PDF(Pubmed)
Abstract：
The rice bran and rice bran wax of the KJ CMU107 rice strain were investigated as potential tablet lubricants in a directly compressed tablet formulation. Stabilized full-fatted rice bran (sFFRB), stabilized defatted rice bran (sDFRB), and rice bran wax (RBW) extracted and purified from crude rice bran oil (cRBO) were tested. Two commercial lubricants, including magnesium stearate (MGS) and hydrogenated cottonseed oil (HVO), were employed as the standards in the formulated mixtures, which contained spray-dried rice starch (SDRS) as a diluent. The tableting was carried out for each formulation, and the obtained tablets were physically and mechanically evaluated. Among the parameters investigated were the general appearance, ejection force, weight variation, hardness, friability, and disintegration time. The powder flow was also determined for each formulation. The results showed that the tablet ejection forces for all the lubricated formulations (58-259 N) were significantly lower than that of the non-lubricated control formulation (349 N). The use of sFFRB as a lubricant at 0.5-2.0% w/w could lower the ejection force up to 78%, but the hardness reduced so drastically that the formulations failed the friability test due to the chipping of the tablets\' edges. Moreover, sDFRB performed significantly better as the use at 0.5-1.0% w/w in the formulation helped to lower the ejection forces by up to 80% while maintaining the changes in the tablet hardness within 10%. RBW functioned effectively as a tablet lubricant at a concentration of 0.5% w/w, yielding tablets with good strength comparable to standard HVO lubricant while helping to reduce the ejection force by 82%. In formulations with good lubrication, i.e., friability < 1%, the powder flow was improved, and the tablet disintegration times were within the same range as the control and HVO formulations. In conclusion, sDFRB displayed a lubricant property at concentrations between 0.5 and 1.0% w/w, with slightly negative effects on the tablet hardness. RBW from KJ CMU107 rice was an effective tablet lubricant at 0.5% w/w, with no effect on tablet hardness. Both materials can be further developed for use as commercial lubricants in direct compression.
摘要：
研究了KJCMU107水稻菌株的米糠和米糠蜡作为直接压制片剂配方中的潜在片剂润滑剂。稳定的全脂米糠（sFFRB），稳定的脱脂米糠（sDFRB），和从粗米糠油（cRBO）中提取和纯化的米糠蜡（RBW）进行了测试。两种商用润滑油，包括硬脂酸镁（MGS）和氢化棉籽油（HVO），被用作配制混合物中的标准，其中含有喷雾干燥的大米淀粉（SDRS）作为稀释剂。对每种制剂进行压片，并对获得的片剂进行物理和机械评价。研究的参数包括一般外观，弹射力,体重变化，硬度,脆性,和崩解时间。还确定了每种制剂的粉末流量。结果显示,所有润滑制剂(58-259N)的片剂喷射力显著低于非润滑对照制剂(349N)的片剂喷射力。使用sFFRB作为润滑剂在0.5-2.0％w/w可以降低弹射力高达78％，但是由于片剂边缘的碎裂，硬度急剧下降，以至于配方不能通过脆碎度测试。此外，sDFRB表现得明显更好,因为在制剂中以0.5-1.0%w/w使用有助于将顶出力降低高达80%,同时将片剂硬度的变化保持在10%以内。RBW在0.5％w/w的浓度下有效地用作片剂润滑剂，生产的片剂具有与标准HVO润滑剂相当的良好强度，同时有助于降低82％的顶出力。在具有良好润滑性的配方中，即，脆性<1%，粉末流动得到改善，片剂崩解时间在与对照和HVO制剂相同的范围内。总之,sDFRB在浓度为0.5-1.0%w/w时显示出润滑性能，对片剂硬度有轻微的负面影响。来自KJCMU107大米的RBW是0.5％w/w的有效片剂润滑剂，对片剂硬度没有影响。这两种材料可以进一步开发用作直接压缩中的商业润滑剂。
