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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。
Objective: To optimize the process of removing tannin from Yuanhu Zhitong Soft Capsule and the purification process of active ingredients, and provide a reference for the industrialized production of the preparation. Methods: Using gallic acid as an indicator component of tannin and tetrahydropalmatine as an indicator component of alkaloids, the removal of tannin and the enrichment of tetrahydropalmatine were investigated by single factor test. optimize. Results: Select AB-type macroporous resin refined Yuanhu pain soft capsule, can remove gallic acid, enrichment tetrahydropalmatine. The optimal conditions for the enrichment of tetrahydropalmatine were as follows: the mass concentration of the sample was 0.28 g · m L-1, the ratio of diameter to height was 1:10, and 1.366 mg of tetrahydropalmatine was adsorbed per gram of resin, 95% ethanol was eluted Flow rate 2 BV · h-1, eluent dosage 5 BV. The adsorption and elution rates of tetrahydropalmatine were 84.7% and 85.0%, respectively. The purity of total alkaloids after purification was 3.63%, which was significantly higher than that before purification (0.349%). CONCLUSION: AB-8 macroporous resin can be used to enrich the active ingredients represented by tetrahydropalmatine in Yuanhu Zhitong soft capsule with the removal of tannin components. In order to improve the clinical efficacy and patient compliance of this preparation, reference.