Impact of Ultrasonic Vibrations on the Stability of Bovhyaluronidase Azoximer in Solution

IF 0.8 4区医学 Q4 CHEMISTRY, MEDICINAL Pharmaceutical Chemistry Journal Pub Date : 2024-05-13 DOI:10.1007/s11094-024-03127-9

A. E. Krasheninnikov, V. V. Sepp, K. S. Bakulin, O. I. Arefieva, A. A. Karsanov

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Abstract

Changes in the quantitative content and specific activity of hyaluronidase enzyme after ultrasonic treatment of solutions of bovhyaluronidase azoximer were studied. Solutions of the finished dosage form of bovhyaluronidase azoximer (Longidase^® lyophilizate for preparation of solution for injection, 3000 IE) and bovhyaluronidase azoximer drug substance (Longidase^® substance-lyophilizate) were studied. The aim of the study was to determine the effect of ultrasound (US) on the stability of bovhyaluronidase azoximer determined from the measured quantitative content and enzymatic activity of the substance in solution. US at a radiation intensity of 61.4 W/L during treatment in an ultrasonic bath did not significantly affect the quantitative content of the bovhyaluronidase azoximer drug substance in solution, while the decrease in the enzymatic activity of the active substance in Longidase solution after 20 and 30 min of ultrasonic treatment was statistically significant. At the same time, the enzymatic activity of the active substance determined by a biochemical method differed significantly (residual activity from 99.70% to 59.27%) depending on the design features of the nebulizers and the nebulization time after nebulization of the bovhyaluronidase azoximer solution in mesh nebulizers from various manufacturers. Nebulization times of min were least associated with the risk of significant loss of stability of bovhyaluronidase azoximer.

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超声波振动对溶液中牛醛酸酶氮氧化物稳定性的影响

研究了超声波处理伏牛醛酸酶偶氮二聚体溶液后透明质酸酶的定量含量和比活性的变化。研究了牛乳醛酸酶偶氮二聚体的成品剂型溶液（用于配制注射用溶液的龙苷酶®冻干溶液，3000 IE）和牛乳醛酸酶偶氮二聚体药物物质（龙苷酶®物质-冻干溶液）。研究的目的是确定超声波（US）对根据测定的溶液中药物的定量含量和酶活性确定的伏牛醛酸酶偶氮二聚体稳定性的影响。在超声波浴中处理期间，辐射强度为 61.4 W/L 的 US 对溶液中伏紫脲酶偶氮二聚体药物物质的定量含量没有显著影响，而 Longidase 溶液中活性物质的酶活性在超声波处理 20 和 30 分钟后的下降具有统计学意义。同时，用生化方法测定的活性物质的酶活性（残留活性从 99.70% 到 59.27%）也因雾化器的设计特点和雾化时间的不同而有显著差异，雾化时间在不同厂家生产的网状雾化器中雾化牛黄醛酸酶偶氮二聚体溶液后的残留活性从 99.70% 到 59.27%不等。分钟的雾化时间与牛黄醛酰脲酶偶氮二聚体稳定性显著降低的风险相关性最小。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Chemistry Journal CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

1.30

自引率

22.20%

发文量

226

审稿时长

3-8 weeks

期刊介绍： Pharmaceutical Chemistry Journal is a monthly publication devoted to scientific and technical research on the creation of new drugs and the improvement of manufacturing technology of drugs and intermediates. International contributors cover the entire spectrum of new drug research, including: methods of synthesis; results of pharmacological, toxicological, and biochemical studies; investigation of structure - activity relationships in prediction of new compounds; methods and technical facilities used; and problems associated with the development of ecologically safe and economically feasible methods of industrial production. In addition, analytical reviews of the international literature in the field provide coverage of the most recent developments around the world. Pharmaceutical Chemistry Journal is a translation of the Russian journal Khimiko-Farmatsevticheskii Zhurnal. The Russian Volume Year is published in English from April. All articles are peer-reviewed.