元胡止痛软胶囊的大孔树脂精制工艺优选

目的:优选元胡止痛软胶囊中鞣质类成分的去除工艺及有效成分的精制工艺,为该制剂的工业化生产提供参考。方法:以没食子酸作为鞣质类的指标成分,延胡索乙素作为生物碱类的指标成分,通过单因素试验考察去除鞣质及富集延胡索乙素的方法并对富集延胡索乙素的工艺条件进行优化。结果:选择AB-型大孔树脂精制元胡止痛软胶囊,可除去没食子酸,富集延胡索乙素。富集延胡索乙素的最佳工艺条件为上样液质量浓度0.28 g·m L-1,径高比1∶10,每克树脂吸附延胡索乙素1.366 mg,洗脱溶剂95%乙醇,洗脱流速2 BV·h-1,洗脱剂用量5 BV。延胡索乙素的吸附率和洗脱率分别为84.7%,85.0%,纯化后总生物碱纯度达3.63%,较纯化前的0.349%显著提高。结论:AB-8型大孔树脂可以在去除鞣质类成分的情况下,富集元胡止痛软胶囊中以延胡索乙素为代表的有效成分,为改善该制剂的临床疗效和患者顺应性提供参考。

Optimization of Purification Process of Yuanhu Zhitong Soft Capsules by Macroporous Resin

Objective: To optimize purification process of Yuanhu Zhitong soft capsules about removing tannins and enriching alkaloids. Method: Gallic acid was indicators to purify tannins, tetrahydropalmatine was indicators to purify alkaloids.Single factor test was adopted to optimize purification process of removing gallic acid and enriching tetrahydropalmatine in Yuanhu Zhitong soft capsules. Result: AB-8 macroporous resin was selected, its best process of enriching tetrahydropalmatine was:the concentration of sample solution of 0.28 g· mL^-1, diameter height ratio of 1:10, the largest adsorption capacity of 1.366 mg for per gram of resin, eluent of 95% ethanol, elution flow rate of 2 BV· h^-1, eluent amount of 5 BV.Under these conditions, adsorption rate was 84.7%, elution ratio was 85.0%.Purity of total alkaloids in the final product was up to 3.63%. Conclusion: AB-8 resin can be used to remove tannins and enrich alkaloids, this study provides a reference for improving clinical efficacy and patient compliance of Yuanhu Zhitong soft capsules.