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Baoyuan detoxification pill microbial limit test for the validation study_671

By Clifford Warren,2014-10-30 10:57
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Baoyuan detoxification pill microbial limit test for the validation study_671

    Baoyuan detoxification pill microbial limit test for the validation study

     Abstract Objective To confirm the method used for the test chemicals for microbial limit. That is tested to confirm the amount of goods on the test, the test conditions, no

    antibacterial activity or its antibacterial activity to be fully eliminate enough to be negligible. Methods The 2005 edition of "Chinese Pharmacopoeia" provisions of the authentication method. Results count results are accurate,

    meet the requirement. Conclusion The experiment is suitable Yasumoto detox pill microbial limit method validation.

     Key words Yasumoto detox pill microbial limit method validation

     Theoretically speaking, each sample of the micro-

    organisms will affect the extent of the impact, testing methods can ensure that microbial contamination can be tested out, it is necessary to verify through testing in order to ensure the accuracy of microbial limit test results, while drug passing rate of testing the existence of Quality

    Supervision, not the clear, comprehensive, real outstanding issues [1]. In accordance with "Chinese Pharmacopoeia" 2005 edition of the former provisions of microbial limits testing methods, there are many bacteria undetected, which is difficult to ensure that drug microbial limit test results are accurate and reliable, but also to bring hidden dangers clinical use. Bao-yuan Department of our hospital

    detoxification pill famous old Chinese doctor Zhang Zhijian, director of long-term clinical experience side. Clinical use

    of chronic nephritis, chronic renal failure, see there is dizziness fatigue, Shenpi limb soft, oliguria foot swelling, waist and knee pain, torpid intake pan vomiting, sleepless nights, looking dull, tongue pale and tender, thin moss Wong,

    greasy and other diseases, a wider clinical use, it is necessary to ensure Yasumoto detox pill microbial limit test results accurate and reliable.

     1 Equipment

     1.1 Equipment Clean Bench, SW CJ ICU (Su-Net Group

    Aetna); biological safety cabinets, BHC 1300ILA/B3 (Su-Net

    Group Aetna); electronic balance, AV412 Mettler Toledo, Inc. (Shanghai Limited company); watertight constant temperature incubator PYX DHS, (Shanghai an Infineon Technologies Co., Ltd.); mold incubator, MJ 180S ? (Shanghai Xinmiao

    Medical Equipment Manufacturing Co., Ltd.); vertical sterilizer, LMQ. R 3260B (Shandong Xinhua Medical

    Instrument Manufacturing Co., Ltd.).

     1.2 medium nutrient agar medium, Qingdao Hi-tech Park

    Haibo Bio-Technology Co., Ltd. (20,060,309); Rose Red sodium agar, Yixing Yongxin Bio Co., Ltd. (050915); pH 7.0 sterile sodium chloride - peptone buffer , Yixing Yongxin Bio Co., Ltd. (051027); bile acid medium, Yixing Yongxin Bio Co., Ltd. (050,509); nutrient broth, Yixing Yongxin Bio Co., Ltd.

    (051,206); mannitol, high-salt agar, Qingdao Hi-tech Park

    Haibo Biotechnology Co., Ltd. (20060112);

    cetyltrimethylammonium bromide agar, Yixing Yongxin Bio Co., Ltd. (050,921); modified Martin medium, Yixing Yongxin Bio Co., Ltd. (050,829).

     1.3 Authentication with strains of Escherichia coli (Escherichia coli) [CMCC (B) 44 102], 4th generation; Staphylococcus aureus (Staphylococcus aureus) [CMCC (B) 26 003], 4th generation; Bacillus subtilis ( Bacillus subtilis) [CMCC (B) 63 501], 4th generation; Pseudomonas aeruginosa (Pseudomonas aeruginosa) [CMCC (B) 10 104], the 3rd

    generation; Candida albicans (Candida albicans) [CMCC (F) 98001] 4th generation; Aspergillus (Aspergillus niger) [CMCC (F) 98 003] 3rd Generation.

     1.4 for the test chemicals and reagents Yasumoto Detox Pills (060.81 thousand), Changzhou City, Jiangsu Province Chinese Medicine Hospital preparation; sodium chloride solution, AR.

     2 Methods

     2.1 bacteria, mold and yeast count method validation [2]

     2.1.1 Preparation for the test solution was obtained for the test quality assurance yuan detoxification pill 10 g, plus pH sterile sodium chloride - peptone buffer to 100 ml, at

    45 ? water bath in the heat, soak, oscillation dissolution, made a: 10 for the test solution.

     2.1.2 Preparation of the Bacterium Escherichia coli, Staphylococcus aureus, Bacillus subtilis were inoculated with fresh culture medium to the nutrient broth, 30 ~ 35 ? culture

    24 ~ 48 h, were collected from these cultures with 0.9% sterile sodium chloride solution made of 50 ml per 100 cfu (colony number) in bacilli.

     To Candida albicans were inoculated into fresh culture medium to the modified Martin, Chi 23 ~ 28 ? incubator 24 ~

    48 h, to take the culture with 0.9% sterile sodium chloride solution per ml made 50 ~ 100 cfu of bacilli.

     Will be a fresh culture of Aspergillus niger were inoculated to the culture medium improved slope Ma Dingqiong

    fat, 23 ~ 28 ? cultured 7 d, so that a large number of spores produced. Then add 5 ml0.9% sterile sodium chloride solution, using sterile glass rod gently spores eluted, and then use a nozzle packed with sterile cotton, and can filter hyphae 10 ml

    straw to suck out the liquid spore-free bacteria test tube,

    with 0.9% sterile sodium chloride solution will bacilli per ml diluted to 50 ~ 100 cfu of bacilli.

     2.1.3 Authentication Methods Plate method (conventional method).