2015年版《中国药典》含片溶化性检查方法调整的回顾

目的：回顾2015年版《中国药典》修订过程中，如何为统一建立中药与化学药品种含片溶化性的检查方法所提供可靠科学实验数据，为完善药典通则方法的整合提供依据。方法：收集市售含片样品，按崩解时限进行测定，制定合理限度。结果：收集含片样品324批，其中中药品种127批，化学药品种197批，所有样品按崩解时限检查法测定，结果68批在5~10 min崩解，189批在10~30 min崩解，67批崩解时间大于30 min。结论：中药与化学药品种的含片溶化性无明显差异，可统一制定一致的限度，为2015年版《中国药典》中含片溶化性检查方法修订提供了详实依据。

Review of the Adjustment of Lozenge Dissolution Test in the Chinese Pharmacopoeia 2015 Edition

Objective: To review the revision process of the 2015 edition of the Chinese Pharmacopoeia, and to provide a reliable experimental basis for the establishment of unified dissolubility test method for lozenges of traditional Chinese medicines and chemical drugs. Methods: Commercially available samples were collected and tested according to the method of disintegration determination to establish a reasonable time limit. Results: A total of 324 batches of samples were collected, including 127 batches of traditional Chinese medicine and 197 batches of chemical drugs, all the samples were tested for disintegration and the results showed that 68 batches disintegrated in 5-10 min, 189 batches in 10-30 min and 67 batches in more than 30 min. Conclusion: There is no significant difference of dissolubility in lozenges between traditional Chinese medicines and chemical drugs, and the same time limit can be established uniformly.