盐酸左旋咪唑滴丸的制备与含量测定

Preparation and Content Determination of Levamisole Hydrochloride Dropping Pills

研究盐酸左旋咪唑滴丸的最佳制备工艺及完成其主药含量的测定。方法:以滴丸的硬度、圆整度、重量差异、溶散时限为考察指标,对PEG4000与PEG6000的质量比、药液温度、滴速、滴距进行单因素分析,并通过正交试验对影响因素进行筛选。结果:最优处方为:PEG4000与PEG6000质量比为1∶0,药液的温度为85~90℃,滴速为50d/min,滴距为8cm。用紫外分光光度计测得PEG4000在主药的吸收峰213.4nm处无吸收,且在2~10μg/mL时,主药的吸光度与药物浓度呈良好的线性关系,线性方程为:y=0.05350x-0.00548(r^(2)=0.99987)。结论:盐酸左旋咪唑滴丸制备方法可靠,质量可控。

To study the best preparation technology of levamisole hydrochloride dropping pills and complete the determination of its main drug content.Methods:Taking the hardness,roundness,weight difference and dissolution time of dropping pills as the investigation indexes,the mass ratio,liquid temperature,dropping speed and dropping distance of PEG4000 and PEG6000 were analyzed by single factor,and the influencing factors were screened by orthogonal design experiment.Results:the optimal formulation was as follows:the mass ratio of PEG4000 to PEG6000 was 1∶0,the temperature of the solution was 85~90℃,the dropping speed was 50d /min and the droppingdistance was 8cm.PEG4000 has no absorption at 213.4nm of the absorption peak of the main drug,and it is 2~10nm μ In the range of g /ml,the absorbance of the main drug has a good linear relationship with the drug concentration.The linear equation is:y=0.05350x-0.00548 (R^(2)=0.99987)。Conclusion:the preparation method of levamisole hydrochloride dropping pills is reliable and the quality is controllable.