盐酸氨溴索含片的研制及质量控制

Preparation and quality control of ambroxol hydrochloride buccal tablets

摘要:

目的研制盐酸氨溴索含片并对其进行质量控制。方法以外观、口感、碎脆度为指标，对多种处方进行比较性研究，得出最佳处方；并对盐酸氨溴索含片的制备工艺进行了研究，得出适宜的制备工艺；盐酸氨溴索含片的溶出度测定采用紫外分光光度法，其含量测定则采用高效液相色谱法。结果本处方最佳处方为每1000片含盐酸氨溴索30g、甘露醇300g、赤藓糖醇250g、阿斯巴甜10g、薄荷油5g、硬脂酸镁6g、10％PVPK30的60％乙醇溶液适量。盐酸氨溴索含片45min的溶出≥75％；盐酸氨溴索含片的含量测定的线性范围为0．40～16．02μg·mL^-1。结论盐酸氨溴索含片处方工艺成熟，适合工业化大生产；检测方法简便、准确、可靠、专属性强，可用于盐酸氨溴索含片的质控标准。

Abstract:

Objective To study the formulation and processing technology of ambroxol hydrochloride buccal tablets, and to establish its quality control. Methods Alternations and doses of supplementary materials and adhesion were used to select optimum formulation, with appearance, taste and fragmentary degree as the assessment index, and the best processing technology and suitable parament were selected according to the experiment results; UV-vis was used to determine the dissolution of ambroxol hydrochloride buccal tablets, and HPLC method for its content in the prepara- tion. Results The optimal formulation was composed of ambroxol hydrochloride （50 g）, mannitol （300 g）, erythritol （250 g）, aspartame （10 g）, mentha arvensis oil （5 g）, magnesium stearate （6 g）, and 10% PVPK30 was dis-solved by 60 % alcohol as the wetting agent. Ambroxol hydrochloride in the preparation was released to more than 75 % in 45 min. The detected concentration of ambroxol hydrochloride was linear at 0.40- 16.02 mg ·mL^-1. Conclusion The formulationn of the ambroxol hydrochloride buccal tablets is reasonable and the preparation technology is reliable, which can be used in industrial production. The methods are simple, accurate, reliable, specific and can be used for the quality control of this buccal tablets.