乳糖、甜菊素、酒石酸、碳酸氢钠、聚乙二醇(PEG6000)等为辅料,优化处方组成与制备工艺,高效液相色谱梯度洗脱法测定该片中人参皂苷Rb1、人参皂苷Rg1、三七皂苷R1的含量,通过室温留样观察试验对其稳定性进行研究。结果:优化出的处方与工艺基本合理、稳定、可行,与放大生产设备相适应,药品质量可控,可工业化生产。三批血塞通泡腾片经室温留样观察试验18个月后,其试验前后的性状和含量无明显变化,鉴别试验均呈正反应,崩解时限、重量差异、微生物限度检查均符合规定。结论:血塞通泡腾片处方组成合理,制备方法简便可行,稳定性良好。

Objective ：To prepare Xuesaitong effervescent tablets and investigate its stability. Methods：Optimize of formulations and manufacturing technology of Xuesaitong effervescent tablets with adjuvants including lactose, steviosin, tartaric acid, sodium bicarbonate and PEG6000. The contents of Panaxsaponin Rbl.Rgl and Notoginsenoside Rl was determined by the method of HPLC gradient elution and the long-term test was carried in order to test the stability of it. Results ：The optimized formulation and technology were rational, stable, feasible and suitable for large scale production. The productions＇ quality could be controlled and suitable for industrialized production. The characteristics and eontents of three batches of Xuesaitong effervescent tablets didn＇t change significantly after 18 months of long-term test. The differential test was positive. The disintegration time, weight variation and microbial limit were all coincided with the requirements. Conluslon：The formulation of Xuesaitong effervescent tablets is rational and the manufacturing technology is simple and effective with excellent stability.