共查询到18条相似文献,搜索用时 140 毫秒
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目的:制备盐酸沙格雷酯渗透泵控释片。方法:采用单冲压片工艺,醋酸纤维素为包衣材料,制备渗透泵片,考察不同的渗透促进剂,包衣增重,释药孔大小对累积释药百分率的影响,并用高效液相法测定药物的含量和释放度。结果:采用柠檬酸为渗透促进剂,包衣处方为醋酸纤维素2%,聚乙二醇400用量8%、包衣增重7%,释药孔径0.5mm,得到渗透泵片在2h释药为9.5%,6h释药46.1%,12h释药96.01%。结论:通过调节促渗剂、包衣增重和释药孔径,盐酸沙格雷酯可以实现理想的药物控制释放。 相似文献
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盐酸普萘洛尔渗透泵片的研制及释药影响因素 总被引:2,自引:0,他引:2
目的 制备水溶性差的药物盐酸普萘洛尔单室渗透泵型控释片,并考察其释药机制和影响释药因素,探讨药物释药规律。方法 采用单因素法考察片芯处方、膜增重和工艺过程对渗透泵释药的影响。结果 制备水溶性差的盐酸普萘洛尔单室渗透泵控释片,氯化钠、活性物质微粉化粒径,吐温80用量,衣膜厚度及片芯硬度是影响释药的主要因素。结论 盐酸普萘洛尔单室渗透泵控释片工艺稳定,能够迭到24h恒速释药。 相似文献
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制备布地奈德固体分散体增溶型单层渗透泵片(以下简称布地奈德渗透泵片),并进行其释药机制研究。方法:用超临界流体技术制备的布地奈德-聚氧乙烯N750固体分散体作为含药片芯,以提高难溶性药物的溶解度;通过单因素实验优化片芯处方和包衣膜处方,制备布地奈德渗透泵片;设计实验考察包衣膜内外渗透压差对制剂稳态释药速率的影响,阐述其释药机制。结果:药物溶解度、促渗透剂种类和用量、增塑剂用量均对布地奈德渗透泵片的体外释药行为有影响,优化处方的体外释药方程为:Q=7.6077t+0.7764,r=0.9997;其释药行为主要受包衣膜内外溶液渗透压控制,扩散释药仅占整个药物释放的30.39%。结论:渗透泵机制在布地奈德渗透泵片释药过程中占主导地位,体外释药符合零级动力学过程。 相似文献
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目的 采用乙基纤维素包衣来制备难溶性药物硝苯地平单室双层渗透泵控释片.方法 测定不同时间药物的释放度,以累积释放量和与国外市售片比较的相似因子(f2)为评价指标,采用单因素实验筛选硝苯地平渗透泵控释片的处方.结果 片芯处方和包衣增重对硝苯地平渗透泵片的体外释药行为有显著影响,含药层中PEO N80与CMS-Na为5∶2,助推层中PEO Coagulant与CMS-Na为2∶1;包衣液中PEG400用量为乙基纤维素的68%,包衣增重10%.自制控释片与市售片的释放曲线相似,且批间差异小,重复性良好.结论 自制硝苯地平双层渗透泵控释片的工艺稳定,体外释药特征符合控释制剂的要求,24 h内释药完全. 相似文献
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夹芯渗透泵片用于水不溶性药物的控制释放夹芯渗透泵片用于水不溶性药物的控制释放 总被引:3,自引:3,他引:3
目的研究夹芯渗透泵片用于水不溶性药物的24 h控制释放。方法以硝苯吡啶为模型药物,制备夹芯渗透泵片,研究处方、释药孔径等因素对夹芯渗透泵片释药规律的影响,并考察包衣的机械性质。结果药物层中聚氧乙烯和膨胀层中氯化钾对释药的正面影响最大。在0.50~1.40 mm,孔径对释药影响不大。醋酸纤维素包衣牢固可靠,能承受0.34~2.85 MPa的内压。结论夹芯渗透泵片能24 h匀速释放水不溶性药物。环境介质和搅拌对释药的影响不大。与市售双层渗透泵片相比,夹芯渗透泵片免去了打孔前的药物层辨认过程,制备过程简化。 相似文献
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包衣处方对盐酸文拉法辛微孔渗透泵型控释片体外释药的影响 总被引:1,自引:0,他引:1
目的考察包衣处方对盐酸文拉法辛口服微孔渗透泵控释片体外释药的影响,并优选最佳包衣处方。方法考察聚乙二醇400(PEG400)的用量、包衣增量、邻苯二甲酸二丁酯(DBP)的种类和用量4个因素对释放的影响,并通过正交设计优化包衣处方。结果盐酸文拉法辛微孔渗透泵控释片的体外释药符合零级释放规律,释药速率受致孔剂、增塑剂、衣膜厚度的影响均较大。结论通过对包衣处方的优化,盐酸文拉法辛口服微孔渗透泵控释片能够恒速释药。 相似文献
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盐酸昂丹司琼渗透泵片的制备与体外释放 总被引:4,自引:1,他引:4
目的制备盐酸昂丹司琼渗透泵型控释片剂(OND-OPT)并考察体外释药特性。方法以锅包衣法制备OND-OPT。通过释放度试验筛选处方并考察OND-OPT的释放特性;通过均匀设计试验建立持续释药时间与衣膜厚度、衣膜中PEG含量和释药孔孔径的关系;考察OND-OPT的释药机制。结果释药孔朝向对不含HPMC的制剂释药有明显影响,而对含HPMC的制剂释药无影响。持续释药时间与衣膜厚度和衣膜中PEG含量有关,与释药孔孔径无显著关系。OND-OPT主要以渗透泵机制释放药物。结论通过调节衣膜厚度和衣膜中PEG含量,OND-OPT可以实现理想的药物控制释放。 相似文献
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乌拉地尔渗透泵片的制备 总被引:1,自引:0,他引:1
目的:制备体外24h恒速释药的乌拉地尔渗透泵片。方法:以氯化钠和高、低分子量(4×106、2×105)的聚氧化乙烯(PEO)组成片芯,醋酸纤维素和聚乙二醇400为包衣液,制备乌拉地尔渗透泵片;采用相似因子(f2)为指标筛选片芯处方,并考察了其释药机制。结果:与理想释药曲线最接近的片芯处方组成为乌拉地尔60mg,氯化钠190mg,PEO(Mr4×106)90mg,PEO(Mr2×105)90mg,药物24h维持零级释放。结论:本渗透泵片制备方法简便,且零级释药特征明显。 相似文献
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目的在以前的实验中研制了复方二甲双胍/格列吡嗪单室渗透泵片,但是其释药机理没有阐明。方法在本文中,主要考察了可能影响药物释放的三个限速因素(半透膜,片心和释药孔)。结果研究发现单位时间内透进渗透泵的水量同二甲双胍的释放速率基本相当,但远小于片心的溶出速率;孔径从0·4到0·8毫米对药物释放无显著影响;片心的渗透压主要由二甲双胍产生。结论从渗透泵系统的数学模型来看,主要限速步骤在于单位时间透过半透膜的水量,不是片心溶出速率和溶液从小孔的释放速率,片心的溶出速率同溶液从小孔的释放速率相等,因此渗透泵系统表现出零极释放。 相似文献
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A method for the preparation of monolithic osmotic pump tablet was obtained by coating the indented core tablet compressed by the punch with a needle. Atenolol was used as the model drug, sodium chloride as osmotic agent and polyethylene oxide as suspending agent. Ethyl cellulose was employed as semipermeable membrane containing polyethylene glycol 400 as plasticizer for controlling membrane permeability. The formulation of atenolol osmotic pump tablet was optimized by orthogonal design and evaluated by similarity factor (f2). The optimal formulation was evaluated in various release media and agitation rates. Indentation size of core tablet hardly affected drug release in the range of (1.00-1.14) mm. The optimal osmotic tablet was found to be able to deliver atenolol at an approximately constant rate up to 24h, independent of both release media and agitation rate. The method that is simplified by coating the indented core tablet with the elimination of laser drilling may be promising in the field of the preparation of osmotic pump tablet. 相似文献
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The preparation of an osmotic pump tablet was simplified by elimination of laser drilling using prazosin hydrochloride as the model drug. The osmotic pump system was obtained by coating the indented core tablet compressed by the punch with a needle. A multiple regression equation was achieved with the experimental data of core tablet formulations, and then the formulation was optimized. The influences of the indentation size of the core tablet, environmental media, and agitation rate on drug release profile were investigated. The optimal osmotic pump tablet was found to deliver prazosin hydrochloride at an approximately constant rate up to 24 hr, and independent on both release media and agitation rate. Indentation size of core tablet hardly affected drug release in the range of 0.80–1.15 mm. The method that is simplified by elimination of laser drilling may be promising for preparation of an osmotic pump tablet. 相似文献
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The preparation of an osmotic pump tablet was simplified by elimination of laser drilling using prazosin hydrochloride as the model drug. The osmotic pump system was obtained by coating the indented core tablet compressed by the punch with a needle. A multiple regression equation was achieved with the experimental data of core tablet formulations, and then the formulation was optimized. The influences of the indentation size of the core tablet, environmental media, and agitation rate on drug release profile were investigated. The optimal osmotic pump tablet was found to deliver prazosin hydrochloride at an approximately constant rate up to 24 hr, and independent on both release media and agitation rate. Indentation size of core tablet hardly affected drug release in the range of 0.80-1.15 mm. The method that is simplified by elimination of laser drilling may be promising for preparation of an osmotic pump tablet. 相似文献
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Patel V Chudasama A Nivsarkar M Vasu K Shishoo C 《Pharmaceutical development and technology》2012,17(3):375-382
Lithium carbonate, a drug with narrow therapeutic index, needs therapeutic drug monitoring and dose adjustment to maintain lithium level within the therapeutic window. Conventional formulations of lithium carbonate exhibit immediate drug release causing swing/fluctuations in the plasma concentration of lithium, consequently leading to unfavorable side-effects and make dose adjustment difficult. The push-pull osmotic pump has been developed for zero order delivery of lithium carbonate for a period of 24 h. The effect of various formulation variables on bilayer core tablet and its semi permeable coating along with orifice diameter have been investigated and optimized for desired drug release profile. Drug release was found to be inversely proportional to the membrane thickness but directly related to the amount of pore formers in the semipermeable membrane. Images from a scanning electron microscope confirmed the presence of pores in the semipermeable membrane which facilitated the required water penetration. No distortion or change in orifice shape was noticed prior to and after the dissolution study. Drug release from the developed formulation was found to be independent of pH, agitation intensity and agitation mode but depended on osmotic pressure of dissolution media. 相似文献