盐酸丙卡特罗片溶出度测定方法的建立及与原研片一致性评价

摘 要：目的：建立盐酸丙卡特罗片溶出度测定方法，评价仿制片与原研片溶出行为的一致性。方法：采用桨板法，转速为50 r·min-1，高效液相色谱法测定累积溶出量。根据仿制药一致性评价要求，考察仿制片与原研片在5种不同溶出介质中的体外溶出行为并比较其相似性。结果：所建立的方法具有测定条件合理、适用性广、操作简便等特点，在5种不同介质中，3批仿制片与原研片15 min时溶出量均大于85%，属于快速溶出，可判定其溶出曲线具有相似性。结论：该方法适用于盐酸丙卡特罗片的溶出度测定，可为其质量一致性评价提供参考。

Establishment of a Dissolution Determination Method for Procaterol Hydrochloride Tablets and Evaluation of Consistency with Original Tablets

Objective: To establish a new method for determining the dissolution degree of procaterol hydrochloride tablets, and evaluate the consistency of the dissolution behavior of generic tablets and original tablets. Methods: The dissolution was determined by HPLC with a paddle method and a fixed rotating speed of 50 r·min-1. According to the requirement of drug consistency evaluation, the dissolution behaviors of generic tablets and original tablets were investigated respectively. Results: The established method had the advantages of reasonable determination conditions, wide applicability and simple operation. In five different dissolution media, the cumulative amount of dissolution of three batches of generic and original tablets were all more than 85% in 15 min, indicating a rapid dissolution. Additionally, the dissolution profiles were similar. Conclusion: The new method is suitable for the dissolution determination of procaterol hydrochloride tablets, and can provide a reference for its quality consistency evaluation.