Kodym A, Bujak T
Department of Drug Form Technology, Karol Marcinkowski Medical Academy, Poznań.
Pharmazie. 2002 Dec;57(12):834-7.
The aim of the study was to work out methods of quality assessment of ointments containing dry extract from fresh leaves of Aloe arborescens Mill. (Lilliaceae) and also of ointments containing both of dry extract and neomycin sulphate. The stability of the ointments, stored at 20 degrees C, was studied and the following criteria were considered: chromatographic analysis (TLC), pH of the ointments, the content of the substances in the dry extract converted to aloenin, the content of aloenin and aloin, anti-microbial activity of neomycin in the ointments, the size of the particles of the dry extract and of neomycin sulphate in the ointment suspension and the sterility of the ointments. After two years of storage at 20 degrees C, the ointments prepared with the anhydrous lipophilic base, did not change their physicochemical characteristics and neomycin in those ointments retained almost 100% of starting anti-microbial activity. Water or propylene glycol significantly decreased the stability of the biologically active substances of the dry extract in the ointments. Besides, in the ointments containing the dry extract and neomycin sulphate, the presence of water or propylene glycol induced degradation of the biologically active substances of the dry extract and a decrease in the anti-microbial activity of neomycin in the ointments. Considering the physicochemical and microbiological stability, the most advisable base for the ointments with aloe and neomycin sulphate was composed of white vaseline, liquid paraffin, solid paraffin, cholesterol.
本研究的目的是制定含库拉索芦荟(百合科)鲜叶干浸膏软膏以及含干浸膏和硫酸新霉素软膏的质量评估方法。研究了在20℃下储存的软膏的稳定性,并考虑了以下标准:色谱分析(薄层色谱法)、软膏的pH值、干浸膏中转化为芦荟宁的物质含量、芦荟宁和芦荟苷的含量、软膏中新霉素的抗菌活性、软膏悬浮液中干浸膏和硫酸新霉素颗粒的大小以及软膏的无菌性。在20℃下储存两年后,用无水亲脂性基质制备的软膏未改变其理化特性,且这些软膏中的新霉素几乎保留了100%的初始抗菌活性。水或丙二醇显著降低了软膏中干浸膏生物活性物质的稳定性。此外,在含干浸膏和硫酸新霉素的软膏中,水或丙二醇的存在会导致干浸膏生物活性物质的降解以及软膏中新霉素抗菌活性的降低。考虑到理化和微生物稳定性,含芦荟和硫酸新霉素软膏最适宜的基质由白凡士林、液状石蜡、固体石蜡、胆固醇组成。