中英文版欧盟药典EP明胶

欧洲药典 7.0

Definition

Purifiedproteinobtainedeitherbypartialacidhydrolysis(typeA),partial

alkalinehydrolysis(typeB)orenzymatic hydrolysis of collagen fromanimals(including fish and poultry); it may also be a mixture of different types. The hydrolysis leads to gelling or non-gelling product

grades. Both product grades are covered by this monograph. Gelatin described in this monograph is not suitable for parenteral administration or for other special purposes.

定义

通过酸性水解(A型)，部分碱性水解（B型）从动物（包括鱼，家畜）获得的蛋白质

通过水解从而得到凝胶或非凝胶类型。两种产品类型都包含在本药典中。本药典中的明胶不适用于注射给药或用于其他用途。 形态特征

外观：淡黄色或者淡棕黄色，通常为透明的片状，碎片、颗粒状或者粉末 水溶性：一般不容易常用有机溶剂， 凝胶类型在冷水中膨胀。

等电子点是明胶不同用途的相对参考质量指标：A型明胶Ph 6.0~9.5, B型明胶pH4.7~5.6, 对于不同用途的明胶pH范围可略微不同. 不同类型的明胶透明度，色泽不同。

CHARACTERS

Appearance: faintly yellow or light yellowish-brown, solid,

usually occurring as translucent sheets, shreds, granules or powder. Solubility: practically insoluble in common organic solvents gelling grades swell in cold water and give on heating a colloidal solution which on cooling forms a more or less firm gel. The isoelectric point is a relevant quality parameter for use of gelatin in different applications: for type A gelatin it is typically between pH 6.0 and pH 9.5 and for type B gelatin is typically between pH 4.7 and pH 5.6. These ranges cover a variety of different gelatins and for specific applications a narrower tolerance is usually applied.

Different gelatins form aqueous solutions that vary in clarity and colour. For a particular application, a suitable specification for clarity and colour is usually applied. IDENTIFICATION

A. To 2 mL of solution S (see Tests) add 0.05 mL of copper sulfate solution R. Mix and add 0.5 mL of dilute sodium hydroxide solution R. A violet colour is produced. B. To 0.5 g in a test-tube add 10 mL of water R. Allow to stand for 10 min, heat at 60 °C for 15 min and keep the tube upright at 0 °C for 6 h. Invert the tube; the contents immediately flow out for non-gelling grades and do not flow out immediately for gelling grades. 鉴别

A 在2mlS溶液（见下文试验）中添加0.05ml硫酸铜。混匀，然后添加0.5ml稀释的NaOH溶液，产生紫色。

B．在试管中添加10 ml水,0.5g 明胶，让试管竖立10分钟，加热60°C 15 分钟，同时保持试管在0°C情况下竖立6小时。倒转试管，对于非凝胶类型，试管内物立即流出；对凝胶类型，试管内物不立即流出 试验： S溶液

在无二氧化碳的水中，55℃温度下溶解1.00g明胶，后用水稀释至100 ml，保持溶液在该温度下进行试验 pH: S溶液 3.8~7.6

电导率：≤1 mS·cm?1 ， 30± 1.0 °C 1.0%溶液

SO2:≤50 ppm

Test:S solution

Dissolve 1.00 g in carbon dioxide-free water R at

about 55 °C, dilute to 100 mL with the same solvent and keep the solution at this temperature to carry out the tests. pH (2.2.3): 3.8 to 7.6 for solution S.

Conductivity (2.2.38): maximum 1 mS·cm?1, determined on a 1.0 per cent solution at 30 ± 1.0 °C.

Sulfur dioxide (2.5.29): maximum 50 ppm.Peroxides: maximum 10 ppm, determined using peroxide teststrips R.

过氧化物≤10 ppm，使用过氧化物测试条.

过氧化酶将将过氧化物转化成蓝色物质。颜色的强度与过氧化物的数量成正比，同时可与比色刻度试纸对比从而估算过氧化物的浓度。

Peroxidase transfers oxygen from peroxides to an organic redox indicator which is converted to a blue oxidation product. Theintensity of the colour obtained is proportional to the quantity of peroxide and can be compared with a colour scale providedwith the test strips, to determine the peroxide concentration.

Suitability test. Dip a test strip for 1 s into hydrogen peroxidestandard solution (10 ppm H2O2) R, such that the reaction zoneis properly wetted. Remove the test strip, shake off excess liquid and compare the reaction zone after 15 s with the colour scaleprovided with the test strips used. The colour must match thatof the 10 ppm concentration, otherwise the test is invalid.

适用性试验：将试纸浸入过氧化物标准液（10 ppm H2O2)1秒， 反应区湿润后，移出试纸，甩去多于的液体，15秒后与比色刻度卡对比。颜色必须与10ppm浓度一致，否则测试无效 测试。 称20.0 g ±0.1 g 待测物放入烧杯中，添加80.0±0.2 ml水，搅拌浸湿所有明胶 ，让样品室温下放置1~3小时。玻璃皿盖上烧杯，将烧杯放置在65±2℃水浴中20±5分钟，使样品溶解。用玻璃棒搅拌烧杯，使溶液均匀混合。试纸放在测试液中浸润1秒，反应区湿润。移出试纸，甩去多于液体，15秒后反应区与比色刻度试纸对比，比色刻度试纸的浓度数值乘以5计算出 过氧化物ppm浓度

Test. Weigh 20.0 ± 0.1 g of the substance to be tested in abeaker and add 80.0 ± 0.2 mL of water R. Stir to moisten allgelatin and allow the sample to stand at room temperature for1-3 h. Cover the beaker with a watch-glass. Place the beakerfor 20 ± 5 min in a water bath at 65 ± 2 °C to dissolve thesample.

Stir the contents of the beaker with a glass rod toachieve a homogeneous solution. Dip a test strip for 1 s into thetest solution, such that the reaction zone is properly wetted.Remove the test strip, shake off excess liquid and compare thereaction zone after 15 s with the colour scale provided withthe test strips used. Multiply the concentration read from thecolour scale by a factor of 5 to calculate the concentration inparts per million of peroxide in the test substance.

Gel strength (Bloom value): 80 to 120 per cent of the labellednominal value.

The gel strength is expressed as the mass in grams necessaryto produce the force which, applied to a plunger 12.7 mm indiameter, makes a depression 4 mm deep in a gel having aconcentration of 6.67 per cent m/m and matured at 10 °C. Apparatus. Texture analyser or gelometer with:

— a cylindrical piston 12.7 ± 0.1 mm in diameter with a plane pressure surface with a sharp bottom edge,

— a bottle 59 ± 1 mm in internal diameter and 85 mm high. Adjust the apparatus according to the manufacturer’s manual. Settings are: distance 4 mm, test speed 0.5 mm/s. 冻力 （6.67% m/m, 10°C） 装置：质构仪 或者凝胶强度测定仪：

1. 带直径12.7±0.1mm圆柱形活塞，尖型底部的压力面 2. 带有内部直径59±0.1mm、 高85mm的瓶

根据说明书调整装置，设置为：间隔4mm，测试速度 0.5mm/s 方法

实施两次试验：将7.5g待测物分别放置瓶中，，添加105 ml水，每个瓶盖上表面皿，让瓶竖立1~4小时。 水浴65 ± 2 °C 加热15分钟，加热时，用玻璃棒轻轻搅动，保证溶液均匀混合。室温下冷却15分钟，，将瓶转移到恒温控制的水浴 10.0 ± 0.1 °C， 配以设备保证瓶子所在的平台水平，用 橡胶塞盖上瓶，竖立17±1小时，将样品瓶从水浴中移出并迅速擦拭去瓶外壁的水。连续将两瓶放置在装置的平台中央，使得活塞尽可能接触样品中点，并开始测量。记录2次测量的平均值。