目的 建立全覆盖抽样的普伐他汀钠片的近红外光谱法一致性检验模型，考察制剂工艺的差别和原料药晶型的差异，通过稳健、准确、代表性强的近红外光谱一致性模型实现普伐他汀钠片的快速检验和筛查。方法 对评价性抽验抽取的5个企业中的4个共65批样品建立普伐他汀钠片近红外一致性检验模型，并对4个厂家的原料药的近红外光谱图进行比较。结果 建立了4个厂家普伐他汀钠片剂的近红外一致性模型，预测成功率均为100%；4种原料药和1种无定型粉末的近红外光谱图显示不同晶型光谱图具有差异。结论 近红外光谱法能够用于快速鉴别质量工艺稳定的普伐他汀钠片产品，对制剂工艺进行考察，并能够区分不同晶型的原料药。

Objective To develop near-infrared spectroscopy (NIRS) uniformity models for sampling of Pravastatin Sodium Tablets from overall manufactures in Chinese market, to evaluate the uniformity of Pravastatin Sodium Tablets and their active pharmaceutical ingredients, and provide robust, accurate, and representative uniformity models. Methods NIRS models for 65 batches of tablets were built for four individual manufactures from five manufactures. The active pharmaceutical ingredients form the four manufactures and an amorphous powder were investigated by comparing NIR spectrum. Results Uniformity Models for the four different manufactures were built with prediction rate 100%, respectively. The spectra of four active pharmaceutical ingredients and an amorphous powder showed differences in various crystallographic forms of NIRS. Conclusion It demonstrates the potential of NIRS being a rapid and highly effective method for the identification of Pravastatin Sodium Tablats, the investigation of their preparation process, and the discrimination of the active pharmaceutical ingredients from their various crystallographic forms.

国家重大新药创制专项（2011ZX09303-001）