还原型谷胱甘肽联合门冬氨酸鸟氨酸治疗婴儿肝炎综合征的临床研究

目的探讨注射用还原型谷胱甘肽联合注射用门冬氨酸鸟氨酸治疗婴儿肝炎综合征的临床疗效。方法选择2015年12月—2016年12月漯河市第一人民医院收治婴的儿肝炎综合征患儿70例作为研究对象,全部患儿随机分为对照组和治疗组,每组各35例。对照组静脉滴注注射用门冬氨酸鸟氨酸,0.5 g加入到5%葡萄糖溶液50 m L中,1次/d。治疗组在对照组基础上静脉滴注注射用还原型谷胱甘肽,0.3 g加入到5%葡萄糖溶液30 m L中,1次/d。两组患儿均连续治疗14 d。观察两组的临床疗效,比较两组生化指标和炎症因子。结果治疗后,对照组和治疗组的总有效率分别为88.6%、97.1%,两组比较差异有统计学意义(P0.05)。治疗后,两组丙氨酸氨基转移酶(ALT)、总胆酸(TBA)、总胆红素(TBIL)、直接胆红素(DBIL)和谷氨酰转肽酶(GGT)水平均显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组白细胞介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)水平均显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论注射用还原型谷胱甘肽联合注射用门冬氨酸鸟氨酸治疗婴儿肝炎综合征具有较好的临床疗效,能显著降低ALT、TBA、TBIL、DBIL和GGT水平,减轻炎症水平,具有一定的临床推广应用价值。     

门冬氨酸鸟氨酸联合乳果糖治疗肝性脑病的疗效观察

目的 观察注射用门冬氨酸鸟氨酸联合乳果糖口服液治疗肝性脑病患者的临床疗效.方法 将84例重型肝炎或肝硬化并发肝性脑病患者随机分为观察组和对照组各42例.观察组给予注射用门冬氨酸鸟氨酸静脉滴注,乳果糖口服液灌肠;对照组给予精氨酸注射液静脉滴注,0.9%氯化钠注射液灌肠,两组疗程均为7d.观察患者治疗前后的临床症状体征、不良反应、肝肾功能指标及血氨水平,比较临床疗效变化.结果 观察组总有效率92.86%,对照组总有效率76.19%,差异有统计学意义(WTBXP<0.05);治疗后观察组患者的ALT、TBil及血氨水平比对照组低(P<0.05,P<0.01),差异显著.结论 注射用门冬氨酸鸟氨酸联合乳果糖口服液对改善肝功能、治疗肝性脑病有显著的临床疗效,且不良反应较少,具有临床推广价值.     

异甘草酸镁联合门冬氨酸鸟氨酸治疗乙肝肝硬化肝性脑病的临床疗效

目的探讨采用异甘草酸镁联合门冬氨酸鸟氨酸治疗乙型肝炎(乙肝)肝硬化肝性脑病的临床疗效。方法 90例乙肝肝硬化肝性脑病患者为研究对象,随机分为观察组及对照组,各45例。两组均给予常规基础治疗。对照组采用门冬氨酸鸟氨酸进行治疗,观察组采用异甘草酸镁联合门冬氨酸鸟氨酸进行治疗。比较两组患者的临床治疗效果,治疗前后血氨、胆红素、丙氨酸氨基转移酶(ALT)水平及美国国立卫生研究院卒中量表(NIHSS)评分,不良反应发生情况。结果观察组治疗总有效率97.78%高于对照组的75.56%,差异具有统计学意义(χ2=9.615, P=0.002<0.05)。治疗3 d后,两组患者的血氨水平较本组治疗前降低,且观察组降低程度优于对照组,差异均具有统计学意义(P<0.05);治疗1周后,两组患者的胆红素水平较本组治疗前降低,且观察组降低程度优于对照组,差异均具有统计学意义(P<0.05)。治疗1周后,两组患者的ALT水平和NIHSS评分均较本组治疗前降低,且观察组降低程度优于对照组,差异均具有统计学意义(P<0.05)。两组患者的不良反应发生率比较,差异无统计学意义(χ2=0.212, P=0.645>0.05)。结论采用异甘草酸镁联合门冬氨酸鸟氨酸用药方式治疗乙肝肝硬化肝性脑病具有非常显著的临床疗效。     

胰胆舒胶囊联合生长抑素治疗重症急性胰腺炎的临床研究

目的研究胰胆舒胶囊联合注射用生长抑素治疗重症急性胰腺炎的临床疗效。方法选取2017年12月—2018年12月乐山市人民医院治疗的100例重症急性胰腺炎患者作为研究对象,采用随机数字表法将所有患者分为对照组和治疗组,每组各50例。对照组患者静脉滴注注射用生长抑素,将6 mg注射用生长抑素溶于100 mL生理盐水中,采用微量泵缓静滴24 h,静脉滴注速度0.25 mg/h。治疗组在对照组治疗的基础上口服胰胆舒胶囊,3粒/次,3次/d。两组患者均接受治疗14 d。观察两组患者的临床疗效,同时比较两组的临床症状缓解时间、生化指标和炎症因子水平。结果治疗后,对照组和治疗组的总有效率分别为80.00%、94.00%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组患者腹水消失时间、腹痛消失时间、血淀粉酶恢复时间、排气恢复时间均显著短于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者血清淀粉酶(AMS)、血清脂肪酶(LPS)和门冬氨酸氨基转移酶(AST)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);并且治疗组生化指标水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者的C反应蛋白(CRP)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)水平均显著降低,同组治疗前后比较差异有统计学意义(P0.05);并且治疗组炎症因子水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论胰胆舒胶囊联合注射用生长抑素治疗重症急性胰腺炎具有较好的临床疗效,能够改善患者临床症状和生化指标水平,安全性较高,值得在临床上推广应用。     

门冬氨酸鸟氨酸联合乳果糖口服治疗肝性脑病的疗效观察

目的探讨门冬氨酸鸟氨酸联合乳果糖口服在肝性脑病患者中应用治疗的临床效果。方法选取我院2011年6月至2014年6月期间因肝性脑病需住院治疗患者70例,随机分为2组,每组35例,分别予以门冬氨酸鸟氨酸联合乳果糖口服(观察组)和常规治疗(对照组),比较两组治疗后实验室指标、肝性脑病积分、促醒时间以及临床效果。结果观察组患者治疗后ALT、AST、TBIL和血氨值均低于对照组,差异具有统计学意义(P<0.05);观察组患者治疗后肝性脑病计分和促醒时间均低于对照组,差异具有统计学意义(P<0.05);观察组显效率和总有效率均高于对照组,病死率低于对照组,差异具有统计学意义(P<0.05)。结论门冬氨酸鸟氨酸联合乳果糖口服治疗肝性脑病临床效果较好,实验室指标恢复快,适合临床广泛推广使用。     

双歧杆菌四联活菌片联合乌司他丁治疗急性胰腺炎的临床研究

目的探讨双歧杆菌四联活菌片联合注射用乌司他丁治疗急性胰腺炎的临床疗效。方法选取2014年6月—2017年6月在驻马店市中心医院消化内科进行治疗的急性胰腺炎患者206例为研究对象,根据用药的差别将入组患者分为对照组和治疗组,每组各103例。对照组静脉滴注注射用乌司他丁,20万单位加入到5%葡萄糖注射液250 m L中,1次/d。治疗组在对照组基础上给予双歧杆菌四联活菌片,1.5 g进行水化后自胃管灌注,夹管2 h,3次/d。两组患者均连续治疗7 d。观察两组的临床疗效,比较两组的临床症状恢复时间、血清因子水平、急性生理与慢性健康评分(APACHEⅡ评分)和生活质量调查表(SF-36)评分。结果治疗后,对照组和治疗组的总有效率分别为84.47%、98.06%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组腹痛、腹胀、腹膜刺激征恢复时间均短于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清C反应蛋白(CRP)、降钙素(PCT)、可溶性细胞黏附因子-1(s ICAM-1)、白细胞介素-1β(IL-1β)、肿瘤坏死因子-α(TNF-α)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血淀粉酶(BAMY)、尿淀粉酶(UAMY)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组APACHEⅡ评分显著下降,SF-36评分明显升高,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组这些观察指标的改善程度明显优于对照组,两组比较差异具有统计学意义(P0.05)。结论双歧杆菌四联活菌片联合注射用乌司他丁治疗急性胰腺炎具有较好的临床疗效,可改善临床症状,降低炎症水平,改善生存质量,具有一定的临床推广应用价值。     

生长抑素联合乌司他丁治疗粘连性肠梗阻的临床研究

目的探讨注射用生长抑素联合注射用乌司他丁治疗粘连性肠梗阻的临床疗效。方法选取2012年2月—2017年2月北京市顺义区医院和河北省第七人民医院收治的76例粘连性肠梗阻患者作为研究对象,将患者随机分为对照组和治疗组,每组38例。对照组静脉滴注注射用乌司他丁,将10万单位乌司他丁溶于0.9%氯化钠溶液250 mL中,1次/d。治疗组在对照组治疗的基础上静脉滴注注射用生长抑素,0.25mg/h,直到肛门恢复排便、排气。观察两组患者的临床疗效,比较两组的临床指标、血清炎性因子水平和不良反应情况。结果治疗后,治疗组的总有效率为84.21%,显著高于对照组的68.42%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组胃肠减压量、腹胀缓解时间和排气恢复时间明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清内毒素(LPS)、超敏C反应蛋白(hs-CRP)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组血清炎性因子水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗期间,治疗组不良反应总发生率为7.89%,低于对照组的26.32%,两组不良反应发生率比较差异具有统计学意义(P0.05)。结论注射用生长抑素联合注射用乌司他丁治疗粘连性肠梗阻的具有较好的临床疗效,可显著降低患者炎症反应,不良反应低,具有一定的临床推广应用价值。     

门冬氨酸鸟氨酸治疗肝硬化伴发肝性脑病的疗效观察

目的探究门冬氨酸鸟氨酸治疗肝硬化伴发肝性脑病的疗效。方法选取2016年1月至2018年4月来我院治疗肝硬化伴发肝性脑病患者90例作为研究对象,运用随机分组法分为观察组(n=45)和对照组(n=45),对照组采用常规治疗,观察组采用门冬氨酸鸟氨酸药物治疗,观察两组患者治疗有效率以及血清丙氨酸转氨酶(ALT)、总胆红素(TBIL)、血氨(NH3)水平。结果观察组患者治疗有效率为95.56%明显高于对照组治疗有效率80.00%,且观察组ALT、TBIL、NH3水平均显著降低,数据差异显著具有统计学意义(P <0.05)。结论门冬氨酸鸟氨酸治疗肝硬化伴发肝性脑病效果良好,显著改善各项生理指标,帮助患者快速痊愈,值得广泛推广。     

丹参注射液联合甲泼尼龙治疗肾病综合征的临床研究

目的研究丹参注射液联合注射用甲泼尼龙琥珀酸钠治疗肾病综合征的临床疗效。方法选取2016年10月—2017年10月宜宾市第二人民医院接收的120例肾病综合征患者作为研究对象,将所有患者随机分为对照组和治疗组,每组各60例。对照组静脉滴注注射用甲泼尼龙琥珀酸钠,40 mg加入到生理盐水100 mL中,1次/d。治疗组在对照组治疗的基础上静脉滴注丹参注射液,20 mL加入到5%葡萄糖注射液250 mL中,1次/d。两组患者均持续治疗2周。观察两组患者的临床疗效,同时比较两组治疗前后的肾功能指标、血流变学指标和血清炎性因子水平。结果治疗后,治疗组的总有效率为93.33%,显著高于对照组的78.33%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者的尿素氮(BUN)、血肌酐(Scr)和24h尿蛋白定量水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组肾功能指标显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者纤维蛋白原(FIB)和血浆黏度(PV)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组血流变学指标水平显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者白细胞介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组血清炎性因子显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论丹参注射液联合注射用甲泼尼龙琥珀酸钠治疗肾病综合征具有较好的临床疗效,能够显著改善患肾功能和血流变学相关指标,安全性较高,具有一定的临床推广应用价值。     

门冬氨酸鸟氨酸注射液抗肝性脑病的疗效观察

目的：观察门冬氨酸-鸟氨酸治疗肝性脑病的临床疗效。方法：回顾性分析本院2008年3月～2010年12月收治入院的肝性脑病患者56例,将其随机分为两组,治疗组28例,对照组28例。对照组常规治疗,治疗组采用门冬氨酸-鸟氨酸治疗并测定患者治疗前、后血清氨的水平,观察其临床疗效。结果：肝性脑病患者血氨水平明显增加,且与肝性脑病病情程度相关,两组相比,差异具有统计学意义（P〈0.05）。结论：门冬氨酸-鸟氨酸治疗后血氨含量下降程度和肝性脑病清醒时间明显优于对照组,门冬氨酸-鸟氨酸对肝性脑病具有明显疗效。     

Safety assessment of poloxamers 101, 105, 108, 122, 123, 124, 181, 182, 183, 184, 185, 188, 212, 215, 217, 231, 234, 235, 237, 238, 282, 284, 288, 331, 333, 334, 335, 338, 401, 402, 403, and 407, poloxamer 105 benzoate, and poloxamer 182 dibenzoate as used in cosmetics

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.     

HPLC法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

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。     

Arformoterol: (R,R)-eformoterol, (R,R)-formoterol, arformoterol tartrate, eformoterol-sepracor, formoterol-sepracor, R,R-eformoterol, R,R-formoterol

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.     

欧洲刺柏（Juniper）

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。     

Oral Presentations (LDD, LPES, LNM, LPAT, LNT, LPPT, LPM)

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 (T_m), 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 T_m 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.