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zhouwenliWLW

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目的 通过实验确定PNG的处方和制备工艺。方法 1)考察甘露醇及氯化钠用量,优选冻干粉针最佳处方。2)考察活性炭用量及其对主要成分含量的影响。3)考察pH值调节剂及注射液配制的pH值范围,确定制备工艺。结果 PNG冻干制剂工艺中加入10%甘露醇和10%氯化钠时外观最好,且无塌陷、无裂纹、水分最低,活性炭用量为3%时既达到了除热原的目的又不影响PNG含量。结论 PNG冻干制剂的处方合理,制备工艺可行。
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genhunter

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zhouwenliWLW: 金币+30, 翻译EPI+1, ★★★很有帮助, 谢谢你! 2016-03-19 10:22:40
Objectives: To experimentally determine the formulation for PNG and manufacturing process. Method:  We evaluated 1) the effects of the dosages of mannitol and sodium chloride on the lyophilization process, and optimized the composition of the lyophilized powder. 2) effects of the dosage of activated carbon and its influence on the contents of main ingredients. 3) the type of buffering agent used for the adjustment of pH and the range of pH for the finished injectile, and based on these factors, we finalized the manufacturing process. The best appearance of the freeze-dried cake of PNG was obtained with 10% mannitol and 10% sodium chloride in the formulation, and finished products had no collapses or cracks, had the lowest water contents; the chosen dosage for activated carbon is 3%, which allows to remove pyrogen and not to affect the contents of PNG. Conclusion: The formulation for the PNG lyophilized preparation is rational and the processing is feasible
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