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.     

不同包衣的多种维生素丸的稳定性考察

多种维生素丸在贮存过程中维生素A和维生素C的含量下降较快,为了解决这一问题,通过改变包衣材料和包衣方法,采用留样观察法和加速实验法进行观察,得出薄膜包衣可大大提高药丸的质量。但从制定有效期的角度来说,仍需在薄膜包衣的防潮性能上做进一步的探索。     

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.     

阿胶颗粒薄膜包衣前后的理化性质研究

目的通过对阿胶颗粒薄膜包衣前后的理化性质分析,为阿胶颗粒进行薄膜包衣的必要性、可行性提供理论依据。方法通过对阿胶颗粒进行薄膜包衣前后的溶化性、外观性状和吸湿性进行对比分析,探讨颗粒包衣前后理化性质的变化。结果薄膜包衣对阿胶的溶化性、外观性状的影响比较小,但不同薄膜衣对阿胶颗粒的吸湿性影响比较明显,其中薄膜包衣预混剂英依美防潮效果较好,在相对湿度75%条件下84 h的吸湿率为0.84%,而薄膜包衣羟丙基甲基纤维素(HPMC)的吸湿率为0.98%;两种包衣颗粒的临界相对湿度无明显差别,约在70%,但均比未包衣颗粒的临界相对湿度50%大。结论薄膜包衣预混剂英依美防潮效果较好,且不干扰阿胶颗粒的质量,车间环境的相对湿度控制在约60%可更好地保证产品质量。     

薄膜包衣技术制备通脉养心丸的探讨

目的：采用薄膜包衣技术制备通脉养心丸。方法：以欧巴代OY-A、OY-B对通脉养心丸进行包衣，并就其质量与其他包衣丸对比。结果：采用欧巴代OY-A、OY-B两层包衣的包衣丸较糖衣丸易于溶散，经3个月加速稳定性试验，其外观及内在质量均未发生较大差异性变化，各项实验检查结果均符合规定。结论：薄膜包衣工艺简单，增重少，质量稳定，值得推广应用。     

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。     

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。     

青霉素V钾片包衣处方研究及稳定性考察

目的：通过研究不同包衣处方对青霉素V钾片进行包衣,并考察稳定性。方法：采用水溶性防潮包衣材料和醇溶性防潮包衣材料分别对青霉素V钾片进行包衣,并就其质量稳定性进行对比。结果：采用醇溶防潮包衣的青霉素V钾片,具有较佳的防潮性能和稳定性。结论：利用醇溶防潮包衣材料进行青霉素V钾片薄膜包衣,产品质量稳定,值得广泛应用。     

具有杰出水汽阻隔性能的新型速释薄膜包衣系统——欧巴代(R)200新一代优化型薄膜包衣系统

上世纪90年代,卡乐康公司(www.colorcon.com.cn)在全球推出了以聚乙烯醇(PVA)为成膜材料的包衣系统.因具有黏度低、成膜性好、防潮性能强等优点,PVA被广泛用于各种片剂的薄膜包衣.从2007～2009年美国FDA批准的新药审批(NDA)数据来看,PVA已取代羟丙甲纤维素(HPMC),成为全配方包衣预混系统首选的成膜材料. 理想的速释薄膜包衣系统应具有包衣效率高、防潮性能好、对片芯的释放没有影响等特征.欧巴代(R)200 (Opadry(R) 200)是卡乐康最新优化的速释包衣系统,通过配方优化,保留了各种高分子材料用于速释薄膜包衣的优点.欧巴代(R) 200是适用于挑战性片芯的薄膜包衣系统,具有卓越的防潮性能和杰出的颜色稳定性,能够在更高的固含量条件下实现稳定的包衣.本文报道了欧巴代(R) 200的各种基础性能及在模型药物上的应用.     

木香顺气丸薄膜包衣工艺研究

目的研究用薄膜包衣技术改进木香顺气丸的质量稳定性。方法采用薄膜包衣工艺技术,选取3种包衣液处方对本品素丸进行包衣,考察包衣前后丸子的相关质量指标。结果本品素丸包薄膜衣对溶散时限影响较小,对含量测定几无影响,稳定性试验表明包衣丸比未包衣素丸的吸湿率低。结论本品可以采用胃溶型薄膜包衣预混剂进行包衣,对提高其防吸湿性有明显效果,且工艺操作简单。     

依那普利非洛地平缓释片水性薄膜包衣工艺研究

目的:探讨依那普利非洛地平缓释片水性薄膜包衣的工艺.方法:以马来酸依那普利含量均匀度、溶出度及包衣合格率为评价指标,采用正交试验法优化水性薄膜包衣的工艺参数.结果:优选包衣液中欧巴代浓度为8%、含药包衣液喷速为30 g·min-1、包衣锅转速为10 r·min-1,此工艺稳定可行.结论:正交设计法可用于依那普利非洛地平缓释片水性薄膜包衣工艺的优化.     

Effect of surface roughness and coating solvent on film adhesion to tablets.

The adhesion of a polymer film to selected tablet substrates was studied. The effect of tablet surface roughness and film-coating solvent on the adhesion of the film to the tablet was determined. A film-coating solvent having a solubility parameter close to that of the polymer was found to produce a stronger adhesional bond than a solvent having a lower surface tension. An increase in tablet surface roughness also increased film adhesion to the tablet. The adhesion was measured as the force required to peel a section of film from the tablet with a stress-strain analyzer.     

Tablet film-coating with amylose-rich maize starch.

The purpose of the present study was to investigate an aqueous-based amylose-rich maize starch (Hylon VII) film-coating process of tablets performed by a side-vented pan coating system. Three formulation or process parameters of potential importance, including the plasticizer concentration (X(1)), the temperature of coating pan (X(2)) and the spray rate of the coating solution (X(3)), were evaluated using a central composite face-centred experimental design. Only a few process-related limitations associated with the aqueous film coating of Hylon VII were observed, and, in general, the coated tablets were of fairly good quality. At low spray rates, the temperature of the coating pan did not affect the roughness of the coated tablets. At higher spray rates, higher temperature gave smoother films. As regards surface quality and smoothness, a plasticizer concentration (i.e., a 1:1 mixture of sorbitol and glycerol) of approximately 65% of the polymer weight, seems to be suitable for the present formulations. The dissolution of all Hylon VII-coated tablets in an acidic medium was rapid, more than 75% of the drug (theophylline) dissolved within 15 min. On the basis of the present results, it can be concluded that amylose-rich maize starch (Hylon VII) may be considered as an aqueous film-coating agent to be used for pharmaceutical purposes and in established film-coating processes.     

聚乙烯吡咯烷酮系列辅料在药剂上的应用

对聚乙烯吡咯烷酮系列辅料在药剂制备中，尤其在粘合、分散、薄膜包衣以及控释等方面的用途进行了综述。     

Determination of parameters for successful spray coating of silicon microneedle arrays

Coated microneedle patches have demonstrated potential for effective, minimally invasive, drug and vaccine delivery. To facilitate cost-effective, industrial-scale production of coated microneedle patches, a continuous coating method which utilises conventional pharmaceutical processes is an attractive prospect. Here, the potential of spray-coating silicon microneedle patches using a conventional film-coating process was evaluated and the key process parameters which impact on coating coalescence and weight were identified by employing a fractional factorial design to coat flat silicon patches. Processing parameters analysed included concentration of coating material, liquid input rate, duration of spraying, atomisation air pressure, gun-to-surface distance and air cap setting. Two film-coating materials were investigated; hydroxypropylmethylcellulose (HPMC) and carboxymethylcellulose (CMC). HPMC readily formed a film-coat on silicon when suitable spray coating parameter settings were determined. CMC films required the inclusion of a surfactant (1%, w/w Tween 80) to facilitate coalescence of the sprayed droplets on the silicon surface. Spray coating parameters identified by experimental design, successfully coated 280μm silicon microneedle arrays, producing an intact film-coat, which follows the contours of the microneedle array without occlusion of the microneedle shape. This study demonstrates a novel method of coating microneedle arrays with biocompatible polymers using a conventional film-coating process. It is the first study to indicate the thickness and roughness of coatings applied to microneedle arrays. The study also highlights the importance of identifying suitable processing parameters when film coating substrates of micron dimensions. The ability of a fractional factorial design to identify these critical parameters is also demonstrated. The polymer coatings applied in this study can potentially be drug loaded for intradermal drug and vaccine delivery.     

Comparative static curing versus dynamic curing on tablet coating structures

Curing is generally required to stabilize film coating from aqueous polymer dispersion. This post-coating drying step is traditionally carried out in static conditions, requiring the transfer of solid dosage forms to an oven. But, curing operation performed directly inside the coating equipment stands for an attractive industrial application. Recently, the use of various advanced physico-chemical characterization techniques i.e., X-ray micro-computed tomography, vibrational spectroscopies (near infrared and Raman) and X-ray microdiffraction, allowed new insights into the film-coating structures of dynamically cured tablets. Dynamic curing end-point was efficiently determined after 4 h. The aim of the present work was to elucidate the influence of curing conditions on film-coating structures. Results demonstrated that 24 h of static curing and 4 h of dynamic curing, both performed at 60 °C and ambient relative humidity, led to similar coating layers in terms of drug release properties, porosity, water content, structural rearrangement of polymer chains and crystalline distribution. Furthermore, X-ray microdiffraction measurements pointed out different crystalline coating compositions depending on sample storage time. An aging mechanism might have occur during storage, resulting in the crystallization and the upward migration of cetyl alcohol, coupled to the downward migration of crystalline sodium lauryl sulfate within the coating layer. Interestingly, this new study clearly provided further knowledge into film-coating structures after a curing step and confirmed that curing operation could be performed in dynamic conditions.     

盐酸洛美沙星片的工艺改进

目的:为了进一步提高盐酸洛美沙星片溶出与吸收性能。方法:采用微粉化及新型片剂辅料。结果:制备了高效盐酸洛美沙星薄膜衣片。结论:经对照检验,结果溶出度较市售品显著加速     

盐酸地尔硫(艹卓)延迟释放片的制备

以盐酸地尔硫(艹卓)为模型药物,不溶性乙基纤维素为阻滞材料,Eudragit L100及S100为致孔剂,采用薄膜包衣法制得延迟释放片.结果表明,阻滞层包衣材料的配比和增塑剂柠檬酸三乙酯的用量是影响延迟效果的主要因素.