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本试验旨在对伊维菌素微乳制剂进行无菌检查方法学验证和无菌检查试验,确认本试验所用的方法适用于该制剂的无菌检查。按《中国兽药典》2005版一部(附录118)所载"无菌检查法"项下进行试验,通过对阳性对照菌、不同量冲洗液等条件的选择,采用薄膜过滤法对10瓶供试品(每种试验菌的样品量)进行检测,建立了无菌检查方法。经方法验证,用400mL 0.1%蛋白胨水溶液冲洗后,含供试品容器中的7个阳性菌试验组与阳性菌对照组相比均生长良好,说明供试品的该检验量在该检验条件下无抑菌作用或其抑菌作用可以忽略不计,可以用该方法进行供试品的无菌检查。对3批供试品进行无菌检查,阳性对照菌均在24h内生长良好,阴性对照均澄清,无菌生长,3批供试品均澄清,无菌生长,无菌检查试验结果符合规定。 相似文献
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为建立盐酸头孢噻呋无菌原料的无菌检查方法，本试验按照方法适用性试验的有关要求，对前处理、冲洗总量等进行了考察。取供试品500mg，加10mL2.6%无菌碳酸钠溶液使溶解，再转移至490mL0.85%无菌氯化钠溶液中，作为供试液按照薄膜过滤法处理，用pH7.0无菌氯化钠-蛋白胨缓冲液为冲洗液，每张滤膜每次冲洗量为100mL，冲洗5次。结果显示，方法适用性试验中，供试品6种阳性菌试验组与阳性菌对照组相比均生长良好，供试品组、阴性对照组均无菌生长，说明供试品在该条件下已消除其抑菌作用，方法合理，结果准确、可靠，可作常规无菌检查法。 相似文献
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为建立盐酸头孢噻呋乳房注入剂的无菌检查方法,本试验按照《中华人民共和国兽药典》2015年版一部附录1101无菌检查法中方法适用性试验的有关要求,对取样量、稀释液种类、冲洗方式、加酶量等进行了考察。取供试品置于无菌分液漏斗中,加300 mL无菌十四烷酸异丙酯,摇匀,再加200 mL含1%聚山梨酯80的0.1%无菌蛋白胨溶液,充分振摇,静置,取水层,按照薄膜过滤法处理,用pH 7.0无菌氯化钠－蛋白胨缓冲液为冲洗液,每张滤膜每次冲洗量为100 mL,冲洗4次,每管培养基中加入600万单位的青霉素酶溶液。结果显示,方法适用性试验中,供试品6种阳性菌试验组与阳性菌对照组相比均生长良好,供试品组、阴性对照组均无菌生长,说明供试品的检验量在该检验条件下已消除其抑菌作用。盐酸头孢噻呋具有较强的抑菌活性,本试验采用薄膜过滤法,建立了合理的无菌检查方法,能有效去除盐酸头孢噻呋乳房注入剂中的抑菌成分,使检验结果更准确、可靠,可作为该制剂的常规无菌检查方法。 相似文献
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苄星氯唑西林乳房注入剂无菌检查方法研究 总被引：1，自引：1，他引：0
本试验旨在建立苄星氯唑西林乳房注入剂无菌检查法并进行验证.采用离心—薄膜过滤—酶中和相结合的方法,按照《中国兽药典》2010年版一部附录进行试验.结果显示采用离心—薄膜过滤—酶中和相结合的方法,以0.5%聚山梨酯-80 pH 7.0氯化钠—蛋白胨缓冲液冲洗,冲洗量400 mL/膜,在最后的培养基中加入不少于300万单位的青霉素酶可有效消除样品对各试验菌株的抗菌活性;验证试验结果显示各验证菌生长良好,各供试品管均未见菌生长.结果表明本试验成功建立了可靠、准确、可用于苄星氯唑西林乳房注入剂的无菌检查法. 相似文献
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In order to establish the determination method of ivermectin (IVM) in the ivermectin microemulsion injection by high performance liquid chromatography (HPLC), Hypersil ODS2 colunm (5 μm,4.6 mm×250 mm) was used in this study. The mobile phase composed of methanol, acetonitrile and water (35:60:5,V/V/V) at a flow rate of 1 mL/min. The detection wave length was set at 244 nm and the column temperature was 30 ℃. The results showed that the HPLC system suitability of IVM was good. A good linear correlation of IVM was observed within the concentration range 80 to 320 μg/mL, and the average recovery rate was 101.90%±2.94% with RSD was 2.88%, the regression equation was Y=22 700X+2 510 (R2=0.9998). The RSD of IVM content in ivermectin microemulsion injection was 1.86%. The method was accurate and reliable,reproducible,easy to operate, which could be used in new type of ivermectin microemulsion injection. The method could be used as the basis of quality control and establishing a quality standard, and to provide basis for quality evaluation, also can provide reliable reference for safe veterinary clinical application in the future. 相似文献
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为建立伊维菌素微乳中伊维菌素含量的高效液相色谱（HPLC）测定方法,选用Hypersil ODS2 （5 μm,4.6 mm×250 mm）色谱柱,流动相为甲醇∶乙腈∶水为35∶60∶5（V/V/V）,检测波长为244 nm,柱温为30 ℃,流速为1 mL/min进行测定。结果显示,伊维菌素在该色谱条件下,系统适应性良好,在80~320 μg/mL浓度范围内线性关系良好,回归方程为：Y=22 700X+2 510,R2=0.9998,总平均回收率为101.90%±2.94%,RSD为2.88%,对中试生产的3批伊维菌素微乳进行含量测定,RSD为1.86%。表明该含量测定方法准确可靠,重现性好,可用于伊维菌素微乳中伊维菌素含量的测定,并为该新型制剂的质量标准的制定和质量评价提供依据,也为后期的临床安全应用提供可靠的参考。 相似文献
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伊维菌素小单室脂质体工艺配方优化及质量分析 总被引：1，自引：1，他引：0
为获得高包封率的伊维菌素小单室脂质体,本研究对其制备工艺进行了优化,并选取超声波频率、超声时间、卵磷脂与胆固醇质量比、伊维菌素与卵磷脂质量比各因素进行正交交互作用考察,同时利用反相高效液相色谱法对各工艺配方组合下伊维菌素小单室脂质体的包封率进行了测定。结果显示,伊维菌素小单室脂质体的制备最佳配方和工艺组合为超声波频率200 kHz,超声时间6 min,伊维菌素与大豆卵磷脂质量比为1:10。经过优化组合,得到了较高品质的伊维菌素小单室脂质体,平均载药量达到(92.35±0.61)%,药物品质优良,且制备工艺简单可行。 相似文献
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本文报道应用两种活体诊断方法检测牛结核病的试验结果。2010～2011年度,应用PPD皮内变态反应方法分3批次对5156头奶牛和奶水牛实施监测,监测阳性数57头,阳性率1.11%。采集该57头牛抗凝全血,应用γ-干扰素酶联免疫吸附试验进行检测,检出阳性样品3份,阳性率5.26%。对14头第一批PPD皮内变态反应阳性牛进行病理检验和进行细菌分离培养和PCR检测,结果3份样品分离培养呈阳性,其中1份PCR鉴定为结核分枝杆菌,2份为非分枝杆菌。PCR方法检测的14份组织样品中,2份为结核分枝杆菌阳性,1份为牛结核分枝杆菌阳性。结合病理剖检和病原PCR诊断,分析比较PPD皮内变态反应试验和γ-干扰素酶联免疫吸附试验的敏感性和特异性,由于PPD纯度、非特异性反应、结果判定的主观性等因素,导致PPD皮内变态反应监测检出假阳性率较高。 相似文献
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【目的】制备鸭疫里默氏杆菌(Riemerella anatipestifer,RA)贵州流行株蜂胶灭活疫苗。【方法】选取RA血清2型贵州流行株(RA-SS-8株)为基础菌株,依次利用分光光度法和平板计数法测定细菌生长曲线,再进行灭活条件筛选,以蜂胶为佐剂制备RA贵州流行株蜂胶灭活疫苗,并进行无菌检验、安全性检验及免疫鸭攻毒保护性试验。【结果】分光光度法测定RA-SS-8株菌液D600 nm值随培养时间变化显示,细菌在0~3 h时增殖缓慢,在3~10 h时增殖趋势明显加快,在10 h以后增殖逐渐趋于平缓,随着培养时间的延长,细菌最终进入衰亡期;平板计数法结果显示,RA-SS-8株D600 nm值为0.1~0.8时,该菌处于对数生长期,且D600 nm值与活菌数呈现良好的线性关系;RA-SS-8株最佳灭活条件为0.2%甲醛溶液、37 ℃灭活12 h;蜂胶灭活疫苗含菌量为3.8×109 CFU/mL,蜂胶干物质含量为10 mg/mL;无菌检验巧克力琼脂培养基上未见菌落生长;安全性检验以2倍免疫剂量接种雏鸭在观察期内未表现出不良反应,大体病变观察未见明显病变;免疫鸭攻毒保护性试验显示,蜂胶灭活疫苗免疫组鸭对RA-SS-8株的攻击后保护率为70%,蜂胶灭活疫苗对试验鸭心脏、肝脏组织均具有良好的保护效果。【结论】本研究成功制备了RA贵州流行株蜂胶灭活疫苗,为蜂胶灭活疫苗制备和动物免疫试验奠定基础。 相似文献
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Lumaret JP Alvinerie M Hempel H Schallnass HJ Claret D Römbke J 《Veterinary research》2007,38(1):15-24
According to European Union recommendations, a test method has been developed to evaluate the effects of veterinary pharmaceuticals on dung feeding insects. This test method was evaluated with the dung beetle Aphodius constans by using fecal residues of ivermectin after a pour-on administration. Dung of different age (and thus containing different concentrations of ivermectin) as well as mixtures of highly-contaminated spiked dung with untreated control dung were studied in five test runs in two laboratories. The concentration of ivermectin (active substance; a.s.) in the dung samples was verified analytically. The main test endpoint was the survival of first instar larvae. The LC50 using dung directly obtained from treated cattle ranged from 470 to 692 microg a.s. kg(-1) dung (dry weight; d.w.) and 67 to 97 microg a.s. kg(-1) dung (fresh weight; f.w.). Using mixtures, the outcome of two tests was almost identical: 770 to 781 microg a.s. kg(-1) dung (d.w.); 109 to 132 microg a.s. kg(-1) dung (f.w.). In comparison to the LC50 values obtained when ivermectin was spiked in control dung at several concentrations (LC50 880-985 microg a.s. kg(-1) dung (d.w.)), the LC50 values were again very similar. Three conclusions can be drawn from these results. The proposed test method seems to be robust and allows for the initiation of an international validation process (including ringtesting). Because of only small differences found in tests in which the test substance was spiked into control dung and those in which dung from treated cattle was applied, the use of a standard test method is proposed. The effects of ivermectin on ecologically relevant dung beetles obtained in a standardised test method reflect the results from field studies and are in the range of environmentally relevant concentrations. 相似文献
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为建立一种适用于现场快速检测猪流行性腹泻病毒(PEDV)的环介导等温扩增(LAMP)检测方法,针对猪流行性腹泻病毒(PEDV)的M基因编码区序列,分别设计合成3组引物,通过对引物的筛选和反应条件优化,建立了PEDV RT-LAMP可视化快速检测方法。灵敏度和特异性试验结果显示,本方法在65℃45 min对PEDV的检测灵敏度为2 copies/μL,与猪传染性胃肠炎病毒、猪轮状病毒、猪瘟病毒、猪伪狂犬病毒、猪繁殖与呼吸综合征病毒均无交叉反应。利用该方法对30份送检的临床样品进行检测,检出阳性样品8份,与荧光定量RT-PCR检测结果一致。试验表明,所建立的RT-LAMP检测方法具有特异性好、灵敏度高、快速、结果可视、设备适用范围广等优点,适用于PEDV现场快速检测。 相似文献
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为比较不同方法检测鸡白痢沙门氏菌抗体消长的规律，以便为种鸡场净化提供科学指导，本研究以鸡白痢沙门氏菌活菌和灭活免疫原分别接种SPF鸡，采用平板凝集、微量凝集和ELISA试验定期检测血清中的特异性抗体，并以Kappa检验判定不同检测方法之间的一致性程度。结果显示，平板凝集试验在接种后检出抗体阳转的时间早于ELISA，但ELISA检出抗体阳性的持续时间更长，且更符合抗体消长规律；3种检测方法的结果之间仅具有微弱一致性（Kappa系数为0.002~0.295）。本研究结果表明，不同鸡白痢沙门氏菌抗体检测方法之间存在较大差异，但从总体来看，ELISA无假阳性干扰，检出抗体的持续时间较长，更符合抗体消长规律，在单一鸡白痢沙门氏菌感染的情况下，更有利于种鸡场对该病进行净化。 相似文献
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为了鉴定甘肃武威地区某牛场中牛病毒性腹泻病的发病情况,分别采集了13只病牛的血液样品、粪便样品配合诊断,通过血清学诊断方法和PCR鉴定的方法对样本进行了检测,结果显示血清学方法中的13份血液样本有8份为阳性,粪便样本提取RNA,进行RT-PCR同样可以检测到8份样本中扩增得到片段大小为267bp的条带,检测的13份样本有8份样本的血清学检测和粪便PCR检测均为阳性,本次检测的阳性率为61.54%,结果表明本次检测的甘肃武威地区某养殖场的牛病毒性腹泻阳性率相对较高,需要加强牛病毒性腹泻的防控,采取科学的手段治理该类疾病降低其对养牛产业的损失。 相似文献
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埃普利诺菌素浇泼剂对牦牛皮蝇幼虫驱除效果试验 总被引：3，自引：0，他引：3
应用埃普利诺菌素浇泼剂驱除牦牛皮蝇幼虫,并设埃普利诺菌素注射剂药物对照组和阳性对照组。结果：剖检埃普利诺菌素浇泼剂300μg/kg,400μg/kg,500μg/kg剂量组牦牛与药物对照埃普利诺菌素注射剂组及伊维菌素浇泼剂组牦牛,均未检出皮蝇1期幼虫,而阳性对照组牦牛皮蝇1期幼虫感染率35.0%,平均感染强度29.4（9～53）条。翌年3、5月份两次触摸检查牛背部皮下瘤疤和皮肤虫孔,4个药物试验组牦牛均未检出,而阳性对照组牦牛两次检查平均感染率45.16%,平均感染强度6.45个。试验证明埃普利诺菌素浇泼剂低、中、高3个剂量对寄生于牦牛的皮蝇幼虫驱净率、驱虫率均达100.0%,高效安全。 相似文献
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为获得副猪嗜血杆菌荚膜多糖及其抗血清,本试验采用热酚法提取副猪嗜血杆菌SC096株荚膜多糖,并进行SDS-PAGE及银染检测,然后用荚膜多糖制备的油乳疫苗免疫家兔制备抗血清,并进行琼脂扩散试验及间接血凝试验检测.试验结果显示,热酚法可制备高浓度的荚膜多糖;SDS-PAGE电泳及银染结果显示条带呈弥散性分布,荚膜多糖分子质量55 ku左右;琼脂扩散试验结果呈阳性;间接血凝试验中红细胞发生高达10孔滴度的凝集现象.副猪嗜血杆菌SC096株荚膜多糖的提取及其抗血清的制备,为其他含荚膜的细菌抗血清的制备提供了方法和理论依据, 也为细菌荚膜多糖抗原性及其疫苗研究奠定了基础. 相似文献
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WANG Ling GUO Zhi-ting YANG Feng LI Hong-sheng WEI Xiao-juan ZHOU Xu-zheng 《中国畜牧兽医》2017,44(11):3365-3371
The purpose of this study was to validate the microbial limit test method for anticoccidial drug Dichroa febrifuga oral liquid (DFOL),and provide data base for its quality control and researching the new veterinary drug. The direct inoculation method was used to validate the antibacterial activity for DFOL, and the bacterial counting,determination of recovery rate and inspection of control bacteria were measured using a validated test condition and method (conventional method).The results showed that DFOL had no or faint bacteriostasis verified by validated test method, the determination and inspection of bacteria could be determined by conventional method. The normal plate counting were used to detect the amount of Escherichia coli,Staphylococcus aureus, Bacillus subtilis, Candida albicans and Aspergillus niger in DFOL in which the recovery rate were all more than 70%,and the results were not disturbed by sample and diluents. The control bacteria including Escherichia coli,Salmonella paratyphi B,Staphylococcus aureus,and Pseudomonas aeruginosa were tested according to conventional method,whose growth were detected in the test group and positive control group, while no growth were detected in the negative control group and sample group. In conclusion,the microbial limit test method for DFOL had been validated in this study,and the conventional method could be applied to DFOL for bacteria,moulds and yeast counting as well as the inspection for control bacteria. The process of test was in accordance with the regulations of microbial limits test method,the method was convenient and simple,and the results was reliable. 相似文献