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性激素制剂厂房设计和生产中的风险管理
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作者 申伟 杨悦 《中国处方药》 2019年第2期36-38,共3页
高活性药品包括高致敏性药品(如青霉素类)、生物制品、β-内酰胺结构类药品、甾体类、性激素类避孕药品、细胞毒素类和其他高活性API和制剂,一般具有高选择性,或有可能导致癌症、基因突变、发育影响或低剂量的生殖毒性,因其比其他药物... 高活性药品包括高致敏性药品(如青霉素类)、生物制品、β-内酰胺结构类药品、甾体类、性激素类避孕药品、细胞毒素类和其他高活性API和制剂,一般具有高选择性,或有可能导致癌症、基因突变、发育影响或低剂量的生殖毒性,因其比其他药物能更准确、更具有选择性地靶向染病细胞,且具有低剂量、高药效特点,近年来在生产品种及产量上都呈现较大的增长,除存在较高的产品质量风险外,还具有严重的操作人员接触伤害和环境污染等环境、健康与安全(EHS)风险。如何科学采取措施,降低高活性药品生产中的质量相关风险和EHS相关风险,与国际接轨,已成为目前高活性药品生产企业面对的问题。文章以性激素制剂为例,从职业暴露限值(OEL)确定、设备选型和工艺操作、空调设计、人员防护、环境保护等环节介绍了风险管理在厂房设计和生产的应用,以期为其他药品生产企业中高活性产品的厂房设计和生产,以及开展国际GMP认证等提供借鉴和帮助。 展开更多
关键词 风险管理 性激素制剂 厂房设计 人员防护 废物处理
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妇产科常见病用药 第9讲 闭经
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作者 林金芳 《中国临床医生杂志》 2004年第2期54-56,共3页
关键词 妇科疾病 闭经 性激素制剂 诱发排卵药 注意事项 促性腺激素
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Effects of p38 MAPK inhibitor on the rat pain behavior and proinflammatory cytokines in a metastatic bone cancer pain model
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作者 Cuiju Tang Shiying Yu +3 位作者 Min Zhang Rui Jiang Na Li Huiting Xu 《The Chinese-German Journal of Clinical Oncology》 CAS 2008年第3期154-158,共5页
Objective: To observe the effects of p38 mitogen activated protein kinase (MAPK) inhibitor SB203580 by intrathecal injection on the pain behavior and the spinal proinflammatory cytokines in a rat model of bone canc... Objective: To observe the effects of p38 mitogen activated protein kinase (MAPK) inhibitor SB203580 by intrathecal injection on the pain behavior and the spinal proinflammatory cytokines in a rat model of bone cancer pain induced by breast cancer cells. Methods: Eleven rats were used to establish the models of bone cancer pain, six rats were treated by intrathecal SB203580 injection, and the other 5 were as the controls. The paw withdrawal latency (PWL), histology and the spinal levels of IL-1β and TNF-α were detected. Results: All the 11 rats presented evident bone destruction and thermal hyperalgesia after intra-tibial injection of breast cancer cells. No effect of SB203580 on the bone destruction was observed. However, following intrathecal injection of SB203580, the left PWLs (12.12± 1.26 s at 16 days and 12.99 ± 1.65 s at 19 days) were significant higher than that of controls (9.05 ± 1.08 s at 16 days and 8.55 ± 1.60 s at 19 days), P 〈 0.05. Meanwhile, inkathecal injection of SB203580 evidently reduced the levels of spinal IL-1β and TNF-α. Conclusion: Intrathecal injection of SB203580 in a rat model of bone cancer pain cannot prevent the tibial destruction but significantly depress the thermalgia sensitivity, which might result from inhibiting inkacellular p38 MAPK signaling transduction, and thereby reducing the release of the proinflammatory cytokines. 展开更多
关键词 p38 MAPK inhibitor bone cancer pain thermal hyperalgesia proinflammatory cytokine
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