加味续筋接骨丸的制备工艺及质量标准研究

Study on preparation process and quality standard of Additional Xujin Jiegu Pills

目的研究建立加味续筋接骨丸的成型工艺,制定加味续筋接骨丸的质量标准,保证产品质量稳定、可控。方法通过单因素实验法,考察药材出粉率、蜂蜜的炼制、和药蜜温、用蜜量、干燥条件、药材灭菌方法及条件,并以3批样品制备工艺的稳定性为考察,优化其和药蜜温、用蜜量、干燥条件和灭菌要求等;采用显微鉴别法和薄层色谱法(TLC)进行鉴别。结果加味续筋接骨丸最佳成型辅料为蜂蜜,制成小蜜丸后检验指标均符合要求,采用显微鉴别法的特征图谱可以鉴别制剂中的部分药材(三七、红花、熟地黄、地龙、杜仲、全蝎、龙血竭);采用薄层色谱法(TLC)可以鉴别加味续筋接骨丸中三七和桃仁。结论优选的制备工艺简单,鉴别方法稳定,对加味续筋接骨丸的质量控制非常实用。

Objective To study the forming process of Additional Xujin Jiegu Pills and establish the corresponding quality standard,ensure stable and controllable product quality.Methods Carried out with powder yield,honey refining,mixed medicinal honey temperature,honey consumption,drying conditions,sterilization methods were inspected by single factor test.Conditions of medicinal materials as indicators,the stability of the preparation process of three batches of samples was investigated,the mixed medicinal honey temperature,honey consumption,drying conditions and sterilization requirements were optimized.The specific chromatogram of microscopic identification and thin-layer chromatography(TLC)were used to identify.Results Honey is the best auxiliary material of Additional Xujin Jiegu Pills.After making small honey pill,the test index is in line with the requirements.The specific chromatogram of microscopic identification was used to identify some medicinal materials(pseudo-ginseng,safflower,prepared rehmannia root,earthworm,eucommia,scorpio,resina draconis)in the preparation.Additionally,notoginseng radix and peach kernel in Additional Xujin Jiegu Pills were identified using thin-layer chromatography(TLC).Conclusion The optimized preparation process is simple and the identification method is stable,which are very useful for the quality control of Additional Xujin Jiegu Pills.