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1.
目的探讨双歧杆菌三联活菌胶囊联合生长抑素治疗急性胰腺炎的临床疗效。方法选取2012年1月—2016年6月在亳州市人民医院治疗的急性胰腺炎患者136例,随机分为对照组和治疗组,每组各68例。对照组静脉注射注射用生长抑素,首次使用微量泵静脉推注100μg,然后以50μg/h匀速泵入。治疗组在对照组的基础上口服双歧杆菌三联活菌胶囊,4粒/次,1次/12 h。两组患者连续治疗14 d。评价两组患者临床疗效,同时比较治疗前后两组患者白细胞(WBC)、C反应蛋白(CRP)、淀粉酶(AMY)和乳酸脱氢酶(LDH)等生化指标以及胃肠道功能评分。结果治疗后,对照组和治疗组总有效率分别为82.35%和92.65%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者WBC、CRP、AMY和LDH生化指标以及胃肠道功能评分均显著降低,同组比较差异具有统计学意义(P0.05);且治疗组上述观察指标显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论双歧杆菌三联活菌胶囊联合生长抑素治疗急性胰腺炎疗效显著,具有一定的临床推广应用价值。  相似文献   

2.
目的研究胰胆炎合剂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2017年1月—2017年12月西安交通大学第一附属医院收治的急性胰腺炎患者120例为研究对象,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乌司他丁,10万单位加入到0.9%氯化钠注射液500 m L中,静滴时间2 h,1次/d。治疗组在对照组治疗的基础上口服胰胆炎合剂,1袋/次,2次/d。两组患者持续治疗7 d。观察两组的临床疗效,比较两组的临床症状恢复时间和生化指标水平。结果治疗后,对照组和治疗组的总有效率分别为85.00%、96.67%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组腹痛缓解时间、胃肠功能恢复时间、血尿淀粉酶正常时间、白细胞计数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C反应蛋白(CRP)、白细胞(WBC)、淀粉酶(AMY)和乳酸脱氢酶(LDH)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);且治疗组生化指标水平明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论胰胆炎合剂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,能改善患者临床症状,调节CRP、WBC、AMY和LDH水平,安全性较好,具有一定的临床推广应用价值。  相似文献   

3.
目的观察注射用乌司他丁联合地塞米松磷酸钠注射液治疗急性呼吸窘迫综合征的临床效果。方法选取2016年3月—2017年3月成都市第二人民医院收治的急性呼吸窘迫综合征患者96例为研究的对象,将所有患者随机分为对照组和治疗组,每组各48例。对照组静脉滴注地塞米松磷酸钠注射液,5 mg加入到5%葡萄糖注射液250 m L中,2次/d。治疗组在对照组的基础上静脉滴注注射用乌司他丁,5万单位加入到5%葡萄糖注射液250 m L中,2次/d。两组患者均连续治疗2周。观察两组的临床疗效,比较两组的住院时间、住重症监护室(ICU)时间、病死率和肺功能指标。结果治疗后,对照组和治疗组的总有效率分别为77.1%、95.8%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组住院时间、住ICU时间、病死率均低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组氧合指数均显著升高,治疗组呼吸频率显著降低,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)。结论注射用乌司他丁联合地塞米松磷酸钠注射液治疗急性呼吸窘迫综合征具有较好的临床疗效,可以改善肺功能,缩短住院时间和住ICU时间,降低病死率,具有一定的临床推广应用价值。  相似文献   

4.
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。  相似文献   

5.
目的探讨乌司他丁注射液联合醒脑静注射液治疗急性重型高血压脑出血的临床疗效。方法选取2015年3月—2019年2月在南阳市中心医院神经外科治疗的180例急性重型高血压脑出血患者为研究对象,所有患者随机分为对照组和治疗组,每组各90例。对照组患者静脉滴注醒脑静注射液,20 mL/次,1次/d;治疗组患者在对照组治疗基础上静脉滴注乌司他丁注射液,20万单位/次,2次/d,两药间隔1 h滴注。两组患者均连续治疗14 d。观察两组的临床疗效,比较两组的格拉斯哥昏迷(GCS)评分、美国国立卫生研究院卒中量表(NIHSS)评分、Barthel指数(BI)评分、血清炎症因子水平。结果治疗后,对照组与治疗组总有效率分别为67.78%、83.33%,两组比较差异有统计学意义(P0.05)。治疗3、7、14d后,两组患者GCS评分均较治疗前升高,差异有统计学意义(P0.05);治疗7、14 d后,治疗组患者GCS评分显著高于对照组,差异具有统计学意义(P0.05)。治疗后,两组患者NIHSS评分明显下降,BI评分显著升高,同组治疗前后比较差异具有统计学意义(P0.05),且治疗组患者NHISS评分、BI评分均显著优于对照组,两组比较差异均具有统计学意义(P0.05)。治疗后,两组患者血清超敏C反应蛋白(hs-CRP)、白细胞介素-1(IL-1)、白细胞介素-8(IL-8)、肿瘤坏死因子α(TNF-α)水平均较治疗前显著降低(P0.05),且治疗组炎症因子水平显著低于对照组,差异有统计学意义(P0.05)。结论乌司他丁注射液联合醒脑静注射液治疗急性重型高血压脑出血具有较好的临床疗效,可改善临床症状,增强炎症反应的抑制能力,提高生活质量,安全性较高,具有一定的临床推广应用价值。  相似文献   

6.
目的观察麻仁软胶囊联合双歧杆菌乳杆菌三联活菌片治疗热积证功能性便秘的临床疗效。方法选取2016年9月—2017年9月天津中医药大学第一附属医院、天津北辰区中医院收治的功能性便秘患者64例,随机分为对照组(30例)和治疗组(34例)。对照组患者口服双歧杆菌乳杆菌三联活菌片,4片/次,3次/d。治疗组患者在对照组的基础上口服麻仁软胶囊,2粒/次,1次/d。两组患者均连续治疗4周。观察两组患者临床疗效,比较治疗前后两组患者临床症状积分、中医症状评分和焦虑自评量表(SAS)评分。结果治疗后,对照组和治疗组的总有效率分别为80.00%和91.18%,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者排便频率、排便速度、排便时间、排便费力、粪便性状积分,腹胀、腹痛、口臭、口干中医症状评分较治疗前均显著降低,同组比较差异具有统计学意义(P0.05);且治疗后治疗组上述评分均显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者SAS评分显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组SAS评分显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论麻仁软胶囊联合双歧杆菌乳杆菌三联活菌片治疗热积证功能性便秘临床疗效较好,可显著改善临床症状和焦虑症状,具有一定的临床推广应用价值。  相似文献   

7.
目的探讨注射用乌司他丁联合丹参川芎嗪注射液治疗重症急性胰腺炎的临床疗效。方法选取泉州德诚医院2016-2018年收治的重症急性胰腺炎患者72例,随机分为对照组与联合组,各36例。对照组予以注射用乌司他丁治疗,联合组在对照组基础上联合丹参川芎嗪注射液治疗,两组均治疗2周。比较两组临床疗效、治疗前后炎性因子〔白介素6(IL-6)、白介素8(IL-8)及肿瘤坏死因子α(TNF-α)〕,并观察两组不良反应发生情况。结果联合组临床疗效优于对照组(P<0.05)。治疗前两组IL-6、IL-8、TNF-α水平比较,差异无统计学意义(P>0.05);治疗后联合组IL-6、IL-8、TNF-α水平低于对照组(P<0.05)。联合组不良反应低于对照组(P<0.05)。结论注射用乌司他丁联合丹参川芎嗪注射液治疗重症急性胰腺炎的临床疗效确切,可降低炎性因子水平,且安全性较高。  相似文献   

8.
目的探索乌司他丁联合奥曲肽治疗急性重症胰腺炎临床治疗效果。方法研究选择本院2015年5月至2019年5月收治的75例急性重症胰腺炎患者作为研究对象,按照随机分组方法将研究对象分为两组,对照组选择奥曲肽治疗,观察组选择乌司他丁联合奥曲肽治疗,观察两组患者的临床症状。结果观察组患者有效率为97.37%,对照组总有效率81.08%,可见观察组临床治疗效果明显,对比差异显著(P<0.05);观察组患者两组患者CTSI评分和Ranson评分明显低于对照组,两组对比差异显著(P <0.05);治疗前观察组白细胞计数、C反应蛋白(CRP)和血清淀粉酶AMS等指标与对照组相近,对比无差异(P> 0.05);治疗后血清指标均明显下降,且观察组血清指标明显低于对照组患者,两组对比差异显著(P <0.05)。结论乌司他丁联合奥曲肽治疗急性重症胰腺炎临床治疗效果较好,明显提升治疗有效率,改善患者临床症状和血清指标,具有临床推广价值。  相似文献   

9.
目的探究复方麝香注射液联合注射用尤瑞克林治疗急性脑梗死的临床疗效。方法选取2016年3月—2017年12月于上海市第八人民医院收治的急性脑梗死患者150例作为研究对象,按随机数字表法将患者分为对照组和治疗组,每组各75例。对照组患者静脉滴注注射用尤瑞克林,0.15PNA加入到0.9%氯化钠注射液100m L中,30min滴注完毕,1次/d。治疗组在对照组治疗的基础上静脉滴注复方麝香注射液,20 mL加入到0.9%氯化钠注射液250 mL中,1次/d。两组患者均连续治疗14 d。观察两组患者的临床疗效,比较治疗前后两组的美国国立卫生研究院卒中量表评分(NIHSS)、ADL评分、血液流变学指标和炎性因子水平。结果治疗后,对照组和治疗组的总有效率分别为80.00%、92.00%,两组比较差异具有统计学意义(P0.05)。治疗后,两组NIHSS评分明显下降,ADL评分明显上升,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组NIHSS评分显著低于对照组,ADL评分显著高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血浆黏度(PV)、全血高切黏度(HBV)、全血低切黏度(LBV)和红细胞压积(HCT)水平均明显下降,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组血液流变学指标均显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组血清肿瘤坏死因子(TNF-α)、白细胞介素-6(IL-6)和金属基质蛋白酶(MMP-9)水平均明显下降,同组治疗前后比较差异具有统计学意义(P0.05);且治疗后治疗组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)。结论复方麝香注射液联合注射用尤瑞克林治疗急性脑梗死疗效显著,可促进患者神经功能的恢复,改善血流动力学指标及炎症反应,具有一定的临床推广应用价值。  相似文献   

10.
目的研究地衣芽孢杆菌胶囊联合美沙拉秦缓释颗粒治疗轻中度活动期溃疡性结肠炎的临床疗效。方法选取2015年1月—2018年1月中国医科大学附属盛京医院消化内科收治的明确诊断为轻度和中度的初治溃疡性结肠炎住院患者100例为研究对象,采用数字随机表法将所有患者分为对照组和治疗组,每组各50例。对照组口服美沙拉秦缓释颗粒,1.0 g/次,4次/d。治疗组在对照组治疗基础上口服地衣芽孢杆菌活菌胶囊,0.5 g/次,3次/d。两组患者均连续服药12周。观察两组的临床疗效、光镜下组织学损伤情况、内镜愈合率和黏膜愈合率,比较两组的改良Mayo评分、Mayo内镜亚组评分、Geboes评分、肠道菌群数量。结果治疗后,对照组、治疗组的总有效率分别为80.00%、94.00%,两组总有效率比较差异有统计学意义(P0.05)。治疗后,两组改良Mayo评分、Mayo内镜亚组评分均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);且治疗组Mayo评分明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,对照组、治疗组肠光镜下上皮杯状细胞和腺体增加,固有层见少量淋巴细胞、嗜酸性粒细胞浸润。治疗后,两组患者Geboes评分均显著下降,同组治疗前后比较差异具有统计学意义(P0.05),且治疗组的Geboes评分显著低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,对照组内镜愈合率为26%,治疗组内镜愈合率为30%,两组内镜愈合率比较差异无统计学意义。治疗后,对照组黏膜愈合率为8%,治疗组黏膜愈合率为8%,两组内镜愈合率比较差异无统计学意义。治疗后,两组双歧杆菌、乳酸杆菌的菌群数量明显升高,粪肠球菌的菌群数量明显降低,同组治疗前后比较差异具有统计学意义(P0.05),并且治疗后治疗组双歧杆菌、乳酸杆菌的菌群数量显著高于对照组,大肠杆菌、粪肠球菌的菌群数量显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论地衣芽孢杆菌胶囊联合美沙拉秦缓释颗粒治疗轻中度活动期溃疡性结肠炎具有较好的临床疗效,能够改善内镜和组织学损伤,改善临床症状,调节肠道菌群结构,具有一定的临床推广应用价值。  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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