Standardization of bee venom as a raw material for the production of medicines for immunotherapy, including allergen and allergoid from bee venom

• Gayane E. Avoyan
• Оlga S. Kulaga
• Irina А. Nikolaeva
• Igor V. Andreev
• Аndrey Yu. Toptygin
• Nikolay G. Cherchenko
• Mikhail N. Sankov
• Аlexander I. Martynov
• Vladimir I. Gegechkori
• Olesya V. Saltykova
• Valery V. Smirnov

Abstract

Introduction. Pharmaceutical industry widely uses beekeeping products to obtain medicines. Among beekeeping products for medical use, bee venom represents number three on its importance. Pharmaceuticals based on bee venom are used externally, or as injections, or for oral administration. In the production of medicines containing bee venom, it is important to take into account the dose and possible individual response of the human body. The chemical composition of raw bee venom is very complex. Currently, there is no modern normative documentation for standardization of bee venom as a raw material for pharmaceutical preparations. Hence, quality control and standardization of the substance of bee venom intended for the production of medicines represent the urgent need.

Aim of research is to study the physicochemical characteristics of raw bee venom of various batches in order to evaluate and standardize its quality.

Material and methods. We have studied 5 batches of raw bee venom from the same manufacturer. The analysis was carried out on the basis of GOST 30426-97 Methods of purification and standardization of purified bee venom were developed in this study. Those included gel chromatography and PAAG electrophoresis.

Results. According to the results of studies of raw bee venom, 4 batches of 5 did not correspond the requirements of the GOST 30426-97 in terms of mass fraction of water-insoluble impurities (6.01 %); mass fraction of water (9.17 %); hemolysis time (300 s), mass fraction of melittin and apamin (35 %; 0.6 %), respectively. Methods for the purification and standardization of preparations from raw bee venom were suggested.

Conclusion. In our study, we have proven the low level of the standardization of raw poison. The lack of approved normative documents leads to the fact that different pharmaceutical companies use different methods for evaluating the quality of raw materials and methods for their purification, which, in turn, affects the quality of final pharmaceutical products. Therefore the part of General Pharmacopoeia «Raw Bee Poison» (related to standardization of raw materials from which pharmaceuticals are being obtained) should be developed.

Keywords:bee venom; standardization; Pharmacopoeia; allergen; allergoid; melittin; apamin

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