发布时间 : 星期六 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
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
300~400 V) for a gel of about 12 cm × 10 cm. Carry out the electrophoresis for 12 min. Place the gel in a mixture consisting of 10 volumes of anhydrous ethanol R and 90 volumes of buffer solution A for 2 min. Carry out the electrophoresis for 20 min. Place the gel in a mixture consisting of 30 volumes of anhydrous ethanol R and 70 volumes of buffer solution A for 2 min. Carry out the electrophoresis for 20 min. Stain the gel in the staining solution for 10 min. Destain the gel for 15 min under running tap water followed by 10~15 min with water R until the band in the electropherogram obtained with reference solution (c) is visible. Allow the gel to dry. 系统适用性System suitability:
— 电泳的对照溶液c显示一个可见光波段。
the electropherogram obtained with reference solution (c) shows a visible band; — 电泳的对照溶液b得到的谱带是显而易见的，并且其位置与电泳的对照溶液a位置近似。
the band in the electropherogram obtained with reference solution (b) is clearly visible and similar in position to the band in the electropherogram obtained with reference solution (a).
结果：供试品溶液中没有任何第二条谱带比对照液b中的谱带更强烈（2 %）
Results: any secondary band in the electropherogram obtained with the test solution is not more intense than the band in the electropherogram obtained with reference solution (b) (2 percent).
蛋白质(2.5.33, 方法 2)：最大值为3.0 %（以干燥品计）
Protein (2.5.33, Method 2): maximum 3.0 per cent (dried substance). 供试品溶液：用0.1 M氢氧化钠稀释1.0 mL溶液S1至50.0 mL。
Test solution: Dilute 1.0 mL of solution S1 to 50.0 mL with 0.1 M sodium hydroxide. 对照液：精确称量0.100 g牛白蛋白R，用0.1M氢氧化钠稀释至50.0 mL，所有额外的稀释都使用0.1M氢氧化钠。
Reference solutions: Dissolve about 0.100 g of bovine albumin R, accurately weighed,
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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
in 0.1 M sodium hydroxide and dilute to 50.0 mL with the same solvent. Carry out all additional dilutions using 0.1 M sodium hydroxide. 氯化物(2.4.4)：最大值0.5 %
Chlorides (2.4.4): maximum 0.5 per cent.
用水R稀释1 mL溶液S2至15 mL。不加硝酸。准备5 mL氯化物标准溶液（5 ppm Cl）和10 mL水R
Dilute 1 mL of solution S2 to 15 mL with water R. Do not add diluted nitric acid. Prepare the standard using 5 mL of chloride standard solution (5 ppm Cl) and 10 mL of water R. 重金属(2.4.8)：最大值20 ppm。 Heavy metals (2.4.8): maximum 20 ppm.
1.0 g符合测试C。准备2 mL的铅R标准溶液(10 ppm Pb)。
1.0 g complies with test C. Prepare the reference solution using 2 mL of lead standard solution (10 ppm Pb) R.
干燥失重(2.2.32)：最大值12.0 %。105℃，1.000 g干燥4小时。
Loss on drying (2.2.32): maximum 12.0 per cent, determined on 1.000 g by drying in an oven at 105 °C for 4 h. 【化验】 ASSAY
供试品溶液（a）：称量0.100 g 待检测试样品，用水R稀释至100 mL。
Test solution (a): Weigh 0.100 g (m1) of the substance to be examined, dissolve in water R and dilute to 100.0 mL with the same solvent.
供试品溶液（b）：用水R稀释5.0 mL供试品溶液（a）至50.0 mL。 Test solution (b): Dilute 5.0 mL of test solution (a) to 50.0 mL with water R.
标准溶液（a）：称量0.100 g硫酸软骨素钠CRS（用干燥失重测试方法预先干燥），用水R稀释至100.0 mL。
Reference solution (a): Weigh 0.100 g (m0) of chondroitin sulfate sodium CRS, previously dried as described in the test for loss on drying, dissolve in water R and
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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
dilute to 100.0 mL with the same solvent.
标准溶液（b）：用水R稀释5.0 mL标准溶液（a）至50.0 mL。
Reference solution (b): Dilute 5.0 mL of reference solution (a) to 50.0 mL with water R. 滴定液（a）：称量4.000 g氯化十六烷基吡啶R用水R稀释至1000 mL。
Titrant solution (a): Weigh 4.000 g of cetylpyridinium chloride monohydrate R and dilute to 1000 mL with water R.
滴定液（b）：称量1.000 g氯化十六烷基吡啶R用水R稀释至1000 mL。
Titrant solution (b): Weigh 1.000 g of cetylpyridinium chloride monohydrate R and dilute to 1000 mL with water R.
执行目测滴定法或光度滴定法如下Perform either visual or photometric titration as follows:
目测滴定法：用滴定液（a）滴定40.0 mL标准溶液（a）和40.0 mL的供试品溶液（a）。溶液会出现浑浊，在终点时，液体出现明显的，几乎白色的悬浮沉淀。如果滴定前加入1 %亚甲基蓝0.1 mL则沉淀物将更加明显。
Visual titration: Titrate 40.0 mL of reference solution (a) and 40.0 mL of test solution (a) with titrant solution (a). The solution becomes turbid. At the end point, the liquid appears clear, with an almost-white precipitate in suspension. The precipitate is more apparent if 0.1 mL of a 1 per cent solution of methylene blue R is added before starting the titration. The precipitated particles are more apparent against the blue background. 光度滴定法：用滴定液（b）滴定40.0 mL标准溶液（b）和40.0 mL的供试品溶液（b）。在可见光范围内使用合适的自动滴定仪配备合适的波长光度（不是至关重要）确定终点。 Photometric titration: Titrate 50.0 mL of reference solution (b) and 50.0 mL of test solution (b) with titrant solution (b). To determine the end point, use a suitable autotitrator equipped with a phototrode at a suitable wavelength (none is critical) in the visible range.
计算硫酸软骨素钠含量百分比使用以下表达式
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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
Calculate the percentage content of chondroitin sulfate sodium using the following expression:
v1?m0100??Z
v0?m1100?hv0 = 适当体积的滴定液滴定适当体积的标准溶液（mL)
Volume of appropriate titrant solution when titrating the appropriate reference solution, in millilitres;
v1 = 适当体积的滴定液滴定适当体积的供试品溶液（mL)
Volume of appropriate titrant solution when titrating the appropriate test solution, in millilitres;
h = 待测样品的的干燥失重（%）
Loss on drying of the substance to be examined, as a percentage; Z = 硫酸软骨素钠CRS中H2O(C14H19NNa2O14S)x的百分比
Percentage content of H2O (C14H19NNa2O14S)x in chondroitin sulfate sodium CRS. 微生物限度检查Microbial contamination
细菌总数≤103个/g，霉菌和酵母菌数≤102个/g，金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、胆汁耐受革兰氏阴性菌均为每g不得检出； 沙门菌每10g不得检出。
TAMC does not exceed 103 CFU/g; TYMC does not exceed 102 CFU/g; Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Bile-tolerant gram-negative bacteria is absence per gram; Salmonella is absence per 10 grams. 【贮藏】密封、避光保存
【Storage】In an airtight container, protected from light. 【标准来源】《欧洲药典》7.0版
【Standard】European Pharmacopoeia 7th edition 【半成品复验期】一年 【Retest period】One year
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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
【成品有效期】二年 【Expiry date】Two year
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