Otte M, Ridder P, Dageförde J
Klinik für Innere Medizin, Medizinische Universität zu Lübeck.
Dtsch Med Wochenschr. 1987 Sep 25;112(39):1498-502. doi: 10.1055/s-2008-1068278.
In-vitro activity of 14 commercial pancreatin preparations, commonly used in the Federal Republic of Germany, were tested. All had been declared by their manufacturers to contain more than 6000 FIP (Fédération International Pharmaceutique) units of lipase and to be acid resistant. The declared lipase and amylase amounts were found to be present in 11 of the 14 preparations. Three of the 14 preparations, said to be acid resistant were found not to be so in buffer with falling pH values between 4.0 and 2.5, so that there occurred an, at times marked, loss of enzyme activity. Most noticeable was the poor solubility of most preparations at pH 6.6. Only three of the 14 liberated their total enzyme content within 60 minutes, as they should for theoretical reasons, based on the relatively short duodeno-cecal transit time.
对德意志联邦共和国常用的14种市售胰酶制剂进行了体外活性测试。所有产品的制造商均宣称其脂肪酶含量超过6000 FIP(国际制药联合会)单位且耐酸。结果发现,14种制剂中有11种的脂肪酶和淀粉酶含量与宣称相符。14种制剂中据称耐酸的3种在pH值在4.0至2.5之间下降的缓冲液中并非如此,导致酶活性有时显著丧失。最值得注意的是,大多数制剂在pH 6.6时溶解度较差。基于十二指肠至盲肠相对较短的转运时间,从理论上讲,14种制剂中只有3种在60分钟内释放出全部酶含量。