泰万菌素兽用国家标准品的研制

Preparation of National Standard of Tylvalosin for Veterinary Use

旨在研制首批泰万菌素兽用国家标准品,用于酒石酸泰万菌素及其制剂中泰万菌素的效价测定。采用精制后的泰万菌素酒石酸盐为原料进行本批泰万菌素标准品的研制,原料分装后按照酒石酸泰万菌素质量标准及《中华人民共和国兽药典》2015年版中的规定对其进行质量检测及均匀性评价,采用紫外-可见分光光度法测定最大吸收波长,60℃减压干燥法测定干燥失重,高效液相色谱法测定泰万菌素A组分,并以原始发明厂的标准品为基准,采用抗生素微生物检定法中三剂量管碟法进行协作标定,对标定结果进行合并计算,作为本批标准品的效价赋值。结果显示,分装后的标准品经60℃减压干燥至恒重后减失重量为2.0%,均匀性评价符合要求,在289 nm的波长处有最大吸收,抗生素微生物检定法测定的泰万菌素效价为822 U·mg-1。本研究研制的首批泰万菌素兽用国家标准品各项检测指标均符合规定,可作为国家标准品发放,用于酒石酸泰万菌素原料及制剂中泰万菌素的效价测定,便于生产企业和质量检定部门进行酒石酸泰万菌素原料及制剂的质量控制,对于提高和保证兽药质量具有重要意义。

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.