Nur Azizah, Noval Noval, Putri Vidiasari Sudarsono
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摘要

抗高血压药物经历首过代谢,因此口服生物利用度较低。它导致药物使用频率增加和浓度波动,影响患者的舒适度。选择缓释片制剂是因为它能释放活性物质,而且生物利用度好。芹菜提取物是一种有效的降压物质,因为它含有黄酮类化合物,所以用黄原胶和硬脂酸镁制成缓释片,以达到恒定和可控的释放速度。本研究旨在了解不同浓度黄原胶和硬脂酸镁对芹菜提取物缓释片的评价结果,并得出最佳处方。片剂的生产采用直接压片法。粉末的评价包括通过漏斗的流动特性,休止角,压缩指数和水分含量。片剂评价包括感官、重量均匀性、大小均匀性、硬度、脆性、崩解时间和溶出度试验。评价结果数据采用单纯形点阵设计进行分析。各配方的粉体评价结果均满足漏斗流动性能、休止角、压缩系数、含水率等指标的要求。理化评价结果表明,制剂均符合重量均匀性、硬度和脆性试验的要求。在粒度均匀性测试中,所有配方均不符合要求。崩解时间试验结果表明,F1不符合要求。同时,溶出度试验结果表明,以F4为最佳配方,其释放速度稳定可控。采用单纯形点阵法分析,以黄原胶52 mg、硬脂酸镁3 mg为最优配方。
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Optimasi Formulasi Tablet Lepas Lambat Ekstrak Seledri (Apium graveolens L.) Menggunakan Polimer Xanthan Gum dan Lubrikan Magnesium Stearat dengan Metode Simplex Lattice Design (SLD)
Antihypertensive drugs undergo first-pass metabolism and therefore have low oral bioavailability. It causes an increase in the frequency of drug use and concentration fluctuations that affect patient comfort. The sustained release tablet formulation was chosen because it can deliver the active substance with good bioavailability. An active antihypertensive substance that can be used is celery extract because it contains flavonoids, so a sustained release tablet formulation was made using xanthan gum and magnesium stearate to produce a constant and controlled release rate. This study aims to knowing the results of celery extract sustained release tablet evaluation using different concentrations of xanthan gum and magnesium stearate, and also obtains the optimal formulation. The manufacture of tablets uses the direct compression method. Powder evaluations include flow property through a funnel, angle of repose, compressibility index, and moisture content. Tablet evaluations include organoleptic, weight uniformity, size uniformity, hardness, friability, disintegration time, and dissolution tests. The evaluation results data were analyzed using Simplex Lattice Design. The powder evaluation result of all formulations meets the requirements of flow property through a funnel, angle of repose, compressibility index, and moisture content. Physical evaluation of the tablets shows all formulations meet the requirement of weight uniformity, hardness, and friability tests. On the size uniformity test, all formulations do not meet the requirement. The disintegration time test results show that F1 does not meet the requirement. Meanwhile, the dissolution test results show that F4 is the best formula because it shows constant and controlled release rate. Based on analyzed using Simplex Lattice Design, the F4 is the most optimal formula with xanthan gum 52 mg and magnesium stearate 3 mg.
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