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硝酸甘油片的质量研究是药剂学和药物分析的一个十分引人注目的课题。其质量影响因素颇多,硝酸甘油本身的纯度和辅料的选择是很重要的,容器、填充料等也有一定影响。国外产品的有效期较长,如美国Parke-Davis公司的产品(商品名Nitrostat)有效期为5yr;而国内产品的有效期仅定的1yr,这对经销、保管和使用带来诸多不便。硝酸甘油片的质量指标中,含量和含量匀度检查是很关键的;若要对批次较多的样品进行以上项目的考查,则快速、准确的测定方法是必须的。1985年版《中国药典》规定的苯酚二磺酸比色法比较费事费时,不便进行较大量的测试工作。美国药典(XXI)的第五补充本将含量及含量均匀度检查由比色法改为HPLC法(外标法计算结果)。我们也曾报道
The study of the quality of nitroglycerin tablets is a very compelling subject for pharmacy and drug analysis. The quality of many influencing factors, the purity of nitroglycerin itself and the choice of accessories is very important, containers, fillers, also have a certain impact. Foreign products are valid for a long time, such as the United States Parke-Davis company’s products (brand name Nitrostat) is valid for 5yr; while the domestic product is only valid for 1yr, which distribution, storage and use of a lot of inconvenience. Nitroglycerin tablets quality indicators, the content and content of the degree of uniformity is critical; to batch more samples for the examination of the above items, the rapid and accurate determination of the method is necessary. Phenol disulfonic acid colorimetric method stipulated in the 1985 edition of “Chinese Pharmacopoeia” is relatively time-consuming and inconvenient for a large amount of testing. The fifth edition of the US Pharmacopoeia (XXI) changed the content and content uniformity from colorimetric method to HPLC method (calculated by external standard method). We have also reported