治疗乳房炎的中药芩红灌注剂质量标准的建立

芩红灌注剂是一种新研制的用于治疗奶牛乳房炎的中药复方制剂，为了确保芩红灌注剂临床用药的安全性和生产工艺的稳定性，研究建立了其质量标准；采用薄层色谱法（TLC）对芩红灌注剂中黄芩、金银花和红花进行定性鉴别，参照《中国兽药典》中灌注剂的检查方法，对芩红灌注剂的相对密度、pH、无菌、有关物质和装量等进行检查，采用高效液相色谱法（HPLC）对黄芩苷进行定量检测。试验结果表明，芩红灌注液样品与对照药材及对照品在相应位置上呈现相同颜色的斑点，表明用于鉴别黄芩、金银花和红花的TCL法专属性、重现性和耐用性均良好，芩红灌注剂的相对密度、pH、无菌、有关物质和装量均符合相关规定，并确立芩红灌注剂的相对密度为不低于1.00（30 ℃），pH为5.0~7.0，测定芩红灌注剂中黄芩苷含量的HPLC法精密度、稳定性、重复性、线性、专属性和耐用性均较好，含量测定中黄芩苷在0~9.20 μg范围内与峰面积线性关系良好（R²=0.9999），平均回收率为100.04%（RSD=1.34%，n=9）。所建立的质量标准准确可行，重复性好，可用于芩红灌注剂的质量控制，为其大规模的生产和临床应用奠定基础。

Establishment a Chinese Medicine Quality Standard of Qinhong Perfusate for the Treatment of Mastitis

Qinhong perfusate is a newly developed Chinese medicine compound preparation for the treatment of dairy cow mastitis.In order to ensure the safety of clinical medication and the stability of production technology,the quality standard of Qinhong perfusate was studied and established.Scutellaria baicalensis,honeysuckle and safflower were identified by TLC,referring to the inspection methods of perfusate in Chinese Veterinary pharmacopoeia.The relative density,pH,sterility,related substances and contents of Qinhong perfusate were examined,and baicalin was quantitatively detected by high performance liquid chromatography.The results showed that the samples of Qinhong perfusate showed the same color spots at the corresponding positions with the control medicinal materials and the control products.The TCL method for identification of Scutellaria baicalensis,honeysuckle and safflower had good specificity,reproducibility and durability.The relative density,pH,sterility,related substances and loading amount of Qinhong perfusate all conformed to the relevant regulations,and the relative density of Qinhong perfusate was not less than 1.0 (30 ℃) and the pH was 5.0-7.0.The precision,stability,repeatability,linearity,specificity and durability of the HPLC method for determination of baicalin content in Qinhong perfusate were good.The linear relationship between baicalin content and peak area was good in the range of 0-9.20 μg(R²=0.9999).The average recovery was 100.04%(RSD=1.34%,n=9).The established quality standard was accurate,feasible and reproducible.It could be used for the quality control of Qinhong perfusate and laid a foundation for its large-scale production and clinical application.