摘要
目的:结合临床使用现状,对不同厂家前列地尔注射液进行质量对比研究,评价不同厂家间制剂的质量差异,为临床使用提供参考。方法:参考国家药品标准WS_1-(X-041)-2002Z-2008,对制剂贮藏及临床输注过程中相关的乳粒稳定性、不同溶煤复配后粒径变化、溶血磷脂酰胆碱、前列腺素A1限量、前列腺素E_1含量、不同溶煤复配后稳定性等进行综合评价。结果:3厂家前列地尔注射液存在质量差异。结论:与原研厂产品相比,国产仿制药的质量尚有提升空间。
OBJECTIVE According to the clinic use of Alprostadil Injection,To evaluate the quality of Alprostadil Injection from different manufacturers,and provide reference for clinical application.METHODS Based on storage and clinic infusion,the research priorities include stability of Alprostadil Injections globule,globule size distributionin in different infusion,lysophosphatidylcholine,PGA_1,PGE_1 and stability in different infusion,according to the strict standards No.WS_1-(X-041)-2002Z-2008.RESULTS There were some differences in the products from three Manufacturers.CONCLUSION Compared with the original product,there have space for domestically produced generic drugs to promote their quality.
引文
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