ABSTRACT
Introduction: The present study shows the processing of the pharmacopoeia article for the preparation of Di- clofenac sodium extended release matrix tablet formulated from alternative characteristic poly- mer. The matrix tablets were prepared according to traditional method of the wet granula- tion for tablet form medicine. Method: A standardization study made use of several international pharmacopoeias, such as the Mongolian National Pharmacopoeia (MNP 2011), United States Pharmacopoe- ia (USP 32), Chinese Pharmacopoeia (CP 2010) and U.S Department of F.D.A for the sub- stance’s requirements. Result: The results from this study showed a completely processed manufacturing pharma- copoeia issue of the Diclomon 100 mg retard tablet and its technological and standardized re- quirements.
ABSTRACT
Introduction: Factors are increasing in Mongolia, which is producing food product using sea buckthorn berry. However, those factors use pulp oil, juice and throw skins, pulp and seeds. Those solid remains named pomace. The pomace contains many kinds of vitamins, trace elements and other biologically active substances including fat soluble vitamins /А, Е, К/, fatty acids / linoleic, linolienic, oleic/, carbohydrates, water soluble vitamins /С, В1, В2, folic acid/, flavonoids, carotenoids. Therefore, pomace is usable as raw material for biological active product. Goal: The aim of study is to invent sample of biological active product including seabackthorn pomace Materials and methods: The seabuckthorn pomace was provided by Monos Foods Co Ltd. Ascorbic acid and other expient were provided by Drug Research Institute. Sea buckthorn (H. rhamnoides) pomace was dried by Labconco freezone L12 freeze dryer in Drug Research Institute. Moisture and total ash were determined by method according to MNS 5225:2002, contents of total fat was determined by Soxhlet method, vitamin C and total acidity were analyzed by titremitric method, total flavonoid was analyzed spectrophotometric method and impurity of dry pomace was measured by The State Pharmacopoeia of the Russian Federation XI. Quality requirements of tablet, capsule and granule were determined by Mongolian National First Pharmacopeia. Total bacteria and fungal were determined by method in MNS 5194:2002 and MNS 5193:2002. Results: Dried seabuckthorn pomace was standardized according to MNS 5225:2002. The results indicated that dried seabuckthorn contains humidity 4.3%, total ash 2.16%, β-carotin 110.3%, fiber 31.78%, total flavonoid 0.25%, impurity 0.13%, acidity 2.06%, total fat 33.3%, total fungi count 3*102 and bacterial count 2*102, respectively. We created tablets 0.3 g contain dry pomace and determined quality and quantity parameters. Quality requirements of tablets were standardized and following results were obtained: the 0.3g tablet had an average weight 0.301g, the dissolution of the 0.3g tablet was 97.6%, disintegration 2.93 minute and ascorbic acid 30.66 mg. Furthermore, capsules contain dry pomace were created. Its average weight was 0.45g ±7.5%, disintegration 24 minute and β-carotine 0.12 mg, respectively. Finally, granule product contains vitamin C and dry pomace was created. In this granules content β-carotene 1.32 mg and vitamin C 145 mg, respectively. Conclusion: Quality requirements and microbial contaminants of dry seabuckthorn pomace were agreed with MNS 5225:2002. 0.45 g capsule, 0.3 g tablets, 5g granule were created. Those new products meet the general requirements for tablet; capsule and granule by Mongolian National First Pharmacopeia, and 0.45g capsule, 5g granule products were more suitable for production of biological active products. Key words: sea buckthorn pomace, (H. rhamnoides), biological active product
ABSTRACT
Introduction: The World Health Organization (WHO) according respiratory allergic diseases, nasal mucosal disease , which is one factor to create asthma and more than 300 million people become infected is accured in 2012[1]. In 2012, acconding to statistics of the Ministry of Health for our country was noted of 5% of the total population of the allergic disease and astma.Also In 2000, the prevalence of astma among the population was 2.4%, but in 2010 increased by 4.8%. Accordingly , the prevalence of the disease is increasing year by year, that’s why the imported new drug’s of diseases in the market and the need to produce domestically. Domestic market, we used allergic rhinitis, mucosal inflammatory treatment cholorphenamine 4 mg (Monos Industry LLC), Tavegil (Novartis Russia ), ketotifen (So pharma, Bulgaria), letizine 10 mg (KRKa, Slovani), Cetirizine 10 mg (Bertecs pharma, Russian). Letizine 10 mg, Cetirizine 10 mg drugs are contain of Ceterizine dicholoride, widely used in the treatment of foreign drug. Divided in the medical treatment of children aged 2-6 years , these drugs are expected to give a child , so we import the drug entering the appropriate doses of the company with the goal to obtain. For that purpose we determination allergon tablet’s technological process. Conclusion: Technological experiment “Alergon 5 mg ” tablets were selected ingredients of ceterizine dihydrocholoride 0.005 g, glucose monohydrate 0.09444 g, K-30 0.00006 g, magnesium stearat 0.0005 g. According to our study, ”Allergon 5 mg” tablets average weight, weigth range, disintegration, hardness, assay meets the standards set in the Mongolian National Pharmacopeia requirement of “Tablet drug ”.