Standardization of Critical Quality Indicators of Liposomes of Siberian Musk Deer Prepucial Gland Extract

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.