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淀粉-金属硅酸盐共沉淀物的制备与表征——作为片剂超级崩解剂的评价

Preparation and characterization of starch-metal silicate Co-precipitates--evaluation as tablet superdisintegrant.

作者信息

Singh Inderbir, Kaur Birender, Juneja Prateek

出版信息

Polim Med. 2014 Jul-Sep;44(3):157-66.

Abstract

BACKGROUND

Starch is a potential biomaterial used for various pharmaceutical applications because of its unique physicochemical and functional characteristics. A number of modification techniques, such as physical, chemical, enzymatic and genetic or a combination of any of these methods have been reported with the aim of enhancing the positive attributes and eliminating the shortcomings of the native starches.

OBJECTIVES

The present studies deal with the development of co-precipitates of corn starch with different silicates (Mg, Ca, Al) with an aim of using it as a tablet superdisintegrant. Co-precipitates of starch with different silicates were prepared and FTIR-ATR, XRD and SEM techniques were used for the characterization of conjugates.

MATERIAL AND METHODS

The conjugate were analyzed for various powder evaluation test like angle of repose, bulk density, tapped density, Hausner's ratio, Carr's index, swelling index and effective pore radius.

RESULTS

The prepared co-precipitates were found to possess good powder flow properties. The swelling and effective pore radius of all co-precipitates (SMgC, SAlC and SCaC) was found in the range between 30-100% and 15.89-21.71 μm respectively. Different ratios of the prepared co-precipitates were used to formulate fast disintegrating tablets. Fast disintegrated tablets formulated using starch silicate conjugates as superdisintegrant were evaluated for diameter, thickness, hardness, friability, tensile strength, in vitro tablet disintegration, water absorption ratio, wetting time and in vitro dissolution studies. The effective pore radius and swelling of the co-precipitates were correlated with the in vitro disintegration, water absorption ratio and wetting time of the tablets.

CONCLUSIONS

It was concluded that silicated co-precipitates of starch could be used as superdisintegrants in pharmaceutical tablet formulations.

摘要

背景

淀粉因其独特的物理化学和功能特性,是一种可用于多种药物应用的潜在生物材料。为了增强天然淀粉的积极特性并消除其缺点,已报道了多种改性技术,如物理、化学、酶促和基因方法或这些方法的组合。

目的

本研究致力于开发玉米淀粉与不同硅酸盐(镁、钙、铝)的共沉淀物,旨在将其用作片剂超级崩解剂。制备了淀粉与不同硅酸盐的共沉淀物,并使用傅里叶变换红外光谱-衰减全反射(FTIR-ATR)、X射线衍射(XRD)和扫描电子显微镜(SEM)技术对共轭物进行表征。

材料与方法

对共轭物进行各种粉末评价试验,如休止角、堆密度、振实密度、豪斯纳比、卡尔指数、溶胀指数和有效孔径。

结果

发现制备的共沉淀物具有良好的粉末流动性。所有共沉淀物(SMgC、SAlC和SCaC)的溶胀率和有效孔径分别在30%-100%和15.89-21.71μm范围内。使用制备的不同比例的共沉淀物来制备快速崩解片。对以淀粉硅酸盐共轭物作为超级崩解剂制备的快速崩解片进行直径、厚度、硬度、脆碎度、拉伸强度、体外片剂崩解、吸水率、湿润时间和体外溶出度研究。共沉淀物的有效孔径和溶胀与片剂的体外崩解、吸水率和湿润时间相关。

结论

得出结论,淀粉的硅酸盐共沉淀物可作为药物片剂配方中的超级崩解剂。

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