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利用废蛋壳粉作为辅料制备维生素D3片剂

Utilization of Waste Eggshell Powder as an Excipient for Vitamin D3 Tablet Preparation.

作者信息

Haq Nazrul, Ibrahim Mohamed Abbas, Alsarra Ibrahim A, Alshehri Sultan, Alam Prawez, Shakeel Faiyaz

机构信息

Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.

Department of Pharmaceutical Sciences, College of Pharmacy, AlMaarefa University, P.O. Box 71666, Ad Diriyah 13713, Saudi Arabia.

出版信息

ACS Omega. 2024 Jan 11;9(3):3980-3987. doi: 10.1021/acsomega.3c08416. eCollection 2024 Jan 23.

Abstract

Keeping in mind the health scenario in Kingdom of Saudi Arabia with respect to vitamin D3 (VD3) deficiency and its significant role in calcium homeostasis and human metabolism, this research is exploring the combination of eggshell (as a source of calcium) and VD3 as a very economical solution for this problem. Eggshells from local restaurant were collected, washed, ground, sieved, and characterized by Fourier transforms infrared spectroscopy (FTIR), scanning electron microscopy (SEM), differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Brunauer-Emmett-Teller (BET) techniques. The results of FTIR, SEM, DSC, XRD, and BET indicate that eggshell powder (ESP) was properly processed. Directly compressed tablets containing 2.5 mg of VD3 (equivalent to 50,000 IU), that are based on the use of ESP as tablet filler, were manufactured based on mixing Avicel PH 101 with ESP in different ratios (9:1, 1:1, and 1:9) in addition to the use of both Avicel PH 101 and ESP alone as tablet filler. Tablets properties were evaluated according to USP30-NF25 pharmacopoeia tests in terms of weight variation test, drug content uniformity, tablet hardness, tablet friability, tablet disintegration, and in vitro dissolution profile. The VD3 contents were found to be 98.77-102.35% in all formulations. After 90 min of study, all formulations showed in vitro drug release content in the range of 99.29-101.05%. All of the tested parameters of ESP tablets were similar to those of commercial Avicel PH 101. All of the tested properties of tablets with ESP as a filler were found to be within the acceptable limits of the pharmacopeia recommendations. Therefore, ESP could be exploited for its use as a filler in direct compression tablets.

摘要

考虑到沙特阿拉伯王国维生素D3(VD3)缺乏的健康状况及其在钙稳态和人体新陈代谢中的重要作用,本研究正在探索将蛋壳(作为钙源)和VD3结合起来,作为解决这一问题的非常经济的方案。收集当地餐馆的蛋壳,进行清洗、研磨、筛分,并通过傅里叶变换红外光谱(FTIR)、扫描电子显微镜(SEM)、差示扫描量热法(DSC)、X射线衍射(XRD)和布鲁诺尔-埃米特-泰勒(BET)技术进行表征。FTIR、SEM、DSC、XRD和BET的结果表明蛋壳粉(ESP)已得到妥善处理。以ESP作为片剂填充剂,制备了含2.5mg VD3(相当于50,000IU)的直接压片,除了单独使用Avicel PH 101和ESP作为片剂填充剂外,还将Avicel PH 101与ESP按不同比例(9:1、1:1和1:9)混合使用。根据美国药典30-国家处方集25的药典测试,从重量差异测试、药物含量均匀度、片剂硬度、片剂脆碎度、片剂崩解度和体外溶出曲线等方面对片剂性质进行了评估。所有制剂中的VD3含量均为98.77-102.35%。经过90分钟的研究,所有制剂的体外药物释放含量在99.29-101.05%范围内。ESP片剂的所有测试参数与市售Avicel PH 101的参数相似。以ESP作为填充剂的片剂的所有测试性质均在药典建议的可接受范围内。因此,ESP可作为直接压片中的填充剂加以利用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d1b2/10810005/240d649a220d/ao3c08416_0001.jpg

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