发布时间 : 星期五 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
硫酸软骨素钠（供口服用）成品、半成品质量标准 Quality Standard of Finished & Bulk Product of
Chondroitin Sulfate Sodium (for oral)
【中文名】硫酸软骨素钠（供口服用） 【Chinese name】硫酸软骨素钠（供口服用）
【汉语拼音名】Liusuan Ruangusuna（Gongkoufuyong）
【Chinese Phonetic Alphabet】Liusuan Ruangusuna（Gongkoufuyong） 【英文名】Chondroitin Sulfate Sodium(for oral) 【English name】Chondroitin Sulfate Sodium(for oral) 【曾用名】硫酸软骨素、硫酸软骨素A钠
【Former name】Chondroitin Sulfate、Chondroitin Sulfate A Sodium 【物料编码】半成品：B04，成品：C04
【Material code】Bulk product: B04,Finished product ：C04. A.中国标准CHINESE STANDARD
本品系自猪的喉骨、鼻中骨、气管等软骨组织提取制得的硫酸化链状粘多糖钠盐。硫酸软骨素钠主要为N-乙酰半乳糖胺（2-乙酰胺-2脱氧-β-D-吡喃半乳糖）和D-葡萄糖醛酸的共聚物的硫酸酯钠盐，共聚物内己糖通过β-1，3及β-1，4糖苷键交替连接。按干燥品计算，含硫酸软骨素钠法定标准应为90.0 %～105.0 %；内控标准应为92.0 %～102.0 %。Chondroitin Sulfate Sodium(for oral) is the sodium salt of the sulfated linear glycosaminoglycan obtained from cartilage system of pig such as throat bone, nasal bone and trachea and so on . Chondroitin Sulfate Sodium consists mostly of the sodium salt of the sulfate ester of N-acetylchondrosamine (2-acetamido-2-deoxy-β-D- galactopyranose) and D-glucuronic acid copolymer. These hexoses are alternately
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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
linked β-1, 4 and β-1, 3 in the polymer. Calculated on the dried basis, the official standard is 90.0 %～105.0 %of chondroitin sulfate sodium, the internal standard is 92.0 %～102.0 % of chondroitin sulfate sodium. 【性状】CHARACTERS
本品为白色或类白色粉末；略带咸味；无臭；有引湿性。本品的水溶液具粘稠性，加热不凝结。本品在水中易溶，在乙醇、丙酮或冰醋酸中不溶。White or off-white powder , saltish , odourless and hygroscopic. The aqueous solution is ropy , no clotting.Freely soluble in water, insoluble in ethanol , acetone and glacial acetic acid. 【鉴别】IDENTIFICATION
（1） 本品的红外光吸收图谱应与硫酸软骨素钠对照品的图谱一致。照《红外分光光度
法操作规程》（WC0201-01）。Infra-red spectra of this substance should be corresponding to the infra-red reference spectra of Chondroitin Sulfate Sodium. Following the SOP of Infrared Spectrophotometry（WC0201-01）.
（2） 本品含量测定项下硫酸软骨素A与C的峰高比应为5.0～6.0。Under the item of
Content Determination ,the peak height of the Chondroitin Sulfate A and C should be 5.0～6.0.
（3）本品的水溶液显钠盐的鉴别（1）反应（《中国药典》2010年版二部附录II ）。The identification of sodium of aqueous solution.（Chinese pharmacopoeia [P].2010 edition, second part，appendix II）。 【检查】TESTS
比旋度 取本品，精密称定，用水溶解并定量稀释制成每1 mL中含40 mg的溶液。照《旋光度测定法操作规程》（WC0173-01）测定，比旋度法定标准应为﹣28°至﹣33°，内控标准应为﹣29°至﹣32°。
Specific Rotation: Accurately weigh the substance ,dissolve with water and dilute to
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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
the solution of 40mg in 1ml. Test following the SOP for Optical Rotation Test（WC0173-01）.The official standard of Specific Rotation is ﹣28°to ﹣33°,the internal standard is ﹣29°to ﹣32°.
酸度 取本品0.5 g，用水10 mL溶解后，照《PH值测定法操作规程》（WC0152-01）测定，PH值法定标准应为6.0～7.0，内控标准应为6.2～6.8。
PH Sample 0.5g the product, dissolve with 10ml water .Test following the SOP of PH Test, the official standard is 6.0～7.0,the internal standard is 6.2～6.8.
含氮量 取本品，照《氮测定法操作规程》（WC0156-02第二法）进行测定，按干燥品计算，含氮（N）量法定标准应为2.5～3.5 %，内控标准应为2.6～3.4 %。
Nitrogen content :Sample and test following the SOP of Nitrogen Test（WC0156-02 sencond method ）.The official standard of nitrogen content is 2.5～3.5 %,the internal standard is 2.6～3.4 %.
氯化物 取本品约0.01 g，照《氯化物检查法操作规程》（WC0159-01）测定，与标准氯化钠溶液5 mL制成的对照液比较，不得更浓（ 0.5 %）。
Chloride Weigh 0.01g the product ,test following the SOP of Chloride Test（WC0159-01）。Compare to the reference solution prepared from 5ml standard solution of NaCl,NMT 0.50 %.
硫酸盐 称取本品0.1 g，照《硫酸盐检查法操作规程》（WC0172-01）测定，与标准硫酸钾溶液2.4 mL制成的对照液比较，不得更浓（ 0.24 %）。Weigh 0.1g this substance , test following SOP for Sulfate Test （WC0172-01），Compare to the reference solution prepared from 2.4ml standard solution of potassium sulfate,NMT 0.24 %.
干燥失重 取本品，照《干燥失重检查法操作规程》（WC0160-01），在105℃干燥4小时，减失重量法定标准不得过10.0 %，内控标准不得过8.0 %。
Loss on drying: Sample and test the substance following the SOP for Loss On Drying
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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
Test （WC0160-01）。Dry at 105℃ for 4 h, the official standard of loss is NMT 10.0 % of its weight, internal standard is NMT 8.0 %.
炽灼残渣 取本品1.0 g，照《炽灼残渣检查法操作规程》（WC0153-01）测定，按干燥品计算，遗留残渣法定标准应为20.0 %～30.0 %，内控标准应为22.0 %～28.0 %。 Residue on ignition: Sample 1.0g the substance ,test following the SOP of Residue On Ignition Test （WC0153-01）.Calculate on the dried basis ,the official standard of the residue is 20.0 %～30.0 %,the internal standard is 22.0 %～28.0 %
重金属 取炽灼残渣项下遗留的残渣，照《重金属检查法操作规程》（WC0154-01第二法）测定，含重金属不得过百万分之二十。
Heavy Metal Sample the residue under the item of Residue On Ignition,Test following the SOP of Heavy Metal Test（WC0154-01 the second method）.The content of heavy metal is NMT 20 ppm.
残留溶剂 取本品，照《残留溶剂测定法操作规程》（WC0170-01）测定。所含乙醇量应不超过0.5 %。
Residual solvent Sample the substance ,test following the SOP of Residual Solvent （WC0170-01）. The content of ethanol is NMT 0.5 %. 【含量测定】Content
照《高效液相色谱法操作规程》（WC0194-01）测定。Test following the SOP for High Performance Liquid Chromatography Method（WC0194-01）。
色谱条件与系统适用性试验：用强阴离子交换硅胶为填充剂，以pH 3.5的水为流动相A，以pH 3.5的2 mol/L，氯化钠溶液为流动相B，按下表进行线性梯度洗脱，流速为1.0 mL/min，Chromatographic condition and system suitability Test: Strong anion exchange silica gel as filler and the water of pH 3.5 as mobile phase A , 2 mol/L NaCl solution of
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