Substantiation of the composition and technology for obtaining combined sustained-release tablets for the treatment of hypertension

T. O. Ponomarenko, D. I. Dmytrievsky, I. O. Kryklyva, V. Hrytsenko
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Abstract

Aim. To develop the composition and technology for obtaining the combined drug of indapamide with enalapril of the prolonged action. Materials and methods. Indapamide and enalapril maleate substances as active components, and polyvinylpyrrolidone, calcium stearate, lactose monohydrate, hydroxypropyl methylcellulose as excipients were used. The pharmaco-technological studies were conducted according to the methods of the State Pharmacopoeia of Ukraine (SPhU). Results and discussion. The pharmaco-technological properties of tablet mixtures and the quality of finished tablets were compared using direct pressing and preliminary wet granulation. Conclusions. It has been found that the use of the method of pre-granulation of the tablet mixture allows obtaining a finished product that fully meets the requirements of the SPhU.
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一种治疗高血压的联合缓释片的合成物及制备工艺的证实
的目标。目的研制吲哚帕胺与依那普利联用的长效药物的组成及制备工艺。材料和方法。以吲达帕胺和马来酸依那普利物质为活性成分,以聚乙烯吡咯烷酮、硬脂酸钙、一水乳糖、羟丙基甲基纤维素为赋形剂。按照乌克兰国家药典(SPhU)的方法进行药理学研究。结果和讨论。比较了直接压片法和湿法初步造粒法制备的混合片剂的药效学性能和成品片剂的质量。研究发现,使用片剂混合物的预造粒方法可以获得完全符合SPhU要求的成品。
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