Russian Journal of BiotherapyRussian Journal of BiotherapyРоссийский биотерапевтический журнал1726-97841726-9792Publishing House ABV Press113810.17650/1726-9784-2019-18-1-25-36REVIEWSОБЗОРЫ ЛИТЕРАТУРЫChondroitin sodium sulfate – impurities and standardization problems (literature review)Хондроитина сульфат натрия – примеси и проблемы стандартизации (обзор литературы)https://orcid.org/0000-0002-1204-8234KomarovaЕ. L.КомароваЕ. Л.
Russian Federation

of. 1, 8 Simferopolsky Blvd., 117149 Moscow

117149 Москва, Симферопольский б-р, 8, оф. 1

komelia@mail.ruhttps://orcid.org/0000-0001-5181-4547ChernovaS. V.ЧерноваС. В.
Russian Federation

Build. 2, 8 Trubetskaya St., 119991 Moscow

119991 Москва, ул. Трубецкая, 8, стр. 2

KasumovaK. V.КасумоваК. В.
Russian Federation

Build. 2, 8 Trubetskaya St., 119991 Moscow

119991 Москва, ул. Трубецкая, 8, стр. 2

TabachnayaM. S.ТабачнаяМ. С.
Russian Federation

Build. 2, 8 Trubetskaya St., 119991 Moscow

119991 Москва, ул. Трубецкая, 8, стр. 2

https://orcid.org/0000-0002-0566-3079ОvsyannikovaL. V.ОвсянниковаЛ. В.
Russian Federation

Build. 2, 8 Trubetskaya St., 119991 Moscow

119991 Москва, ул. Трубецкая, 8, стр. 2

https://orcid.org/0000-0003-1046-4442EllerК. I.ЭллерК. И.
Russian Federation

2/14 Ustyinsky Proezd, 109240 Moscow

109240 Москва, Устьинский проезд, 2/14

LLC “Prodekspertiza”OOO «Продэкспертиза»Sechenov First Moscow State Medical University of the Ministry of Health of the Russian FederationФГАОУ ВО Первый МГМУ им. И.М. Сеченова Минздрава России (Сеченовский университет)Federal Research Center of Nutrition and BiotechnologyФГБУН «Федеральный исследовательский центр питания и биотехнологии»1904201918125361904201919042019https://bioterapevt.abvpress.ru/jour/article/view/1138

Modern research in the field of chondroitin sulfate chemical composition is considered. Clinical efficiency and safety are shown to depend on the nature and quality of the raw material used, ways of its technological processing and the degree of purification. The composition of chemical compounds (CC) variable is stated to represent the mixture of 2 main isomeric forms: chondroitin 4-sulfate and chondroitin 6-sulfate. In the animal tissue chondroitin 4-sulfate dominates, the content of which is 70 %; the content of chondroitin 6-sulfate is 30 %. The cartilages of sharks and other hydrobionts have got low content of chondroitin 4-sulfate (10 %) and chondroitin 6-sulfate 80 %. Complex polymeric structure and instability of CC composition make the problem of drug standardization on its basis complicated. The impurities encountered in substances are considered. The impurities are divided into several groups: related impurities, technological or mechanical ones uncharacteristic of CC. Comparative analysis of requirements for raw material from the point of view of normative documentation of different countries is carried out and their considerable difference is detected. It has been shown that for raising pharmacological activity the producer of drugs must take into account all the parameters of CC including the structural composition, molecular weight and presence of impurities.

В статье рассмотрены современные исследования в области химического строения хондроитина сульфата (ХС) и его фармакологической активности. Показано, что клиническая эффективность и безопасность зависит от природы и качества используемого для производства сырья, способов технологической переработки, степени очистки. Состав ХС переменный и представляет собой смесь 2 основных изомерных форм – хондроитина 4-сульфат (Х4С) и хондроитина 6-сульфат (Х6С). В тканях молодых животных преобладает Х4С, содержание которого составляет ~70 %, а содержание Х6С ~30 %. Хрящи акул и других гидробионтов имеют низкое содержание Х4С (~10 %), а Х6С – около 80 %. Сложная полимерная структура и непостоянство состава ХС осложняют задачу стандартизации препаратов на его основе. Рассмотрены примеси, встречающиеся в субстанциях. Примеси разделены на 3 группы: родственные, технологические и механические, несвойственные ХС. Проведен сравнительный анализ требований к сырью и методов анализа ХС по нормативной документации различных стран и выявлено их значительное различие. Показано, что для повышения фармакологической активности производитель лекарственных препаратов должен учитывать все параметры субстанции ХС, включая структурный состав, молекулярную массу, наличие примесей.

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