泰万菌素兽用国家标准品的研制

doi:10.11843/j.issn.0366-6964.2020.08.023

Abstract

Abstract: This experiment was conducted to prepare the first batch of national standard of tylvalosin to determine the potency of tylvalosin in tylvalosin tartrate and its preparations. The refined tylvalosin tartrate was used as raw material. After dispersal of the raw materials, the quality inspection and uniformity evaluation were tested according to the requirements of quality standard and Chinese Veterinary Pharmacopoeia 2015 edition. Ultraviolet spectrophotometry was applied to determine the maximum absorption wavelength. Vacuum drying at 60 ℃ was applied to determine the loss on drying. HPLC was applied to determine the tylvalosin A. Based on the standard products of the original invention factory, the three dose tube dish method in antibiotic microbiological assay was used for collaborative calibration. The results showed that the weight loss was 2.0%, the uniformity evaluation was in accordance with the regulations, the maximum absorption wavelength was 289 nm, the potency value was 822 U·mg^-1. The prepared national standard of tylvalosin met all the relevant requirements. It is convenient for production enterprises and quality inspection departments to control the quality of tylvalosin tartrate and its preparations, and it is of great significance to improve and ensure the quality of veterinary drugs.

Key words: tylvalosin, national standard, antibiotic microbiological assay, potency

CLC Number:

S859.79

DAI Qing, YANG Xiuyu, HAN Ningning, WANG Xuan, ZHAO Hui. Preparation of National Standard of Tylvalosin for Veterinary Use[J]. Acta Veterinaria et Zootechnica Sinica, 2020, 51(8): 1985-1992.

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Preparation of National Standard of Tylvalosin for Veterinary Use

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