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目的归纳汇总变更国内生产药品制剂的原料药产地的条件及应该进行的研究验证工作。方法从技术角度阐述此项变更时应进行的相关研究验证工作。结果与结论Ⅱ类变更条件中,应对新旧产地原料药的质量标准、晶型、溶解性(粒度)经研究验证后说明变更前后的一致性,也包括与制剂体内吸收和疗效有关的指标。制剂应证明原料药产地变更并未引起制剂质量发生变化,并与原产地原料药生产的制剂的稳定性情况进行比较。Ⅲ类变更条件中,重点比较产地变更后原料药的杂质和原料药与制剂体内吸收和疗效有关的指标(如晶型、分子量分布、黏度等)的变化。制剂质量应进行相应的研究,证明新产地生产的原料药适用于制剂的生产并与原产地原料药生产的制剂的稳定性情况进行比较。 相似文献
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花草档案别名 长柄合果芋、紫梗芋、剪叶芋、丝素藤、白蝴蝶、箭叶科属 天南星科合果芋属原产地 中美、南美的热带雨林中形态特征 叶上有长柄,呈三角状盾形,叶脉及其周围呈黄白色。根旱肉质。茎有气生根,蔓性强。 相似文献
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柿子原产地在中国,已有一千多年的栽培历史。主要种植地区在河南、山西、陕西、河北等地山区。柿子19世纪传入法国和地中海各国,后又传入美国。经过人工培育后的美洲柿已经有了许多优良品种,味道也超过东方柿子。 相似文献
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陶莎 《Journal of traditional Chinese medicine》2009,(2):97-100
In TCM it is held that urticaria is mostly due to weak constitution with deficiency of qi and blood, or prolonged illness that causes consumption of qi and blood. Such constitution can result in formation of wind due to blood deficiency, and intemal-extemal lack of resistance due to qi-deficiency, which gives chances to pathogenic wind to invade the body, hence the occurrence of urticaria. Therefore, this disease is a complicated one with deficiency in the origin and excessiveness of pathogen. The Acupuncture and Moxibustion Department of Guanganmen Hospital has adopted acupuncture treatment for this disease through treating both the incidental and fundamental simultaneously, and obtained quite good clinical therapeutic effects as is summarized in the following. 相似文献
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