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目的:比较六个厂家的尼莫地平片剂及胶囊剂的溶出度,从而考察其内在的质量。方法:按照中国药典2000年版二部附录中有关溶出度及分光光度法的规定,分别测定16批供试品在水、15％乙醇溶液、0.1 mol/L盐酸溶液、磷酸盐缓冲液(pH 6.8)4种溶出介质中的溶出度。结果:从16批供试品在水、15％乙醇溶液、0.1mol/L盐酸溶液、磷酸盐缓冲液(pH 6.8)4种溶出介质中的溶出度的结果,看尼达尔片在水、0.1mol/L盐酸溶液、磷酸盐缓冲液(pH6.8)3种溶出介质中的溶出度略高于进口产品,较明显高于其他国产品牌,在15％乙醇溶液的介质中,尼达尔片与其他5种样品的溶出量基本一致。结论:尼达尔片由于以特殊工艺方法制成,采用了先进的固体分散技术,使有效成分以分子状态进入载体网状骨架中,形成非结晶性无定形物,从而使溶出 度提高,使之在质量上与进口及国内其他产品相比占优势。
OBJECTIVE: To compare the dissolution of nimodipine tablets and capsules from six manufacturers in order to examine their intrinsic quality. Methods: According to the regulations of dissolution and spectrophotometry in appendix of 2000 edition of Chinese Pharmacopoeia, 16 batches of test samples were respectively tested in water, 15% ethanol solution, 0.1 mol / L hydrochloric acid solution, phosphate buffer solution Dissolution in 4 dissolution media. Results: The results of dissolution of 16 batches of samples in four dissolution media of water, 15% ethanol solution, 0.1 mol / L hydrochloric acid solution and phosphate buffer solution (pH 6.8) mol / L hydrochloric acid solution, phosphate buffer solution (pH6.8) three dissolution medium slightly higher than the dissolution of imported products, more significantly higher than other domestic brands in the medium of 15% ethanol solution, The other five samples of the dissolution of the same. Conclusion: Due to the special process, the Nidal tablets have adopted the advanced solid dispersion technology to make the effective components enter into the carrier network skeleton in the molecular state to form the non-crystalline amorphous substance, so as to improve the dissolution rate. In terms of quality and imports and other domestic products dominated.