[摘要]目的:比较黄藤素片微生物方法验证中的加菌方法不同,所出现的回收率差异。
[Abstract] Objective:To compare the different recovery rates resulted from different methods in putting bacterial in microbiology verifying test of Huangtengsu tablet.
方法:剖析某地区药品微生物检查验证试验的现状以及存在的问题和根源。
METHODS: the status quo of verification test in microbial test of drugs in an area, and the problems and their root causes were analyzed.
目的:建立脑立清胶囊微生物限度检查的方法并验证。
OBJECTIVE: To establish a microbial limit test method for Naoliqing capsules and validate the methodology.
目的对阿托品眼膏的微生物限度检查进行方法验证。
Objective To verify the microbial limit test for atropine eye ointment.
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).
方法采用理化分析、药理试验、薄层析检查、微生物测定、临床验证观察等方法进行系统研究。
Methods Physicochemical analysis, pharmacological test, thin-layer examination, microbiological assay and observation of clinical verification were used to carry out systematic study.
目的建立一种可行的验证方法,对中国药典收载的微生物限度检查法的有效性进行评价。
OBJECTIVE To establish a doable validation method for estimating the microbial limit tests in Chinese Pharmacopoeia.
目的建立氧氟沙星栓微生物限度检查方法并验证。
Objective to establish a method for microbial limit test of ofloxacin suppositories.
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: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.
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.
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.
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.
方法按中国药典2005年版一部微生物限度检查法进行验证和试验。
Methods We testified and checked the microbial limit with 2005 "Chinese Pharmacopoeia".
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.
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.
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.
目的:验证一种罗红霉素片微生物限度检查的方法。
Objective: To establish a microbial limit test method for Roxithromycin Tablets.
按照《中国药典》2005版微生物限度检查方法进行验证试验。
Microbial limit tests were validated according to Chinese Pharmacopoeia Edition 2005.
目的建立非水溶性抗生素原料的微生物限度检查方法并对其进行验证。
OBJECTIVE To provide a method of microbial limit test on insoluble antibiotic material.
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.
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.
目的建立合适的微生物限度检查方法,对银黄颗粒、清喉利咽颗粒、柴黄颗粒3种中成药的微生物限度检查方法进行验证。
Objective To establish the limited check method for microorganism and to inspect whether the method for 3 Chinese potent drugs is valid.
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;
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;
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