Standardization of lyophilized dosage form of dimeric macrocyclic tannin

Background. Over the last years the studies have increased interest in screening antitumor and anti-angiogenic substances that block several mechanisms of angiogenesis activation in tumors. A great attention is paid to development of effective and low toxic drugs as inhibitors of angiogenesis which are derived from herbal raw material. The article is devoted to the results of standardization of the dosage form of dimeric macrocyclic tannin (DMT) obtained from Chamerion angustifolium (L.) Holub in N.N. Blokhin National Medical Research Center of Oncology, which has a great potential as an antiangiogenic agent. Objective: to determine quality criteria for standardization of the drug “DMT, lyophilisate for preparation of solution for injections 100 mg”. Materials and methods. The study used “DMT, lyophilisate for preparation of solution for injections 100 mg” and DMT substance. Methods: spectrophotometry, infrared spectroscopy, high performance liquid chromatography, potentiometry, polarimetry. Results. Quality criteria for lyophilized DMT dosage form were determined with the account of Russian State Pharmacopoeia (XIII edn.) requirements to the drugs for injections and methods for their evaluation were defined. Conclusions. Laboratory studies demonstrated that the determined quality criteria and the defined methods for their evaluation are feasible for adequate quality control of dosage form “DMT, lyophilisate for preparation of solution for injections 100 mg”.

димерный макроциклический танин, физико-химические характеристики, стандартизация, количественный анализ, dimeric macrocyclic tannin, physicochemical characteristics, standardization, quantitative analysis