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采用不同技术的干酵母片的制剂与评价

Formulation and evaluation of dried yeast tablets using different techniques.

作者信息

Al-Mohizea Abdullah M, Ahmed Mahrous O, Al-jenoobi Fahad I, Mahrous Gamal M, Abdel-Rahman Aly A

机构信息

Department of Pharmaceutics, King Saud University, Riyadh, Saudi Arabia.

出版信息

Eur J Pharm Biopharm. 2007 Aug;67(1):253-9. doi: 10.1016/j.ejpb.2006.12.011. Epub 2006 Dec 23.

Abstract

The aim of this study was to prepare and evaluate dried yeast tablets using both direct compression and dry granulation techniques in comparison with the conventional wet granulation as well as commercial product. Wet granulation technique is not favorable for producing the yeast tablets due to the problems of color darkening and the reduction of the fermentation power of the yeast as a result of the early start of the fermentation process due to the presence of moisture. Twenty six formulae of dried yeast tablets were prepared and evaluated. Certain directly compressible vehicles were employed for preparing these tablets. The quality control tests (weight uniformity, friability, disintegration time and hardness) of the prepared dried yeast tablets were performed according to B.P. 1998 limits. All batches of the prepared tablets complied with the B.P. limits of weight uniformity. Moreover, small values of friability % (1% or less) were obtained for all batches of dried yeast tablets with acceptable hardness values, indicating good mechanical properties which can withstand handling. On the other hand, not all batches complied with the limit of disintegration test which may be attributed to various formulation component variables. Therefore, four disintegrating agents were investigated for their disintegrating effect. It was found that the method of preparation, whether it is direct compression, dry granulation or wet granulation, has an effect on disintegration time of these dried yeast tablets and short disintegration times were obtained for some of the formulae. The shortest disintegration time was obtained with those tablets prepared by direct compression among the other techniques. Therefore, the direct compression is considered the best technique for preparation of dried yeast tablets and the best formula (which showed shorter disintegration time and better organoleptic properties than the available commercial yeast tablets) was chosen. Drug content for dried yeast granular powder, and the chosen best prepared formula, was determined by gas chromatography (GC). It was found that this formula gave the same alcohol content produced by an equal amount of the dried yeast granular powder. This result in conjunction with weight uniformity indicated drug content uniformity of the prepared dried yeast tablets.

摘要

本研究的目的是采用直接压片和干法制粒技术制备并评估干酵母片,并与传统湿法制粒以及市售产品进行比较。由于存在水分导致发酵过程提前开始,从而出现颜色变深以及酵母发酵能力降低的问题,湿法制粒技术不利于制备酵母片。制备并评估了26种干酵母片配方。使用了某些可直接压片的辅料来制备这些片剂。根据1998年英国药典的标准对制备的干酵母片进行质量控制测试(重量差异、脆碎度、崩解时限和硬度)。所制备片剂的所有批次均符合英国药典的重量差异标准。此外,所有批次的干酵母片脆碎度百分比值均较小(1%或更低),硬度值可接受,表明其具有良好的机械性能,能够经受住搬运。另一方面,并非所有批次都符合崩解试验的标准,这可能归因于各种制剂成分变量。因此,研究了四种崩解剂的崩解效果。发现制备方法,无论是直接压片、干法制粒还是湿法制粒,都会对这些干酵母片的崩解时限产生影响,并且某些配方的崩解时限较短。在其他技术中,直接压片法制备的片剂崩解时限最短。因此,直接压片被认为是制备干酵母片的最佳技术,并选择了最佳配方(与市售酵母片相比,其崩解时限更短,感官性质更好)。通过气相色谱法(GC)测定干酵母颗粒粉末以及所选最佳制备配方的药物含量。发现该配方产生的酒精含量与等量干酵母颗粒粉末产生的酒精含量相同。这一结果与重量差异相结合,表明所制备干酵母片的药物含量均匀。

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