尼莫地平薄膜包衣片的研制

目的：对尼莫地平片进行包衣以达到防潮的目的。方法：采用EudragitE100等辅料进行薄膜包衣。结果。达到了防潮效果。未改变药片的质量。结论：应用本法进行尼莫地平片包衣,既能防潮,又不影响片剂溶出度。     

新型水性胃溶薄膜包衣预混辅料的制备及防潮防裂性能研究

目的研究新型水性胃溶薄膜包衣预混辅料。方法制备一种新型水性胃溶薄膜包衣预混辅料，对其处方结构和制备工艺特点进行分析。将用该预混辅料配制的包衣液分别对复方丹参片、花红片、普乐安片和钙尔奇D片进行包衣，在温度（40±2）℃、相对湿度（75±5）％的条件下进行裸片加速试验7d，考察其防潮防裂性能；通过对该预混辅料中镁元素含量及100目筛余率的测定，考察其均匀度和粒度。结果该预混辅料粒度小于100目，混合均匀度不低于99．5％，并具有较强的防潮、防裂性能。结论制备得到了一种粒度细、均匀度高、防潮防裂性能强的水性胃溶薄膜包衣预混辅料。     

薄膜包衣技术在中药固体制剂防潮中的应用

中药制剂易吸潮严重影响药品的稳定性.本文简要介绍了中药制剂吸湿性原理、薄膜包衣的优点及应用现状,重点从薄膜包衣的成膜原理、处方组成、影响包衣制剂的工艺参数等方面综述薄膜包衣在中药防潮中的应用.近几年,虽然薄膜包衣已广泛应用于药物制剂,但由于中药成分的复杂性,薄膜包衣在中药防潮方面的研究和应用还不够深入.随着对新型薄膜包衣材料及薄膜包衣技术的研究,薄膜包衣在中药方面的应用将得到进一步的关注,并将在中药现代化发展进程中发挥较大的潜力.     

普乐安片薄膜包衣工艺研究

采用自配薄膜包衣液及两种市售薄膜包衣材料对普乐安片进行薄膜包衣，比较了包衣材料的防潮性能，并对包衣液的用量进行了筛选。     

防潮型包衣材料Opadry AMB包复阿司匹林片研究

用特殊防潮性包衣材料--OpadryAMB对阿司匹林片进行包衣,考察素片和薄膜包衣片中阿司匹林的含量、溶出度、稳定性等.结果表明阿司匹林包复Opadry薄膜衣后增加了稳定性,OpadryAMB防潮效果明显.     

薄膜包衣西罗莫司滴丸防潮性考察

摘 要 目的： 对西罗莫司（SRL）滴丸进行薄膜包衣,以期达到防潮的目的。方法: 选用欧巴代为SRL滴丸的包衣材料,对其使用溶剂、欧巴代浓度、增重及包衣工艺参数进行筛选,确定包衣处方及工艺;测定包衣SRL滴丸的临界相对湿度,并与未包衣SRL滴丸进行比较。结果:选用95%的乙醇作为溶剂系统,其中欧巴代的浓度为6.5%,增重为4%,进风温度为（35±2）℃,进液速度为12 ml·min^-1,喷雾压力为3.0 MPa。包衣SRL滴丸的临界相对湿度为63.1%,明显高于未包衣SRL滴丸（36.1%）。结论: 欧巴代薄膜包衣可明显提高SRL滴丸的防潮性能,有利于其稳定性。     

中药提取物薄膜包衣工艺研究

目的:采用自制薄膜包衣液及市售薄膜包衣材料对中药提取物进行薄膜包衣.比较包衣材料的防潮性能,并对包衣增重进行筛选.结果:自制薄膜包衣液及市售薄膜包衣材料均可用于中药提取物的薄膜包衣.结论:从成本和质量上考虑,选择欧巴代AMB作为中药提取物片的包衣材料是最合适的.     

金胆片全水型薄膜包衣的生产工艺研究

目的:对金胆片包衣生产工艺进行研究,降低包衣片的顶裂、剥落现象,同时优化包衣的生产工艺条件.方法:通过崩解、耐温湿试验比较醇溶型薄膜包衣及全水型薄膜包衣对金胆片理化性质的影响,通过正交试验摸索出全水型薄膜包衣的最佳工艺条件.结果:全水型薄膜包衣可显著减少金胆片项裂、剥落现象,提高贮存期稳定性,在优选的金胆片工艺条件下各项质量指标均合格.结论:金胆片可采用全水型薄膜包衣.     

健脑补肾丸薄膜包衣研究

目的考察果维膜对健脑补肾丸的薄膜包衣效果。方法用吸湿率、防潮性、耐撞击性等进行比较。结果与结论薄膜包衣丸防潮性等明显优于普通包衣丸。     

枸橼酸钾缓释微丸的制备及其质量初步研究*（

目的：制备枸橼酸钾缓释微丸并对其进行质量初步研究。方法：采用离心造粒粉末层积法制备载药丸芯,以乙基纤维素水分散体为缓释膜材对载药丸芯进行流化包衣;以国外枸橼酸钾缓释片为参比制剂,对自制缓释微丸的溶出度、稳定性等主要质量指标进行了初步考察。结果：离心造粒制得的微丸圆整度好,有一定强度,适合包衣;当缓释包衣增重达10%,并采用60℃老化4h工艺时,所制备的缓释微丸在纯化水介质中的溶出曲线与参比制剂重合度较高,且稳定性良好。     

丙戊酸钠薄膜衣片的制备及稳定性研究

目的研究丙戊酸钠薄膜衣片的制备方法。方法分别用全水型和醇溶型薄膜包衣预混剂对该素片进行包衣,与该品种同规格糖衣片同时进行稳定性考察比较。结果用全水型和醇溶型薄膜包衣预混剂对该产品素片进行包衣后,当增重达到（3．5±0．3）％时,本品6个月时的水分含量分别为6.3％、6．6％,糖衣片为8．9％,其他项目比糖衣片也显出一定的优势,且均符合规定。结论按该工艺生产的丙戊酸钠薄膜衣片符合质量标准要求,工艺稳定可靠,适合大生产需要。     

Silk fibroin as a novel coating material for controlled release of theophylline

The aim of this study was to explore potential use of the silk fibroin (SF) as an aqueous coating material for theophylline tablets. We have examined the film forming and coating properties of heat-treated fibroin, SF solution having different amounts of polyethylene glycol (PEG) and 1-ethyl-3-(3-dimethyl aminopropyl)carbodiimide (EDC) cross-linked SF. Heat-treated SF material possessed a brittle structure, which resulted in poor film forming and coating properties. The optimum PEG amount in SF solution was determined as 17% (by weight) for an acceptable film forming and zero order release profile. EDC cross-linked SF has shown a very good film forming and coating property with a potential for sustaining the drug release from coated theophylline tablets. Dissolution data for coated theophylline tablets were analyzed using Ritger and Peppas equation to describe the mechanism of drug release. Drug release from the EDC coated tablets followed zero-order kinetics. Release rate constants were found to be 0.26, 0.19, 0.16% min⁻¹ for single-coated, double coated, and triple coated tablets, respectively. These results clearly demonstrated that silk fibroin has high utility as a novel aqueous coating material for controlled release products.     

Evaluation of Moisture Sorption by Tablet Cores Containing Superdisintegrants During the Aqueous Film Coating Process

A physical-chemical analysis of the extent of sorption of water by tablets containing superdisintegrants was carried out following the aqueous film coating of formulated tablets. Characterization of the uncoated and coated tablet properties was conducted using thermo-gravimetric analysis, differential scanning calorimetry, mercury intrusion porosimetry, and measurement of the tablet tensile strength. Tablet residual moisture content, pore system characteristics, tensile strength, and glass transition temperature of the amorphous polymer components of the tablet matrix were significantly affected after the coating operation. These findings were attributed to the penetration of water from the aqueous film coating solution into the tablet matrix.     

全水型薄膜包衣预混剂在复方丹参片生产中的应用研究

目的研究全水型薄膜包衣技术在复方丹参片生产中的应用,提高复方丹参片的质量稳定性。方法进行加速试验,比较复方丹参片全水型薄膜衣片与醇溶性薄膜衣片的综合质量和稳定性。结果全水型薄膜包衣片外观明显优于醇溶性薄膜衣片,在稳定性考察过程中含量测定和崩解时限均无明显变化。结论全水型薄膜包衣预混剂可用于复方丹参片的包衣生产。     

A case study exploring the impact of an oxygen barrier coating on formulation stability, in-vitro dissolution and bioperformance

Objectives The impact of a carmellose sodium (sodium carboxymethycellulose)‐based coat (Opaglos 2) on the stability of an oxygen‐sensitive compound A and in‐vitro dissolution and bioperformance of compound B has been investigated. Methods Tablets containing compounds A and B were coated with various weight gains of Opaglos 2 and a comparative elegance coating (poly(vinyl alcohol)‐based Opadry II). Film‐coated tablets were assessed for oxidative degradation under accelerated stability conditions (30°C/65% RH and 40°C/75% RH). Key findings An apparent rank order of restriction of oxygen (O₂) permeability afforded by the coatings was observed, with only higher Opaglos 2 coating weight gains (6 and 8% w/w) providing adequate oxidative degradation stability for up to 52 weeks. Improved stability at the higher coating weight gains was attributed to incomplete polymeric film formation at lower coating weight gains. The 6% and 8% w/w Opaglos 2 formulations showed dissolution retardation compared with elegance‐coated formulations in USP dissolution apparatus II, predicting significant impact on formulation bioperformance. However, pharmacokinetic studies in Beagle dogs showed similar bioperformance for all formulations. Conclusions The Opaglos 2 coating system evaluated in these studies afforded adequate protection from oxidative degradation with no negative impact on bioperformance as compared to elegance coating. However, further studies are needed using several compounds to assess the broader applicability of these coatings.     

阿司匹林多单元肠溶片的制备及体外溶出度考察

目的：研制阿司匹林多单元肠溶微丸片。方法：采用阿司匹林粉末包衣先制备肠溶包衣微粒,再与适量辅料混合后直接压片制备肠溶阿司匹林微粒片,并对影响其质量的关键因素进行了考察。结果：制备的微粒片溶出度符合阿司匹林肠溶制剂质量的标准要求。     

Development and evaluation of the tablets coated with the novel formulation termed thin-layer sugarless coated tablets

The purpose of this study was to develop and evaluate the thin-layer sugarless coated tablets containing Vitamin C, Vitamin E, Vitamin B2, calcium pantothenate, and L-cysteine. As a result of the formulation study, three coating layers, 2% under coating (UC), 38% build-up coating (BC), and 5% syrup coating (SC) were necessary for sufficient impact toughness, elegant appearance, and improvement of appearance stability after storage at 25 degrees C/75% RH for 6 months under open conditions. We demonstrated that the thin-layer sugarless coated tablets are superior to the sugar-coated tablets in terms of small tablet size and stability of calcium pantothenate. It was due to the coating method, the continuous spray mist method, which can minimize the thicknesses of coating layers and the moisture content in the tablets. We also demonstrated that the thin-layer sugarless coated tablets are superior to the film-coated tablets in terms of masking ability of the unpleasant odor and the appearance, stability of the appearance, and low hygroscopicity. It was due to the dense, opaque, and stable coating layers mainly consist of erythritol. We revealed that thin-layer sugarless coated tablets have both advantages of film-coated tablets and sugar-coated tablets.     

温度对 3 种中药浸膏片包衣工艺参数的影 响简

目的 研究温度对3种中药浸膏片包衣工艺的影响.方法 将素片置恒湿变温环境中,不同时间称定片重,记录、计算吸湿增重,分析吸湿数据;将素片置干燥环境中,其余条件相同情况下,记录、计算减重百分率、绘制减重速率曲线图.结果 冠心平片和健肾片的吸湿速率随温度升高而降低,而保肾片的吸湿速率随温度升高而升高;保肾片和冠心平片在60℃的减重百分率大于50℃的减重百分率,而健肾片的减重百分率在50℃和60℃之间变化不明显.结论 吸湿性参数、干燥速率参数可为包衣工艺参数的制订提供科学数据.     

氧化苦参碱肠溶包衣微丸的制备

目的:制备氧化苦参碱肠溶包衣微丸。方法:采用单因素试验考察包衣锅转速、包衣锅温度和喷枪压力对包衣条件的影响,并比较各种树脂包衣液的性质,选出适宜的包衣材料;采用包衣锅法制备微丸;以体外释放度评价包衣效果。结果:包衣条件为包衣锅转速50r.min-1、包衣温度30℃、喷枪压力0.10MPa;包衣材料为湖州Ⅲ号聚丙烯酸树脂;制备的微丸体外释放度符合2005年版《中国药典》(二部)要求。结论:所选方法可制备出体外释放良好的氧化苦参碱肠溶包衣微丸。