CURRENT APPROACHES TO THE PATTERN OF CREATION OF PHARMACOPOEIAL ARTICLES ON RAW MEDICINAL PLANT MATERIALS

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DOI: https://doi.org/None
Issue: 
4
Year: 
2015

Professor E.I. Sakanyan, PhD; Professor N.D. Bunyatyan, PhD; I.V. Sakaeva, PhD; M.N. Lyakina, PhD; T.B. Shemeryankina, PhD; N.A. Postoyuk, PhD; N.P. Rukavitsyna Scientific Centre for Expert Evaluation of Medical Products, Ministry of Health of the Russian Federation; 8 Petrovsky Boulevard, Moscow 127051

On developing the Russian Pharmacopoeia, the structure of its articles (PAs) on raw medicinal plant materials (RMPM) has been continually improved. The WHO guideline on good pharmacopoeial practices, with the specialists from the Russian Federation who have participated in its creation, is to ensure the unification of requirements for drug quality in different countries of the world community. One of the sections of this guideline deals with the creation, contents, and statement of monographs/PAs on RMPM. The structure of these articles has been optimized and basic quality indices have been enumerated during the studies harmonizing the requirements for the contents of PAs on RMPM. Recommended methods for analysis have been substantiated. The section «Numerical indicators» has been excluded. The quality indices involved in PAs are given in order of enumeration. RMPM quality indices, such as «Heavy Metals», «Residues of Pesticides», have been first introduced into the practice of Russian pharmacopoeial analysis.
Keywords: 
raw medicinal plant materials
pharmacopoeial article
monograph
harmonization of pharmacopoeial standards
quality indices
References: 
  1. Gosudarstvennaya farmakopeya SSSR. H izdanie. M.: Medicina, 1968; 1079. [State Pharmacopoeia of the USSR. X-ed . Moscow: Medicine , 1968; 1079. (in Russian)].
  2. Gosudarstvennaya farmakopeya SSSR. XI izdanie. Vyp. 1. Obshhie metody analiza. M.: Medicina, 1987; 336. [State Pharmacopoeia of the USSR. XI-ed., Vol. 1. Total analysis methods. Moscow: Medicine, 1987; 336. (in Russian)].
  3. Gosudarstvennaya farmakopeya SSSR. XI izdanie. Vyp. 2. Obshhie metody analiza. Lekarstvennoe rastitel`noe syr`e. M.: Medicina, 1989; 400. [State Pharmacopoeia of the USSR. XI-ed. Vol. 2. General methods of analysis. Medicinal plant raw material. Moscow: Medicine, 1989; 400. (in Russian)].
  4. Gravel` I.V., Ivanova E.A. Trebovaniya zarubezhnyh farmakopey k kachestvu lekarstvennogo rastitel`nogo syr`ya po soderzhaniyu pesticidov. Farmaciya, 2010; 7: 50–53. [Gravel I.V., Ivanova E.A. Requirements of foreign Pharmacopoeias for the quality of medicinal plant raw materials in terms of amounts of pesticides. Farmatciya, 2010; 7: 50-53. (in Russian)].
  5. Evropeyskaya farmakopeya 7.0. Tom 1. M.: Remedium, 2011; 1812. [European Pharmacopoeia 7.0 . Vol. 1. M .: Remedium , 2011; 1812. (in Russian)].
  6. Semenchenko V.F. Istoriya farmacii. M.: IKC «MarT»; Rostov-na-Donu: Izdatel`skiy centr «MarT», 2003; 640. [Semenchenko V.F. History of Pharmacy . Moscow: ECC «MarT» ; Rostov- on-Don : Publishing Center «MarT», 2003; 640. (in Russian)].
  7. Otraslevoy standart «91500.05.001.0. Standarty kachestva lekarstvennyh sredstv. Osnovnye polozheniya». Prikaz Ministerstva zdravoohraneniya Rossii № 388 ot 01.11.2001 «O gosudarstvennyh standartah kachestva lekarstvennyh sredstv». [Industry Standard «91500.05.001.0. Quality standards of medicinal products. The main provisions». Order of the Ministry of Health of Russian Federation from 01.11.2001 № 388 «About government standards of quality of medicinal products». (in Russian)].
  8. Tereshkina O.N., Rudakova I.P., Gravel` I.V., Samylina I.A. Problemy normirovaniya tyazhelyh metallov v lekarstvennom rastitel`nom syr`e. Farmaciya, 2010; 2: 7–11. [Tereshkina O.N., Rudakov I.P., Gravel I.V., Samylina I.A. Problems of standardization of heavy metals in medical plant raw materials. Farmatciya, 2010; 2: 7–11. (in Russian)].
  9. Indian Pharmacopoeia. Sixth Edition (6.0). Vol. 1–3. Ghaziabad: The Indian Pharmacopoeia Commission, 2010; 2829.
  10. Pharmacopoeia of the People's Republic of China. Vol. 1. Beijing: China Medical Science Press, 2010; 1584.
  11. Pharmacopoeia of the People's Republic of China. Vol. 2. Beijing: China Medical Science Press, 2010; 1386.
  12. Quality Control Methods for Herbal Materials. World Health Organization, 2011; 187. http://apps.who.int/medicinedocs/en/d/Jh1791e/
  13. The International Pharmacopoeia. Fourth Edition 2011 (incl. First and Second Supplements). http://apps.who.int/phint/en/p/about/
  14. The Japanese Pharmacopeia Sixteenth Edition. Pharmaceuticals and medical devices agency, 2011; 2320.
  15. United States Pharmacopeia, 35th edition. United States Pharmacopeial Convention: [sayt]: 2012. URL: http://www.uspnf.com/uspnf/login. Dostup po podpiske.