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【答案】应助回帖
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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
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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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