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1.
建立了双葛止泻口服液的微生物限度检查方法。根据2015年版《中华人民共和国兽药典(二部)》通则1102非无菌产品微生物限度检查:微生物计数法,以及通则1103非无菌产品微生物限度检查:控制菌检查法和通则1104非无菌兽药微生物限度标准进行方法适用性试验。结果表明,采用薄膜过滤法对样品进行需氧菌总数、霉菌和酵母菌计数方法适用性试验,试验组与菌液对照组的比值为0.5~2,采用常规法进行控制菌检查方法适用性试验,试验组检出阳性试验菌。所建立的方法可作为双葛止泻口服液微生物限度的检查方法。  相似文献   

2.
微生物限度检查法是检查非规定制剂及原料、辅料受微生物污染程度的方法,检查项目包括细菌数、真菌数、酵母菌数及控制菌情况.但具有抑菌成分的药品由于其抑菌活性的干扰,常规检查结果不能真实地反映出药品中污染微生物的情况,必须先消除供试品中的抑菌活性,再根据<中国药典>规定的方法进行检查,并对所采取的检查方法进行验证,以确认抑菌活性的消除和检查方法的可靠性.具有抑菌作用的各个药品的抑菌效果不同,因此适合的微生物限度检查法也不同.试验对诺氟沙星胶囊微生物限度检查方法进行了进一步的研究,试图找到一种可以消除诺氟沙星胶囊在试验条件下抑菌作用的新方法.  相似文献   

3.
本研究旨在验证抗球虫中药常山口服液的微生物限度检查法,为其质量控制、研发新兽药奠定基础。试验通过直接接种法考察常山口服液的抑菌活性,并采用验证过的试验条件和方法（常规法）进行细菌计数、回收率测定及控制菌的检查,建立常山口服液微生物限度检查方法,并进行验证试验。结果证实常山口服液无抑菌作用或抑菌作用极其微弱,可采用常规法建立检查方法。常山口服液对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌及黑曲霉的加菌回收率均大于70%,且供试品和所用稀释剂对此结果无干扰。按常规方法对大肠埃希菌、乙型副伤寒沙门氏菌、金黄色葡萄球菌、铜绿假单胞菌进行控制菌验证检查发现,试验组、阳性对照组均检出相应的试验菌,阴性对照组和供试液组均未检出相应的试验菌。综上所述,常规法可用于常山口服液细菌、霉菌和酵母菌的计数检验,控制菌检查及微生物限度检查,试验过程符合微生物限度检查法规定,且方法简便,可操作性强,结果准确可靠。  相似文献   

4.
目的:建立益肾清列口服液微生物限度检查法并进行方法适用性研究。方法:按照《中华人民共和国药典》2015年版·四部非无菌产品微生物限度制剂1105、1106、1107通则中相关规定,对该制剂进行微生物限度检查方法的适用性研究。需氧菌总数检查、霉菌和酵母菌计数采用增加培养基体积法(1∶50),控制菌大肠埃希菌采用薄膜过滤法,200 mL稀释液冲洗2次,可检出阳性指示菌,采用上述方法对益肾清列口服液各试验菌进行回收试验测试及对控制菌检查方法进行方法适用性研究。结果:需氧菌总数、霉菌和酵母菌适用性研究试验中各菌的回收比值均符合《中华人民共和国药典》2015年版规定,控制菌检查方法可行。结论:该方法适用于益肾清列口服液的微生物限度检查,标准可行。  相似文献   

5.
为了探讨和建立抗球虫中药常山散的微生物限度检查方法,以大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌及黑曲霉为挑战菌株,采用中国兽药典(2010版)收载的薄膜过滤法考察验证常山散的抑菌活性,并采用验证过的试验条件和方法进行细菌计数、回收率测定及控制菌的检查,对常山散微生物限度检查方法学进行建立和验证试验。结果验证试验证实,采用薄膜过滤法可消除供试品常山散的抑菌活性,可用于建立检查方法;常山散对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌及黑曲霉的加菌回收率均大于70%。控制菌按薄膜过滤法验证检查,试验组、阳性对照组均检出相应的试验菌,阴性对照组和空白对照组均未检出相应的试验菌。表明采用薄膜过滤法处理中药常山散,试验过程复合中国兽药典微生物限度检查法相关规定,可用于常山散细菌、真菌和酵母的计数检验,控制菌检查及微生物限度检查,且操作简单、快速、数据准确可靠。  相似文献   

6.
目的吡喹酮咀嚼片为内服给药制剂,制剂中含有适合微生物生长的氮源和碳源,因此在原料采购、储存,以及在制剂制备过程和储存等环节,如处理和控制不当,则有滋生微生物的可能,因此对本制剂需要进行微生物限度检查,由于本制剂含有动物组织(鱼粉),依据按照2010年版《中国兽药典》一部附录143-158微生物限度检查标准,对吡喹酮咀嚼片进行了细菌、霉菌及酵母菌计数方法和控制菌检查方法的验证,旨在为规范药品的微生物限度检查提供依据。  相似文献   

7.
目的:建立脂必妥片微生物限度检查方法。方法:按照《中华人民共和国药典2部》2010年版微生物限度检查方法。结果:脂必妥片对大肠杆菌和金黄色葡萄球菌有一定的抑制作用,对其他试验菌均无抑制作用。结论:本品对细菌的计数方法应采用培养基稀释法,霉菌及酵母菌计数方法、控制菌检查可用常规检验法。  相似文献   

8.
<正> 随着人工饲料的稳定,人工饲料育正在逐步普及。但人工饲料育必须保持高度的清洁环境乃至无菌饲育环境,以防止饲料的恶化和确保蚕的健康度。为此进行了饲育蚕体内污染细菌简易检查法和无菌饲育室微生物发生情况检查法的开发研究。一、蚕体内污染细菌简易检查法(配套试剂盘)的开发研究人工饲料育中,如在稚蚕期采用无菌饲育法,无疑可以防止饲料的恶化和蚕病的发生,且可大大减少给饵回数,使饲育操作更为省力。为确保稚蚕不感染,需对蚕在移至开放育时进行体内微生物的检查。传统的检查方法必须具备微生物的专业知识和娴熟的检测  相似文献   

9.
建立了复方磺胺喹噁啉溶液的微生物限度检验方法。采用薄膜过滤法,通过固定的冲洗量并观察试验菌回收率来确定适宜的检验方法。结果表明,样品在冲洗量为500 mL时对细菌、霉菌无抑制作用。复方磺胺喹噁啉溶液微生物限度检查应采用薄膜过滤法,冲洗量为500mL。  相似文献   

10.
利用常规法和培养基稀释法对氯氮平片微生物限度检查方法进行验证。结果表明,采用培养基稀释法时各试验菌回收率均大于70%;控制菌检测时,试验组检出控制菌大肠埃希菌,阴性菌对照组未检出阴性对照菌金黄色葡萄球菌。该试验表明氯氮平片具有微弱的抑菌作用,可采用培养基稀释法进行微生物限度检查。  相似文献   

11.
Evaluation of heartworm immunodiagnostic tests   总被引：1，自引：0，他引：1  
In this report, the use of appropriate statistical methods for the evaluation of heartworm immunodiagnostic tests is discussed. The evaluation of these tests is complicated by factors causing variation in sensitivity, specificity, accuracy, and predictive values of positive and negative test results. The primary sources of inconsistency are variation in the prevalence of heartworm infection among populations of dogs and the sensitivity of immunodiagnostic tests to various categories of heartworm infections (ie, patent, immune-mediated occult, unisex occult, and immature occult). Sample size (ie, number of dogs tested) affects the confidence limit values of sensitivity and specificity. At least 100 dogs should be used in each testing group (infected and uninfected) to generate values of sensitivity or specificity within reasonably narrow confidence limits. Use of more than 200 dogs in each testing group contributes little to further narrowing of confidence limits. The selection of appropriate statistical tests for comparison of tests or comparison of the sensitivity or specificity of a single diagnostic test to various categories of heartworm infections is critical. The McNemar paired chi 2 test is appropriate for comparison of diagnostic tests, but it must be done by use of duplicate sera from each animal. A chi 2 test of independence, or, in the case of a small sample size, the Fisher exact test, is appropriate for comparing the sensitivity or specificity of a single diagnostic test to various categories of heartworm infection.  相似文献   

12.
In 30 random-source dogs, we determined sensitivity and specificity of 5 serologic tests for detection of canine heartworm antigens. Seventeen of the dogs were infected naturally with adult Dirofilaria immitis, and 4 of the infected dogs were amicrofilaremic. The ability of the serologic tests to predict whether a dog was infected or uninfected (overall test accuracy) ranged from 73 to 97%. Sensitivity was not affected by circulating D immitis microfilariae, but was markedly influenced by the number of adult D immitis present. False-positive reactions were rare and were not associated with intestinal parasites or Dipetalonema reconditum microfilariae. Modifications of some of the test procedures were necessary to maximize test accuracy and reproducibility. These modifications and other technical details might limit the usefulness of some of the tests in a veterinary practice.  相似文献   

13.
We review the principles and practical application of receiver-operating characteristic (ROC) analysis for diagnostic tests. ROC analysis can be used for diagnostic tests with outcomes measured on ordinal, interval or ratio scales. The dependence of the diagnostic sensitivity and specificity on the selected cut-off value must be considered for a full test evaluation and for test comparison. All possible combinations of sensitivity and specificity that can be achieved by changing the test's cut-off value can be summarised using a single parameter; the area under the ROC curve. The ROC technique can also be used to optimise cut-off values with regard to a given prevalence in the target population and cost ratio of false-positive and false-negative results. However, plots of optimisation parameters against the selected cut-off value provide a more-direct method for cut-off selection. Candidates for such optimisation parameters are linear combinations of sensitivity and specificity (with weights selected to reflect the decision-making situation), odds ratio, chance-corrected measures of association (e. g. kappa) and likelihood ratios. We discuss some recent developments in ROC analysis, including meta-analysis of diagnostic tests, correlated ROC curves (paired-sample design) and chance- and prevalence-corrected ROC curves.  相似文献   

14.
When brucellosis false positive serological reactions happen in cattle, the serial use of pairs of specificity-correlated serological tests (rose bengal, complement fixation, competitive ELISA) results in specificities lower than expected. In this situation, highly specific tests, such as the indirect ELISA used alone, may be more adequate than serial testing.  相似文献   

15.
Polymerase chain reaction (PCR) and dot blot hybridisation (DBH) tests for detecting pigeon circovirus (PiCV) DNA were developed and evaluated using tissue samples obtained from diseased and clinically normal pigeons, which originated in Belgium and Northern Ireland. When PCR product was visually detected, the limit of detection of the PCR test was 31 fg, while that of the DBH was 1.6p g. For evaluation purposes, the results of the PCR and DBH tests, performed with DNAs extracted from samples of bursa of Fabricius (BF), were compared with those of in situ hybridisation (ISH) and histology. In 32 samples tested by all four tests, 27 (84%) were positive by PCR, 24 (75%) were positive by ISH, 20 (63%) were positive by DBH, and 13 (41%) were positive by histology. Additional PCR testing showed that in some disease-affected birds, PiCV DNA could be detected in a range of tissues including thymus, spleen, liver, kidney and brain. The PCR detection of PiCV DNA in BF samples from clinically normal birds indicated that PCR can detect infections in the absence of disease, a finding that mitigates against its use as a disease diagnostic. In addition, nucleotide sequence determinations indicated that PCR test performance was adversely affected by the sequence diversity exhibited by selected PiCVs. The application of the DBH test to dilutions of test samples indicated that the BF from some diseased pigeons contained very large amounts of virus DNA, as much as 10(13)genome copies/g tissue, and suggested that this test may be a convenient method of providing a semi-quantitative estimate of virus load.  相似文献   

16.
The objective of this study was to investigate the relationship between different screening tests of haemostasis and amidolytic plasma activities of unfractionated (standard) heparin in dogs. Different doses of intravenous (i.v.) [25, 50 or 100 IU Kg(-1)bodyweight (BW)] and subcutaneous (s.c.) heparin (250, 500 and 750 IU kg(-1)) were given to groups each of five clinically healthy adult beagles. Measurements of heparin activity with a factor Xa-dependent chromogenic substrate, activated partial thromboplastin time (APTT) (two different reagents), thrombin time (TT, two different thrombin activities in the reagent: 3 and 6 IU ml(-1)) and the reaction time of the resonance thrombogram (RTG -r) with two different measuring devices were performed at different times. The relationship between ratio values (actual/baseline values) of the coagulation tests and heparin activity was analysed based on regression analysis and correlation coefficient.The greatest alterations were seen for the TT([3 IU ml(-1)])and the RTG -r which were near or exceeded the upper limit of measuring range, if 25 IU kg(-1)BW heparin were given i.v. at heparin plasma levels of 0.54 +/- 0.13 IU ml(-1). These results show, that only APTT and TT measured with high thrombin activity assay appear suitable for guiding high dose heparin therapy in dogs. Averaged alterations of APTT ratio in canine plasma were less than those observed in people for similar plasma heparin levels, indicating that the guideline extrapolated from people for monitoring high dose heparin therapy using APTT may not be valid for use in dogs.After coagulation times had been converted into ratio values, based on regression analysis and Wilcoxon's test, differences of heparin sensitivity were found not only for TT measured with different thrombin activities but also for different APTT reagents (P < 0.001). The correlation between amidylotic antifactor Xa activity and ratio of coagulation times was only moderate and found to be lower for RTG -r (instrument 1: r(s)= 0.711; instrument 2: r(s)= 0.573) than for the other coagulation tests (r(s)= 0.822 to r(s)= 0.890). This indicates a considerable variability of the ratio values of the screening tests at defined heparin plasma activities. These results show, that blood coagulation tests in general are little or unsuitable for heparin antifactor-Xa activity control.  相似文献   

17.
The aim of the research was to assess the prevalence of antibodies to Coxiella burnetii in dairy cattle herds in Poland and to compare the results of real-time PCR and ELISA tests performed on bulk tank milk (BTM) samples. In total, 2635 serum samples collected from 969 dairy cattle herds from all provinces were tested using ELISA. Additionally, BTM specimens from 101 herds were analysed by ELISA and real-time PCR targeting IS1111 element. Presence of anti-C. burnetii antibodies was confirmed in 25.39% of serum samples in 237 herds (24.46%) and the herd-level seroprevalence in Voivodeships varied from 2.5% to 61.4%. Moreover, 46 (45.5%) of analysed bulk tank milk samples gave postive result in ELISA and microbial DNA was detected in 40 (39.6%) of tested herds. The comparative analysis of ELISA and real-time PCR results obtained for BTM samples using the chi-square test showed statistically significant relationship between results of both methods.  相似文献   

18.
The early, preclinical stages of bovine TB can be detected in live animals by the use of tests of cellular immunity (the skin, gamma-interferon and lymphocyte transformation tests). Tests of humoral (antibody) immunity, Mycobacterium bovis PCR probes on early tissue cultures or live cattle specimens, and tests based on "electronic nose" technology have been developed more recently. The key measure of diagnostic test accuracy is the relationship between sensitivity and specificity, which determines the false-positive and false-negative proportions. None of the tests currently available for the diagnosis of bovine TB allow a perfectly accurate determination of the M. bovis infection status of cattle. Although various factors can reduce the sensitivity and specificity of the skin tests, these remain the primary ante mortem diagnostic tools for TB in cattle, providing a cost-effective and reliable means of screening entire cattle populations. Despite the inescapable limitations of existing diagnostic tests, bovine TB has been effectively eradicated from many developed countries and regions with the implementation of sound programmes of regular tuberculin skin testing and removal of reactors, coupled with slaughterhouse surveillance for undetected infections, repeat testing and culling of infected herds, cattle movement restrictions to prevent introduction of infected animals and occasional slaughter of entire herds with intractable breakdowns. This is likely to remain the mainstay of bovine TB control programmes for the foreseeable future. Additionally, newer ancillary in vitro diagnostic assays are now available to TB control programme managers to supplement the skin tests in defined circumstances according to the specific disease situation in each country or region. The strategic deployment of ancillary in vitro tests alongside the primary skin tests has enhanced the detection of M. bovis-infected cattle and reduced the number of animals slaughtered as false positives.  相似文献   

19.
The objective of this study was to compare the sensitivity of different diagnostic tests for pancreatitis in cats. Twenty-one cats with confirmed pancreatitis were evaluated at the Small Animal Clinic of the School of Veterinary Medicine in Hannover, Germany, between September 1997 and January 1999. Clinical signs of affected cats were nonspecific, with 95% of the cats showing anorexia and 86% lethargy. Also, hematologic and biochemical abnormalities of affected cats were nonspecific. Serum feline trypsin-like immunoreactivity (fTLI) in these 21 cats with pancreatitis was 127.5 +/- 109.5 microg/L (mean +/- SD; range, 24-500 microg/L). Fourteen of the 21 cats with pancreatitis had complicating conditions. Their serum fTLI was 153.9 +/- 124.3 microg/L (mean +/- SD; range, 29 500 microg/L). In this study, abdominal ultrasound showed a sensitivity for pancreatitis of 24%, and abdominal computed tomography had a sensitivity of 20%. Serum fTLI had a sensitivity between 86% when a cut-off value of 49 microg/L was used (upper limit of the control range) and 33% when a cut-off value of 100 microg/L was used. We conclude that in this group of cats with pancreatitis, measurement of serum fTLI was the most sensitive diagnostic test of those evaluated. Abdominal ultrasound, however, may be a valuable diagnostic tool in some cats with pancreatitis.  相似文献   

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