Abouttheestablishmentofthemicrobiallimittestofmiconazolenitrateliniment-毕业论文翻译

1、About the establishme nt of the microbial limit test of micon azole nitrate linimentPapers to write network:Abstract Objective Toestablish miconazole nitrate liniment microbial limit test method for the determ in atio nof micon azole n itratelinimentfive kinds of test bacteria Escherichia coli andot

2、her recoveries, two con trol bacteria(Pseudo monasaerug ino sa, Staphylococcus aureus in specti on method to verify the results using the membra ne filtrati on method, and 0.1% Tween 80-pH7.0 sodiumchloride- peptonebuffer flush ing age nt to check this product the total number of bacteria,fungi and

3、yeast counts, its testbacterial recovery was over 70%. Similarly the method to check the goodsPseudo monasaerug ino sa,Staphylococcus aureus, the test group were positive, n egativebacteria con trol group weren egative.con clusi ons associated with membra ne filtrati on method 0.1% Tween 80-pH7.0 so

4、dium chloride - peptonebufferflush ing age nt elim in ati on of micon azole nitrate lin ime nt in hibiti onun der the experime ntalcon diti ons,whichsuccessfully detected the varieties microbial polluti on.Keywordsmic on azolenitrateliniment,microbial limit test methodvalidati onAbstract:Objective T

5、o establish a method of microbial limit test for micon azolenitrate liniment. MethodsCen trifugalsedime ntati on and culture medium diluted method were used to validate the accuracy and feasibility of microbial limit test.Results The recovery of bacteria, yeast and mould were above 70% . P . aerug i

6、nosa and S.aureus were positive and Gram n egative orga ni sms were n egative. Con clusi ons Membra ne filtrati on and the polysorbate 80 sodium chloridepeptone buffer can be used to test thetotal viable aerobic count and specified orga ni sms (include S. aureus and P aeruginosa ) for miconazole nit

7、rate lin ime nt.Keywords:micon azolenitratelin ime nt,microbial limit test, method validationMicrobial limittest is to check the non-prescriptive formulatio ns and raw materials, auxiliary materials in cludeexam in ati onsof anu mber of bacteria,fun gi,yeast count andcon trolbacteria check 1. Drugs

8、with antibacterialingredientsbecause of its suppression by the extent of microbial con tam in atio nbacteria activein terfere neerouti neexam in ati onresults can not be a true reflecti on ofmicrobialcon tam in ati onin pharmaceutical <<Chin ese Pharmacopoeia > > provisi ons checks must

9、first eliminate the antibacterialactivity of the test articleand have the take the check method validati on to con firm eliminationantibacterialactivity and check the reliabilityof the method. an tibacterial drugs, the an tibacterial effect of each species, and therefore suitable for various varieti

10、es of microbial limit test.The authors have used the conventionalmethod,mediumdiluti onmethod andmembra nefiltratio nmethod (pH7.0 sodium chloride prote inpept onebufferflush ing micon azole nitrate lin ime nt microbial limit test results are not reached Pharmacopoeia requireme nts. Twee n 80 pro aq

11、ueous surface-activeage nt,hav ing asolubilizing action, so this membrane filtration method, together with a buffer solution of 0.1% Tween 80 pH7.0 sodium chloridepept onedo flush ing age nt checks thedrug bacteria, fun gi, yeast count and con trol bacteria, with satisfactory results, and provide as

12、cientific basis for the microbial limit test similar drugs.1 Materials 1.1 stra ins of E. coli (Escherichia coli)CMCC (B)44102, Staphylococcus aureus(Staphylococcus aureus) CMCC (B) 26 003, Bacillus subtilis (Bacillus subtilis) CMCC (B63-501 Staphylococcusaureus (Staphylococcus aureus) CMCC (B) 2600

13、3,Pseudo monasaerug inosa(Pseudo monasaerug inosaCMCC (B) 10 104 Candida albicans (Candida albicans) CMCC (F) 980 011 Black Aspergillus (the Asperg illus niger) CMCC (F) 98003, provided by the Institute of Biology of Guangdong stra ins algebra are 3rd gen erati on.1.2 medium and reage nt pH7.0 sodiu

14、m chloridepept one buffer, the buffer of 0.1% Twee n 80 pH7.0 sodium chloridepept one,nu trie ntbroth, modified Martinmedium, nu trie nt agar medium, ben gal medium, gall salt lactose medium, bromide, cetyl trimethyl ammon ium agar, dihydrochloridedimethyl-p-phe nylen ediam inereage nt,PDP agar medi

15、um,trichloromethane,mannitol,sodiumchloride agar medium and the Gram sta in.1.3 Sample micon azole nitrate liniment, Actavis(Foshan Pharmaceutical Co., Ltd., batch number: 0606950, in gredie nts:micon azolen itrate, rose musk fragra nee,alcohol, dimethyl sulfoxide.2 Methods and Results2.1 the brothp

16、reparatio n of 12.1.1 lear n from 37C to 18 to 24 h,Staphylococcusaureus, Bacillus subtilisand Escherichia12coli broth culture 1 mL of culture added 9 mL 0.9% sterilesodium chloride soluti on,diluted 10 times and made ofthe bacterial content of 50 suspe nsion, do viable count.100 cfu per 1 mL bacter

17、ial2.1.2 learn 25 C for 18 24 h of culture whiteCandida liquid culture for 1 mL, 9 mL of 0.9% sodium chloridesolution,diluted 10 times and produced anumber of bacteria per 1 mL of 50 to 100 cfu bacterial suspe nsion, do viable count.The 2.1.3 fresh cultures ino culated with Aspergillus ni ger to the

18、 modified Martin agar sla nt medium, cultured 5 7 d, 3 5 mL 0.9% sterile sodium chloride soluti on, and the spores eluti on the n sucked outof the spore suspe nsions made with sterile 0.9% sodium chloride soluti on to a sterile test tube, containing spores of 50 100 cfu per 1 mL of the spore suspe n

19、sion, and do a viable count.2.2 Preparati on for the test soluti on 2 to takethis product 10 mL, plus pH7.0 sterile sodium chloride peptone buffer to 100 mL, and mix as 1:10 for the test soluti on.2.3 authe nticati onmethod 2.3.1 bacteria,fungi and yeast count method Determ ination of RecoveryThe me

20、mbra nefiltrati on method, together with0.1% Tween 80 pH7.0 sodium chloride peptonebuffersoluti on was used as wash ing age nt in the recovery of the test bacteria experime nt, the mean of three in depe ndent parallel test results are show n in Table 1 3.Links to free papers Downl oad Cen ter Test g

21、roup: take 10 mL of the test solution to the membranefilter with sterile 0.1% Tween 80pH7.0sodium chloride pept one buffer The soluti on was washed three times, each 100 mL, and added 1 mL of test broth(50 100 cfu / mL rinse remove the membra ne after the last wash ing fluid, bacteria face posted on

22、 a pre-prepared nu trie nt agar , set on medium ormedium plates ben galcultured for 48 h or 23 28C 30 35 C cultured for 72h to record the nu mber of coloni es. experime ntal group of bacteria recovery rate = (average number of colonies of the test group - for the test control group the average numbe

23、r of colonies) bacilli group s average numberof colo niesx 100%. broth group 4: inthe filterpreviously added about 20 mL of sterile 0.9% sodium chloride soluti on, and the n draw the 1 mL of the test broth (50 100 cfu / mL to the filter, the filter aga in with 100 mL of sterile 0.1% Tween 80 pH7.0 s

24、odium chloride Pept one buffer flush in g, remove the membra ne, bacteria face affixed to a pre-preparednu trie ntagar medium orben gal medium plates training, training methods with experime ntal group.(3) the test control group: the same way as the experime ntal group, but without test broth. dilue

25、nt control group: the same method with thetest group, which for the test soluti onwith sodiumchloride pH7.0prote inpept onebuffer in stead. Thebacteria recovery rate of the diluentcontrolgroup =group average dilue nt con trol group, the average nu mber of colonies broth nu mber of colonies x 100%Tab

26、le 1 of each test strain recovery is omittedFrom Table 1, i n three separate parallel test bacteria recovery of dilue nt in the con trol group, the experime ntal group of bacteria recovery were not less than 70%. Available membra ne filtrati on method, together with 0.1% Twee n 80 pH7.0 sodium chlor

27、ide pept one buffer flush ing method checks miconazolenitrate the liniment bacteria,fungi and yeast count.2.3.2 con trol bacteriacheck ingmethodvalidati on Test group: take for the test solution of 10 mL to a membrane filter with a sterile 0.1% Tween 80 pH7.0 sodium chloride peptone buffer, washed 3

28、 times, each time of 100 mL, and the last rinse solution 50 100 cfu test bacteria(Pseudo monasaerug inosa validati on testbacteria Pseudo monas aerug ino sa, ri nse and remove themembra ne into the pre-prepared accord in gly medium, check the bacteria exam in ati on method in accorda nee with the co

29、rresp onding con trol. negative bacteria control group: the same way asthe experime ntal group, the bacteria cha nged to 50 100cfu n egative con trol bacteria (two con trol bacteria verifiedn egative con trol bacteria were Escherichia coli. broth group: Add approximately 20 mL of sterile0.9% sodium

30、chloride soluti on in the filter in adva nee, i nthe draw of 50 100 cfu test bacteria to the membra nefilter with 100 mL of 0.1% Twee n 80 pH7.0 chloro sodiumpept one buffer flush ing 1. rinse to remove the membra ne,the the bacteria face-posted on pre-prepared a good nu trie nt agar medium, the set

31、 (36 + -1C cultured for 48h to record the nu mber of viable cells 5.3 parallel tests results were con siste nt with the testresults in Table 2.Table 2 aga instPseudo monasaerug inosaandStaphylococcusaureus validation results slightlyFromTable 2, the membra ne0.1% Twee n pH7.080filtrati on method com

32、b ined withsodium chloride pept one buffer soluti on was used as wash ing age nt checks the Pseudo monas aerug inosa and Staphylococcus aureus, methods established.3 Discussi onMic on azolenitrate liniment is a broad-spectruman tifu ngaldrugs containing micon azole n itrate,etha noland dimethyl sulf

33、oxide in gredie nt aga inst dermatophytes, candida have an antibacterial effect, some inhibitionofcerta in bacteria & It ;< Chin ese Pharmacopoeia> 2005Editi onprovides microorga ni sms from the goods inmicrobial limit test of drugs, their method should be validated to con firm that the an tib

34、acterial activity of the test has been eliminatedand to ensure the reliability ofthe inspectionmethod. limit test to establish studiessuggest that the choice of membranefiltration methodassociated with 0.1% Twee n-80 pH7.0 sodium chloride pept one buffer flush ing age nt to check the product of the nu mber of bacteria,fun gi,yeast count and con trolbacteria(Pseudo monaseffectiveaerug ino sa,Staphylococcus aureus, and experime nt, the bacteria can reach more tha n 70% recovery rate in the total nu mber ofbacteria, fungi and yeast coun ts, Pseudo mo