各种藻酸盐基筏形抗酸产品的理化性质比较研究

Hemali Savla, Isha Naik, Chandrashekhar Gargote, Nischal Shashidhar, Sneha G. Nair, M. Menon
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摘要

背景:以海藻酸盐为基础,具有抑制反流活性的筏形抗酸产品是一种复杂的配方,有望实现有效的筏形形成,并导致酸袋的消除或移位,这通常表现在胃食管反流病(GERD)中。方法:在本研究中,对印度市场上销售的六种海藻酸盐基筏板成型产品的酸中和性能、强度、回弹性以及筏板的结构和热性能进行了比较。还测定了海藻酸盐含量的百分比。结果:与含有铝基和镁基抗酸剂的产品相比,含有钙基抗酸剂的产品在加入模拟胃液(SGF)后几秒钟内形成了体积大、多孔和漂浮的筏子。不同产品的酸中和能力值差异不明显。未观察到ANC与成筏能力或中和持续时间之间的相关性。木筏结构影响了它们的中和剖面。木筏具有多孔性和吸水性,可能是由于被困抗酸剂的释放而保留了ANC。此外,只有两种产品的强度超过了英国药典规定的不小于7.5 g。6个产品中有3个产品的海藻酸钠含量在标准范围内(85-115%)。结论:高海藻酸盐含量和钙基抗酸剂的筏形配方比低海藻酸盐含量或铝基或镁基抗酸剂的筏形配方具有更好的理化性能,如ANC、中和曲线、筏形强度和筏形回弹性。
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Physicochemical properties of various alginate-based raft-forming antacid products: a comparative study
Background: Alginate-based, raft-forming antacid products with reflux suppressant activity are complex formulations expected to achieve effective raft formation and cause elimination or displacement of the acid pocket, which is typically manifested in gastroesophageal reflux disease (GERD).Methods: In the present study, six alginate-based raft-forming products commercially available in the Indian market were compared in terms of their acid neutralization properties, strength, resilience and structural and thermal properties of their rafts. Percent alginate content was also determined.Results: Rafts of products containing calcium-based antacids formed voluminous, porous and floating rafts within seconds of addition to the simulated gastric fluid (SGF) compared with the products that contained aluminium and magnesium-based antacids. Marked differences were not evident in the ANC (acid neutralization capacity) values of the various products. No correlation was observed between ANC and raft-forming capacity or duration of neutralization. Raft structures affected their neutralization profiles. Rafts of porous and absorbent nature could retain their ANC probably due to release of trapped antacids. Further, raft strengths of only two products were above the British Pharmacopoeia specification of not less than 7.5 g. Sodium alginate content was within specifications (85-115%) for three of the six products.Conclusions: Raft-forming formulations with higher alginate content and calcium-based antacids have better physicochemical properties such as ANC, neutralization profiles, raft strength and raft resilience than those with lower alginate content or those containing aluminium or magnesium-based antacids.
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