宠物用丹参咀嚼片制备工艺研究及质量标准建立

Research on the preparation of chewable Salvia miltiorrhiza tablet for pets and on establishment of related quality standard

旨在确定宠物用丹参咀嚼片的制备工艺并建立其质量标准。本试验通过湿法制粒辅料种类、制粒工艺、压片工艺进行考察,确定其制备工艺,采用薄层色谱法、高效液相色谱法(HPLC)对宠物用丹参咀嚼片中丹参酮ⅡA、丹酚酸B分别开展定性和定量研究,建立其质量标准。结果:将丹参喷雾粉加辅料混合均匀,混合时间5 min,转速100 r/min,以10%淀粉浆为黏合剂制成颗粒,干燥温度40~50℃,0.3%硬脂酸镁作为润滑剂,压片速率10~35 r/min;薄层鉴别显示丹参酮ⅡA斑点清晰,分离度良好且专属性强;高效液相色谱显示丹酚酸B在8.0~256.0μg/mL范围内线性关系良好(R^(2)=0.999 9),系统适用性、专属性、精密度、稳定性、重复性、系统耐用性良好,加样回收率为95.0%~105.0%;对6批样品中丹酚酸B进行含量测定,设定含量限度为11.484 1 mg/g。综上,本试验确定的宠物用丹参咀嚼片制备工艺稳定可行,建立的薄层鉴别方法和高效液相色谱含量测定方法可用于宠物用丹参咀嚼片的质量控制。

This study was to determine the preparation process of chewable Salvia miltiorrhiza tablet for pets and to establish the quality standard for the preparation.In the test,the preparation process was determined by observing and examining the wet grain accessories,granulation process and tablet pressing process.Thin layer chromatography and high performance liquid chromatography(HPLC)were used to carry out qualitative and quantitative studies on Tanshinone IIA and Salvianolic acid B in the chewable tablets,and to establish a quality standard for the prepared tablet.The results showed that,in the tablet,the Salvia miltiorrhiza spray powder was mixed evenly.The mixing time was 5 min,100 r/min,with 10%starch slurry as adhesive,at drying temperature 40-50℃,with 0.3%magnesium stearate as lubricant;and the compression rate was 10-35 r/min.The identification results showed that Tanshinone IIA had clear spots,good separation and strong specificity.The high performance liquid chromatography results showed that Salvianolic acid B had a good linear relationship from 8.0 to 256.0μg/mL(R^(2)=0.9999),system applicability,specificity,precision,stability,repeatability,and system durability,with a sample recovery of 95.0%-105.0%.For Salvianolic acid B in the six samples,the content limit was set at 11.4841 mg/g.It showed that the preparation process of the chewable tablets for pets determined in this test was stable and feasible,and that the established thin layer identification method and HPLC determination method were helpful for the quality control of preparing chewable Salvia miltiorrhiza tablet for pets.