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胰酶制剂由于在质量标准、剂型和临床应用上还存在一些问题,因而影响到其生物利用度和临床疗效。本文提出:应当制定胰酶中蛋白酶、淀粉酶、脂肪酶的质量标准;应制订合理的胰酶制剂处方,并列举了国外制剂处方以供参考;应保证酶活力发挥的最适 pH 环境;根据在不同 pH 条件下肠溶衣片剂崩解时限测定结果及有关报道,认为胰酶制成肠溶衣制剂供临床应用是不合适的。
Pancreatin preparations, due to quality standards, dosage forms and clinical applications, there are still some problems, thus affecting its bioavailability and clinical efficacy. This paper proposes that the quality standards of protease, amylase and lipase in trypsin should be established, reasonable prescription of trypsin preparation should be made, and prescription of foreign preparation should be listed for reference. The optimal pH environment should be guaranteed for enzyme activity. Under different pH conditions enteric-coated tablet disintegration time-limited test results and reports that trypsin enteric-coated preparations for clinical application is not appropriate.