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目的测定尼莫地平脂肪乳干乳的体外溶出度,并比较其与尼莫地平进口片、尼莫地平脂肪乳、尼莫地平国产片及国产胶囊的体外溶出度差异。方法以紫外分光光度法作为定量方法,以人工胃液为溶出介质,采用转篮法测定溶出度。以相似因子法评价尼莫地平脂肪乳干乳的溶出度。结果尼莫地平脂肪乳干乳、尼莫地平脂肪乳和进口片的溶出度明显高于尼莫地平国产片和国产胶囊的溶出度,尼莫地平干乳的溶出度与尼莫地平脂肪乳和尼莫地平进口片的溶出度均相似,且与尼莫地平脂肪乳的相似程度更高。尼莫地平干乳的溶出度与国产片和国产胶囊的溶出度均不相似。结论尼莫地平干乳明显优于国产片和国产胶囊,而与进口片质量相似。
OBJECTIVE To determine the dissolution rate of nimodipine emulsion in vitro and to compare its in vitro dissolution with nimodipine tablet, nimodipine emulsion, nimodipine tablet and domestic capsule. Methods UV spectrophotometry as a quantitative method to artificial gastric juice as the dissolution medium, using spin basket method for the determination of dissolution. The similarity factor method was used to evaluate the dissolution of nimodipine emulsion. Results The dissolution rate of nimodipine emulsion, nimodipine emulsion and imported tablets was significantly higher than that of nimodipine-made tablets and domestic capsules. The dissolution rate of nimodipine dry milk and nimodipine emulsion and The dissolution profiles of nimodipine tablets were similar and were similar to those of nimodipine fat emulsion. The dissolution rate of nimodipine dry milk is not similar to the dissolution rate of domestic and domestic capsules. Conclusion Nimodipine dry milk is obviously superior to domestic and domestic capsules, but similar to imported tablets.