小儿用阿奇霉素口腔崩解片的制备及质量控制

Preparation and Quality Control of Azithromycin Orally Disintegrating Tablets for Children's Use

目的:制备小儿用阿奇霉素口腔崩解片并建立其质量控制方法。方法:以丙烯酸树脂为载体制备阿奇霉素固体分散体,用粉末直接压片法制备口腔崩解片;采用紫外分光光度法测定其中主药的含量,并对其崩解时限、体外溶出度进行考察。结果:所制制剂为白色片剂,检查、鉴别均符合2005年版《中国药典》中的相关规定;阿奇霉素检测浓度的线性范围为15.02～35.05μg·mL^(-1) (r=0.999 9),平均回收率为99.9%(RSD=0.3%);成品在39s内完全崩解,药物在5 min内几乎全部溶出。结论:该制剂处方合理,制备简单,质量可控。

OBJECTIVE： To prepare azithromycin orally disintegrating tablets for children＇ s use and establish its quality control method. METHODS： Acrylic resin was used as carrier to prepare azithromycin solid dispersion, and powder direct compression method was used to prepare the orally disintegrating tablets. The UV spectrometry was adopted to determine the content of azithromycin, meanwhile the disintegration time and dissolution rate were evaluated. RESULTS： The preparation was white tablets and it was up to the standard specified in Chinese Pharmacopeia （.2005 Edition） in inspection and identification. The linear range of azithromycin was 15.02-35.05μg · mL^-1 （r = 0.999 9） and its average recovery was 99.9% （RSD = 0.3% ） . The prepared tablets disintegrated completely within 39 s, and the dissolution rate of the tablets within 5 minutes reached to about 100%. CONCLUSION： The preparation is reasonable in formulation, convenient in preparation, and controllable in quality.