【信息】USP剂型分类的变化

清歌一曲月如霜

【信息】USP剂型分类的变化

Classification of Dosage Forms according to the USP

The USP classification ("Taxonomie") of pharmaceutical dosage forms is presented in an article of the USP Pharmacopeial Forum 39 (3). The USP categorises 5 different dosage forms:
Injections and implanted drug products (parenteral)注射和植入制剂（肠外给药）
Oral drug products口服制剂
Topical and transdermal drug products外用和透皮制剂
Mucosal drug products ( = dosage forms absorbed via the mucous membranes)粘膜给药制剂
Products for inhalation or nasal administration吸入或鼻腔给药制剂
The USP is currently elaborating a General Chapter for each of these 5 medicinal product groups. The fundamental
requirements can already be found in Chapter <1151> on pharmaceutical dosage forms. Moreover, it is planned to create additional chapters about the 5 product groups mentioned above - if this has not been done yet - among other things also regarding the quality requirements on these products and the relevant "Performance Tests" which are essential for each dosage form.
The article "Product Quality and Product Performance General Chapters" in PF 39 (3) clearly describes the planned
approach and the classification of the USP. The table at the end provides a good overview of each chapter and the current status of implementation.
More information can be found in the Pharmacopeial Forum.

清歌一曲月如霜

剂型分类根据USP

USP分类（“Taxonomie）药品剂型的USP药典论坛39（3）在一篇文章中提出。 USP分类5种不同剂型：
注射和植入药物产品的肠外注射和植入制剂（肠外给药）
口服药物口服制剂
外用药物的透皮产品外用和透皮制剂
粘膜的药物产品（=剂型通过粘膜吸收）粘膜给药制剂
吸入或鼻腔给药产品吸入或鼻腔给药制剂
USP正在制订这5个药用产品组总章。最根本的
要求已经可以发现在第二章<1151>药品剂型。此外，它计划创建额外的章节对上述的5组 - 如果这尚未完成 - 其中包括有关的质量要求对这些产品和相关的“性能测试”，这是必不可少的，每个剂型。
“产品质量和产品性能通则”清楚地描述了计划在PF39（3）
方法和分类的USP。表底提供了很好的概述每章实施的当前状态。
更多信息，可以发现在药典论坛。