【摘 要】
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考察了在溶出度试验中采用近红外光谱法(NIRS)监测药物溶出行为的可行性,以期为药品质量控制提供更多的替代方法。以包含叶酸和4种辅料的速释片为模型进行溶出试验,试验条件
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考察了在溶出度试验中采用近红外光谱法(NIRS)监测药物溶出行为的可行性,以期为药品质量控制提供更多的替代方法。以包含叶酸和4种辅料的速释片为模型进行溶出试验,试验条件为:采用欧洲药典收载的桨法(apparatus 2),1 L溶出杯中装入Milli-Q水500 ml为溶出介质,温度(37±0.5)℃,转速50 r/min。NIRS原位测定是通过在傅里叶变换红外光谱仪上连接一个透反射探头,从而得到红外光谱。采用偏最小二乘
The feasibility of monitoring drug dissolution behavior by near infrared spectroscopy (NIRS) in the dissolution test was investigated in order to provide more alternatives for drug quality control. The dissolution test was carried out on the immediate release tablets containing folic acid and four excipients under the following conditions: apparatus 2 loaded with European Pharmacopoeia, 500 ml of Milli-Q water as the dissolution medium in a 1 L vessel, , Temperature (37 ± 0.5) ℃, speed 50 r / min. In situ measurements of NIRS are made by attaching a transreflective probe to a Fourier transform infrared spectrometer to obtain the infrared spectrum. Partial least squares
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