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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 pediatric azithromycin orally disintegrating tablet and establish its quality control method. Methods: The azithromycin solid dispersion was prepared with acrylic resin as carrier. The orally disintegrating tablet was prepared by powder direct compression method. The main drug content was determined by UV spectrophotometry. The disintegration time and in vitro dissolution were investigated. Results: The prepared preparations were white tablets, and the test and identification were in accordance with the relevant provisions of the 2005 edition of Chinese Pharmacopoeia. The linear range of azithromycin was 15.02-35.05 μg · mL -1 (r = 0.999 9) , The average recovery was 99.9% (RSD = 0.3%). The finished product completely disintegrated within 39s, and the drug almost completely dissolved within 5 minutes. Conclusion: The preparation prescription is reasonable, preparation is simple, quality controllable.