论文部分内容阅读
制备对乙酰氨基酚固体分散体,采用拉曼光谱法与经典方法进行验证,以期获得一种新的简单易行的固体分散体的验证方法。以聚乙二醇6000(PEG6000)为载体,用熔融法和溶剂-熔融法制备对乙酰氨基酚固体分散体,在457.5 nm激发波长下扫描得到其拉曼光谱、10～90°(2θ)范围扫描获得X-射线粉末衍射图,经KBr压片后,在400 cm-1～4000 cm-1范围内扫描得到傅里叶变换红外光谱(FT-IR)图,分别分析固体分散体与药物、载体和物理混合物的差别,验证固体分散体的形成。两种方法制备的固体分散体中对乙酰氨基酚可能均以分子、无定形和微晶状态分散,三种鉴别方法得到的结果一致。通过X-射线衍射法和红外光谱法佐证了拉曼光谱法在用于对乙酰氨基酚固体分散体验证中的可行性,而且拉曼光谱法简单易行,是一种新的验证固体分散体形成的物相鉴别方法,也是一种理想的、很有前景的分析方法。
Acetaminophen solid dispersion was prepared by Raman spectroscopy and classical methods to verify, in order to obtain a new simple and easy solid dispersion validation method. The solid dispersion of paracetamol was prepared by melting method and solvent - melting method with polyethylene glycol 6000 (PEG6000) as carrier, and its Raman spectrum was scanned at 457.5 nm excitation wavelength. The range of 10 ~ 90 ° (2θ) X-ray powder diffraction (XRD) patterns were obtained after scanning with KBr. Fourier transform infrared (FT-IR) spectra were obtained in the range of 400 cm-1 to 4000 cm-1. The difference between the carrier and the physical mixture verifies the formation of the solid dispersion. Acetaminophen may disperse in molecular, amorphous and microcrystalline state in the solid dispersions prepared by the two methods. The results obtained by the three methods are the same. The feasibility of Raman spectroscopy in the validation of acetaminophen solid dispersions was demonstrated by X-ray diffraction and infrared spectroscopy, and Raman spectroscopy is a simple and convenient method to validate solid dispersions The formation of the phase identification method, but also an ideal, very promising analytical methods.