目的对克拉霉素片微生物限度检查方法进行方法学验证。
Objective To verify the microbial limit test for clarithromycin tablet by methodology.
目的：对黄连上清丸微生物限度检查方法进行方法学验证。
Objective: To verify the microorganism limited inspecting method of Huanglian Shangqing pill.
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.
目的：对阿莫西林胶囊微生物限度检查方法进行方法学验证。
Objective: To verify the microorganism limited inspecting method of Amoxicillin Capsules.
结论对罗红霉素分散片进行方法学验证，结果符合药典要求。
Conclusion the results of methodological validation to Roxithromycin Dispersible Tablets are in line with the demand of the Chinese Pharmacopoeia.
结论根据样品的抑菌性，通过方法学验证选择合适的检验方法。
Conclusion According to the bacteriostasis of products, the appropriate test method can be selected through the methodology validation.
目的：建立阿咖酚散的微生物限度检查法，并对该法进行方法学验证。
OBJECTIVE: To establish a microbial limit test method for Akafen powder and validate the methodology.
经方法学验证试验得出的检查方法可用于国玉伤痛宁软膏的微生物限度检查。
The validation results showed that the method could be used for microbial limit test for Guoyu Shangtongning Ointment.
结果： 线性回归、精密度、 重复性、回收率等方法学验证均符合规定。
Results:The calibration curves, average recoveries, precision, accuracy, etc were qualified.
用比浊法测定与管碟法测定的结果无明显差异，方法学验证说明浊度法测定可行。
There were no significant differences in determination results between turbidimetric method and diffusion method. Methodology verification demonstrated that turbidimetric method was feasible.
结论经实验方法学验证，该方法灵敏、准确，适用于原料药中有机溶剂残留量的测定。
It is quite suitable to be used in the analysis of the organic volatile solvents in bulk pharmaceuticals.
经方法学验证试验得出的检查方法可用于驴胶补血颗粒、银杏叶胶囊的微生物限度检查。
The validation results showed that the method could be used for microbial limit test for Liujiaobuxue Granules and Yinxingye Capsules.
目的：考察2005年版中国药典微生物限度检查方法学验证试验中加菌时间点的合理性。
Objective:To discussing the rationality for the time of adding the tested microorganisms with validate method in the microbial limit test which was described in the Chinese Pharmacopeia(ChP) 2005.
方法按中国药典2005版有关规定，采用5种阳性对照菌回收率试验进行其方法学验证试验。
Methods the 5 control strains recovery test validation method was used as described in the Chinese Pharmacopoeia 2005 edition.
经方法学验证试验得出的检查方法可用于复方氨酚烷胺片剂、胶囊剂和颗粒剂的微生物限度检查。
The validation results showed that the method can be used for microbial limit test of compound paracetamol and amantadine hydrochloride tablets and capsules.
方法采用比浊法和管碟法对硫酸庆大霉素颗粒的效价测定进行比较，并对比浊法进行方法学验证。
Methods Turbidimetric method was used to determine the titer of gentamycin sulfate granules and the findings were compared with those detected by diffusion method.
结论通过对该品种的方法学验证确定该制剂可采用常规法进行微生物限度检查，不需去除抑菌成分。
Conclusion The methodological validation determines that this preparation can be examined with conventional microbial limit test, no need to remove anti-bacterial components.
方法：采用2005年版《中国药典》(一部)附录“微生物限度检查法”项下相关内容进行方法学验证。
METHODS: the method verification was carried out in accordance with the microbial limit test recorded in the appendix of China Pharmacopeia (2005 edition, Volume I).
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.
验证重用方法学是解决这一问题的有效途径。
Verification reuse methodology can solve this problem effective.
验证重用方法学是解决这一问题的有效途径。
Verification reuse methodology can solve this problem effectively.
设计验证的结果应当记录在设计历史文档中。这些结果包括设计识别、方法学、日期和实施审核的人员。
The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.
方法：以2株细菌、2株真菌对4种口服头孢拉定制剂做了微生物限度检查方法学的比较和验证实验。
Methods: the proposed method of the microbial limit tests of 4 kinds of oral cefradine was compared and verified by 2 strains of bacterium and 2 strains of fungus.
方法：以2株细菌、2株真菌对4种口服头孢拉定制剂做了微生物限度检查方法学的比较和验证实验。
Methods: the proposed method of the microbial limit tests of 4 kinds of oral cefradine was compared and verified by 2 strains of bacterium and 2 strains of fungus.
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