1.首都医科大学中医药学院(北京 100069)
2.首都医科大学中医络病研究北京市重点实验室(北京 100069)
刘攀婷,女,在读本科生,主要从事中药资源与分子生药学研究
吴莎,副教授,硕士生导师;E-mail:wusha729@163.com
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刘攀婷,吕诺,吴莎等.化瘀胶囊制备工艺及主要成分含量测定研究[J].上海中医药大学学报,2022,36(01):8-13.
LIU Panting,LYU Nuo,WU Sha,et al.Study on the preparation process of Huayu Capsule and content determination of its main components[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(01):8-13.
刘攀婷,吕诺,吴莎等.化瘀胶囊制备工艺及主要成分含量测定研究[J].上海中医药大学学报,2022,36(01):8-13. DOI: 10.16306/j.1008-861x.2022.01.002.
LIU Panting,LYU Nuo,WU Sha,et al.Study on the preparation process of Huayu Capsule and content determination of its main components[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(01):8-13. DOI: 10.16306/j.1008-861x.2022.01.002.
目的,2,制备化瘀胶囊,建立高效液相色谱(HPLC)法同时测定其中5种主要成分含量,为化瘀胶囊质量控制提供依据。,方法,2,取药材适量,采用水蒸气蒸馏法提取挥发油,采用饱和水溶液法制备挥发油的β-环糊精包合物,将包合物与稠膏、辅料混合制备颗粒,整粒后制备胶囊。对颗粒进行外观、粒度、水分、流动性、溶化性检查;对胶囊进行水分、崩解时限检查。建立HPLC法测定化瘀胶囊中5种主要成分柚皮苷、橙皮苷、新橙皮苷、羟基红花黄色素A和苦杏仁苷的含量,并进行方法学考察。,结果,2,制得的化瘀胶囊,包合物得率为64.9%,挥发油包合率为55.2%,对颗粒和胶囊的各项质量检查均符合国家药典规定。所建立的HPLC分析方法,线性关系、精密度、重复性、稳定性、加样回收率等均符合要求。测得6份化瘀胶囊样品中柚皮苷、橙皮苷、新橙皮苷、羟基红花黄色素A、苦杏仁苷的平均含量分别为7.56 mg/g、1.63 mg/g、4.84 mg/g、0.61 mg/g、1.13 mg/g。,结论,2,该制备工艺简单可行,所建立的含量测定方法简便,重复性和稳定性好,精密度高,可为化瘀胶囊的质量控制研究提供参考。
Objective: To prepare Huayu Capsule and establish a high performance liquid chromatography (HPLC) method for simultaneously determining five main components and providing basis for quality control of Huayu Capsule.,Methods,2,A proper number of medicinal materials were taken. The volatile oil was extracted by steam distillation, and then was prepared into a β-cyclodextrin inclusion complex by saturated aqueous solution method. The inclusion complex was mixed with concentrated extract and excipients to prepare granules, and then the capsules were obtained. The appearance, particle size, moisture, fluidity and solubility of the granules were detected, and the water content and disintegration time of the capsules were determined. The HPLC method was established for the content determination of naringin, hesperidin, neohesperidin, hydroxysafflower yellow A and amygdalin in Huayu Capsule, and the methodological investigation was performed.,Results,2,For the prepared Huayu Capsule, the yield of inclusion complex was 64.9% and the inclusion rate of volatile oil was 55.2%. All quality tests on granules and capsules were in accordance with the provisions of the pharmacopoeia. For the established HPLC method, the linear relationship, precision, repeatability, stability and recovery met the requirements. The average contents of naringin, hesperidin, neohesperidin, hydroxysafflower yellow A and amygdalin in six samples of Huayu Capsule were 7.56, 1.63, 4.84, 0.61 and 1.13 mg/g respectively.,Conclusion,2,The preparation process is simple and feasible. The established content determination method is simple and convenient, with good repeatability and stability and high precision, which can provide reference for the quality control of Huayu Capsule.
化瘀胶囊挥发油包合物质量控制含量测定
Huayu Capsulevolatile oilinclusion complexquality controlcontent determination
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