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目的:改善环扁桃酯胶囊的装量差异及崩解时限。方法:以装量差异和崩解时限为考察指标。对环扁桃酯胶囊的处方工艺进行优化。结果:通过处方工艺优化,选用Avicel PH302作稀释剂,Ac-Di-Sol作崩解剂,可改善环扁桃酯胶囊的装量差异及崩解时限。结论:AvicelPH302具有极佳的流动性,在胶囊充填过程中,可以大大改善粉体的流动性,减小胶囊的装量差异。Ac-Di-Sol作为崩解剂的效果优于国产CMS-Na。明显缩短胶囊的崩解时间。 相似文献
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目的 研发仿制药泰比培南酯细粒剂,并研究参比制剂的关键质量属性.方法 对泰比培南酯原料药进行溶解性、强制降解及不同溶剂中的溶液稳定性考察,并对泰比培南酯细粒剂的溶出曲线、粒度分布、有关物质和含量等关键质量属性进行考察研究.结果 原料药泰比培南酯极微溶于水,且溶解度具有pH依赖性,酸性越强,溶解度越大,但在pH 1.0和... 相似文献
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国产麦迪霉素胶囊的溶出度研究 总被引:1,自引:0,他引:1
目的研究国产麦迪霉素胶囊的溶出度。方法通过稳定性试验考察处方组成、制粒工艺及不同包装材料对麦迪霉素胶囊溶出度的影响。结果表明不同处方、工艺所制备的国产麦迪霉素胶囊的初始溶出度,在20m in时几乎都达100%,但经加速试验30d或长期试验90d后,其溶出度急剧下降,在60m in时仍低于50%。而用日本进口的麦迪霉素原料制备的胶囊,其溶出度及稳定性均很好,经加速试验30d或长期试验90d后,经时20m in的溶出量均大于90%。结论在同样的处方工艺条件下,国产麦迪霉素胶囊放置后溶出度下降较快,而日本进口原料制备的麦迪霉素胶囊稳定性良好。 相似文献
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OBJECTIVE To prepare the pseudoephedrine-resinate complex, and assess its moistureproof capability. METHODS Using an ion exchange resin (IER) as a carrier, the pseudoephedrine-resinate complex was prepared by a batch process. The drug concentration, drug/IER ratio and reactive temperature for the pseudoephedrine-resinate complex was optimized according to the drug-loading capacity of the pseudoephedrine-resinate complex and the drug adsorption efficiency of the IER. The pseudoephedrine-resinate complex was characterized by the morphology which was observed using a optical microscope. X-ray diffraction analysis and differential scanning calorimetry analysis were employed to confirm the formation mechanism of the pseudoephedrine-resinate complex. The moistureproof capability of the pseudoephedrine-resinate complex under different humidity environments was investigated. RESULTS The amount of IRE, pseudoephedrine hydrochloride and purified water showed a direct impact on the drug-loading capacity of the pseudoephedrine-resinate complex and the drug adsorption efficiency of the IER. From the prospective of saving industrial production costs, the ratio of the three materials was reasonable for 10∶2∶100. By X-ray diffraction analysis and differential scanning calorimetry analysis, the drug in pseudoephedrine-resinate complex was combined with ion-exchange resins by chemical bond. The moisture absorption- liquefaction problem of the capsules containing pseudoephedrine hydrochloride was successfully solved by the pseudoephedrine-resinate complex. CONCLUSION The pseudoephedrine-resinate complex could be prepared by batch method of ion exchange and had good moistureproof capability under high humidity environment. 相似文献
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目的建立头孢克肟分散片的微生物限度检查方法,并对其进行方法学验证。方法细菌计数采用薄膜过滤法,霉菌及酵母菌计数采用平皿法,根据中国药典2005年版二部分别使用5种实验菌验证。通过3次独立的平行试验,分别计算各试验菌每次试验的回收率。控制菌检查采用薄膜过滤法。结果各试验菌的回收率均高于70%,稀释液回收率也均高于70%,控制菌检查具有专属性,满足中国药典2005版验证试验的基本要求。结论本品的微生物限度检查方法有效可行,可用于头孢克肟分散片的微生物限度检查。 相似文献
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氢溴酸右美沙芬(Dextromethophanhydrobro-mide)是一种中枢镇咳药[1~3],在国外已应用多年,主要用于感冒及其它原因引起的咳嗽,剂量较小,疗效较高。氢溴酸右美沙芬软胶囊是在氢溴酸右美沙芬糖浆剂的基础之上开发的一种新剂型,为了... 相似文献
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目的 建立头孢克肟分散片的微生物限度检查方法,并对其进行方法学验证。方法 细菌计数采用薄膜过滤法,霉菌及酵母菌计数采用平皿法,根据中国药典2005年版二部分别使用5种实验菌验证。通过3次独立的平行试验,分别计算各试验菌每次试验的回收率。控制菌检查采用薄膜过滤法。结果 各试验菌的回收率均高于70%,稀释液回收率也均高于70%,控制菌检查具有专属性,满足中国药典2005版验证试验的基本要求。结论 本品的微生物限度检查方法有效可行,可用于头孢克肟分散片的微生物限度检查。 相似文献