建立复方磺胺嘧啶锌乳膏无菌检查法。
A sterility test method for the Compound Sulfadiazine Zinc Cream was established.
结论:建立的亚胺培南一水合物无菌检查法可供实用。
Conclusion: The established sterility test method for Imipenem monohydrate may be practical.
结论:经方法学验证,醒脑静注射液无菌检查法准确可靠。
Conclusion: The method is accurate and reliable. It can be used for sterility test of Xingnaojing injection.
本试验参照《中国药典》2005年版二部无菌检查法进行试验。
The test method was carried out according to the method in volume two, Chinese Pharmacopoeia Edition 2005.
方法按《中国药典》2005年版附录无菌检查法项下薄膜过滤法。
Methods the method was based on the membrane filtration of sterility test of Chinese Pharmacopoeia 2005.
方法:无菌检查法的验证试验——抑细菌和抑真菌试验及冲洗量试验。
Methods: The validation for sterility test includes inhibition test for bacteria and fungi and irrigation test.
结果:确定了亚胺培南一水合物无菌检查法的最佳冲洗条件及操作方法。
Results: the best washing condition and operation method for the sterility tests of Imipenem Monohydrate were determined.
只要其性质许可,这些药品将使用供试产品无菌检查法项下的膜过滤法来检测。
Pharmacopeial articles are to be tested by the Membrane Filtration method under test for Sterility of the product to be Examined where the nature of the product permits.
结果:确定了注射用阿莫西林钠克拉维酸钾无菌检查法的最佳冲洗条件及操作方法。
Result: the best washing condition and operation method for the sterile test of Amoxicilin sodium and Clavulanate potassium for injection were determined.
如果膜过滤技术是不适合的,则使用在供试产品无菌检查法项下的培养基直接接种法。
If the membrane filtration technique is unsuitable, use the Direct Inoculation of the Culture Medium method under Test for Sterility of the Product to be Examined.
结果与结论细胞因子类制品不同的品种和剂型可以采用不同的无菌检查法,并对新建立的无菌检查法进行方法学验证。
Results and Conclusion Different varieties and formulations of cytokines could apply dissimilar methods in sterile test. Methodology validations were performed for these new established tests.
本试验取硫酸庆大霉素注射液,按《中国药典》2005年版二部附录所载的“无菌检查法”项下进行方法学验证试验。
According to the "sterile test method" which is recorded in the appendix in Chinese Pharmacopoeia (2005 Edition), the methodology validation is experimented with Gentamycin sulfate injection.
本试验取硫酸庆大霉素注射液,按《中国药典》2005年版二部附录所载的“无菌检查法”项下进行方法学验证试验。
According to the "sterile test method" which is recorded in the appendix in Chinese Pharmacopoeia (2005 Edition), the methodology validation is experimented with Gentamycin sulfate injection.
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