| 周颖,魏宁漪,林兰,宁保明.沙美特罗替卡松吸入粉雾剂递送剂量均一性的测定[J].中国药品标准,2018,19(3):180-186 |
| 沙美特罗替卡松吸入粉雾剂递送剂量均一性的测定 |
| Determination of the Delivered Dose Uniformity of Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation by DUSA Method |
| 投稿时间：2018-02-13 修订日期：2018-06-08 |
| DOI： |
| 中文关键词: 粉雾剂 昔萘酸沙美特罗 丙酸氟替卡松 递送剂量均一性 含量均匀度 排空率 |
| 英文关键词: Dry powder inhaler Salmeterol xinafoate Fluticasone propionate Delivered dose uniformity Uniformity of dosage units Emptying rate |
| 基金项目:国家重大新药创制,化药制剂质量评价关键技术研究,吸入制剂有效性评价方法研究(2015ZX093001002009)第一 |
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| 中文摘要: |
| 目的：使用递送剂量均一性测定装置(DUSA管)方法对沙美特罗替卡松吸入粉雾剂的递送剂量均一性进行研究。分析和比较递送剂量均一性与排空率和含量均匀度数据的区别与关系。方法: 沙美特罗替卡松吸入粉雾剂连接DUSA管,调节真空泵控制空气流速为90L/min,采用高效液相色谱法测定9批样品的递送剂量均一性。结果:采用DUSA管方法测定了沙美特罗替卡松吸入粉雾剂中沙美特罗及氟替卡松的递送剂量均一性,并与排空率及含量均匀度测定结果比较。结论:与排空率及含量均匀度相比,DUSA管法测定递送剂量均一性,更符合患者用药的实际剂量。 |
| 英文摘要: |
| Objective: To Characterize and compare delivered dose uniformity profiles by using dosage unit sampling apparatus (DUSA), uniformity of dosage units and emptying rate. Method: Salmeterol xinafoate and fluticasone propionate powder for inhalation was connected with DUSA through an adaptor, and the flow rate was controlled at 90L/min by a vacuum pump. An HPLC method was utilized for the determination of salmeterol xinafoate and fluticasone propionate. The delivered dose uniformity of salmeterol xinafoate and fluticasone propionate powder for inhalation was measured by DUSA. Results: The contents per actuation of 9 batches of samples were determined. The results of salmeterol and fluticasone were less than the contents determined by the current official method. Conclusion: Delivered dose uniformity are more precised method for assessment of the quality of DPI compared with uniformity of dosage units and emptying rate. |
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