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.
无菌检查在无菌条件下进行。
The test for sterility is carried out under aseptic conditions.
建立注射用硫酸头孢匹罗的无菌检查方法。
To establish a method for sterility of Cefpirome Sulfate for Injection.
结论为替硝唑注射液无菌检查方法提供依据。
CONCLUSION Provides the basis for the tinidazole injection asepsis inspection method.
下面的培养基已经被证实适合进行无菌检查。
The following culture media have been found to be suitable for the test for sterility.
目的建立注射用头孢尼西钠的无菌检查方法。
Objective To establish a methods for determining sterility test of Cefonicidum Natricum for Injection.
结论:注射用奥沙利铂的无菌检查通过验证。
Conclusion: This method is accurate, it can be used for sterility test of Oxaliplatin for Injection.
目的建立参附注射液无菌检查方法并对其进行验证。
Objective To establish and verify the sterility test method for Ginseng and Prepared Aconite Injection.
建立盐酸左氧氟沙星氯化钠注射液的无菌检查方法。
A test method for sterility of Levofloxacin Hydrochloride and Sodium chloride Injection 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.
结论:大豆-胰酪胨培养基是一种更灵敏的无菌检查培养基。
Conclusion:Soya-bean caseincligest medium was a more sensitive medium for all sorts of microbial growth.
如果没有找到微生物生长的证据,则该供试产品符合无菌检查。
If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.
目的探讨薄膜过滤法在小容量注射剂无菌检查中应用的可行性。
Objective:To determine the validity of membrane filtration method in the sterility test of little capacity injection.
采用验证过的试验方法进行注射用硫酸头孢匹罗的无菌检查可行。
The validated method can be used to test for sterility of Cefpirome Sulfate for 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.
结论采用该法对烧伤一号油剂进行无菌检查,方法可行,结果准确。
Conclusion the established sterility test method of the Burn I oil agent is scientific and accurate.
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.
方法采用直接接种法,通过无菌验证试验确定无菌检查方法的有效性。
Conclusion The sterility test reassured by verification test is feasible and reliable.
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.
在生产环境中发现的微生物应定期地作为用于无菌检查方法验证的挑战菌种;
The microorganism which discovered in the production environment should take regularly uses in the sterility test method confirmation the challenge mold mushroom spawn;
结论:该法能消除注射用头孢美唑的抑菌作用,使无菌检查结果准确、可靠。
Conclusion:The method mentioned in this study can eliminate the antibacterial effect of injecting cefmetazole, therefore the examination was of nicety and reliability.
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.
隔离系统按相关的要求进行验证,其内部环境的洁净度须符合无菌检查的要求。
The isolation system shall be validated according to the relevant requirements, and the cleanliness of the internal environment shall comply with the requirements of the sterility test.
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.
无菌检查应在无菌条件下进行,为了达到该条件,检测环境应符合无菌检查的规定。
The test for sterility is carried out under aseptic conditions. In order to achieve such conditions, the test environment has to be adapted to the way in which the sterility test is performed.
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.
按照下面供试产品无菌检查项下的描述,使用除了下面变更之外完全相同的方法,进行试验。
Carry out a test as described below under test for Sterility of the Product to be Examined using exactly the same methods, except for the following modifications.
结论:经过验证,该方法能够有效地完成注射用磷霉素钠的无菌检查,适合该药品的无菌检查。
Conclusion : after confirmation, the certification tests of fosomycin sodium for injection asepsis check can be completed with film filtration mean, so the mean is fit for fosfomycin asepsis check.
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