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尼莫地平临床上主要用于防治缺血性脑血管疾病．该药为难溶性药物，生物利用度低，本文采用了固体分散技术制备了尼莫地平两种固体分散物，其体外溶出速率１０分钟以内达８０％以上，较市售片有显著提高．两种固体分散物中，固体分散物Ⅰ为本实验室研制，固体分散物Ⅱ参照国内、外文献用ＰＶＰ为载体制备．两种固体分散物均能明显提高尼莫地平的体外溶出速率，但固体分散物Ⅱ易于老化，经相对湿度ＲＨ７５％４０℃贮藏３个月溶出速率明显下降，同样条件下，固体分散物Ⅰ则无明显变化．二种固体分散物Ｘ－射线衍射图谱表明尼莫地平以非晶体状态存在，而在ＲＨ７５％４０℃条件下放置３个月后，固体分散物ⅡＸ－射线衍射图谱出现了尼莫地平结晶峰．
Nimodipine mainly for the prevention and treatment of ischemic cerebrovascular disease. The drug is a poorly soluble drug with low bioavailability. In this paper, two solid dispersions of nimodipine were prepared by solid dispersion technique. The dissolution rate of nimodipine in vitro was more than 80% in 10 minutes, which was significantly higher than that of the commercially available tablets. The two solid dispersions, the solid dispersion I developed for the laboratory, with reference to domestic and foreign solid dispersion II prepared with PVP as a carrier. Both solid dispersions can significantly improve the dissolution rate of nimodipine in vitro, but the solid dispersions Ⅱ are easy to aging. The dissolution rate of the solid dispersions Ⅱ is obviously decreased after being stored at 40 ℃ for 3 months under the relative humidity of 75% RH. Under the same conditions, No significant changes. The X-ray diffraction patterns of the two solid dispersions showed that nimodipine was present in an amorphous state, whereas the X-ray diffraction pattern of solid dispersion II showed a nimodipine crystallization peak after 3 months at RH75% 40C.