复方胃舒胶囊提取工艺优选及质量标准

Optimization of Extraction Technology and Study on Quality Standard for Compound Weishu Capsules

摘要:

目的: 优选复方胃舒胶囊的提取工艺并建立其质量标准。 方法: 以干膏得率和盐酸小檗碱、盐酸巴马汀提取量为综合评价指标,采用正交试验考察乙醇体积分数、提取时间及料液比对提取工艺的影响,单因素试验考察提取次数;薄层色谱法对复方胃舒胶囊中黄连、吴茱萸进行定性鉴别,采用HPLC测定小檗碱含量。 结果: 最佳提取工艺为加11倍量60%乙醇加热回流提取3次,每次1 h。薄层色谱鉴别斑点清晰,阴性对照无干扰;盐酸小檗碱、盐酸巴马汀线性范围分别为3.156~202,1.375~88 mg·L^-1,平均回收率分别为100.2%,99.7%,RSD分别为1.76%,1.89%。 结论: 优选的提取工艺稳定可行、重复性好,可用于复方胃舒胶囊的工业化生产;建立的质量控制方法简便、准确、专属性强,可有效控制本品质量。

Abstract:

Objective: To optimize extraction process of compound Weishu capsules(CWC) and establish its quality standard. Method: With yield of dry extract,berberine hydrochloride(BH) and palmatine hydrochloride(PH) as comprehensive evaluation index,orthogonal design was carried out to optimize extraction process by taking the concentration of ethanol,extraction time and liquid-solid ratio as factors,extraction times was investigated by single factor test.Coptidis Rhizoma and Euodiae Fructus in CWC were identified by TLC,the content of BH and PH were determined by HPLC. Result: Optimum extraction process was as following:reflux extracted 3 times with 11 times the amount of 60% ethanol with 1 h each time.TLC identification spots were fairly clear and the blank test showed no interference.The linear range of BH and PH was 3.156-202 and 1.375-88 mg·L^-1,respectively with r=0.999 9;The average recovery was 100.2% and 99.7%,respectively with RSD of 1.76% and 1.89%. Conclusion: This optimized technology was stable and feasible with good repeatability,and it could be used in industrial production of CWC. This established quality control method was simple,special,reproducible,and effective for quality control of CWC.