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1、BASF用于直接壓片工藝的輔料產(chǎn)品介紹￠直接壓片工藝特點(diǎn)￠直接壓片復(fù)合物輔料òLudipress?òLudipress?LCE￠直接壓片干性粘合劑òKollidon?VA64òKollidon?VA64Fine1Copyright2005BASFAktiengesellschaft直接壓片工藝特點(diǎn)2Copyright2005BASFAktiengesellschaft直接壓片工藝優(yōu)勢(shì)顯而易見的優(yōu)勢(shì):無(wú)需通過加熱以除去造粒過程中應(yīng)用的溶劑，從而提高藥物活性成分穩(wěn)定性減少壓片工藝步驟生產(chǎn)時(shí)間和能源節(jié)省工藝簡(jiǎn)單化和經(jīng)濟(jì)化Ludipress?3Copy
2、right2005BASFAktiengesellschaftLudipress?Ludipress?LCE壓片－－僅需一步操作ExcipientsActivesContractManufacturingValueAdded壓片只需一步操作用于直接壓片工藝性能卓越的輔料5CCopyright2005BASFAktiengesellschaftopyright2005BASFAktiengesellschaft產(chǎn)品介紹Ludipress?組成成分:乳糖93%填充劑Kollidon?303.5%粘合劑Kollidon?CL3.5%崩解劑每種成分均符
3、合當(dāng)前廣泛應(yīng)用的幾種藥典所規(guī)定的質(zhì)量標(biāo)準(zhǔn)，從而在產(chǎn)品生產(chǎn)最初階段－原材料上就確保產(chǎn)品質(zhì)量。Ludipress?6Copyright2005BASFAktiengesellschaft生產(chǎn)工藝工藝步驟減少到僅幾部操作藥物?其它Ludipress潤(rùn)滑劑活性成分物料稱重稱重稱重稱重混合壓片包裝Ludipress?7Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)我們提供給您的輔料Ludipress?是通過特殊工藝生產(chǎn)的產(chǎn)品，具有以下特點(diǎn)：卓越的流動(dòng)性理想的粒徑分布易與活性成分混合充分，無(wú)分層現(xiàn)象受潤(rùn)滑劑影響小粘合力高低吸
4、濕性Ludipress?8Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－粒徑分布粒徑分布Differential(%)Integral(%)201009080706010504030201000Particlesize(μm)0.11.010.0100.01000.0Ludipress?9Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－流動(dòng)性用于直接壓片的輔料流動(dòng)性比較休止角[°]60Sanaq101L55.950AvicelPH10146.240TablettoseCellac
5、toseAvicelPH200Ludipress?36.036.235.73030.520100Ludipress?10Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－硬度即使應(yīng)用較低壓片力，Ludipress?也能夠確保片子的硬度.硬度[N]200Ludipress?簡(jiǎn)單物理混合100藥片力[kN]0102030Ludipress?11Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－硬度壓片機(jī)旋轉(zhuǎn)速度及壓片力對(duì)低劑量藥物片子硬度的影響硬度[N]采用旋轉(zhuǎn)式壓片200機(jī)壓片18016
6、0140120100806040252001590806054020轉(zhuǎn)速[rpm]壓片力[kN]Ludipress?12Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－脆碎度應(yīng)用Ludipress?制得片子具有非常低的脆碎度配方咖啡因125.0mg維生素C60mgLudipress?374.5mgLudipress?139mg硬脂酸鎂0.5mg硬脂酸鎂1mg藥物活性成分顆粒粉末粒徑分布:粒徑分布:形態(tài)max.35%<150μmmin.90%<150μmmin.90%<500μm壓片力20kN20kN20kN20k
7、N片重500mg500mg200mg200mg直徑12mm12mm8mm8mm脆碎度0.1%0.1%0.3%0.1%Ludipress?13Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－崩解及藥物釋放片子在數(shù)秒內(nèi)開始崩解–與片子硬度無(wú)關(guān)00:00sLudipress?14Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)－崩解及藥物釋放片子在數(shù)秒內(nèi)開始崩解–與片子硬度無(wú)關(guān)00:20sLudipress?15Copyright2005BASFAktiengesellschaft產(chǎn)品特點(diǎn)
8、－崩解及藥物釋放片子在數(shù)秒內(nèi)開始崩解–與片子硬度無(wú)關(guān)00:40sLudipress?16Copyright2005BASFAktiengesellsc
