医药导报
醫藥導報
의약도보
HERALD OF MEDICINE
2001年
6期
376-377
,共2页
甲硝唑片%溶出度%影响因素
甲硝唑片%溶齣度%影響因素
갑초서편%용출도%영향인소
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50℃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8，9，10 mm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50℃时制成的甲硝唑片溶出度分别为94.55±1.67(n＝5)和84.32±2.60(n＝5)；颗粒大、硬度大时溶出度较低，反之，则溶出度较高；直径8，9，10 mm的甲硝唑片30 min累积溶出度分别为98.85%、99.64%、99.51%。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。
目的：攷察影響甲硝唑片溶齣度的因素。方法：壓片前分彆按5種不同比例加羧甲基澱粉鈉(CMS-Na)及硬脂痠鎂，混勻，壓片，測其溶齣度；分彆以87℃與50℃的澱粉漿作粘閤劑製軟材，壓片，測其溶齣度；分彆以不同大小、不同硬度的顆粒壓片，測其溶齣度；同批顆粒分彆製成直徑8，9，10 mm三種規格的片劑，測其溶齣度。結果：CMS-Na能顯著提高甲硝唑片溶齣度；澱粉漿溫度為87℃與50℃時製成的甲硝唑片溶齣度分彆為94.55±1.67(n＝5)和84.32±2.60(n＝5)；顆粒大、硬度大時溶齣度較低，反之，則溶齣度較高；直徑8，9，10 mm的甲硝唑片30 min纍積溶齣度分彆為98.85%、99.64%、99.51%。結論：崩解劑對甲硝唑片溶齣度影響較大；顆粒的大小、硬度及澱粉漿的溫度對甲硝唑片溶齣度亦有影響；片劑直徑大小對甲硝唑片溶齣度影響不大。
목적：고찰영향갑초서편용출도적인소。방법：압편전분별안5충불동비례가최갑기정분납(CMS-Na)급경지산미，혼균，압편，측기용출도；분별이87℃여50℃적정분장작점합제제연재，압편，측기용출도；분별이불동대소、불동경도적과립압편，측기용출도；동비과립분별제성직경8，9，10 mm삼충규격적편제，측기용출도。결과：CMS-Na능현저제고갑초서편용출도；정분장온도위87℃여50℃시제성적갑초서편용출도분별위94.55±1.67(n＝5)화84.32±2.60(n＝5)；과립대、경도대시용출도교저，반지，칙용출도교고；직경8，9，10 mm적갑초서편30 min루적용출도분별위98.85%、99.64%、99.51%。결론：붕해제대갑초서편용출도영향교대；과립적대소、경도급정분장적온도대갑초서편용출도역유영향；편제직경대소대갑초서편용출도영향불대。
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.
