Several studies confirmed a correlation between elevated hydrogen peroxide (H₂O₂) levels in patients with intestinal bowel diseases (IBD) and the negative effects caused by its presence. The objective of this study was to explore the potential use of catalase (CAT) to diminish the level of H₂O₂ and its deleterious action on intestinal mucosa. Oral dosage forms of a CAT bioactive agent targeted to the intestines were designed and tested in various simulated gastric and intestinal media. Monolithic tablets (30% loading) were prepared using commercial CarboxyMethylCellulose (CMC) or synthesized CarboxyMethylStarch (CMS) and TriMethylAmineCarboxyMethylStarch (TMACMS) as matrix-forming excipients. For starch derivatives, the presence of the ionic groups (carboxymethyl and trimethylamine) was validated by spectral analysis. In vitro studies have shown that tablets formulated with TMACMS and 30% CAT resisted the acidity of the simulated gastric fluid and gradually released the enzyme into the simulated intestinal fluid. The investigation of the CAT release mechanism revealed the role of anionic and cationic groups of polymeric excipients and their involvement in the modulation of the CAT dissolution profile. The proposed drug delivery system can be considered an efficient solution to target CAT release in the intestine and contribute to the reduction of H₂O₂ associated with intestinal inflammation.

中文翻译：

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用于肠道靶向递送的过氧化氢酶整体片剂的设计

几项研究证实了肠道肠疾病（IBD）患者的过氧化氢（H ₂ O ₂）水平升高与其存在引起的负面影响之间存在相关性。这项研究的目的是探讨过氧化氢酶（CAT）减少H ₂ O ₂含量的潜在用途。及其对肠粘膜的有害作用。在各种模拟的胃和肠介质中设计和测试了靶向肠道的CAT生物活性剂的口服剂型。使用市售的羧甲基纤维素（CMC）或合成的羧甲基淀粉（CMS）和TriMethylAmineCarboxyMethylStarch（TMACMS）作为形成基质的赋形剂制备单片片剂（30％载量）。对于淀粉衍生物，通过光谱分析验证了离子基团（羧甲基和三甲胺）的存在。体外研究表明，用TMACMS和30％CAT配制的片剂可抵抗模拟胃液的酸性，并逐渐将酶释放到模拟肠液中。对CAT释放机理的研究揭示了聚合物赋形剂中阴离子和阳离子基团的作用及其在CAT溶出度曲线调节中的作用。拟议的药物输送系统可以被认为是靶向肠道中CAT释放并有助于减少H的有效解决方案₂ O ₂与肠道炎症有关。