乌达木L100肠溶塞雷肽酶及塞雷肽酶控释片的研制

A. Rani, A. Uppala
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引用次数: 1

摘要

塞拉肽酶是一种抗炎酶,常用于治疗各种炎症性疾病。与非甾体抗炎药不同,它没有胃肠道相关的副作用,可以安全地用于慢性疾病。控释片的配方可以减少给药频率,从而提高患者的依从性。由于塞拉肽酶具有酸性,采用溶剂蒸发技术将其与聚合物Eudragit l100制成肠内分散体。采用不同比例的聚合物,通过对肠溶药物的释放研究,选择了最佳的固体分散体。以不同比例的乙基纤维素、羟丙基甲基纤维素和甲基纤维素为原料,制备了塞拉肽酶固体分散体控释片。在pH 6.8的磷酸盐缓冲液中进行6小时的药物释放研究。含有125 mg乙基纤维素的制剂可控释至6小时。
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Enteric dispersion or Serratiopeptidase with Eudragit L100 and Formulation of Controlled Release Tablets of Serratiopeptidase
Serratiopeptidase is an anti inflammatory enzyme commonly used in the treatment of various inflammatory disorders. It is found to have no GI related side effects unlike NSAIDs and can be safely used for chronic conditions. Formulations of controlled release tablets can decrease the frequency of administration and thereby improve the patient compliance. As Serratiopeptidase is acid-liable, it is made into enteric dispersion with the polymer viz. Eudragit L 100 by solvent evaporation technique. The polymer is used in various proportions and the optimum solid dispersion was selected based on the drug release study for enteric products. The controlled release tablets of the Serratiopeptidase solid dispersion were prepared with the polymers viz. ethyl cellulose, hydroxypropylmethylcellulose and methylcellulose in various proportions. Drug release study was conducted for 6 hours in pH 6.8 phosphate buffer. The formulation containing ethyl cellulose in 125 mg quantity showed drug release in controlled manner upto 6 hours.
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