Background

Pancreatic enzyme-replacement therapy (PERT), provided as pancreatin to patients with pancreatic exocrine insufficiency (PEI), is considered an essential substitute for the pivotal physiological function the pancreas fulfills in digestion. PEI involves a reduction in the synthesis and secretion of pancreatic enzymes (lipase, protease, amylase), which leads to an inadequate enzymatic response to a meal and consequently to maldigestion and malabsorption of nutrients. The efficacy of PERT is strongly dependent on enzyme activity, dissolution, and pancreatin particle size.

Objective

The physiological properties of eight pancreatin preparations (nine batches; five different brands) available in Russia and CIS (Commonwealth of Independent States: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan) were investigated.

Methods

The lipase activity, dissolution, and particle size distribution of samples from multiple batches of pancreatin of different strengths were measured.

Results

Regarding lipase activities, all pancreatin preparations except Micrazim® matched the labeled content. Considerable differences were observed in particle size and dissolution.

Conclusion

Pancreatin preparations available in Russia and CIS demonstrate product-to-product and batch-to-batch variability regarding the measured properties of lipase activity, dissolution, and particle size. This may impact the efficacy of PERT and therefore clinical outcomes.

中文翻译：

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俄罗斯和独联体销售的用于治疗胰腺外分泌功能不全的胰酶制剂的体外特性差异

背景

胰腺酶替代疗法 (PERT) 作为胰酶提供给胰腺外分泌功能不全 (PEI) 患者，被认为是胰腺在消化过程中发挥的关键生理功能的重要替代品。PEI 涉及胰酶（脂肪酶、蛋白酶、淀粉酶）​​的合成和分泌减少，这导致对膳食的酶促反应不足，从而导致营养物质的消化不良和吸收不良。PERT 的功效在很大程度上取决于酶活性、溶解度和胰酶粒径。

客观的

研究了俄罗斯和独联体（独联体：亚美尼亚、阿塞拜疆、白俄罗斯、哈萨克斯坦、吉尔吉斯斯坦、摩尔多瓦、俄罗斯、塔吉克斯坦、乌兹别克斯坦）供应的八种胰酶制剂（九个批次；五个不同品牌）的生理特性。

方法

测量了多批不同浓度的胰酶样品的脂肪酶活性、溶解度和粒度分布。

结果

关于脂肪酶活性，除 Micrazim® 外的所有胰酶制剂均与标记含量相符。在粒径和溶解度方面观察到了相当大的差异。

结论

俄罗斯和独联体可用的胰酶制剂在脂肪酶活性、溶出度和粒径的测量特性方面表现出产品间和批次间的差异。这可能会影响 PERT 的疗效，从而影响临床结果。