title: ÐÐ¸Ð¾ÑÐµÑ Ð½Ð¾Ð»Ð¾Ð³Ð¸Ñ Ð¿Ð¾Ð»ÑÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°ÑÐ° Ð¸ Ð¾ÑÐµÐ½ÐºÐ° ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Ð½Ð° ÐµÐ³Ð¾ Ð¾ÑÐ½Ð¾Ð²Ðµ
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¼Ð°Ð³Ð¸ÑÑÑÐ°
titleType: Subtitle
title: Biotechnology for the production of protamine sulfate and quality control of the drug based on it
Creators: name: Ð¡Ð°Ð¼ÐµÐ¹ÑÐµÐ²Ð°, Ð®Ð»Ð¸Ñ
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2022
Subjects: ÐÐ¸Ð¾ÑÐµÑ Ð½Ð¾Ð»Ð¾Ð³Ð¸Ñ
Ð¿ÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°Ñ
ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÐºÐ°ÑÐµÑÑÐ²Ð°
Ð²Ð°Ð»Ð¸Ð´Ð°ÑÐ¸Ñ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¸Ñ Ð¼ÐµÑÐ¾Ð´Ð¸Ðº
protamine sulfate
quality control
validation of analytical methods

description: Ð¢ÐµÐ¼Ð° Ð²ÑÐ¿ÑÑÐºÐ½Ð¾Ð¹ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð¾Ð¹ ÑÐ°Ð±Ð¾ÑÑ: Â«ÐÐ¸Ð¾ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸Ñ Ð¿Ð¾Ð»ÑÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°ÑÐ° Ð¸ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Ð½Ð° ÐµÐ³Ð¾ Ð¾ÑÐ½Ð¾Ð²ÐµÂ». Ð Ð°Ð±Ð¾ÑÐ° Ð¿ÑÐ¾Ð²ÐµÐ´ÐµÐ½Ð° Ð½Ð° Ð±Ð°Ð·Ðµ Ð¿ÑÐµÐ´Ð¿ÑÐ¸ÑÑÐ¸Ñ ÐÐ Â«ÐÐ¾Ð²Ð¾ÑÐ¸Ð±ÑÐ¸Ð¼ÑÐ°ÑÐ¼Â». ÐÐ°Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð¿Ð¾ÑÐ²ÑÑÐµÐ½Ð° Ð¸Ð·ÑÑÐµÐ½Ð¸Ñ ÑÐ¿Ð¾ÑÐ¾Ð±Ð¾Ð² Ð¿Ð¾Ð»ÑÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°ÑÐ° Ð¸ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¾Ð¼Ñ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÐºÐ°ÑÐµÑÑÐ²Ð° Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Â«ÐÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°Ñ, ÑÐ°ÑÑÐ²Ð¾Ñ Ð´Ð»Ñ Ð²Ð½ÑÑÑÐ¸Ð²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð²Ð²ÐµÐ´ÐµÐ½Ð¸Ñ, 10 Ð¼Ð³/Ð¼Ð»Â». Ð Ð»Ð¸ÑÐµÑÐ°ÑÑÑÐ½Ð¾Ð¼ Ð¾Ð±Ð·Ð¾ÑÐµ ÑÐ°ÑÑÐ¼Ð¾ÑÑÐµÐ½Ñ ÑÐ¿Ð¾ÑÐ¾Ð±Ñ Ð¿Ð¾Ð»ÑÑÐµÐ½Ð¸Ñ Ð¿ÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°ÑÐ° Ð¸Ð· Ð¼Ð¾Ð»Ð¾Ðº ÑÑÐ± Ð¸ Ñ Ð¿Ð¾Ð¼Ð¾ÑÑÑ ÑÐµÑÐ½Ð¾Ð»Ð¾Ð³Ð¸Ð¸ ÑÐµÐºÐ¾Ð¼Ð±Ð¸Ð½Ð°Ð½ÑÐ½ÑÑ ÐÐÐ, ÐºÐ°Ð·Ð°Ð½Ñ Ð¾Ð±Ð»Ð°ÑÑÐ¸ ÐµÐ³Ð¾ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ñ. ÐÑÐ¸Ð²ÐµÐ´ÐµÐ½Ñ Ð¼ÐµÑÐ¾Ð´Ñ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¾Ð³Ð¾ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Â«ÐÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°Ñ, ÑÐ°ÑÑÐ²Ð¾Ñ Ð´Ð»Ñ Ð²Ð½ÑÑÑÐ¸Ð²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð²Ð²ÐµÐ´ÐµÐ½Ð¸Ñ, 10 Ð¼Ð³/Ð¼Ð»Â»: Ð¾Ð¿Ð¸ÑÐ°Ð½Ñ Ð¼ÐµÑÐ¾Ð´Ñ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¾Ð³Ð¾ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð¹ ÑÐ¾ÑÐ¼Ñ Ð¸ Ð¼ÐµÑÐ¾Ð´Ñ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ Ð´ÐµÐ¹ÑÑÐ²ÑÑÑÐµÐ³Ð¾ Ð²ÐµÑÐµÑÑÐ²Ð° Ð´Ð°Ð½Ð½Ð¾Ð³Ð¾ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ°. Ð ÑÐºÑÐ¿ÐµÑÐ¸Ð¼ÐµÐ½ÑÐ°Ð»ÑÐ½Ð¾Ð¹ ÑÐ°ÑÑÐ¸ Ð±ÑÐ»Ð¸ Ð°Ð¿ÑÐ¾Ð±Ð¸ÑÐ¾Ð²Ð°Ð½Ñ Ð¼ÐµÑÐ¾Ð´Ð¸ÐºÐ¸ Ð°Ð½Ð°Ð»Ð¸ÑÐ¸ÑÐµÑÐºÐ¾Ð³Ð¾ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Â«ÐÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°Ñ, ÑÐ°ÑÑÐ²Ð¾Ñ Ð´Ð»Ñ Ð²Ð½ÑÑÑÐ¸Ð²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð²Ð²ÐµÐ´ÐµÐ½Ð¸Ñ, 10 Ð¼Ð³/Ð¼Ð»Â», Ð¿ÑÐ¾Ð²ÐµÐ´ÐµÐ½Ð° Ð²Ð°Ð»Ð¸Ð´Ð°ÑÐ¸Ñ Ð¼ÐµÑÐ¾Ð´Ð¸ÐºÐ¸ Ð¾Ð¿ÑÐµÐ´ÐµÐ»ÐµÐ½Ð¸Ñ ÑÐ¾Ð´ÐµÑÐ¶Ð°Ð½Ð¸Ñ Ð°Ð·Ð¾ÑÐ° Ð¸ Ð¼ÐµÑÐ¾Ð´Ð¸ÐºÐ¸ Ð¾Ð¿ÑÐµÐ´ÐµÐ»ÐµÐ½Ð¸Ñ Ð°Ð½ÑÐ¸Ð³ÐµÐ¿Ð°ÑÐ¸Ð½Ð¾Ð²Ð¾Ð¹ Ð°ÐºÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸. ÐÑÐ» Ð¿ÑÐ¾Ð²ÐµÐ´ÐµÐ½ ÐºÐ¾Ð½ÑÑÐ¾Ð»Ñ ÐºÐ°ÑÐµÑÑÐ²Ð° ÑÑÐµÑ ÑÐµÑÐ¸Ð¹ Ð»ÐµÐºÐ°ÑÑÑÐ²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð¿ÑÐµÐ¿Ð°ÑÐ°ÑÐ° Â«ÐÑÐ¾ÑÐ°Ð¼Ð¸Ð½Ð° ÑÑÐ»ÑÑÐ°Ñ, ÑÐ°ÑÑÐ²Ð¾Ñ Ð´Ð»Ñ Ð²Ð½ÑÑÑÐ¸Ð²ÐµÐ½Ð½Ð¾Ð³Ð¾ Ð²Ð²ÐµÐ´ÐµÐ½Ð¸Ñ, 10 Ð¼Ð³/Ð¼Ð»Â» Ð¿ÑÐ¾Ð¸Ð·Ð²Ð¾Ð´ÑÑÐ²Ð° ÐÐ Â«ÐÐ¾Ð²Ð¾ÑÐ¸Ð±ÑÐ¸Ð¼ÑÐ°ÑÐ¼Â».
description: Theme of the graduate qualification work is: Â«Biotechnology for the production of protamine sulfate and quality control of the drug based on itÂ». The work was carried out on the basis of JSC Â«NovosibkhimfarmÂ». This work is devoted to the study of methods for production of protamine sulfate and analytical quality control of the drug Â«Protamine sulfate, solution for intravenous administration, 10 mg/mlÂ».In the literature review, methods for production of protamine sulfate from fish milt and using recombinant DNA technology are considered, and the areas of its application are indicated. The methods of analytical control of the drug Â«Protamine sulfate, solution for intravenous administration, 10 mg/mlÂ» are given: methods of analytical control of the dosage form and methods of control of the active substance of this drug are described.In the experimental part, the methods of analytical control of the drug Â«Protamine sulfate, solution for intravenous administration, 10 mg/mlÂ» were tested, the method for determining the nitrogen content and the method for determining antiheparin activity were validated. The quality control of three batches of the drug Â«Protamine sulfate, solution for intravenous administration, 10 mg/ml" manufactured by JSC Â«NovosibkhimfarmÂ» was carried out.