Objective To discuss the current situation of drug sterility test in our country.
目的讨论目前我国药品无菌试验的实际情况。
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.
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 no evidence of microbial growth is found in the repeat test, the product examined complies with the test for sterility.
如果在复检中未发现微生物生长的证据，则该供试产品符合无菌试验的要求。
If no evidence of microbial growth is found, the product to be examined complies with the test for sterility.
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。
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.
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。
The validated method can be used to test for sterility of Cefpirome Sulfate for 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。
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.
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。
Methods Sterility test, mycoplasma detection, pyrogen detection and abnormal toxicity test were performed respectively on culture supernatant of neural stem cells from bone marrow.
方法对骨髓源性神经干细胞的培养上清分别进行无菌试验、支原体检测、热原质检测和异常毒性试验。
Objective To establish a methods for determining sterility test of Cefonicidum Natricum for Injection.
目的建立注射用头孢尼西钠的无菌检查方法。
Objective:The suitable method was selected for the sterility tests of Imipenem Monohydrate to guarantee the test result accurate and reliable.
前言： 目的：选择对亚胺培南一水合物无菌检查的适宜检查方法，保证检验结果的准确性和可靠性。
As to be the drag manufacturer, it will directly influence the biological quality control of sterility product that the contaminations control during injection production and sterility test.
作为药品生产单位，无菌注射剂生产中污染的控制及无菌检查直接影响到无菌产品的微生物方面的质量控制。
A test method for sterility of Levofloxacin Hydrochloride and Sodium chloride Injection was established.
建立盐酸左氧氟沙星氯化钠注射液的无菌检查方法。
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.
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。
Objective:To determine the validity of membrane filtration method in the sterility test of little capacity injection.
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。
In the case of validation, recovery, toxicity of the dilution medium and sterility (negative test) are examined to guarantee the suitability of the test in the presence of the product.
如果需要确认和恢复，就要检测稀释培养基的毒性和无菌性(阴性测试)以确保该测试适用于现存药品。
Methods the method was based on the membrane filtration of sterility test of Chinese Pharmacopoeia 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。
Conclusion: This method is accurate, it can be used for sterility test of Oxaliplatin for Injection.
结论：注射用奥沙利铂的无菌检查通过验证。
Conclusion the established sterility test method of the Burn I oil agent is scientific and accurate.
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。
Objective:To verify soybean-casein digest medium in USP whether or not substitute fungi medium in Pharmacopeia of P. R. China(ChP)by sterility test.
前言： 目的：验证美国药典用大豆- 酪蛋白消化物培养基能否替代中国药典无菌检查用的真菌培养基。
Conclusion: The method is accurate and reliable. It can be used for sterility test of Xingnaojing injection.
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：经方法学验证，醒脑静注射液无菌检查法准确可靠。
应用推荐