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利用单纯形-重心混合设计优化一种用于胃肠道耐受性的益生菌片剂。

Design and optimization of a probiotic tablet for gastrointestinal tolerance by a simplex-centroid mixture.

机构信息

Faculty of Chemical and Process Engineering Technology, Universiti Malaysia Pahang, Lebuhraya Tun Razak, Kuantan, Malaysia.

出版信息

Drug Dev Ind Pharm. 2021 Feb;47(2):189-196. doi: 10.1080/03639045.2020.1862176. Epub 2020 Dec 16.

Abstract

In this study, a simplex-centroid mixture design using design of experiment (DOE) software was implemented to evaluate the effect of biopolymers as excipients, which are hydroxypropyl methylcellulose, and alginate, on the gastrointestinal tolerance of probiotic tablet containing . Microbial viability and dissolution time were used to evaluate the ideal formulation made using 39.01% carboxymethylcellulose and 60.99% alginate as excipients, which protected the probiotics from the acidic condition in the stomach with good dissolution time. The formulated probiotic tablet is more stable in terms of viability when stored at 4 °C compared to room temperature. However, the viability remains above 10 CFU/tablet after six months of storage at room temperature. This study shows that the simplex-centroid mixture design is valid and can be used to formulate probiotic tablets that possess gastrointestinal tolerance. This study can lead to the development of commercial production of probiotic yeast tablets with gastrointestinal tolerance.

摘要

在这项研究中,使用实验设计(DOE)软件实施了单纯形质心混合物设计,以评估生物聚合物作为赋形剂的效果,这些赋形剂是羟丙基甲基纤维素和海藻酸钠,对含有益生菌片剂的胃肠道耐受性的影响。使用微生物存活率和溶解时间来评估使用 39.01%羧甲基纤维素和 60.99%海藻酸钠作为赋形剂的理想配方,该配方可以使益生菌免受胃酸的影响,并且具有良好的溶解时间。与室温相比,在 4°C 下储存时,配方益生菌片剂在存活率方面更稳定。然而,在室温下储存六个月后,其存活率仍保持在每片 10 CFU 以上。这项研究表明,单纯形质心混合物设计是有效的,可用于制备具有胃肠道耐受性的益生菌片剂。这项研究可以促进具有胃肠道耐受性的益生菌酵母片剂的商业生产。

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