发布时间 : 星期四 文章158硫酸软骨素钠（供口服用）成品、半成品质量标准-2012修订更新完毕开始阅读69c6bc016c85ec3a86c2c506
文件名称:硫酸软骨素钠（供口服用）成品、半成品质量标准 文件编码:TC0158-02
Doc.Name:Quality Standard of Finished & Bulk Product of Chondroitin Sulfate Sodium (for oral) Doc.No.: TC0158-02
【Expiry date】Two year
C. 欧洲标准 EUROPEA STANDARD
H2O (C14H19NNa2O14S)x
【定义】 DEFINITION
主要是2双糖天然共聚物：[4)-(β-D-吡喃葡糖醛酸)-(1→3)-[2-(乙酰氨基)- 2-脱氧-β-D-半乳糖 4-硫酸盐]-(1→] 和 [4)-(β-D-吡喃葡糖醛酸)-(1→3)-[2-(乙酰氨基)-2-脱氧-β-D-半乳糖 6-硫酸盐]-(1→]的钠盐。在完全水解后释放出半乳糖胺、葡萄糖醛酸、乙酸和硫酸。其从陆生和海生动物的软骨中获得，根据不同的动物物种来源，其4-硫酸盐基团和6-硫酸盐基团的比例不同。
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文件名称:硫酸软骨素钠（供口服用）成品、半成品质量标准 文件编码:TC0158-02
Doc.Name:Quality Standard of Finished & Bulk Product of Chondroitin Sulfate Sodium (for oral) Doc.No.: TC0158-02
Natural copolymer based mainly on the 2 disaccharides : [4)-(β-D-glucopyranosyl uronic acid)-(1→3)-[2-(acetylamino)- 2-deoxy-β-D-galactopyranosyl 4-sulfate]-(1→] and [4)-(β-D-glucopyranosyl uronic acid)-(1→3)-[2-(acetylamino) -2-deoxy-β-D- galactopyranosyl 6-sulfate]-(1→], sodium salt On complete hydrolysis it liberates D-galactosamine, D-glucuronic acid, acetic acid and sulfuric acid. It is obtained from cartilage of both terrestrial and marine origins. Depending on the animal species of origin, it shows different proportions of 4-sulfate and 6-sulfate groups. 含量：95 %~105 %（以干燥品计）
Content: 95 per cent to 105 per cent (dried substance). 【生产】 PRODUCTION
用于提取硫酸软骨素钠的动物必须符合适合人类消费的动物健康要求。
The animals from which chondroitin sulfate sodium is derived must fulfil the requirements for the health of animals suitable for human consumption. 【性状】 CHARACTERS 外观：白色或类白色，引湿性粉末
Appearance: white or almost white, hygroscopic powder. 可溶性：易溶于水，难溶于酒精和丙酮（96 %）
Solubility: freely soluble in water, practically insoluble in acetone and in ethanol (96 per cent).
【鉴定】 IDENTIFICATION
A.红外吸收分光光度法 Infrared absorption spectrophotometry (2.2.24). 准备：溴化钾R
Preparation: discs of potassium bromide R.
对照：硫酸软骨素钠来源于陆生的使用硫酸软骨素钠CRS，来源于海生的使用硫酸软骨素钠(海生)CRS。
Comparison: for chondroitin sulfate sodium of terrestrial origin use chondroitin sulfate
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文件名称:硫酸软骨素钠（供口服用）成品、半成品质量标准 文件编码:TC0158-02
Doc.Name:Quality Standard of Finished & Bulk Product of Chondroitin Sulfate Sodium (for oral) Doc.No.: TC0158-02
sodium CRS and for chondroitin sulfate sodium of marine origine use chondroitin sulfate sodium (marine) CRS. B. 钠反应（b）溶液S1 (见检查)
Solution S1 (see Tests) gives reaction (b) of sodium (2.3.1). C. 检查项下有关物质的电泳图
Examine the electropherograms obtained in the test for related substances. 结果：电泳图中供试品溶液（a）与标准溶液主峰位置一致
Results: the principal band in the electropherogram obtained with the test solution is similar in position to the principal band in the electropherogram obtained with reference solution (a). 【检查】 TESTS
溶液S1：溶解2.500 g硫酸软骨素钠供试品于50.0 mL 无二氧化碳水R中 Solution S1: Dissolve 2.500 g in 50.0 mL of carbon dioxide-free water R. 溶液S2：稀释1.0 mL溶液S1至10mL水R中
Solution S2: Dilute 1.0 mL of solution S1 to 10.0 mL with water R. pH(2.2.3): 溶液S1 pH为5.5~7.5 pH (2.2.3): 5.5 to 7.5 for solution S1.
比旋度(2.2.7)：﹣20~﹣30（陆生）或﹣12~﹣19（海生）（以干燥品计），溶液S1中测得。
Specific optical rotation (2.2.7): ? 20 to ? 30 (terrestrial origin) or ? 12 to ? 19 (marine origin) (dried substance), determined on solution S1. 特性粘度：0.01 m3/kg ~0.15 m3/kg。 Intrinsic viscosity: 0.01 m3/kg to 0.15 m3/kg.
供试品溶液（a）：称量5.000 g(m0p)的硫酸软骨素钠供试品，室温下加入11.7 g/L的氯化钠R溶液80 mL，室温下摇动溶解30分钟。用11.7 g/L的氯化钠R溶液稀释至100.0 mL。0.45 μm膜过滤，弃掉前10 mL。供试品溶液（a）仅是指示性，供试品溶液（a）必须调
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文件名称:硫酸软骨素钠（供口服用）成品、半成品质量标准 文件编码:TC0158-02
Doc.Name:Quality Standard of Finished & Bulk Product of Chondroitin Sulfate Sodium (for oral) Doc.No.: TC0158-02
整初始计量的粘度
Test solution (a): Weigh 5.000 g (m0p) of the substance to be examined and add about 80 mL of an 11.7 g/L solution of sodium chloride R at room temperature. Dissolve by shaking at room temperature for 30 min. Dilute to 100.0 mL with an 11.7 g/L solution of sodium chloride R. Filter through a membrane filter (nominal pore size 0.45 μm) and discard the first 10 mL. The concentration of test solution (a) is only indicative and must be adjusted after an initial measurement of the viscosity of test solution (a). 供试品溶液（b）：15.0 mL供试品溶液（a）加入11.7 g/L的氯化钠R溶液5.0 mL。 Test solution (b). To 15.0 mL of test solution (a) add 5.0 mL of an 11.7 g/L solution of sodium chloride R.
供试品溶液（c）：10.0 mL供试品溶液（a）加入11.7 g/L的氯化钠R溶液10.0 mL。 Test solution (c). To 10.0 mL of test solution (a) add 10.0 mL of an 11.7 g/L solution of sodium chloride R.
供试品溶液（d）：5.0 mL供试品溶液（a）加入11.7 g/L的氯化钠R溶液15.0 mL。 Test solution (d). To 5.0 mL of test solution (a) add 15.0 mL of an 11.7 g/L solution of sodium chloride R.
在25.00 ± 0.03 °C下确定11.7 g/L的氯化钠R溶液流动时间以及4个供试品溶液（t1, t2, t3 和 t4）的流动时间。使用合适的悬浮层粘度计（规格：粘度计常数= 0.005 mm2/s2，粘度范围= 1-5 mm2/s，管R内直径 = 0.53 mm，球泡C体积 = 5.6 mL，管N内直径 = 2.8-3.2 mm）及漏斗形下毛细管端。使用相同粘度计测量所有样本，测量所有样本流出时间三次。每个样本的平均相差不超过0.35 %，t1的流动时间应不小于1.6 × t0不超过1.8 × t0，否则测试无效。如果不是这种情况，调整供试品溶液（a）浓度并重复上述过程。 Determine the flow-time (2.2.9) for an 11.7 g/L solution of sodium chloride R (t0) and the flow times for the 4 test solutions (t1, t2, t3 and t4), at 25.00 ± 0.03 °C. Use an appropriate suspended level viscometer (specifications: viscometer constant = about 0.005 mm2/s2, kinematic viscosity range = 1-5 mm2/s, internal diameter of tube R =
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