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1.
《中国抗生素杂志》2009,45(7):679-685
目的 了解神经外科病房临床分离菌的耐药性变迁,为临床合理用药提供依据。方法 收集2015—2018年间我院 神经外科住院患者送检标本的细菌培养及体外药敏试验结果,使用WHONET 5.6软件对药敏数据进行统计分析。结果 2015— 2018年共分离非重复临床分离菌2123株,其中革兰阴性菌1563株(73.6%)、革兰阳性菌560株(26.4%);标本类型以痰液(62.6%)、 尿液(12.8%)、脑脊液(8.9%)和血液(8.6%)为主;分离居前5位的细菌是鲍曼不动杆菌(20.3%)、肺炎克雷伯菌(16.4%)、铜绿假单 胞菌(14.5%)、大肠埃希菌(8.9%)和金黄色葡萄球菌(7.7%);鲍曼不动杆菌对亚胺培南和美罗培南的耐药率均>65%,铜绿假单胞 菌对碳青霉烯类药物的耐药率在30%左右,肺炎克雷伯菌2015—2016年对碳青霉烯类的药物耐药率均<30%,2017年对碳青霉 烯类药物耐药性明显升高(亚胺培南41.3%、美罗培南41.9%),2018年对碳青霉烯类药物的耐药性有较大幅度的下降(亚胺培南 3.4%、美罗培南3.4%),大肠埃希菌对碳青霉烯类的药物耐药率仍较低(<3%),金黄色葡萄球菌对苯唑西林的耐药率由57.9%降 至15.8%,未发现对利奈唑胺和万古霉素耐药的金黄色葡萄球菌。凝固酶阴性的葡萄球菌(CNS)是血液和脑脊液标本中分离居首 位的细菌,二者耐甲氧西林的凝固酶阴性的葡萄球菌(MRCNS)的检出率均>80%,在脑脊液中还分离到2株对利奈唑胺耐药的科 氏葡萄球菌。结论 神经外科病房临床分离菌以鲍曼不动杆菌、肺炎克雷伯菌和铜绿假单胞菌为主,近年来肺炎克雷伯菌的分 离率有明显增高的趋势,非发酵菌和肠杆菌科细菌对碳青霉烯类药物的耐药率也呈上升的趋势,耐甲氧西林的金黄色葡萄球菌  相似文献   

2.
刘跃  刘秀英 《抗感染药学》2019,16(3):404-407
目的:分析安福地区肺结核患者伴下呼吸道感染痰液中病原菌的分布及其药敏结果。方法:选取2015年3月—2018年6月间安福地区收治的肺结核伴下呼吸道感染患者82例资料,统计和分析其患者痰液中病原菌的分布及其药敏结果。结果:82例肺结核伴下呼吸道感染患者中,经病原菌培养分离出95株病原菌,其中革兰阴性菌65株占68.42%,革兰阳性菌8株占8.42%和真菌22株占23.16%;肺炎克雷柏菌、鲍曼不动杆菌和铜绿假单胞菌对氨苄西林的耐药率均高达100.00%,而鲍曼不动杆菌和铜绿假单胞菌对呋喃妥因的耐药率也高达100.00%,金黄色葡萄球菌和表皮葡萄球菌对苯唑西林的耐药率也高达100.00%;而万古霉素对金黄色葡萄球菌、表皮葡萄球菌均完全敏感(其敏感率为100.00%),阿米卡星对鲍曼不动杆菌和铜绿假单胞菌也完全敏感(其敏感率为100.00%)。结论:基于肺结核患者合并下呼吸道感染痰液中病原菌的分布情况及药敏结果,可以得出疗效较好的抗生素,为临床合理、科学使用抗生素提供依据。  相似文献   

3.
目的了解血流感染主要病原菌的分布特点及对常用抗菌药物的耐药情况,以指导临床合理用药。方法对2006年1月—2011年6月期间本院临床各科室送检的血培养标本采用美国Bactec9120全自动血培养仪进行培养,Vitek-32型仪进行菌种鉴定,纸片扩散法测定菌株对抗菌药物的敏感性,头孢西丁法检测耐甲氧西林葡菌球菌,WHONET5.6软件分析数据。结果共分离出598株病原菌,其中革兰阳性球菌282株,占47.2%;革兰阴性杆菌289株,占48.3%,真菌15株,占2.5%。最常见的感染菌分别为大肠埃希菌、表皮葡萄球菌、肺炎克雷伯菌、金黄色葡萄球菌、铜绿假单胞菌及鲍曼不动杆菌。金黄色葡萄球菌和表皮葡萄球菌中耐甲氧西林葡萄球菌检出率分别为63.9%和87.9%,其对青霉素耐药率均>95.0%,均未发现对万古霉素和替考拉宁耐药株。大肠埃希菌和肺炎克雷伯菌对碳青霉烯类抗生素耐药率最低,对氨苄西林耐药率分别为93.8%和100%。铜绿假单胞菌对亚胺培南耐药率为16.7%,而鲍曼不动杆菌对亚胺培南耐药率高达63.6%,鲍曼不动杆菌对其他抗菌药物的耐药率均>60%。结论本单位血流感染以大肠埃希菌和葡萄球菌为主。表皮葡萄球菌较金黄色葡萄球菌耐药性严重,非发酵菌比肠杆菌科细菌耐药性严重,尤其是鲍曼不动杆菌引起的血流感染无经验抗菌药物可选,必须在药敏试验指导下用药。  相似文献   

4.
目的 了解神经外科病房临床分离菌的耐药性变迁,为临床合理用药提供依据。方法 收集2015—2018年间我院 神经外科住院患者送检标本的细菌培养及体外药敏试验结果,使用WHONET 5.6软件对药敏数据进行统计分析。结果 2015— 2018年共分离非重复临床分离菌2123株,其中革兰阴性菌1563株(73.6%)、革兰阳性菌560株(26.4%);标本类型以痰液(62.6%)、 尿液(12.8%)、脑脊液(8.9%)和血液(8.6%)为主;分离居前5位的细菌是鲍曼不动杆菌(20.3%)、肺炎克雷伯菌(16.4%)、铜绿假单 胞菌(14.5%)、大肠埃希菌(8.9%)和金黄色葡萄球菌(7.7%);鲍曼不动杆菌对亚胺培南和美罗培南的耐药率均>65%,铜绿假单胞 菌对碳青霉烯类药物的耐药率在30%左右,肺炎克雷伯菌2015—2016年对碳青霉烯类的药物耐药率均<30%,2017年对碳青霉 烯类药物耐药性明显升高(亚胺培南41.3%、美罗培南41.9%),2018年对碳青霉烯类药物的耐药性有较大幅度的下降(亚胺培南 3.4%、美罗培南3.4%),大肠埃希菌对碳青霉烯类的药物耐药率仍较低(<3%),金黄色葡萄球菌对苯唑西林的耐药率由57.9%降 至15.8%,未发现对利奈唑胺和万古霉素耐药的金黄色葡萄球菌。凝固酶阴性的葡萄球菌(CNS)是血液和脑脊液标本中分离居首 位的细菌,二者耐甲氧西林的凝固酶阴性的葡萄球菌(MRCNS)的检出率均>80%,在脑脊液中还分离到2株对利奈唑胺耐药的科 氏葡萄球菌。结论 神经外科病房临床分离菌以鲍曼不动杆菌、肺炎克雷伯菌和铜绿假单胞菌为主,近年来肺炎克雷伯菌的分 离率有明显增高的趋势,非发酵菌和肠杆菌科细菌对碳青霉烯类药物的耐药率也呈上升的趋势,耐甲氧西林的金黄色葡萄球菌 的检出率呈逐年下降的趋势,加强医院内感染防控措施及细菌耐药监测,合理使用抗菌药物。  相似文献   

5.
目的监测分析2013年我院临床分离细菌构成及耐药情况。方法采用MIC法进行药敏试验,参照临床实验室标准化协会(CLSI)2013版标准判读结果,采用WHONET 5.6软件进行数据分析。结果共收集临床分离的非重复细菌3396株,排名前六的为大肠埃希菌1294株(38.1%)、肺炎克雷伯菌458株(13.49%)、粪肠球菌318株(9.36%)、铜绿假单胞菌137株(4.03%)、鲍曼不动杆菌137株(4.03%)、金黄色葡萄球菌134株(3.95%)。耐甲氧西林金黄色葡萄球菌(MRSA)检出率为37.3%;大肠埃希菌、肺炎克雷伯菌中超广谱β-内酰胺酶(ESBLs)检出率分别为40.0%、19.7%;泛耐药鲍曼不动杆菌检出率为61.2%;泛耐药铜绿假单胞菌检出率为5.3%。结论应重视细菌耐药监测分析,促进合理使用抗菌药物。  相似文献   

6.
目的了解我院近年来常见细菌的分离率及耐药情况,为医院抗菌药物的遴选和临床合理应用提供依据。方法收集我院2008年1月~2012年6月临床送检标本,按照全国临床检验操作规程(第3版)培养、分离、鉴定,采用K-B纸片扩散法进行药敏试验。将分离出的病原菌及其药敏资料进行统计分析。结果4年多共分离到病原菌7180株,其中 G+菌1799株,占25.1%;G-菌5381株,占74.9%。排名前5位的细菌依次为大肠埃希菌、肺炎克雷伯杆菌、铜绿假单胞菌、阴沟杆菌、鲍曼不动杆菌。鲍曼不动杆菌、金黄色葡萄球菌、铜绿假单胞菌的分离率逐年上升,特别是鲍曼不动杆菌上升的幅度比较大。美洛西林、丁胺卡那霉素、万古霉素、亚胺培南对目标细菌处于较低的耐药率。葡萄球菌属细菌对青霉素耐药率均在93%以上,对红霉素的耐药率在70%以上。未发现耐万古霉素的葡萄球菌。肺炎链球菌对青霉素的耐药率为43.1%,对红霉素、复方新诺明、克林霉素的耐药率在90%左右;对左氧氟沙星、氯霉素较敏感。肠杆菌科细菌对美洛西林、亚胺培南、丁胺卡那霉素较为敏感。铜绿假单胞菌耐药率最低的是多黏菌素B和美洛西林。鲍曼不动杆菌对米诺环素耐药率最低。结论我院常见细菌耐药情况与全国其他地区的水平相近,但美洛西林、氟喹诺酮类等对目标细菌的耐药率低于文献报道,临床应重视细菌学检查,根据细菌耐药情况合理使用抗菌药物。  相似文献   

7.
目的总结西安市2013年度临床分离病原菌分布和耐药特征,为医药管理部门和临床抗菌药物合理应用提供病原菌耐药监测数据。方法常规方法培养分离医院内感染病原菌,并应用半自动或全自动细菌鉴定分析仪鉴定到种,药敏试验方法按CLSI规定的标准进行。采用WHONET5.6软件进行数据统计分析。结果 2013年度共分离出病原菌株19995株,革兰阴性菌12654株占63.29%,革兰阳性球菌5472株占27.37%,真菌821株占分离率的4.11%,革兰阳性杆菌及厌氧菌205株占1.03%;临床分离占前5位的细菌分别为大肠埃希菌、鲍曼不动杆菌、铜绿假单胞菌、肺炎克雷伯菌和金黄色葡萄球菌。耐甲氧西林金黄色葡萄球菌(MRSA)的发生率为53.49%,未发现对万古霉素耐药的金黄色葡萄球菌;屎肠球菌和粪肠球菌对万古霉素耐药率分别为1.75%和0.33%,对利奈唑胺的耐药率分别为0.44%和1.92%;大肠埃希菌和肺炎克雷伯菌超广谱β-内酰胺酶的产生率分别为68.1%和46.8%。结论院内感染病原菌耐药现象较为普遍,耐药率与去年相比没有发生明显改变,但耐药监测工作仍要继续进行下去,尤其对院内感染的重要病原菌MRSA、VRE、碳氢酶烯类药物耐药的肠杆菌科细菌、泛耐药的铜绿假单胞菌和鲍曼不动杆菌要进行重点监测,且应与临床加强沟通,使得检验结果更好的服务于临床。  相似文献   

8.
葛涵  梁友宝  陈尧 《淮海医药》2022,(3):289-292
目的:分析某院临床细菌分布及耐药情况。方法:收集某院内各临床科室分离的细菌菌株及药敏试验的数据,进行统计分析。结果:3 278例临床分离菌株分析结果显示,位居前5位病原菌分别为大肠埃希菌789株(24.1%)、肺炎克雷伯菌541株(16.5%)、铜绿假单胞菌306株(9.3%)、鲍曼不动杆菌298株(9.1%)、金黄色葡萄球菌245株(7.5%)。产超广谱β-内酰胺酶(ESBL)的大肠埃希菌、肺炎克雷伯菌的检出率为63.3%、53.8%,耐甲氧西林金黄色葡萄球菌(MRSA)和凝固酶阴性葡萄球菌的检出率分别为46.5%、74.5%。临床常见前5种多重耐药菌数量由多到少依次为ESBL大肠埃希菌、ESBL肺炎克雷伯菌、多重耐药鲍曼不动杆菌(MDRAB)、耐甲氧西林金黄色葡萄球菌(MRSA)和耐碳氢酶烯类肺炎克雷伯菌(CRKP),CRKP检出率上升较快,差异有统计学意义。结论:某院细菌多重耐药情况严重,临床应根据细菌药敏试验结果科学应用抗菌药物。  相似文献   

9.
Mohnarin2009年度报告:北京地区细菌耐药监测   总被引:2,自引:0,他引:2  
目的 掌握北京地区细菌耐药状况与发展趋势.方法 监测2009年度北京地区11所医院临床分离细菌耐药状况,细菌敏感性测定,用标准纸片扩散法或自动化临床微生物测定方法,以Whonet 5.5软件进行数据分析.结果 共获得临床分离菌28036株,其中革兰阴性菌19170株,占68.4%;革兰阳性菌8866株,占31.6%.最常见的细菌依次为铜绿假单胞菌、大肠埃希菌、鲍曼不动杆菌、金黄色葡萄球菌和肺炎克雷伯菌.耐甲氧西林金黄色葡萄球菌与凝固酶阴性葡萄球菌的发生率分别为55.5%和66.9%;未发现万古霉素耐药葡萄球菌.粪肠球菌和屎肠球菌对万古霉素耐药率分别为0.3%和11.1%;未发现利奈唑胺耐药肠球菌.耐青霉素肺炎链球菌比率为6.9%.大肠埃希菌及肺炎克雷伯菌产ESBIL比率分别为64.3%和46.6%.有0.6%的大肠埃希菌和1.3%的肺炎克雷伯菌对亚胺培南耐药.铜绿假单胞菌对碳青酶烯类的耐药率约30%;鲍曼不动杆菌耐药率超过铜绿假单胞菌.结论 本年度北京地区临床分离细菌耐药现象较为普遍且革兰阴性菌耐药率仍呈上升趋势.  相似文献   

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2008年重庆医科大学附属第一医院细菌耐药性监测   总被引:5,自引:2,他引:3  
目的 了解我院2008年临床常见分离病原菌对常用抗菌药物的耐药情况.方法 药敏实验使用纸片扩散法,数据分析采用WHONET5.4软件.结果 在临床分离的1315株细菌中,革兰阳性菌占22.2%,革兰阴性菌占77.8%.金黄色葡萄球菌和凝固酶阴性葡萄球菌中耐甲氧西林株分别占56.8%和81.3%.葡萄球菌或肠球菌均未发现万古霉素或替考拉宁中介株或耐药株.大肠埃希菌和克雷伯菌产ESBLs株检出率分别为51.1%和27.8%.铜绿假单胞菌对亚胺培南和美罗培南的耐药率为44.8%和32.6%,不动杆菌属对亚胺培南和美罗培南的耐药率为36.5%和35.6%.结论 ICU比非ICU耐药性严重,不动杆菌属对碳青霉烯类耐药率明显上升,监测到泛耐药的铜绿假单胞菌和鲍曼不动杆菌,加强细菌耐药监测对抗菌药物的临床应用和控制细菌耐药性传播具有重要意义.  相似文献   

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Poloxamers are polyoxyethlyene, polyoxypropylene block polymers. The impurities of commercial grade Poloxamer 188, as an example, include low-molecular-weight substances (aldehydes and both formic and acetic acids), as well as 1,4-dioxane and residual ethylene oxide and propylene oxide. Most Poloxamers function in cosmetics as surfactants, emulsifying agents, cleansing agents, and/or solubilizing agents, and are used in 141 cosmetic products at concentrations from 0.005% to 20%. Poloxamers injected intravenously in animals are rapidly excreted in the urine, with some accumulation in lung, liver, brain, and kidney tissue. In humans, the plasma concentration of Poloxamer 188 (given intravenously) reached a maximum at 1 h, then reached a steady state. Poloxamers generally were ineffective in wound healing, but were effective in reducing postsurgical adhesions in several test systems. Poloxamers can cause hypercholesterolemia and hypertriglyceridemia in animals, but overall, they are relatively nontoxic to animals, with LD(50) values reported from 5 to 34.6 g/kg. Short-term intravenous doses up to 4 g/kg of Poloxamer 108 produced no change in body weights, but did result in diffuse hepatocellular vacuolization, renal tubular dilation in kidneys, and dose-dependent vacuolization of epithelial cells in the proximal convoluted tubules. A short-term inhalation toxicity study of Poloxamer 101 at 97 mg/m(3) identified slight alveolitis after 2 weeks of exposure, which subsided in the 2-week postexposure observation period. A short-term dermal toxicity study of Poloxamer 184 in rabbits at doses up to 1000 mg/kg produced slight erythema and slight intradermal inflammatory response on histological examination, but no dose-dependent body weight, hematology, blood chemistry, or organ weight changes. A 6-month feeding study in rats and dogs of Poloxamer 188 at exposures up to 5% in the diet produced no adverse effects. Likewise, Poloxamer 331 (tested up to 0.5 g/kg day(-1)), Poloxamer 235 (tested up to 1.0 g/kg day(-1)), and Poloxamer 338 (at 0.2 or 1.0 g/kg day(-1)) produced no adverse effects in dogs. Poloxamer 338 (at 5.0 g/kg day(-1)) produced slight transient diarrhea in dogs. Poloxamer 188 at levels up to 7.5% in diet given to rats in a 2-year feeding study produced diarrhea at 5% and 7.5% levels, a small decrease in growth at the 7.5% level, but no change in survival. Doses up to 0.5 mg/kg day(-1) for 2 years using rats produced yellow discoloration of the serum, high serum alkaline phosphatase activity, and elevated serum glutamicpyruvic transaminase and glutamic-oxalacetic transaminase activities. Poloxamers are minimal ocular irritants, but are not dermal irritants or sensitizers in animals. Data on reproductive and developmental toxicity of Poloxamers were not found. An Ames test did not identify any mutagenic activity of Poloxamer 407, with or without metabolic activation. Several studies have suggested anticarcinogenic effects of Poloxamers. Poloxamers appear to increase the sensitivity to anticancer drugs of multidrug-resistant cancer cells. In clinical testing, Poloxamer 188 increased the hydration of feces when used in combination with a bulk laxative treatment. Compared to controls, one study of angioplasty patients receiving Poloxamer 188 found a reduced myocardial infarct size and a reduced incidence of reinfarction, with no evidence of toxicity, but two other studies found no effect. Poloxamer 188 given to patients suffering from sickle cell disease had decreased pain and decreased hospitilization, compared to controls. Clinical tests of dermal irritation and sensitization were uniformly negative. The Cosmetic Ingredient Review (CIR) Expert Panel stressed that the cosmetic industry should continue to use the necessary purification procedures to keep the levels below established limits for ethylene oxide, propylene oxide, and 1,4-dioxane. The Panel did note the absence of reproductive and developmental toxicity data, but, based on molecular weight and solubility, there should be little skin penetration and any penetration of the skin should be slow. Also, the available data demonstrate that Poloxamers that are introduced into the body via routes other than dermal exposure have a rapid clearance from the body, suggesting that there would be no risk of reproductive and/or developmental toxicity. Overall, the available data do not suggest any concern about carcinogenesis. Although there are gaps in knowledge about product use, the overall information available on the types of products in which these ingredients are used, and at what concentration, indicates a pattern of use. Based on these safety test data and the information that the manufacturing process can be controlled to limit unwanted impurities, the Panel concluded that these Poloxamers are safe as used.  相似文献   

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乔乐天  刘源  贾号  孙彬 《现代药物与临床》2021,36(12):2502-2506
目的 采用高效液相色谱(HPLC)法同时测定抗妇炎胶囊中木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱10种活性成分。方法 采用InerSustain AQ-C18色谱柱(250 mm×4.6 mm,5 μm),流动相A:乙腈–无水乙醇(80∶20),流动相B:0.1%磷酸溶液,梯度洗脱,检测波长220 nm,体积流量1.0 mL/min,柱温30℃,进样量10 μL。结果 木兰花碱、黄柏碱、药根碱、巴马汀、小檗碱、槐果碱、苦参碱、氧化槐果碱、槐定碱和氧化苦参碱分别在2.69~134.50、1.95~97.50、0.63~31.50、0.86~43.00、11.95~597.50、0.59~29.50、6.08~304.00、4.85~242.50、1.66~83.00、19.79~989.50 μg/mL线性关系良好(r≥0.999 3);平均回收率分别为99.11%、98.23%、96.95%、97.78%、100.02%、97.21%、99.66%、99.52%、98.81%、100.08%,RSD值分别为1.04%、1.23%、1.37%、1.65%、0.70%、1.28%、0.65%、0.81%、1.11%、0.63%。结论 建立的HPLC法可用于抗妇炎胶囊中10种活性成分的测定,作为抗妇炎胶囊质量控制方法。  相似文献   

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《Drugs in R&D》2004,5(1):25-27
Sepracor in the US is developing arformoterol [R,R-formoterol], a single isomer form of the beta(2)-adrenoceptor agonist formoterol [eformoterol]. This isomer contains two chiral centres and is being developed as an inhaled preparation for the treatment of respiratory disorders. Sepracor believes that arformoterol has the potential to be a once-daily therapy with a rapid onset of action and a duration of effect exceeding 12 hours. In 1995, Sepracor acquired New England Pharmaceuticals, a manufacturer of metered-dose and dry powder inhalers, for the purpose of preparing formulations of levosalbutamol and arformoterol. Phase II dose-ranging clinical studies of arformoterol as a longer-acting, complementary bronchodilator were completed successfully in the fourth quarter of 2000. Phase III trials of arformoterol began in September 2001. The indications for the drug appeared to be asthma and chronic obstructive pulmonary disease (COPD). However, an update of the pharmaceutical product information on the Sepracor website in September 2003 listed COPD maintenance therapy as the only indication for arformoterol. In October 2002, Sepracor stated that two pivotal phase III studies were ongoing in 1600 patients. Sepracor estimates that its NDA submission for arformoterol, which is projected for the first half of 2004, will include approximately 3000 adult subjects. Sepracor stated in July 2003 that it had completed more than 100 preclinical studies and initiated or completed 15 clinical studies for arformoterol inhalation solution for the treatment of bronchospasm in patients with COPD. In addition, Sepracor stated that the two pivotal phase III studies in 1600 patients were still progressing. In 1995, European patents were granted to Sepracor for the use of arformoterol in the treatment of asthma, and the US patent application was pending.  相似文献   

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活性成分与药理作用欧洲刺柏药用部位是其浆果,具有促水排泄、防腐、抗胃肠胀气和抗风湿作用,还可改善胃功能。用作促水排泄药可增加尿量(水丢失),但不增加钠排泄。成分萜品烯-4-醇可增加肾小球滤过率,但刺激肾。欧洲刺柏浆果对单纯疱疹病毒体外显示抗病毒活性,并具抗真菌活性。动物实验显示,欧洲刺柏浆果提取物具有堕胎、抗生育、抗炎、抗胚胎植入、降血压、升血压和降血糖作用。欧洲刺柏浆果油具有兴奋子宫的活性,以及利尿、胃肠道抗菌和刺激作用,该油对平滑肌有阻止解痉作用。  相似文献   

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《Scientia pharmaceutica》2010,78(3):555-589
Probiotic microorganisms have been shown to provide specific health benefits when consumed as food supplements or as food components. The main problem of such products is the poor survival of the probiotic bacteria in the low pH of gastric fluid. However the use of synthetic excipients for enteric coating to prevent the exposure of microorganisms to gastric fluid is limited in food supplementary industry. Therefore the aim of this study was to develop an enteric coating formulation containing shellac as a natural polymer. Shellac possesses good resistance to gastric juice; the major disadvantage of this polymer is its low solubility in the intestinal fluid [1, 2]. Thus films containing different ratios of shellac and water-soluble polymers (sodium alginate, hydroxypropyl methylcellulose (HPMC) and polyvinylpyrrolidon (PVP)) or plasticizers (glycerol and glyceryl triacetate (GTA)) were prepared in order to analyse the films’ melting temperatures (Tm), the changes in enthalpy (ΔH), their capability of taking up water, and their solubility in different media. The release characteristics of the films were studied by loading pellets with Enterococcus faecium M74 and coating them with formulations containing different amounts of shellac and polymer or plasticized shellac. Using dissolution tests, performed according to USP XXXI paddle method, the resistance of the coatings to simulated gastric fluid (SGF, pH 1.2) and the release of cells in simulated intestinal fluid (SIF, pH 6.8) was investigated.The trials showed that an increasing amount of plasticizer results in a decrease of Tm and ΔH of the films whereat glycerol had a superior plasticization effect to GTA. The compatibility of films made of water-soluble polymers and shellac was also concentration dependent. HPMC and PVP showed superior compatibility with shellac compared to sodium alginate, since films containing shellac and more than 10% [w/w] sodium alginate tended to separate into two phases. In the end five formulations containing shellac and either 5% [w/w] glycerol, 10% [w/w] PVP, 20% [w/w] PVP, 10% [w/w] HPMC, or 5% [w/w] sodium alginate emerged as feasible for enteric coating purposes.  相似文献   

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