英文药名：ARTZ(Purified Sodium Hyaluronate) 中文药名：纯化透明质酸钠注射剂 生产厂家：科研制药 アルツ関節注25mg 治疗类别名称 关节功能改善剂 批准上市时间：2006年12月 商標名 ARTZ 25mg 一般名 Purified Sodium Hyaluronate（精製ヒアルロン酸ナトリウム） 分子式 (C14H20NNaO11)n 分子量 平均分子量50万～120万 構造式 性状 此产品的白色粉末，颗粒或纤维质量。 此产品是微溶于水，并在乙醇（99.5）几乎不溶。 本产品是吸湿。 操作注意事项 1.本品，因为它使用了“一点切割安瓿”，在上述的安瓿分支的蓝色标记，即尼基在相反方向上折叠。 2.由于本产品是玻璃产品，你不掉落或受到强烈冲击。它可以是在容器的损坏的一个原因。 适应病症 ○膝关节骨性关节炎，肩周炎 ○类风湿性关节炎、膝关节疼痛（以下（1）至（4）满足所有条件时才） （1）若用抗风湿药等的全身治疗的疾病为膝关节疼痛甚至能够控制 （2）如全身炎性病症是小于或等于10毫克/分升的CRP值 （3）如轻度膝关节的症状中度 （4）如果从I级膝关节Ⅲ类水质的拉森透视分类 用法用量 ○膝关节骨性关节炎，肩周炎 成人每一次（安瓿：25毫克）给药，也可以根据由症状给药次数来调节。 ○类风湿性关节炎、膝关节疼痛 成人，每隔1周用药一次，每次2.5毫升（安瓿） 包装规格 1％注射剂 2.5毫升 10安瓿，20安瓿 1％注射器 2.5毫升：10注射器包配方 制造厂商 科研制药有限公司 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/3999408A1171_1_07/ ARTZ(Purified Sodium Hyaluronate) Name of drug classification Joint function improving agent Sales name Alzudposo joint Note 25 mg common name Purified Sodium Hyaluronate (refined sodium hyaluronate) Molecular formula (C14 H20 N Na O 11) n Molecular weight Average molecular weight 500,000 to 1.2 million Property This product is a white powder, grain or fibrous mass. This product is slightly soluble in water and hardly soluble in ethanol (99.5). This product is hygroscopic. composition Active ingredient It contains 25 mg of Japanese Pharmacopoeial sodium hyaluronate in 1 syringe (2.5 mL). Additive Sodium chloride Sodium hydrogen phosphate hydrate Sodium dihydrogenphosphate Contraindications Patients with a history of hypersensitivity to the ingredients of this drug Indication or effect Osteoarthritis of the knee, periarthritis of the shoulder ○ Knee pain in rheumatoid arthritis (only when all the criteria (1) to (4) below are satisfied) Even if overall disease condition can be controlled by treatment with antirheumatic drugs or the like, if there is knee joint pain When the inflammatory symptoms of the whole body are not more than 10 mg / dL as CRP value When the symptoms of the knee joint are mild to moderate When the Larsen X-ray classification of the knee joint is Grade I to Grade III Osteoarthritis of the knee, periarthritis of the shoulder Usually, adult once a syringe (25 mg once as refined sodium hyaluronate) is administered 5 consecutive times per week 5 times in the knee joint cavity or shoulder joint (shoulder joint cavity, unconfined synovial fluid burr or biceps brachiocephalus long tendon Tendon sheath), but the number of administrations should be increased or decreased according to symptoms. Knee pain in rheumatoid arthritis Usually, 2.5 mL per adult (1 syringe, 25 mg once as refined sodium hyaluronate) is administered into the knee joint cavity 5 times continuously every week. As this drug is administered intraarticularly, it should be done under severe sterile operation. Careful Administration Patients with a history of hypersensitivity to other drugs * Patients with liver disorder or a history of it [AST (GOT), ALT (GPT) abnormal values were seen in patients with a history of liver disorder ] Patient with skin disorder or infection in the administration joint [This drug is administered into the joint] Serious side effects shock Shock symptoms (frequency unknown Note) may appear, so observe thoroughly, if abnormalities are observed discontinue administration and take appropriate measures. Medicinal pharmacology This agent coats and protects joint tissue, improves lubrication function, penetrates into degenerative cartilage, inhibits degenerative change, and improves cartilage metabolism. Furthermore, it infiltrates the synovial tissue and suppresses inflammation and degenerative change. In addition, it suppresses the action of the pain-causing substance and exerts a pain-suppressing action. These lead to remission of pain, daily living behavior and improvement of joint range. Joint tissue permeability It penetrates deep into degenerative cartilage and synovial membrane (guinea pig, in vitro). Action on articular cartilage It has affinity for cartilage, covers and protects cartilage surface (rabbit). Suppress degenerative changes in cartilage (rabbit, mouse). Suppresses the production of active oxygen, matrix metalloproteinases -1, 3 and 13 from cartilage involved in cartilage destruction (in vitro 15,). Suppresses the release of proteoglycans from cartilage matrix and improves cartilage metabolism (rabbit, in vitro). Suppress degenerative changes in articular cartilage and promote repair of subchondral bone (rabbit). Action on synovial membrane It acts on synovial cells and inhibits synovial inflammation and degenerative changes (dogs), in vitro). It acts on synovial cells, suppresses the production of interleukin-1β, and suppresses degenerative changes in cartilage (in vitro). Suppress synovial inflammation in collagen-induced experimental arthritis model (rat). Action on synovial fluid It acts on synovial cells and promotes the synthesis of high molecular weight hyaluronic acid (patient: adult male and female 24), dog). Increase hyaluronic acid concentration and molecular weight of pathological synovial fluid and improve spinnability etc. (Patient: adult male and female). Improve chondroitin 4 sulfate and chondroitin 6 sulfate and hyaluronic acid concentrations in synovial fluid (patient: adult male and female). Pain suppressing action In experimental joint pain model suppress bradykinin alone and pain effect by combination of bradykinin and PGE 2 (rat). In a joint pain model based on urate crystals, it suppresses pain-inducing effects (dogs). Suppresses the production of PGE 2 which is an inflammatory pain enhancer and suppresses pain (patient: adult male and female). Improvement of joint contracture It acts as a physical barrier between the tendon and the tendon sheath, preventing adhesion of the tendon (rat). Improve joint range of experimental joint contracture model (rabbit).