ABSTRACT
Background: The investigational new medicine “Chlorphenos 100 ml” is being developed to treat allergy, flu, and inflammatory diseases.[1] The main biologically active substance chlorphenamine maleate blocks histamine H1 receptors and reduces tearing and swelling of the nasal mucosa.[7,9] In this study, “Chlorphenos 100 ml” was tested to see if it met standards for a syrup medicine published in national and international pharmacopeia.[1,7]Goals: The aim of this study was todevelop a new generic syrup medicine technology and standardization procedures.Materials and Methods: “Chlorphenos 100 ml” was prepared following general methods used to produce syrup medicines.[4] Based on the standardization protocols of national and international pharmacopeia, the presence of chlorphenamine maleate was determined using thin-layer chromatograpy and the chlorphenamine maleate content was established using spectrophotometer techniques.[2,3, 8] The pH and the density of the syrup medicine were determined using potentiometric and hydrometric methods respectively. [4,5]Results: The Rf value of the sample from the syrup medicineandthestandardchlorphenaminemaleatewas identical. The main active ingredient chlorphenamine maleate concentration was determined to be 0.43 mg/ ml. The pH of the syrup was measured to be 4.17 and the density was 1.174 mg/ml.Conclusion: The results of this study indicated that the investigational new drug Chlorphenos 100 ml meet the standards set forth in the national and international pharmacopeia. Theseresult also validate thetechnological protocol used to produce Chlorphenos 100 ml syrup. Therefore this medicine is determined to be suitable for factory production.Key words: Chlorphenaminemaleat, Chlorphenos syrupReferences1. China pharmacopeia 2005, page 185 chlorphenamine maleate2. Derivative Spectrophotometry for Simultaneous Analysis of Chlorpheniramine Maleate, Phenylephrine HCl, and Phenylpropanolamine HCl in Ternary Mixtures and Pharmaceutical Dosage Forms. Maryam Kazemipouraand Mehdi Ansarib*3. Simultaneous spectrophotometric determination of paracetamol, phenylephrine and chlropheniramine in pharmaceuticals using chemometric approaches. Khoshayand M.R., Abdollahi H., Ghaffari A., Shariatpanahi M., Farzanegan H.4. Erdenetsetseg G, Khandsuren S, “Medicinetechnologicalvolume I”sweet juice syrup, page 3145. Mongolian national pharmacopeia 2011 page 541, 5446. Friedrich Kluge, Etymologisches Wörterbuch derdeutschen Sprache 2002, 24. Auflage.7. Gisela Wurm, Galenische Uebungen, 1989, 12Auflage, S 1588. EuropianPharmacopia, Fifth edition, Volume 1, S 609
ABSTRACT
BackgroundOn the basis of criteria and indicators of national and international pharmacopoeia pharmacopoeia medicament in syrup determined the composition. On formulations of sweet juice syrup medicine Tomuun received 100 ml. Improved composition drazhzhe “Tomuun 5g,” which made us and added substance has antihistaminic action - chlorphenamine maleate. This additional structure of the flu as well as infectious and inflammatory diseases have a symptomatic effect, that is, reduces tearing, nasal swelling of the nasal mucosa. As the research result shows, Tomuun syrup 100 ml contains ascorbic acid 10.2 ml / mg, paracetamol 2.5 mg / ml, chlorphenamine maleate 0.41 mg / ml.GoalsThe aim of this study was to develop a new generic medicine’s technology and standardization producers. Materials and MethodsSeveral methods have been used for technological producers and chemical analysis in this study. “Tomuun 100 ml” syrup medicine prepared for general cooking techniques syrup medicine. Indicators for Standardization syrup medicine “Tomuun 100 ml” developed on the basic documents of national and international pharmacopoeia. The thin-layer chromatography and HPLC methods used for determining the content of paracetamol and ascorbic acid.ResultsWe have researched the indication syrup medicine for production technology and projected the standardization producers on syrup medicine according to national and international pharmacopoeias.ConclusionAs results from this study shows that “Tomuun” syrup medicine is suitable for several above mentioned criteria and used technological and chemical methods such as HPLC and thin layer chromatography are acceptable for generic medicine’s standard documentation for this medicine.