| 883 |
牛源性物质：脑、眼、脊髓、头骨、脊椎骨（不包括尾椎骨）、脊柱、 扁桃体、回肠末端、背根神经节、三叉神经节、血液和血液制品、舌 （指舌肌含有杯状乳突）；羊源性物质：头骨（包括脑、神经节和眼）、 脊柱（包括神经节和脊髓）、扁桃体、胸腺、脾脏、小肠、肾上腺、胰腺、肝脏以及这些组织制备的蛋白制品，血液和血液制品、舌（指舌 肌含有杯状乳突）；但是，卫生部 2007 年第 116 号公告中的限用牛源 性物质（骨制明胶和胶原、含蛋白的牛油脂和磷酸二钙、含蛋白的牛油脂衍生物）可以使用, 如果生产者使用下述方法, 并且是严格保证 的：1.骨制明胶和胶原, 原料骨（不包括头骨和椎骨）需经以下程序进行 加工处理： （1） 高压冲洗（脱脂）； （2） 酸洗软化, 去除矿物质； （3） 长时间碱处理； （4） 过滤； （5） 138℃以上至少灭菌消毒 4s，或使用 可降低感染性的其他等效方法。 2.含蛋白的牛油脂和磷酸二钙，须来源于经过宰前和宰后检验的牛，并剔除了脑、眼、脊髓、脊柱、扁桃体、回肠末端等特殊风险物质。3.含蛋白的牛油脂衍生物， 需经高温、高压的水解、皂化和酯交换方法生产。 |
Materials with bovine source: brain, eyes, spinal cord, skull, vertebra （not including caudal vertebrae）, spinal column, tonsil, terminal ileum, dorsal root ganglion, ganglion nervi trigemini, blood and blood products, tongue （tongue muscle with calicle mamillary process）.Materials with ovine source: skull （including brain, ganglion and eyes）, spinal column （including ganglion and spinal cord）, tonsil, thymus, spleen, small intestine, adrenal gland, pancreatic gland, liver and their proteinic products, blood and blood products, tongue （tongue muscle with calicle mamillary process）.However, the restricted materials listed in Notification No 116 issued by Ministry of Health in 2007（gelatin and collagen derived from bovine bones, beef tallow and dicalcium phosphate containing proteins, derivatives of beef tallow containing proteins） may be used, if the following have been processed during their manufacturing and can be strictly certified by the producer:a） Gelatin and collagen derived from bovine bones, the bones （not including skull and vertebra） must go through the following process: 1） High pressure washing （degreasing）; 2） Acid washing to intenerate and remove minerals; 3） Long-time alkali processing; 4） Filtration; 5） Continue sterilizing at or above 138℃ for no less than 4 seconds, or other equivalent disinfecting methods.b） Beef tallow and dicalcium phosphate containing proteins, they must go through pre-killing and post-killing quarantines and are obtained after removing specific high-risk materials such as brain,eyes, spinal cord, spinal column, tonsil, and terminal ileum.c） Derivatives of beef tallow containing proteins, they must be produced in high-temperature and high- pressure hydrolyzed, saponified and transesterification methods. |