盐酸氨溴索糖浆处方优化及稳定性研究

Prescription Optimization and Stability Studies of Ambroxol Hydrochloride Syrup

目的:对盐酸氨溴索糖浆进行处方优化。方法:以总杂质为指标,分别对蔗糖、焦亚硫酸钠、枸橼酸钠、桔子香精等辅料成分进行处方筛选,工艺优化,制备最终处方糖浆并考察制剂稳定性。结果:蔗糖50%、焦亚硫酸钠0.08%,桔子香精0.05%,采用枸橼酸钠将药液pH调至4.6~6.0,总杂质含量少,样品稳定性提高,并在气味及口感上提高了口服依从性,所得糖浆符合质量标准。结论:所获得的处方工艺合适,质量稳定,适合工业化生产。

The purpose of this article is to prescription optimization Ambroxol Hydrochloride Syrup. Methods: Sucrose, sodium metabisulfite, sodium citrate,orange essence and other excipients were screened with total impurities as index, optimizing the process, and the final prescription syrup was prepared and the stability of the preparation was investigated. Results: Sucrose 50 %, sodium metabisulfite 0.08 %, orange essence 0.05 %, sodium citrate adjust pH to 4.6~6.0, the total impurity content was less, the stability of the sample was improved, and the oral compliance in smell and taste was improved. The syrup obtained conforms to the quality standard. Conclusion: The prescription process gained by the appropriate, stable quality, suitable for industrial production.