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
空白对照：水 Blank: water
样品：标准品溶液，供试品溶液，空白
Sample: standard solution, sample solution, and blank
取三试管，分别加入2.0 mL现配的碱性酒石酸钠试剂，在一管加入2.0 mL标准溶液，一管加入2.0 mL供试品溶液，一管加入2.0 mL水。十分钟后，各管加入福林酚试剂1.0 mL，快速混匀。30分钟后，用空白最对照，测量标准溶液和供试品溶液的吸光度。 Add 2.0 mL of freshly prepared alkaline cupric tartaric reagent to test tubes containing 2.0 mL of the Standard solution, 2.0 mL of the Sample solution, or 2.0 mL of the Blank. After 10 min, add 1.0 mL of Dilute Folin-Ciocalteu reagent to each test tube, and mix immediately and vigorously. After 30 min, measure the absorbance of the Standard solution and Sample solution against the Blank.
接受标准：按干燥品计算，不超过6.0 %；供试品溶液吸光度不超过标准溶液吸光度。 Acceptance criteria: NMT 6.0 % on the dried basis; the absorbance of the Sample solution is NMT the absorbance of the Standard solution. 重金属：不超过20 ppm（方法2） Heavy metals: NMT 20 ppm (Method II)
溶液颜色及澄清度Clarity and color of solution：
供试品溶液：称量2.5 g硫酸软骨素钠到50 mL容量瓶中，无二氧化碳水溶解稀释至体积，立即检查。
Sample solution: Transfer 2.5 g of Chondroitin Sulfate Sodium to a 50 mL volumetric flask. Dissolve in and dilute with carbon dioxide-free water to volume, and examine immediately.
仪器条件（见分光光度法，光散射 USP 851）
Instrumental conditions (See Spectrophotometry and Light-Scattering 851.) 分析波长：420 nm
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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
Analytical wavelength: 420 nm 比色皿：1 cm Cell: 1 cm
空白对照：无二氧化碳水 Blank: Carbon dioxide-free water 方法：检测供试品溶液的吸光度
Analysis: Measure the absorbance of the Sample solution. 接受标准：吸光度不超过0.35
Acceptance criteria: Its absorbance is NMT 0.35. 比旋度：﹣20.0°~ ﹣30.0°
Specific Rotation: ﹣20.0° to ﹣30.0° 供试品溶液：30 mg/mL Sample solution: 30 mg/mL pH：5.5~7.5，1 %溶液
pH: 5.5~7.5, in a solution (1 in 100)
干燥失重：105℃干燥4小时，其重量损失不得过10.0 %(注：硫酸软骨素钠干燥品容易吸潮，迅速称重，避免暴露于空气中)
Loss on drying: Dry a sample at 105° for 4 h: it loses NMT 10.0 % of its weight. [NOTE—Chondroitin Sulfate Sodium is extremely hygroscopic once dried. Avoid exposure to the atmosphere, and weigh promptly.] 【含量】CONTENT
标准溶液：1.5 mg/mL、1.0 mg/mL、0.5 mg/mL的USP硫酸软骨素钠RS水溶液。 Standard solutions: 1.5, 1.0, and 0.5 mg/mL of USP Chondroitin Sulfate Sodium RS in water
供试品溶液：称量100 mg已干燥的硫酸软骨素到100 mL容量瓶中，30 mL水溶解，
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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
并稀释至体积。
Sample solution: Transfer 100 mg of dried Chondroitin Sulfate Sodium into a 100-mL volumetric flask, dissolve in 30 mL of water, and dilute with water to volume.
稀释剂：称量297 mg磷酸二氢钾，492 mg磷酸氢二钾，250 mg聚山梨醇酯80到1L烧杯，900 mL水溶解，氢氧化钾或磷酸调pH 7.0±0.2，稀释至1L，搅拌混匀。 Diluent: Weigh about 297 mg of monobasic potassium phosphate, 492 mg of dibasic potassium phosphate, and 250 mg of polysorbate 80, and transfer into a 1 L beaker. Dissolve in 900 mL of water, and adjust with potassium hydroxide or phosphoric acid to a pH of 7.0 ±0.2. Dilute with water to 1 L, and mix thoroughly 滴定系统Titrimetric system 模式：光度滴定
Mode: Photometric titration
滴定标准液：1 mg/mL氯化十六烷基吡啶溶液（现配）
Titrant: 1 mg/mL of cetylpyridinium chloride in water Degas before use. 终点检测：光度电极测定浊度。
Endpoint detection: Turbidimetric with a photoelectric probe
将5.0 mL的各标准溶液和供试品溶液单独加入到各滴定容器内，每个加入25 mL稀释剂。搅拌直至光度电极在420 nm 或550 nm或 660 nm处获得一个稳定的读数。仪表在吸收模式调零，用滴定液滴定，由光度电极确定浊度终点。根据标准溶液浓度与消耗的滴定液体积建立的线性回归方程，计算供试品溶液中硫酸软骨素钠的浓度。 Transfer 5.0 mL of each Standard solution and the Sample solution to separate titration vessels, and add 25 mL of Diluent to each. Stir until a steady reading is obtained with a phototrode either at 420, 550, or 660 nm. Set the instrument to zero in absorbance mode. Titrate with Titrant using the phototrode to determine the endpoint turbidimetrically. From a linear regression equation, calculated using the volumes of Titrant consumed versus concentrations of the Standard solutions, determine the
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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
concentration of chondroitin sulfate sodium in the Sample solution. 计算硫酸软骨素钠百分比公式如下：
Calculate the percentage of chondroitin sulfate sodium in the portion Chondroitin Sulfate Sodium taken:
结果Result = (C/CU) ×100
C = 从回归方程中得到的供试品溶液等分试样的硫酸软骨素钠浓度(mg/mL)。
Concentration of chondroitin sulfate sodium in the aliquot of the Sample solution, obtained from the regression equation (mg/mL) CU = 配制供试品溶液时硫酸软骨素钠浓度(mg/mL)。
Concentration of Chondroitin Sulfate Sodium in the Sample solution (mg/mL) 接受标准：按干燥品计算，90.0 %~105.0 %
Acceptance criteria: 90.0 %~105.0 % on the dried basis 微生物限度Microbial contamination
细菌总数不超过1000个/g；霉菌和酵母菌不超过100个/g；大肠埃希菌每g不得检出；沙门菌每10 g不得检出。
The total bacterial count does not exceed 1000 cfu/g; and the total combined molds and yeasts count does not exceed 100 cfu/g; Escherichia coil is absence per gram; salmonella is absence per 10 grams. 【贮藏】 保存在密闭容器内。 【Storage】Preserve in tight containers. 【标准来源】美国药典USP35 NF30,2012 【Standard】According to USP35 NF30,2012 【半成品复验期】一年 【Retest period】One year 【成品有效期】二年
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