Muzíková Jitka, Nováková Petra
Department of Pharmaceutical Technology, Charles University in Prague, Faculty of Pharmacy in Hradec Králové, Czech Republic.
Drug Dev Ind Pharm. 2007 Jul;33(7):775-81. doi: 10.1080/03639040601050197.
The paper deals with a study of tensile strength and disintegration time of compacts made from silicified microcrystalline celluloses, Prosolv SMCC 90, and Prosolv HD 90, in dependence on compression force, addition of two types of lubricants, and two active ingredients. The lubricants were magnesium stearate and sodium stearyl fumarate in a concentration of 0.5%, the active ingredients being ascorbic acid and acetylsalicylic acid in a concentration of 50%. Prosolv SMCC 90 proved to be better compatible than Prosolv HD 90; the compacts were of higher strength, which was markedly increased with increasing compression force. Prosolv HD 90 was more sensitive to additions of lubricants, and a greater decrease in strength was recorded due to the influence of sodium stearyl fumarate. The effect of lubricants on the strength of compacts in the presence of active ingredients was not identical. The disintegration time of compacts from Prosolv HD 90 without as well as with lubricants was shorter than from Prosolv SMCC 90 and was increasing with increasing compression force. Disintegration time was increased with added lubricants, and it was markedly shortened by addition of active ingredients. Compacts containing ascorbic acid possessed a shorter disintegration time than those containing acetylsalicylic acid, and it was not markedly influenced by the presence of lubricants.
本文研究了由硅化微晶纤维素Prosolv SMCC 90和Prosolv HD 90制成的压片的拉伸强度和崩解时间，该研究依赖于压缩力、两种润滑剂的添加量以及两种活性成分。润滑剂为浓度0.5%的硬脂酸镁和硬脂酰富马酸钠，活性成分为浓度50%的抗坏血酸和乙酰水杨酸。结果表明，Prosolv SMCC 90的相容性优于Prosolv HD 90；压片强度更高，且随着压缩力的增加显著提高。Prosolv HD 90对润滑剂的添加更敏感，由于硬脂酰富马酸钠的影响，强度下降幅度更大。在有活性成分存在的情况下，润滑剂对压片强度的影响并不相同。不含润滑剂以及含有润滑剂的Prosolv HD 90制成的压片的崩解时间比Prosolv SMCC 90制成的压片短，且随着压缩力的增加而增加。添加润滑剂会使崩解时间延长，而添加活性成分则会使其显著缩短。含有抗坏血酸的压片的崩解时间比含有乙酰水杨酸的压片短，且润滑剂的存在对其影响不显著。
