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1.
肠溶胶囊是指在胃中不溶或不崩解,而在肠中可溶或崩解的胶囊。它用来包裹要求不在胃中释放,而到小肠溶解释放的药物。这类药物很多,应用很广。因此,寻找理想的肠溶胶囊材料,是药物制剂研究课题之一。我们在用褐藻胶代明胶制无缝鱼肝油丸胶囊实验中发现,褐藻胶可作肠溶胶囊材料,由它制得的褐藻酸钙胶囊,肠溶性稳定,不论胶囊厚薄,在人工胃液中停留多长时间都不崩解,而在人工肠液中均能很快崩解;久贮不变质;无毒副作用;制备工艺简单,常温下便可滴丸烘干,无需冷房;原材料消耗少,来源丰富,成本低。同时还  相似文献   

2.
肠溶片包衣材料改进   总被引:1,自引:0,他引:1  
肠溶片包衣材料改进谢耀奎(广东省揭阳市人民医院揭阳522000)肠溶片包衣材料向来是药学工作者乐于探索的课题之一。以往,我们采用虫胶乙醇液包肠溶衣时,常出现粘片、分布不均匀,有时崩解度不合格等现象。近年来,我们改用丙烯酸树脂Ⅱ号为主加虫胶乙醇液包肠溶...  相似文献   

3.
药物治疗中,口服法是最常使用的投药方法。由于有许多药物对胃肠粘膜有刺激作用,易被胃液破坏,有的药物须在肠道中起作用,才能发挥药物疗效。多年来人们致力于肠溶性和胃不溶性新型胶丸的研制。目前国内外普遍采用的肠港材料[1~3]:如苯二甲酸醋酸纤维、丙烯酸树酯、羟丙基纤维苯二甲酸酯、其肠溶性能不稳定、易老化。为此国家医药总局给厦门鱼肝油厂下达褐藻胶肠溶胶丸(以下简称胶丸)的研制任务,我们就其研制出的胶丸,内置碘油,经口服法经过X线电视录相、定时追踪摄片,进行观察。结果证实胶丸100%于小肠崩解而在胃不崩解,性能…  相似文献   

4.
1.主要用于水易溶性药物的压制片、薄膜衣片、胶囊或滴丸剂及肠溶衣制剂的品种。2.糖衣片的崩解时限宜提高要求。3.崩解时限检査中漂浮的制剂应尽量改用溶出度测定法测定。  相似文献   

5.
虫胶是一种天然产品,来源广,价格低。以虫胶作为西药肠溶衣的应用已较为普及。要开发中成药的新品种,新剂型,也可用虫胶作中草药片包衣材料。为了有效地治疗肠道疾病,消除虫疾,减少对胃的刺激等副作用,我们用虫胶的不同配方进行了肠溶衣的研究,现介绍如下:  相似文献   

6.
酮洛芬肠溶口腔崩解片的处方优化   总被引:1,自引:0,他引:1  
目的优化酮洛芬肠溶口腔崩解片的处方,考察不同压片力和不同微晶纤维素与甘露醇比例对空白崩解片孔隙率、抗张强度和崩解时限的影响。方法采用乳化溶剂扩散法制备酮洛芬肠溶微球;以微球为原料,采用粉末直接压片法制备口腔崩解片。用Statistica统计软件对处方组成进行优化,确定微晶纤维素与甘露醇的比例。结果微晶纤维素用量一定时,随压片力的增大,空白崩解片的孔隙率减小,抗张强度增大,崩解时限延长;压片力一定时,随微晶纤维素用量的增加,空白崩解片的孔隙率和抗张强度增大,崩解时限延长;根据处方优化的结果,选择微晶纤维素与甘露醇质量比为3∶1。当片剂中加入质量分数为8%的PVPP作为崩解剂时,空白崩解片的抗张强度略微增加,崩解时限显著缩短。结论根据优化后的处方,采用粉末直接压片法制备的酮洛芬肠溶口腔崩解片符合设计要求。  相似文献   

7.
实验制备了肠溶辅料羟丙基甲基纤维素酞酸酯(HPMCP)假胶乳水性分散液,并以消炎痛片为底物,分别采用HPMCP假胶乳及HPMCP有机溶媒包衣液制备其肠溶薄膜包衣片。考察并比较了两种包衣系统的消炎痛包衣片的崩解时限、抗胃液性能及在人工肠液中的释药动力学。实验结果表明:两种包衣系统均能使包衣片产生良好的肠溶性;包衣片在人工胃液中的药物泄漏率均符合USPⅩⅫ要求;经统计学检验两种包衣系统的不同包衣水平间的体外累积释药Td值,均无显著性差异(P>0.5),说明在一定包衣增重范围内,衣膜对包衣片释药速度影响不大。  相似文献   

8.
实验制备了肠溶辅料羟丙基甲基纤维素酞酸酯(HPMCP)假胶乳水性分散液,并以消炎痛片为底物,分别采用HPMCP假胶乳及HPMCP有机溶媒包衣液制备其溶薄膜包衣片。考察并比较了两种包衣系统的消炎痛包衣片的崩解时限、抗胃液性能及基人工肠液中的释药动力学,实验结果表明,两种包衣系统均能使包衣片产生了良好的肠溶性;包衣片在人工胃液中的药物泄漏率均符合USPⅩ、Ⅻ要求;经统计学检验两种包衣系统的不同包衣水平  相似文献   

9.
<正>以片剂为代表的口服固体制剂因其质量稳定、剂量准确、携带方便等特点是目前临床最常用的剂型之一。但由于片剂加压成型崩解较慢某些难溶性药物生物利用度较低,且不适用于部分吞服困难患者的服用,因而片剂的推广使用在一定程度上受到了限制~([1])。因此当口腔崩解片(orally disintegrating tablets,ODT)这一新型口服固体速释技术出现时,就立即引起了制药业和学术界的关注。口腔崩解片是指服用  相似文献   

10.
采用颗粒包衣技术掩盖罗红霉素的特有苦味,制成口腔崩解片,并针对口腔崩解片的特点,制定了本品崩解时限的测定方法,对3批试制样品考察其工艺特点及罗红霉素难溶性的性质,制定了溶出度的测定方法,结果接近100%溶出。  相似文献   

11.
Shellac is an important coating material for food products. Since the introduction of aqueous ammoniacal solutions it also regained importance for pharmaceutical applications. Because of the comparatively high dissolution pH of this material, further additives are required if shellac is used as enteric coating material. However, this dissolution behaviour of shellac may be of interest for sustained release or colon targeting applications. In the present study different subcoats containing calcium chloride, citric acid or Eudragit® E, respectively, were applied to immediate release theophylline pellets which were subsequently coated with shellac. Drug release from the resulting pellet formulations was measured. The mechanism of interaction between the modifying subcoat ingredients and the shellac coating was investigated using FT-IR spectroscopy. All formulations with modifying subcoat prolonged drug release. Whereas the effect of calcium chloride was a result of ionic interactions with shellac, the effect of citric acid was a reduction of the degree of dissociation of shellac. The influence of Eudragit® E can be explained by the solubility characteristics of this basic polymer. The application of modifying subcoats is an easy and effective means to achieve sustained release from shellac-coated dosage forms. The choice of a suitable substance and the adjustment of its concentration allow tailor made sustained release profiles.  相似文献   

12.
Nonpareil seeds were loaded with sodium salicylate and enteric coated with organic solvent based systems including polyvinyl acetate phthalate, cellacephate (CAP), shellac, hydroxypropylmethylcellulose phthalate, or Eudragit L as film former. Details of the pan coating procedure used were described. The CAP product showed optimum surface continuity when examined by scanning electron microscopy. The shellac product exhibited least aggregation during coating and consequently gave highest yields. Dissolution studies on the microcapsules in simulated gastric and intestinal media indicated that the CAP coated microcapsules had the most satisfactory enteric properties.  相似文献   

13.
Abstract

Nonpareil seeds were loaded with sodium salicylate and enteric coated with organic solvent based systems including polyvinyl acetate phthalate, cellacephate (CAP), shellac, hydroxypropylmethylcellulose phthalate, or Eudragit L as film former. Details of the pan coating procedure used were described. The CAP product showed optimum surface continuity when examined by scanning electron microscopy. The shellac product exhibited least aggregation during coating and consequently gave highest yields. Dissolution studies on the microcapsules in simulated gastric and intestinal media indicated that the CAP coated microcapsules had the most satisfactory enteric properties.  相似文献   

14.
《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   

15.
The aim of this study was to improve enteric properties of shellac by the formation of succinate derivative through dry media reaction. Shellac and succinic anhydride were mixed and then co-ground by planetary ball mill. The ground mixture was then activated by heating for various times and washed for removal of excess succinic anhydride. The ground mixtures and the heat-activated mixtures were characterized by physical and chemical tests, including acid value, FTIR spectroscopy, (1)H NMR and (13)C NMR spectroscopy, thermal analysis and film properties. The results demonstrated that acid values of heat-activated shellac mixtures increased with the increase of annealing time, suggesting the presence of carboxylic acid moieties of succinate at shellac molecules. The results were in good agreement with the DSC thermograms. The melting peak of shellac disappeared after heating, while melting peak of succinic anhydride gradually decreased, suggesting the utilization of succinic anhydride for the esterification. The shellac succinate formation was also confirmed by (1)H NMR and (13)C NMR spectroscopies. Film prepared from shellac succinate showed improved solubility, especially at the pH of small intestine (5.8-6.7), as compared to native shellac. The shellac succinate film also demonstrated better mechanical property, in terms of increased flexibility. In conclusion, solid-state formation of shellac succinate ester, which had improved enteric properties, was easily accomplished under the concept of "green approach".  相似文献   

16.
Enteric coated HPMC capsules designed to achieve intestinal targeting.   总被引:6,自引:0,他引:6  
The enteric coating of HPMC capsules containing paracetamol was investigated. Two enteric polymers, Eudragit L 30 D-55 and Eudragit FS 30 D were studied, which are designed to achieve enteric properties and colonic release, respectively. The capsules were coated in an Accela Cota 10, and, as shown by optical microscopy, resulted in capsules with a uniform coating. Scanning electron microscopy of the surface of the capsules illustrate that, in contrast to gelatin, HPMC has a rough surface, which provides for good adhesion to the coating. Dissolution studies demonstrated that capsules coated with Eudragit L 30 D-55 were gastro resistant for 2 h at pH 1.2 and capsules coated with Eudragit FS 30 D were resistant for a further 1 h at pH 6.8. The product visualisation technique of gamma scintigraphy was used to establish the in vivo disintegration properties of capsules coated with 8 mg cm(-2) Eudragit L 30 D-55 and 6 mg cm(-2) Eudragit FS 30 D. For HPMC units coated with Eudragit L 30 D-55, complete disintegration occurred predominately in the small bowel in an average time of 2.4 h post dose. For HPMC capsules coated with Eudragit FS 30 D, complete disintegration did not occur until the distal small intestine and proximal colon in an average time of 6.9 h post dose.  相似文献   

17.
The shellac was modified by partial hydrolysis with 2.0% (w/w) NaOH for different times. The hydrolysed shellac was then evaluated for physicochemical and film properties in comparison with native shellac. The tablets coated with native and hydrolysed shellac were also evaluated. The results demonstrated that acid value (AV) of shellac increased with prolongation of hydrolysis time. The solubility of shellac in buffer solution (pH < or = 7) gradually increased with increasing hydrolysis time. The films prepared from hydrolysed shellac were more flexible and soft than those prepared from native shellac. The increasing of flexibility was correlated with the increasing of soft resin in shellac. The water vapor permeability of hydrolysed shellac film was lower than that of native shellac film. The higher acid permeability of the tablet coated with hydrolysed shellac was observed. In ethanol-based film coating, shellac had lower solubility and thus lower drug dissolution from coated tablets was observed. In ammonia-based film coating, the solubility of shellac was improved higher nearby pH 7.0 by an ammonium neutralisation method because of forming well-soluble salts, thereby higher drug dissolution was obtained. Partial hydrolysis provided modified shellac, which is more effective for ammonium salt formation, thus very higher drug dissolution was achieved in the ammonia-based coated tablets.  相似文献   

18.
The purpose of this study was to define coating conditions for the enteric coating of a highly water soluble, acidic tablet core. Acidic tablet cores containing a marker drug were separated into three groups and seal coated to coverage levels of 0% (uncoated, white), 1% (yellow), and 3% (tan) weight gains. By employing a 'color coding' scheme, the different seal coated tablets could be coated simultaneously to reduce the number of experiments and eliminate potential differences that may exist during separate coating processes. In addition, an allotment of each coded tablet type was sequentially numbered with a marker pen, weighed, and recorded in order to identify the precise level of enteric coating as well as to monitor the variability of a given coating operation. The tablets were coated with five Eudragit((R)) L30D-based enteric formulations containing different amounts of plasticizer (10-20 parts) and talc (10-50 parts). During each enteric coating process, a predetermined amount of labeled tablets were removed after attaining 6, 8, and 10% weight gains. The labeled tablets were re-weighed, sorted, and then tested using USP disintegration and dissolution methods. Weight gain measurements of individual tablets indicated low coating variability (6.2% RSD) during the enteric coating processes. Dissolution results revealed that all enteric coat formulations inhibited drug release for 2 h in 0.1 N HCl. In contrast, it was found that tablets without a seal coat failed the USP disintegration test. In addition, seal coated tablets exhibited ca. 1.5-5 fold greater drug release at most intermediate sampling time points in phosphate buffer, pH 6.8, than tablets without a seal coat, suggesting that the dissolution of the latter was delayed by the generation of an acidic microenvironment at the interface of the enteric coat/acidic tablet core. Prior to enteric coating an acidic, highly water soluble substrate, a seal coat barrier should be applied to prevent retardation in drug release. A simple strategy utilizing color coding and tablet marking can be employed to test the effect of a seal coat, evaluate enteric coating formulations and process with minimal experimentation and analyses.  相似文献   

19.
Radiotelemetric method for evaluating enteric coatings in vivo   总被引:1,自引:0,他引:1  
A radiotelemetric method for the in vivo evaluation of enteric coating performance is described, and its advantages and disadvantages are compared with those of other available methods. Hydroxypropyl methylcellulose phthalate was used as the test enteric coating. Four dogs were administered several batches of enteric-coated tablets containing buffers. Tablet disintegration was determined by radiotelemetric detection of the pH drop in the upper intestine due to release of the buffer. Premature rupture of the coating in the stomach was detected by a rise and then a fall in gastric pH prior to gastric emptying. The average gastric emptying time was 80 +/- 18 min (SEM), while the average time for a tablet to disintegrate in the upper intestine was 14.2 +/- 2 min. The average disintegration time was not affected by a change in the batch (for a given tablet core pH) or the dog used, suggesting that the method yielded readily reproducible results. Although there was little correlation with in vitro disintegration times, the method gave results similar to those reported in the literature for the same enteric coating in a human study. Of the formulations tested, it was concluded that buffering the core to pH 4 was most suitable for studying enteric coating performance.  相似文献   

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