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硝酸甘油分光光度法(Fung)用于片剂的测定回收率仅为89.1±1.87,我们进一步系统研究了影响测定的各种因素,提出了回收率为100.8±1.16%的定量方法。用部分硝化法自行制备的低级硝酸酯证明,在1,3-二硝酸甘油、1,2-二硝酸甘油和单硝酸甘油等分解产物总量为完整主药硝酸甘油的5倍时,不干扰测定。方法操作方便、省时、灵敏度高,还适用于硝酸甘油片剂和药膜的含量均一性。测定时所需不含分解产物的硝酸甘油对照品(1%无水乙醇液)能依法制备,至少二年内稳定。方法:精密称取约相当于硝酸甘油1mg 的片剂细粉,加
The recoveries of the Fung for tablets were only 89.1 ± 1.87. We further studied systematically the various factors affecting the determination, and proposed a quantitative method with recovery of 100.8 ± 1.16%. The lower nitrates prepared by the partial nitration process prove that when the total amount of decomposition products such as 1,3-dinitropropanate, 1,2-dinitrate and mononitrate is five times as large as the complete main drug nitroglycerin Determination. The method has the advantages of convenient operation, time saving and high sensitivity, and is also applicable to the content uniformity of the nitroglycerin tablets and the medicinal film. Nitroglycerin (1% ethanol solution) containing no decomposition product required for the determination can be prepared according to the law and is stable for at least two years. Methods: Precision weighing about equivalent to 1mg of nitroglycerin tablets powder, plus