Research on glucochondrozin granules standardization

Abstract

Background: According to WHO research, 80 percent of people over 55 years of age in our country have some kind of arthritis on X-ray examination, and it is common in the hands, feet, and knees. Arthritis significantly limits mobility as people age, and osteoarthritis complications are a leading cause of disability in the elderly, making it a major public health problem. Glucochondrozin granules contain active substances such as glucosamine hydrochloride, chondroitin sulfate, and ascorbic acid, and glucosamine hydrochloride and chondroitin sulfate together are used in therapeutic practice for the treatment and prevention of osteoarthritis. Glucosamine hydrochloride (2-amino-2-deoxy-D-glucose) is an amino monosaccharide that is a component of glycoproteins in human and animal connective tissue, tendons, and mucous membranes and is a biopolymeric compound involved in the biochemical synthesis of glycosaminoglycans and lipids. The raw material for glucosamine hydrochloride is mainly extracted from the “chitin” substance contained in the shells of marine mollusks and oysters. Chondroitin sulfate is a polysaccharide containing sulfated glycosaminoglycans and monosaccharides consisting of N-acetylgalactosamine and glucuronic acid chains. Clinical research has demonstrated that glucosamine hydrochloride enhances joint remodeling, reduces osteoarthritis pain, repairs joint cartilage tissue, and improves joint function. Chondroitin sulfate has been shown in clinical studies to support joint cartilage health by absorbing fluid (especially water) into the connective tissue of joints, relieving osteoarthritis pain, and having antiinflammatory properties. Aim: In this research, the main active ingredient of glucochondrizin granules was determined by a high-performance liquid chromatography (HPLC) method, and it was studied to evaluate the system suitability of the method during the determination by HPLC and to determine the quality and safety parameters of the granules. Materials and Methods: The content of the active substance chondroitin sulfate in glucochondrosin granules was determined by the industrially developed methodology and the suitability of the chromatography system according to USP-31 and the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Q2 (R1) methodology, and the safety and quality criteria of granules was used according to the Mongolian National Pharmacopiea-2011 method. Results: The quantitative content of chondroitin sulfate in glucochondrosin granules is 407.2 mg. According to the results of the suitability of the system for the determination of chondroitin sulfate, the resolution is not more than 2.0, the relative standard deviation is 1.36%, the symmetry coefÏcient is 2.31, and the theoretical plate is 2870. Granules of heavy metals contained in the granules is acceptable, 0.013ppm of lead and 0.028ppm of cadmium. Pathogenic bacteria such as St.aureus, Salmonella, and E.Coli were not found in the granules. The Aerobic bacteria (Cfu/g) in granules is not more than 104, the molds contamination (Cfu/g) is not more than 10.0, and the Enterobacteria (Cfu/g) is not more than 10.0 and is within the acceptable level of microbiological purity. Conclusion: Granules meet the requirements of Mongolian National Pharmacopeia-2011 in criteria of quality and safety. The granules contain an acceptable amount of the active ingredient, chondroitin sulfate. A chromatographic system is suitable for the quantitative determination of chondroitin sulfate by the HPLC method.