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Pharmacology: Sodium hyaluronate has a covering and protective action to the cartilage surface of the joint, a suppressive action to the degenerative change in the cartilage tissue and an ameliorative action to the mobility range in articular contracture. It relieves pain in general arthrosis deformans, improves mobility range of the joints and normalizes synovial fluid.
Action to the Cartilage of the Joint: Sodium hyaluronate was recognized to have entered into the surface layer of the cartilage by administration into the cavity of the knee joint of a normal rabbit. Moreover, in the cartilage of man with arthrosis deformans in the knee (in vitro), distribution of sodium hyaluronate extends widely from the surface layer into the entire layer of the cartilage with the progress of time. This distribution within the cartilage was in agreement with the parts deprived of proteoglycan. Separation of proteoglycan in the cells of articular cartilage of a cow is suppressed by sodium hyaluronate. Administration of sodium hyaluronate in the joint cavity of the knee using a rabbit as the model of arthrosis deformans of the knee and the model of fixed articular contracture of the knee, proved to have suppressed degeneration of cartilage.
Improvement of Mobility Range of the Joints: In the model of fixed articular contracture using the rabbit, mobility range of the joint was improved by administration of sodium hyaluronate into articular cavity.
Toxicology: Nonclinical Tests: Acute Toxicity: LD50 value obtained when single administration was given intra-abdominally in male and female rats were 2014 and 1761 mg/kg, respectively.
Subacute Toxicity: When repeated intra-abdominal administrations were given in rats during 28 days at a dose level of 30, 60, 120 and 240 mg/kg, the indifferent dose recognized was 30 mg/kg. Doses of >60 mg/kg caused a decrease of red blood cells (RBC) and total protein, which was recognized to be dose-dependent. This was considered to have relation with the change of blood picture by the use of sodium hyaluronate, however a tendency of recovery was shown after discontinuation of the drug.
Antigenicity: Sodium hyaluronate was allowed to exhibit its action by IM and intra-articular administration in guinea pigs, and the tests for mobile anaphylaxis, corneal and PCA reactions was carried out. The result showed that there was no antigenicity observed in any of the tests.
Mutagenicity: In the Ames test using bacteria, occurrence of mutagenicity was not recognized.
Local Irritability: Sodium hyaluronate 0.1 mL was dropped into the rabbit eyes and it showed no influence on the cornea, iris and conjunctiva. Irritation to the mucous membrane of the eyes was also negative.
