TECHNOLOGICAL AND STANDARDIZATION STUDY OF “CHLORPHENOS”100 ML SYRUP MEDICINE
- VernacularTitle: TECHNOLOGICAL AND STANDARDIZATION STUDY OF “CHLORPHENOS”100 ML SYRUP MEDICINE
- Author:
Battulga G.
1
;
Oyunbileg S.
;
Byambadulam G.
;
Khurelbaatar L.
Author Information
- Publication Type:Journal Article
- Keywords: TECHNOLOGICAL AND STANDARDIZATION STUDY
- From: Mongolian Pharmacy and Pharmacology 2013;2(1):46-
- CountryMongolia
- Language:English
- 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
