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Practical,regulatory and clinical considerations for development of inhalation drug products 被引量:8
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作者 Shuguang Hou Jiangyue Wu +1 位作者 Xu Li Hong Shu 《Asian Journal of Pharmaceutical Sciences》 SCIE CAS 2015年第6期490-500,共11页
The formulation and device collectively constitute an inhalation drug product.Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical... The formulation and device collectively constitute an inhalation drug product.Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treatment instruction.From the points of formulation,device and patient use,this article summarizes the inhalation drugs,including pressurized metered dose inhaler(pMDI),dry powder inhaler(DPI),and nebulizer that are currently available in the US and UK markets.It also discusses the practical considerations for the development of inhalers and provides an update on the corresponding regulations of the FDA(U.S.Food and Drug Administration)and the EMA(European Medicines Agency). 展开更多
关键词 Pressurized metered dose inhaler(pmdi) Dry powder inhaler(DPI) NEBULIZER FORMULATION Device Clinical application
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高效液相色谱法测定鲑鱼降钙素混悬型气雾剂的含量 被引量:1
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作者 吴涵 陈龙楷 +2 位作者 单紫筠 潘昕 吴传斌 《中国药业》 CAS 2014年第19期42-44,共3页
目的建立测定鲑鱼降钙素混悬型气雾剂中鲑鱼降钙素含量的高效液相色谱法。方法采用Phenomenex Jupiter C18300ù色谱柱(250 mm×4.6 mm,5 μm),流动相A(0.02 mol/L四甲基氢氧化铵,pH=2.5)、流动相B(乙腈)进行二元梯度洗脱... 目的建立测定鲑鱼降钙素混悬型气雾剂中鲑鱼降钙素含量的高效液相色谱法。方法采用Phenomenex Jupiter C18300ù色谱柱(250 mm×4.6 mm,5 μm),流动相A(0.02 mol/L四甲基氢氧化铵,pH=2.5)、流动相B(乙腈)进行二元梯度洗脱,流速为1.0 mL/min,紫外检测波长为220 nm,柱温为40℃。结果鲑鱼降钙素质量浓度在0.8~50 μg/mL范围内与峰面积成良好线性关系,回归方程为A=4.5087×104ρ-7.3948×103,r=0.9997(n=7),加样回收率为98.24%,RSD为1.18%。测得鲑鱼降钙素混悬型气雾剂中鲑鱼降钙素平均含量为每瓶1.41 mg。结论该法准确、可靠、操作简便,适用于鲑鱼降钙素混悬型气雾剂的含量测定。 展开更多
关键词 鲑鱼降钙素 压力定量气雾剂 高效液相色谱法 含量测定
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