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| 尼莫地平口服固体制剂溶出度的研究 | |
| 引用本文： | 李帅,李文莉,王斌,廖彬.尼莫地平口服固体制剂溶出度的研究[J].中南药学,2012,10(8):567-571. |
| 作者姓名： | 李帅 李文莉 王斌 廖彬 |
| 作者单位： | 1. 湖南省食品药品检验研究院,长沙410001;湖南中医药大学,长沙410208 2. 湖南省食品药品检验研究院,长沙,410001 3. 湖南药用辅料检验检测中心,长沙,410014 |
| 基金项目： | 国家药品评价抽验计划质量评价分析(No.2011067) |
| 摘 要： | 目的 测定尼莫地平口服固体制剂在不同溶出介质中的溶出度,并对测定方法进行评价.方法 采用0.25％十二烷基硫酸钠(SDS)、水、pH=1.2人工胃液、pH=4.5醋酸盐缓冲液、pH=6.8磷酸盐缓冲液作为溶出介质,测定尼莫地平的溶出度并绘制曲线.结果 尼莫地平片在含0.25％ SDS溶出介质中的溶出度与生物利用度不相关,而在其他溶出介质具有一定的相关性.结论 SDS掩盖了该制剂内在品质的表达,不能反映该制剂在体内的溶出情况;中国药典收载的溶出度方法可能难以满足本品的测定需要. |
| 关 键 词： | 尼莫地平 溶出度 溶出曲线 溶出介质 体内外相关 |
Dissolution of nimodipine oral solid preparation |
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| LI Shuai , LI Wen-li , WANG Bin , LIAO Bin.Dissolution of nimodipine oral solid preparation[J].Central South Pharmacy,2012,10(8):567-571. | |
| Authors: | LI Shuai LI Wen-li WANG Bin LIAO Bin |
| Institution: | 1.Hunan Institute for Food and Drug Control,Changsha 410001;2.Hunan University of Chinese Medicine,Changsha 410208;3.Hunan Pharmaceutical Excipients Testing and Inspection Center,Changsha 410001) |
| Abstract: | Objective To test the dissolution rate of nimodipine oral solid preparation in different media,and evaluate the test method.Methods SDS(0.25%),water,hydrochloric acid solution(pH=1.2),acetate buffer(pH=4.5),phosphate buffer(pH=6.8)were used as the dissolution media to test the dissolution rate and draw the dissolution curves.Results The dissolution rate of nimodipine oral solid preparation was not related to the bioavailability in 0.25% SDS,but related to other media.Conclusion SDS hides the intrinsic quality of nimodipine oral solid preparation,and this medium cannot reflect the real dissolution in vivo.The dissolution method in Chinese Pharmacopoeia may be difficult to meet the need of the determination. |
| Keywords: | nimodipine dissolution dissolution curve dissolution medium in vivo and in vitro correlation |
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