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中药复方制剂乳癖舒片质量控制研究

Study on Quality Control of Chinese Medicine Compound Preparation Rupishu Tables
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摘要 目的:完善乳癖舒片的质量控制方法,提高制剂质量及稳定性。方法:用薄层色谱法鉴别处方中的柴胡,采用高效液相色谱法测定处方中丹参的丹酚酸B含量。结果:薄层色谱结果表明:四个生产厂家的8批乳癖舒片中均检出柴胡的主斑点,且斑点清晰、分离较好、阴性无干扰;高效液相色谱法结果表明:丹酚酸B的含量在0.04756~4.7561μg进样范围内与峰面积线性关系良好,平均回收率为97.3%(RSD=1.48%)。结论:该方法简便、稳定、可行,可为乳癖舒片质量控制标准的提高做参考。 Objective:To improve the quality controlling method of Rupishu tablets,improve the quality and stability of the preparations.Methods:TLC was used to identify Bupleurum in the prescription,and HPLC was used to determine the content of Danphenolic acid B in the prescription.Results︰The main spots of Bupleurum were detected in the TLC of 8 batches of tablets from 4 manufacturers,and the spots were clear,well separative,and the according blank test showed no interference.The calibration curve showed a good linearity for Danphenolic acid B in the concentration rage of 0.0475 6 to 4.756 1μg by HPLC and the average recovery of Danphenolic acid B was 97.3%(RSD 1.48%).Conclusion︰The above method is simple,stable and feasible.It can be used as a reference for improving the quality control standard of Rupishu tablets.
作者 刘杨 苟琰 彭修娟 LiuYang;Gou Yan;Peng Xiujuan(Chengdu Railway Health School,Chengdu,611741,China;Sichuan Provincial Institute for Food and Drug Control,Chengdu,611731,China;Shaanxi Institute of International Trade & Commerce,Xianyang,712046,China)
出处 《成都中医药大学学报》 2019年第2期39-43,共5页 Journal of Chengdu University of Traditional Chinese Medicine
基金 陕西省中药产业技术创新服务共享平台(2018PT-007)
关键词 乳癖舒片 柴胡 丹参 质量控制 Rupishu tablets Bupleurum Salvia miltiorrhiza Quality controlling
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