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

1.0per 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1

2.7±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。

Method. Perform the test in duplicate. Place 7.5 g of the

substance to be tested in each bottle. Add 105 mL of water R,

place a watch-glass over each bottle and allow to stand for 1-4 h.

Heat in a water-bath at 65 ± 2 °C for 15 min. While heating,

gently stir with a glass rod. Ensure that the solution is uniform

and that any condensed water on the inner walls of the bottle

is incorporated. Allow to cool at room temperature for 15 minand transfer the bottles to a thermostatically controlled bathat 10.0 ± 0.1 °C, and fitted with a device to ensure that theplatform on which the bottles stand is perfectly horizontal.Close the bottles with a rubber stopper and allow to standfor 17 ± 1 h. Remove the sample bottles from the bath andquickly wipe the water from the exterior of the bottle.

Centreconsecutively the 2 bottles on the platform of the apparatus sothat the plunger contacts the sample as nearly at its midpointas possible and start the measurement.

Report the result as theaverage of the 2 measurements.

Iron: maximum 30 ppm.

Atomic absorption spectrometry (2.2.23, Method I).

Test solution. To 5.00 g of the substance to be examined, in a

conical flask, add 10 mL of hydrochloric acid R. Close the flask

and place in a water-bath at 75-80 °C for 2 h. Allow to cool and

adjust the content of the flask to 100.0 g with water R.

Reference solutions. Prepare the reference solutions using

iron standard solution (8 ppm Fe) R, diluted as necessary with

water R.

Wavelength: 248.3 nm.

铁：≤30 ppm

原子吸收光谱测定法

测试液: 待测物5.00 g放入圆锥瓶中，添加10ml盐酸。盖上瓶，放入水浴75~80℃2小时，冷却并向瓶中添加水增至100.0g。

参照液：使用铁标准液（8ppm Fe）准备参照液，必要时可用水稀释

波长：248.0 nm

Chromium: maximum 10 ppm.

Atomic absorption spectrometry (2.2.23, Method I).

Test solution. Test solution described in the test for iron.

Reference solutions. Prepare the reference solutions using

chromium standard solution (100 ppm Cr) R, diluted if

necessary with water R.

Wavelength: 357.9 nm.

铬：≤10ppm

原子吸收光谱测定法

测试液：同铁项下的溶液描述

参照液：使用铬标准液（100ppm Cr）准备参照液，必要时可用水稀释

波长：357.9nm

Zinc: maximum 30 ppm.

Atomic absorption spectrometry (2.2.23, Method I).

Test solution. Test solution described in the test for iron.

Reference solutions. Prepare the reference solutions using

zinc standard solution (10 ppm Zn) R, diluted if necessary

with water R.

Wavelength: 213.9 nm.

锌：≤30ppm

原子吸收光谱测定法。

测试液：见铁项下的溶液描述。

参照液：使用锌标准溶液（10ppm Zn）准备参照液，必要时可用水稀释。波长：213.9nm

Loss on drying (2.2.32): maximum 15.0 per cent, determined

on 1.000 g, by drying in an oven at 105 °C.

水分：≤15.0%，基于1.000 g，105℃干燥箱条件下

Microbial contamination

TAMC: acceptance criterion 103CFU/g (2.6.12).

TYMC: acceptance criterion 102CFU/g (2.6.12).

Absence of Escherichia coli (2.6.13).

Absence of Salmonella (2.6.13).

微生物交叉感染

好氧微生物总数：≤103 CFU/g

大肠杆菌不得检出，沙氏门菌不得检出