The Preparation and Characterization of A Co-Processed Excipient from Purple Sweet Potato (Ipomoea batatas L) Starch and Avicel PH101

Muhammad Hengki Purnama Halim, Ungsari Rizki eka Purwanto, Endang Diyah Ikasari
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Abstract

The Indonesian pharmaceutical industries still rely on imports for more 90% of active raw materials and excipient raw materials. A research is needed to develop the production of pharmaceutical excipients, especially those derived from natural ingredients, to support the country's economy. One source of natural materials are widely available in Indonesia and can be developed is starch from Purple Sweet Potato (Ipomoea batatas L). Starch is often used as dilluent, disintegrat and binder in tablet formulation. Starch, including starch from Purple Sweet Potato, was an excipient tablet that had bad flowability and compressibility, so that the physical properties need to be improved. One way to improve the characterization of amilum is co-processing. The purpose of this study was to develop a co-process from Purple Sweet Potato Starch and combined with Avicel PH 101 as excipient fillers for tablets. The method used in the preparation of these co-process was wet granulation. The formula determination was caried out with Design Expert 10.0.1 software. Results obtained from experiments and recommendation formula from Design Expert 10.0.1 was verified with One Simple T-test with confidence level of 95%. Based on the results it can be concluded that the increased concentration of purple sweet potato starch increased moisture content and lowering compressibility and density. While the increased concentration of Avicel PH 101 increased compressibility and density; it could lower moisture content and the flowability time. The formula that gave the best characteristic of co-processed was obtained at a concentration of purple sweet potato starch and Avicel PH 101 on 62.493%: 37.507%. Based on One Simple T-Test, there is no significant difference between the experimental results with recommendation formula from Design Expert 10.0.1. From the FT-IR test results may indicate that the formation of the co-process did not change the form of the chemical structure of substances, but only changed the physical properties of substance. Based on the results of SEM, the morphology of the shape bond formation co-process so that the granules become larger and purple sweet potato starch forms a round and partly change shape after do the heating at 60°C. Keyword : Co-processing, Purple_Sweet_Potato, Starch, Avicel_PH101, FTIR
紫甘薯(Ipomoea batatas L)淀粉与Avicel PH101共加工辅料的制备与表征
印尼制药业90%以上的活性原料和辅料仍依赖进口。为了支持国家的经济,需要研究开发药用辅料的生产,特别是那些从天然成分中提取的辅料。一种天然材料在印度尼西亚广泛可用并且可以开发的来源是紫甘薯(Ipomoea batatas L)淀粉。淀粉在片剂配方中经常用作稀释剂、崩解剂和粘合剂。淀粉(包括紫薯淀粉)是一种流动性和压缩性较差的赋形片剂,其物理性能有待改进。改进淀粉表征的一种方法是协同加工。本研究以紫薯淀粉为原料,以Avicel PH 101为辅料,制备片剂。在制备这些共制物时采用的方法是湿法制粒。采用Design Expert 10.0.1软件进行公式确定。实验结果和Design Expert 10.0.1中的推荐公式用One Simple t检验进行验证,置信水平为95%。结果表明,紫薯淀粉浓度的增加增加了紫薯淀粉的含水率,降低了紫薯淀粉的压缩率和密度。Avicel PH 101浓度增加,可压缩性和密度增加;它可以降低含水率和流动性时间。当紫薯淀粉和Avicel PH 101的浓度为62.493%:37.507%时,得到了最佳的共加工配方。通过One Simple t检验,实验结果与Design Expert 10.0.1的推荐公式没有显著差异。从FT-IR测试结果可以看出,共过程的形成并没有改变物质的化学结构形式,而只是改变了物质的物理性质。SEM结果表明,60℃加热后,紫薯淀粉的形态键形成过程使颗粒变大,紫薯淀粉呈圆形,部分改变形状。关键词:协同加工,紫薯,淀粉,Avicel_PH101, FTIR
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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