将动物胰脏(主要为猪的,也可用牛、羊、鸡或鸭的)搅碎,然后经过磨浆、烘干,再用乙醚浸取脱脂、粉碎以后,加入适量的元明粉即为成品。
中文名 | 胰酶 |
英文名 | Pancreatin |
别名 | 胰酶 胰酵 胰酵素 胰液素 胰消化素 胰酶来源于猪胰腺 胰酶(11×USP) 胰液素 来源于猪胰腺 胰酵素,胰醇素,胰液素 |
英文别名 | ilozyme intrazyme Pancreatin PANCREATIN beefviokase diastasevera PANCREATIN, 3X PANCREATIN 4X NF PANCREATIN 4X USP GRANULAR |
CAS | 8049-47-6 |
EINECS | 232-468-9 |
化学式 | N/A |
密度 | 1.4-1.52 |
水溶性 | Soluble in water. Insoluble in alcohol and ether. |
蒸汽压 | 0Pa at 25℃ |
溶解度 | 溶于或部分溶于水,形成微混浊溶液; 几乎不溶于乙醇 (96%) 和乙醚。 |
存储条件 | -20°C |
稳定性 | 稳定。与醇、强酸不相容。 |
敏感性 | Sensitive to light |
外观 | 粉末 |
颜色 | beige |
Merck | 13,7075 |
物化性质 | 胰酶系自猪、羊或牛胰中提取的多种酶的混合物。为类白色或微带黄色的粉末,部分溶于水,水溶液在Ph2 ~3时稳定,在pH6以上不稳定,Ca2+的存在可增加其稳定性。部分溶于低浓度的乙醇溶液中,不溶于高浓度乙醇、丙酮和乙醚等有机溶剂中,微臭,但无霉败的臭气,有引湿性。遇酸、热及重金属、鞣酸等蛋白质沉淀剂产生沉淀,失去酶的活力。胰酶制剂为胰酶的肠溶片,除去肠溶衣后,显白色或淡黄色。在中性或微酸性时效力最好,故多与碳氢钠同服。 |
MDL号 | MFCD00131789 |
危险品标志 | Xn - 有害物品 |
风险术语 | R36/37/38 - 刺激眼睛、呼吸系统和皮肤。 R42 - 吸入可能致敏。 R42/43 - 吸入及皮肤接触可能致敏。 |
安全术语 | S22 - 切勿吸入粉尘。 S24 - 避免皮肤接触。 S26 - 不慎与眼睛接触后,请立即用大量清水冲洗并征求医生意见。 S36/37 - 穿戴适当的防护服和手套。 S37/39 - 戴适当的手套和护目镜或面具。 |
WGK Germany | 1 |
RTECS | RT9033000 |
FLUKA BRAND F CODES | 3-10 |
TSCA | Yes |
海关编号 | 35079090 |
上游原料 | 锗 |
下游产品 | L-色氨酸 硫酸软骨素 |
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将动物胰脏(主要为猪的,也可用牛、羊、鸡或鸭的)搅碎,然后经过磨浆、烘干,再用乙醚浸取脱脂、粉碎以后,加入适量的元明粉即为成品。
本品系自猪、羊或牛胰中提取的多种酶的混合物,主要为胰蛋白酶、胰淀粉酶与胰脂肪酶。按干燥品计算,每lg中含胰蛋白酶活力不得少于600单位,胰淀粉酶活力不得少于7000单位,胰脂肪酶活力不得少于4000单位。
本品为类白色至微黄色的粉末;微臭,但无霉败的臭气;有引湿性;水溶液煮沸或遇酸即失去酶活力。
取本品1.0g,置具塞锥形瓶中,加乙醚10ml密塞,时时旋动,放置约2小时后,将乙醚液倾泻至用乙醚湿润的滤纸上,滤过,残渣用乙醚10ml照上法处理,再用乙醚5ml洗涤残渣,合并滤液及洗液至已恒重的蒸发皿中,使乙醚自然挥散后,在105°C干燥2小时,精密称定,遗留脂肪不得过20mg。
取本品,在105°C干燥4小时,减失重量不得过 5.0%(通则 0831) 。
取本品,照非无菌产品微生物限度检查:微生物计数法(通则1105)和控制菌检查法(通则1106)检查。lg供试品中需氧菌总数不得过10 OOOcfu,霉菌和酵母菌总数不得过lOOcfu,不得检出大肠埃希菌。10g供试品中不得检出沙门菌。
对照品溶液的制备 取酪氨酸对照品,精密称定,加0.2mol/L盐酸溶液溶解并定量稀释制成每lml中约含50ug的溶液。供试品原液的制备取本品约0.lg ,精密称定,置乳钵中,加冷至5°C以下的氯化钙溶液(取氯化钙1.47g,加水500ml使溶解,用0.lmol/L盐酸溶液或0.lmol/L氢氧化钠溶液调节pH值至6.0〜6.2 )少量,研磨均勻,移至100ml量瓶中,用上述氯化钙溶液稀释至刻度,摇匀;精密量取适量,用冷至5°C以下的硼酸盐缓冲液(取硼砂2.85g、硼酸10.5g与氯化钠2.50g,加水使溶解成1000ml,调节pH 值至7.5 士0.1)定量稀释制成每lml中约含胰蛋白酶0.12单位的溶液。
测定法 取试管3支,分别精密量取供试品原液lml与上述硼酸盐缓冲液2ml,在40°C水浴中保温10分钟,分别精密加入在40°C水浴中预热的酪蛋白溶液(取酪蛋白对照品1.5g,加0.lmol/L氢氧化钠溶液13ml与水40ml,在60°C水浴中加热使溶解,放冷,用水稀释至100ml,调节pH 值至8.0)5ml,摇匀,立即置40°C 士0.5°C水浴中准确反应30分钟,再各精密加入5%三氯醋酸溶液5ml终止反应,混匀,滤过,取续滤液作为供试品溶液;另精密量取供试品原液1ml,加上述硼酸盐缓冲液2.0ml,在40°C水浴中保温10分钟,精密加人5%三氯醋酸溶液5ml,摇匀,置40°C士0.5°C水浴中准确反应30分钟,立即精密加人酪蛋白溶液5ml,摇勻,滤过,取续滤液作为空白对照;照紫外-可见分光光度法(通则0401) ,在275nm的波长处,测定并计算供试品溶液吸光度的平均值(A )。
供试品溶液的制备 取本品约0.3g,精密称定,置研钵中,加冷至5°C以下的磷酸盐缓冲液(取磷酸二氢钾13.61g与磷酸氢二钠35.80g,加水使溶解成1000ml,调节pH值至6.8)少量,研磨均匀,用上述磷酸盐缓冲液定量稀释制成每lml中约含胰淀粉酶10〜20单位的溶液。
测定法 取1%可溶性淀粉溶液;取经105°C干燥2小时的可溶性淀粉(供胰淀粉酶测定)1.0g,加水10mU搅匀后,边搅拌边缓缓倾入100ml沸水中,继续煮沸20分钟,放冷,用水稀释至100ml]25ml、上述磷酸盐缓冲液10ml、l.2%氯化钠溶液lml与水20ml,置250ml碘瓶中,在40°C水浴中保温10分钟,精密加入供试品溶液lml,摇匀,立即置40°C±0.5°C水浴中准确反应10分钟,加lmol/L盐酸溶液2ml终止反应,摇勻,放至室温后,精密加碘滴定液(0.05mol/L)10mU边振摇边滴加0.lmol/L氢氧化钠溶液45ml,在暗处放置20分钟5加硫酸溶液(l—4)4ml,用硫代硫酸钠滴定液(O.lmol/L)滴定至无色。另取1%可溶性淀粉溶液25ml、上述磷酸盐缓冲液10ml、1.2%氯化钠溶液lml与水20ml,置碘瓶中,在40°C 士0.5°C水浴中保温10分钟,放冷,加lmol / L盐酸溶液2ml,摇匀,加入供试品溶液1.0ml,摇勻,精密加入碘滴定液(0.05mol/L)10ml,边振摇边滴加0.lmol/L氢氧化钠溶液45ml,在暗处放置20分钟,加硫酸溶液( l-4)4ml,用硫代硫酸钠滴定液(0.lmol/L)滴定至无色,作为空白对照,每lml碘滴定液(0.05mol/L)相当于9.008mg无水葡萄糖。
供试品溶液的制备 取本品约O.lg,精密称定9置乳钵中,加冷至5°C以下的三羟甲基氨基甲烷缓冲液(取三羟甲基氨基甲烷606mg,加0.lmol/L盐酸溶液45.7ml,加水至lOOml摇匀,调节pH值至7.1)少量,研磨均匀,用上述缓冲液定量稀释制成每lml中约含胰脂肪酶8〜16单位的溶液。
测定法 取橄榄油乳液(取橄榄油4ml与阿拉伯胶7.5g,研磨均匀,缓缓加水研磨使成100ml,用高速组织捣碎机以每分钟8000转搅拌两次,每次3分钟,取乳剂在显微镜下检查,90%乳粒的直径应在3um以下,并不得有超过l0ml的乳粒)25ml、牛胆盐溶液[取牛胆盐参照试剂适量5用水制成(2—25)的溶液]2ml与水10ml置100ml烧杯中,用氢氧化钠滴定液(0.lmol/L)调节pH值至9.0,在37°C±0.1°C水浴中保温10分钟9再调节pH值至9.0,精密量取供试品溶液lml, 在37°C±0.1°C水浴中准确反应10分钟5同时用氢氧化钠滴定液(0.lmol/L)滴定使反应液的pH值恒定在9.0,记录消耗氢氧化钠滴定液(O.lmol/L )的量(ml)。
助消化药。
遮光,密封,在阴凉干燥处保存。
本品按胰酶的标示量计算,每lg含胰蛋白酶活力不得少于540单位,胰淀粉酶活力不得少于6300单位,胰脂肪酶活力不得少于3400单位。
本品为肠溶片,除去肠溶衣后,显白色至淡黄色。
同胰酶。
(1)0.3g (2)0.5g
遮光,密封,在阴凉干燥处保存。
本品按胰酶的标示量计算,以干燥品计,每lg中含胰蛋白酶活力不得少于540单位,胰淀粉酶活力不得少于6300单位,胰脂肪酶活力不得少于3400单位。
本品内容物为类白色至微黄色粉末。
同胰酶。
0.15g
遮光,密封,在阴凉干燥处保存。
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