目的 建立全覆蓋抽樣的普伐他汀鈉片的近紅外光譜法一致性檢驗(yàn)?zāi)Ｐ?，考察制劑工藝的差別和原料藥晶型的差異，通過(guò)穩(wěn)健、準(zhǔn)確、代表性強(qiáng)的近紅外光譜一致性模型實(shí)現(xiàn)普伐他汀鈉片的快速檢驗(yàn)和篩查。方法 對(duì)評(píng)價(jià)性抽驗(yàn)抽取的5個(gè)企業(yè)中的4個(gè)共65批樣品建立普伐他汀鈉片近紅外一致性檢驗(yàn)?zāi)Ｐ?，并?duì)4個(gè)廠家的原料藥的近紅外光譜圖進(jìn)行比較。結(jié)果 建立了4個(gè)廠家普伐他汀鈉片劑的近紅外一致性模型，預(yù)測(cè)成功率均為100%；4種原料藥和1種無(wú)定型粉末的近紅外光譜圖顯示不同晶型光譜圖具有差異。結(jié)論 近紅外光譜法能夠用于快速鑒別質(zhì)量工藝穩(wěn)定的普伐他汀鈉片產(chǎn)品，對(duì)制劑工藝進(jìn)行考察，并能夠區(qū)分不同晶型的原料藥。

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.

國(guó)家重大新藥創(chuàng)制專項(xiàng)（2011ZX09303-001）