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本文参照卫生部药政管理局对中药静脉注射液的有关要求 ,并根据心脉隆注射液生产工艺特点 ,对十批心脉隆注射液部分质量指标进行了分析研究 ,认为鞣质、总固体物、正丁醇残留量、溶液颜色、重金属、砷盐、炽灼残渣可不列为心脉隆注射液质量标准的检查内容 ,而含量测定中的结合氨基酸含量限度应从不低于10 0mg/ml修改为不低于15 0mg/ml。
In this paper, with reference to the requirements of traditional Chinese medicine intravenous injection by Ministry of Health Administration of Pharmacy, and according to the characteristics of the production process of Xinmailong injection, some quality indexes of ten batches of Xinmailong injection were analyzed and concluded that tannin, total solid Butanol residues, the color of the solution, heavy metals, arsenic salts, residue on ignition may not be listed as the content of the test for the quality standard of Xinmailong injection, but the limit of the content of combined amino acids in the determination of content should not be lower than 100mg / ml Modified to not less than 150mg / ml.