甲硝唑片溶出度影响因素的探讨

Investigation on Influence Factors of Dissolution of Metronidazole Tablet

目的 :考察影响甲硝唑片溶出度的因素。方法 :压片前分别按 5种不同比例加羧甲基淀粉钠 (CMS Na)及硬脂酸镁 ,混匀 ,压片 ,测其溶出度 ;分别以 87℃与 5 0℃的淀粉浆作粘合剂制软材 ,压片 ,测其溶出度 ;分别以不同大小、不同硬度的颗粒压片 ,测其溶出度 ;同批颗粒分别制成直径 8,9,10mm三种规格的片剂 ,测其溶出度。结果 :CMS Na能显著提高甲硝唑片溶出度 ;淀粉浆温度为 87℃与 5 0℃时制成的甲硝唑片溶出度分别为 94.5 5± 1.6 7( n =5 )和 84.32±2 .6 0 (n =5 ) ;颗粒大、硬度大时溶出度较低 ,反之 ,则溶出度较高 ;直径 8,9,10mm的甲硝唑片 30min累积溶出度分别为98.85 %、99.6 4%、99.5 1%。结论 :崩解剂对甲硝唑片溶出度影响较大 ;颗粒的大小、硬度及淀粉浆的温度对甲硝唑片溶出度亦有影响 ;片剂直径大小对甲硝唑片溶出度影响不大。

Objective:To investigate the factors influencing the dissolution of metronidazole tablet. Methods:CMS-Na and magnesium stearate were added with five different ratios before tabletting, respectively, mixed equally and tabletted, then the dissolution was determined; the softmaterials were made with 87℃ and 50℃ of starch as adhesion agent, and respectively, tabletting, then the dissolution was determined; tablets were experessed with the grains of different magnitude and different hardness, then the dissolution were determined same group of grains were expressed into three tablets, of which diameters were 8, 9, 10 mm respectively. Results:CMS-Na could obviously increase the dissolution of metronidazole tablet; when the temperature of starch were 87℃ and 50℃, the dissolution of metronidazole tablet were 94.55±1.67(n=5)and 84.32±2.60(n=5), respectively; when the grain is big, hardness is strong, the dissolution was declined when the grains were big magnitude and strong hardness, on the contrary, the dissolution was higher; the accumulated dissolution of three diameter of 8, 9, 10 mm were 98.85%, 99.64%, 99.51% respectively. Conclusion:the disintegrant had larger effect on the dissolution within 30 minutes of metronidazole tablet; the grain's magnitude and hardness and the temperature of starch had also produced and effect on the dissolution of metronidazole tablet; the magnitude of tablet's diameter had only little effect on the dissolution of metronidazole tablet.