ABSTRACT
Introduction: Mongolian national drug manufacturers produce only 20% of required medicines and most raw materials used for the manufacturing are imported from China [1]. 2574 medicines and active pharmaceutical ingredients were registered in 2011 and 488 of them were antibiotics [2]. There were 36 medicine manufacturers and only two of them manufactured antibiotic capsules in 2010 [3]. In last year number of manufacturing capsule has been increasing.Aim: The main aim of this investigation was to define items of imported and manufactured capsules and do comparative analysis of some capsules and determine types of the capsule drugs registered in Mongolia.Material and methods: Registered medicine list of Mongolia and questionnaire with 22 questions, and capsules of 2 domestic and 3 foreign manufacturers were used for this investigation. Pharmacists working in seven domestic manufacturers were involved in the questionnaire study. Capsules were analyzed at the Drug Control Laboratory of Monos Pharm Manufacturer.Results, conclusion: 10.84% of registered medicines are capsules, of which 16.33% from India, 7.82% from China, 5.78% from Indonesia, 8.5% from Slovenia, and other countries. 3.4% of registered capsules are manufactured in Mongolia.All medicine manufacturers import hard gelatin capsules from China and use for the manufacturing. 71.4% of domestic manufacturers use technological parameters, 57.1% stability and dissolution, 28.5% chemical properties and interaction with active pharmaceutical ingredients and excepients as the main criteria for the capsule selection used for the manufacturing. 40.0% of capsules used for the manufacturing are 0 size capsule.72.2% of manufactured capsules are antibiotics. Quality parameters of imported and manufactured Quality of manufactured and imported Ampicilline capsules were determined in the frame of this investigation. All Ampicilline capsules were met the requirements of MNS 5097:2007.Conclusion: Items of imported and manufactured capsules, selection criteria of capsules used for the manufacturing were determined. Comparative quality analysis of Ampicilline capsule was done and some quality parameters of imported and manufactured Ampicilline capsule were in accordance of MNS 5097:2007.Key words: Ampicillin trihydrate 500 mg, dissolution testReference:1. д. Цэндээхүү, “Эмийн чанарûн хяналтûн зарим асуудалд”, “зшЭ-ийн хүртээмж, хэрэглээ, чанар, аюулгүй байдлûн талаар туршлага солилцъё” олон улсûн бага хурлûн илтгэлийн хураангуй; 2006.2. Эрүүл мэндийн үзүүлэлт 2011. згха-Эмг. уБ. 20113. Эрүүл мэндийн үзүүлэлт 2010. згха-Эмг. уБ. 20104. монгол улсûн эмийн бүртгэлийн жагсаалт 2013