棉棉微晶纤维素粉作为干燥粘合剂在地西泮片制备中的应用

N. Nwachukwu, S. Ofoefule
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引用次数: 0

摘要

背景:微晶纤维素(MCC)是一种常用的片剂干燥粘合剂。加工方法的不同会显著影响其压片性能。目的:评价两种不同干燥方法制备的地西泮片的压片性能和体外释放性能。方法:在氢氧化钠溶液中脱木质素得到α-纤维素,再用2.0 N盐酸水解得到MCC。将中和的湿MCC分成两部分。一部分是流化床干燥(MCC-GossF),另一部分是冻干(MCC-GossF)。以20、30、40%w/w的MCC-GossF和MCC-GossL配制地西泮片。Avicel PH 102 (AVH-102)作为比较标准。采用标准方法对配方进行评价。结果:粉末流动良好,片剂符合英国药典标准。含MCC-GossL (DGL)的地西泮片比含MCC-GossF (DCF)的地西泮片强(p<0.05)。崩解时间< 2 min,脆度≤1%。AVH-102片的强度与DGL片的强度比较好。超过80%的地西泮从药片中释放出来。结论:生长激素mcc是制备地西泮片的良好干结合剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of Microcrystalline Cellulose Powders Obtained from Gossypiumherbaceum As Dry Binder in the Formulation of Diazepam Tablets
Background: Microcrystalline cellulose (MCC) is a popular dry binder in tablet formulation. Differences in its processing methods can significantly affect its tableting properties. Aim: Assessment of the tableting and in-vitro release properties of diazepam tablets formulated with Gossypiumherbaceum (GH) derived MCC that was dried by two different methods. Methods: G.herbaceum bolls were de-lignified in sodium hydroxide solutions to obtain α-cellulose which was hydrolyzed with 2.0 N hydrochloric acid to obtain MCC. The neutralized damp MCC was separated into two portions. One portion was fluid bed dried (MCC-GossF) while the other portion was lyophilized (MCC-GossL). Diazepam tablets were prepared with 20, 30 and 40%w/w of MCC-GossF and MCC-GossL..Avicel PH 102 (AVH-102) served as comparing standard. The formulations were evaluated using standard methods. Results: The powders flowed well and the tablets met with British Pharmacopoiea specifications. Diazepam tablets containing MCC-GossL (DGL) were stronger than those of MCC-GossF (DCF) (p<0.05). The disintegration times were < 2 min and friability ≤ 1%. The strength of tablets containing AVH-102 (DAV) compared well with those of DGL tablets. More than 80% of diazepam was released from the tablets. Conclusion: The GH MCCs served as good dry binders in the formulation of diazepam tablets.
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