藤枝愈痹颗粒制备工艺及质量标准研究

A study on preparation technology and quality standard of Tengzhi Yubi granules

目的:藤枝愈痹颗粒处方为全国名老中医孙学全主任医师的临床经验方,由鸡血藤、青风藤、海风藤、络石藤、桂枝、桑枝、豨莶草和薏苡仁等中药组成。多年的临床研究表明,其具有搜风祛湿、温经散寒、活血通络的功效,可用于治疗风、寒、湿痹所致的关节肿痛、肌肉酸沉、身体重着或者疼痛游走不定等病症。本研究对藤枝愈痹颗粒的制备工艺及其质量标准进行研究,以保证藤枝愈痹颗粒临床用药的安全性及质量可控性。方法:本实验采用正交试验的方法,优选藤枝愈痹颗粒制剂的提取工艺;采用薄层色谱法定性鉴别处方中的桂枝、青风藤等主要中药材,采用高效液相色谱法对藤枝愈痹颗粒中的络石苷进行含量测定,以乙腈-水(30∶70)为流动相,检测波长为230 nm,柱温为25℃,流速为1.0 mL/min。结果:藤枝愈痹颗粒最佳的煎煮工艺为每次加10倍量水,共计加水煎煮3次,每次煎煮时间为1.5 h;桂枝、青风藤定性鉴别的斑点清晰,重现性好;络石苷在0.0136~2.7200μg范围内线性关系良好(r=0.9999),实验的加样回收率为101.10%(n=6),相对标准偏差为1.02%。结论:本次筛选出的藤枝愈痹颗粒最佳制备工艺稳定可行,建立的质量控制方法专属性强、准确度高、重复性好,可作为藤枝愈痹颗粒的质量控制标准。

Objective:The prescription of Tengzhi Yubi granules(藤枝愈痹颗粒)is the clinical experience prescription of Chief Physician SUN Xuequan,a national famous veteran doctor of traditional Chinese medicine.It is composed of Spatholobus suberectus,Caulis sinomenii,Caulis sargentodoxae,Ramulus cinnamomi,Ramulus mori,Herba Siegesbeckiae,Semen Coicis and other Chinese medicinal materials.Years of clinical studies have shown that Tengzhi Yubi granules has the effects of dispelling wind and dampness,warming meridians and dispelling cold,activating blood and dredging collaterals.Tengzhi Yubi granules can be used for joint swelling and pain,muscle acidosis,body weight or pain wandering caused by wind,cold and dampness.In this study,the preparation process and quality standard of Tengzhi Yubi granules were studied to ensure the safety and quality controllability of clinical medication.Methods:Orthogonal test was used to optimize the extraction process of Tengzhi Yubi granules.Cassia twig and orientvine were identified by TLC.Tracheloside was determined by HPLC,acetonitrile-water(30:70)was mobile phase,the detection wave length was 230 nm,flow rate was 1.0 mL/min.Results:The optimal extraction conditions of Tengzhi Yubi granules were as follows:10 folds of water,extracting for 3 times,and 1.5 hour for every decoction.The qualitative identification spots were clear and reproducible.The linear range of Icariin was 0.0136-2.7200μg(r=0.9999),with the average recovery of 101.10%and RSD 1.02%.Conclusion:The optimal preparation process of Tengzhi Yubi granules is stable and feasible,and the established quality control method has strong specificity,high accuracy and good repeatability,which could be used as the quality control standard of Tengzhi Yubi granules.