Abstract
The liposomal form of a new original remedy based on the preputial gland of Siberian musk has been standardized and characterized. For the preparative isolation of musk musk liposomes, an effective and scalable method of high-pressure homogenization was used. The resulting liposomal product was characterized by transmission electron microscopy, dynamic light scattering, preparative and analytical chromatography, and chromatography-mass spectrometry. A specification for the liposomal form of the extract of the prepucial gland of Siberian musk deer, including all critical indicators of the product quality, has been developed. Homogeneous dispersions of musk musk liposomes with uniform size distribution — with distribution maxima at 50 and 240 nm — were obtained. The high physical and chemical stability of the liposomal dispersion was established: the zeta potential of the obtained nanoparticles was -5...-35 mV. The degree of inclusion in the liposomes of the target components of musk musk according to gel-size chromatography and mass spectrometry for musk liposomes for steroid components and total protein was 58–75%. The developed quality indicators of the liposomal product allow for serial standardization of the manufacturing quality control and form the prerequisites for guaranteed high efficiency of the product based on the liposomal form of musk musk extract as an adaptogen of natural origin with an enhanced and pronounced effect.
Highlights
ФГБУН «Научный центр биомедицинских технологий ФМБА России» 143442, Российская Федерация, Московская обл., Красногорский р-н, п
The liposomal form of a new original remedy based on the preputial gland of Siberian musk has been standardized and characterized
The resulting liposomal product was characterized by transmission electron microscopy, dynamic light scattering, preparative and analytical chromatography, and chromatography-mass spectrometry
Summary
Стандартизована и охарактеризована липосомальная форма нового оригинального продукта на основе препуциальной железы мускуса кабарги сибирской. Для препаративного выделения липосом мускуса кабарги использован эффективный и масштабируемый метод гомогенизации при высоком давлении. Разработана спецификация на липосомальную форму экстракта препуциальной железы кабарги сибирской, включающей все критические показатели качества продукта. Получены гомогенные дисперсии липосом мускуса кабарги с равномерным распределением по размерам — с максимумами распределения при 50 и 240 нм. Степень включения в липосомы целевых компонентов мускуса кабарги по данным гель-размерной хроматографии и масс-спектрометрии для липосом мускуса по стероидным компонентам и общему белку составила 58–75%. Для цитирования: Нестеров М.С., Агельдинов Р.А., Хвостов Д.В., Кохан В.С., Левашова А.И., Люблинский С.Л., Каркищенко В.Н. Стандартизация критических показателей качества липосом экстракта препуциальной железы мускуса кабарги сибирской. STANDARDIZATION OF CRITICAL QUALITY INDICATORS OF LIPOSOMES OF SIBERIAN MUSK DEER PREPUCIAL
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