辅料对尼莫地平固体分散体粉体学性质的影响

Effects of excipients on powder technology properties of nimodipine dispersion powders

目的研究辅料对尼莫地平固体分散体粉体学性质的影响,为片剂处方筛选提供依据。方法采用微粉特性测定仪、粉体测定仪、硬度仪和千分尺研究辅料对尼莫地平固体分散体(nimodipinesolid dispersion,NMPSD)粉末的压缩性、应力缓和、休止角和抗张强度的影响。结果NMPSD和微晶纤维素(microcrystalline cellulose,MCC)的均匀混合物,随着MCC质量的增加,可压性先增加后趋于稳定,应力缓和能力减弱,抗张强度增加。加入适量滑石粉(talcum powder,Talc)后,NMPSD和MCC混合物休止角变小,但当Talc加入量增加到一定程度后,休止角反而增大。结论当NMPSD和MCC的质量比为1∶1、Talc质量分数为2.6%时,混合粉末的压缩成型性和流动性最好,适合粉末直接压片。

Objective To optimize the formulation of nimodipine tablets, and investigatethe effects of excipients on powder technology properties of nimodipine solid dispersion （NMPSD）powders. Methods The micro powder characterizer（ MPC-100）, powder tester, hardness tester and micrometer were employed to investigate the effects of excipients on compressibility, stress-relaxation, angle of repose and tensile strength of NMPSD powders. Results When the mass ratio of MCC was below 1：1 （m： m）, the mass ratio of MCC and the compressibility were increased, stress-relaxation was decreased and tensile strength of the mixture of NMPSD and MCC was diminished. When the content of talcum powder was increased a bit, the angle of repose decreased. On the contrary, when the amount of talcum powder was increased too some extent, the angle of repose was increased. Conclusions The compressibility ,stress-relaxation ,tensile strength and angle of repose are suitable for tableting when the ratio of nimodiping dispersion and MCC is 1：1 （m： m） ,the quality score of talc is 2. 6% （w）.