抗骨增生片制备工艺及质量标准研究

目的对抗骨增生片的制备工艺和质量标准分别进行优化与深化。方法以干浸膏得率和提取物中淫羊藿苷的含量作为考核指标,通过L9（34）正交试验法确定抗骨增生片的水煎煮提取工艺。通过选择黏合剂、润滑剂等确定抗骨增生片的成型工艺。采用薄层色谱法对熟地黄、淫羊藿、鸡血藤分别进行定性鉴别;采用高效液相色谱法对淫羊藿中淫羊藿苷进行定量分析,色谱柱为迪马C18柱（200 mm×4.6 mm,5μm）,流动相为乙腈-0.1%磷酸溶液（30：70）,流速为1.0 mL min^-1,检测波长为270 nm。结果制备工艺简便可行;薄层色谱斑点清晰,专属性强;淫羊藿苷进样量在0.051 2～0.460 8μg与峰面积线性关系良好（r=0.999 8）,平均回收率为98.4%,RSD为0.98%。结论优化出的提取工艺和成型工艺方法合理、可行,所建立的定性定量方法简便、准确、重复性好,可作为抗骨增生片的质量控制方法。

Preparative technique and quality standard of Kanggu Zengsheng tablets

Objective To optimize the preparative technology and deepen the quality standard of Kanggu Zengsheng tablets.Methods The yield of dried extract and the content of icariin as the indicators were used.The extraction technology of Kanggu Zengsheng tablets with water decoction was determined by the L9（34） orthogonal test.The formation technology was determined by choosing adhesives and lubricants.Rehmanniae radix praeparata,Epimedii folium and Spatholobi caulis were identified by TLC.Contents of iariin in Epimedii folium were determined simultaneously by HPLC.Chromatographic experiments were performed on Diamonsil C18column（200 mm×4.6 mm,5 μm）,the mobile phase was acetonitrile-0.1% phosphoric acid solution（30 ：70）,the flow rate was 1.0 mL min^-1,and the detection wavelength was 270 nm.Results The preparative technique was simple and feasible.The TLC identification experiments were specific and the spots were clear.Iariin showed a good linearity at 0.051 2-0.460 8 μg（r = 0.999 8）,and the average recovery was 98.4% with RSD of 0.98%.Conclusion The optimum extraction technology and formation technology are reasonable and feasible.The qualitative and quantitative analysis methods are simple,accurate and reproducible,and can be used for the quality control of Kanggu Zengsheng tablets.