不同厂家盐酸倍他司汀片溶出度考察

Comparative Study on Dissolution Profiles of Betahistine Hydrochloride Tablets from Different Manufacturers

关键词:  盐酸倍他司汀片  溶出度  吸收系数法

Key words:  betahistine hydrochloride tablets  dissolution rates  absorption coefficient method

摘要:

目的 对4个厂家生产的盐酸倍他司汀片的溶出度进行考察比较，并探讨各厂家生产的盐酸倍他司汀片的质量差异。方法 采用小杯法，以盐酸溶液(9→1 000)250 mL为溶出介质，分别考察了50 r?min^-1和75 r?min^-1，用吸收系数法测定不同时间点的溶出量，对不同厂家生产的盐酸倍他司汀片的溶出速率曲线进行分析和比较。结果 各厂家产品溶出行为差别较大，产品质量存在差异。结论 不同厂家的盐酸倍他司汀片溶出度存在显著差异，有必要建立盐酸倍他司汀片溶出度检查方法，并对市售产品进行溶出度检查，从而控制药品质量，保证临床用药的有效性。

Abstract:

OBJECTIVE To compare the dissolution rates of betahistine hydrochloride tablets produced by 4 manufacturers and to investigate the quality differences of betahistine hydrochloride tablets produced by various manufacturers. METHODS The cup method was adopted to conduct the dissolution test of rotational speed 50 r?min^-1 and 75 r?min^-1 on Betahistine Hydrochloride tablets. The dissolution medium was hydrochloric acid solution(9→1 000)250 mL. The absorption coefficient method was adopted. The cumulative dissolution curves from different manufacturers were analyzed and compared. RESULTS The dissolution rate of betahistine hydrochloride tablets produced by various manufacturers had the remarkable difference. CONCLUSION The dissolution of betahistine hydrochloride tablets produced by different manufacturers are significantly different, so it is necessary to conduct the dissolution test on betahistine hydrochloride tablets in market, so as to control the quality of drugs and ensure the safety, effectiveness and stability of clinical medication.