摘要:
目的 :对目前临床应用较多的三家厂商(A厂、B厂和C厂)注射用水溶性维生素的9批样品进行质量比较,为临床应用提供参考。 方法 :参考国内外同类产品质量标准,从性状、pH值、复溶性、装量差异、不溶性微粒、溶液澄清度、含量和细菌内毒素等指标进行比较。 结果 :所测样品的外观颜色呈淡黄色、黄色甚至局部棕黄色不等;pH值均在5.6～6.1间;粉针剂在5min内均可完全复溶。澄清度、装量差异、细菌内毒素检查均符合中国药典关于注射剂项下的要求;不溶性微粒≥10μm、≥25μm的粒子数均符合中国药典的要求,但不同药厂的产品微粒数有所差异。三厂家9批样品的维生素组分和防腐剂含量仅A厂3批样品达到要求, 其他两个厂家有个别批号未达到我国卫生部部颁标准的要求。 结论 :总体质量尚可,但不同药厂的产品质量存在一定的差异。
Abstract:
Objective :To evaluate the quality of three different products of water-soluable vitamin for injection(prouducted by AV, BV and CV respectively)and to make a reference for clinical application. Methods : several indicators were compared, such as the physical and chemical properties of the products, the pH, the solubility, the difference at the load capacity, the insoluble particles, the transparency clarity , the content and the toxin produced by certain bacteria according to the quality standards of the same kind prouducts at home and abroad Results :The color of sample varies from light yellow to brown yellow,even the color is diffent at spot.The pH values were between 5.6 -6.1.The powder and injection preparation dissolved in five minutes.The results of the tests of the transparency clarity, the difference at the load capacity and the toxin produced were complied with the Chinese Pharmacopoeia about the request of the injection.The amount of sub-visible particles whose size was larger than 10 or 25μm were accordence with the Chinese Pharmacopoeia.But The amount of sub-visible particles were different among products made in different manufacturers.For the content of vitamin or preservative,just three batches which made in AV were accordence with the standard of MOH among batches .Individual batch numbers that prouducted by the others could not meet the standard requests of the Ministry of Heal. Conclusion : On the whole,the quality is not too bad,but the quality of product made by different manufacturers has some difference.
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