胶塞中环硅氧烷化合物迁移对注射剂质量影响的研究

目的：建立粉针剂中环硅氧烷化合物的测定方法，研究胶塞中环硅氧烷类化合物向药粉中的迁移，以及对药品质量的影响。方法：采用气相色谱法对胶塞和药粉中5种环硅氧烷类化合物进行测定，同时采用浊度测定仪定量测定溶液的澄清度，并对结果进行相关性分析。结果：建立的方法能有效检出各种环硅氧烷类化合物，在药品的放置过程中，环硅氧烷类化合物会向药粉中迁移，能影响药品的澄清度，但未对药品质量产生较大影响。结论：该研究可为粉针剂的辅料包材的相容性研究提供参考。

Objective: To establish a method for the determination of cyclosiloxane compound, to study the migration of the cyclosiloxane compound in rubber stopper to drug powder, and the influence on the quality of drugs.Method: Gas chromatography was used to determine 5 kinds of cyclosiloxane compounds in both rubber stopper and the drug powder, and the turbidity determination instrument was applied to determine the quantitative solution clarity.The correlation analysis was carried out.Results: The establishment of the method can effectively detect a variety of cyclosiloxane compounds.In the process of placing drugs, the cyclosiloxane compounds will migrate to the drug powder and affect the clarity of drugs.But this process did not produce great quality of drugs influences.Conclusion: This study provides a reference for the compatibility study of the encapsulated materials of drugs powder.

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