[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,ex...[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,extraction time and extraction times as factors,and the content of tanshinone I as the index.Salviae Miltiorrhizae,Notoginseng Radix Et Rhizoma and Radix Astragali in the capsules were qualitatively identified by TLC,and the content of tanshinone I in the capsules was determined by HPLC.[Results]The best water extraction process included the steps of adding 12 times of water each time,extracting the materials twice,for 1 h each time.In TLC identification,the test samples showed spots of the same color at the positions corresponding to tanshinone II A,ginsenoside Rg1,notoginsenoside R1 and astragaloside IV reference samples.[Conclusions]Danshen Jianxin Capsules was prepared by the water extraction method,which is characterized by high efficiency and being suitable for mass production.The quality control method is reliable,fast and accurate,which can effectively control the quality of the product.展开更多
目的系统评价复方丹参滴丸辅助羟苯磺酸钙治疗糖尿病性视网膜病变(DR)的临床效果。方法检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统、PubMed、Embase、Web of Science和Cochrane Library建库至2023年7月复...目的系统评价复方丹参滴丸辅助羟苯磺酸钙治疗糖尿病性视网膜病变(DR)的临床效果。方法检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统、PubMed、Embase、Web of Science和Cochrane Library建库至2023年7月复方丹参滴丸联合羟苯磺酸钙治疗DR的临床随机对照试验。结果共纳入11项临床随机对照试验,共848例患者,观察组425例,对照组423例。meta分析结果显示,与对照组比较,试验组视野灰度值[均值差(MD)(95%CI):-0.92(-0.96,-0.88),P<0.00001]、血管瘤体积[MD(95%CI):-3.11(-3.33,-2.89),P<0.00001]、出血斑面积[MD(95%CI):-0.76(-0.85,-0.67),P<0.00001]、黄斑厚度[MD(95%CI):-55.62(-62.59,-48.65),P<0.00001]、血管内皮生长因子水平[MD(95%CI):-17.63(-21.6,-13.59),P<0.00001]、肿瘤坏死因子-α水平[MD(95%CI):-13.3(-16.09,-10.68),P<0.00001]更低,视力[MD(95%CI):0.13(0.05,0.20),P<0.00001]更好。无明显不良反应或事件发生。敏感性分析检验证实模型稳定性高,结论可信度高。结论根据目前临床证据,复方丹参滴丸与羟苯磺酸钙联用可提高DR的临床疗效。展开更多
基金Supported by Self-financed Scientific Research Project of Administration of Traditional Chinese Medicine of Guangxi Zhuang Autonomous Region(GXZYZ20210290)The First Batch of High-level Talent Research Project of Affiliated Hospital of Youjiang Medical University for Nationalities in 2019(Y20196311)Basic Scientific Research Ability Improvement Project for Young and Middle-aged Teachers in Guangxi Universities in 2020(2020KY13034).
文摘[Objectives]This study was conducted to establish the quality standard of Danshen Jianxin Capsules.[Methods]Orthogonal design was adopted to optimize the water extraction process by taking the amount of water added,extraction time and extraction times as factors,and the content of tanshinone I as the index.Salviae Miltiorrhizae,Notoginseng Radix Et Rhizoma and Radix Astragali in the capsules were qualitatively identified by TLC,and the content of tanshinone I in the capsules was determined by HPLC.[Results]The best water extraction process included the steps of adding 12 times of water each time,extracting the materials twice,for 1 h each time.In TLC identification,the test samples showed spots of the same color at the positions corresponding to tanshinone II A,ginsenoside Rg1,notoginsenoside R1 and astragaloside IV reference samples.[Conclusions]Danshen Jianxin Capsules was prepared by the water extraction method,which is characterized by high efficiency and being suitable for mass production.The quality control method is reliable,fast and accurate,which can effectively control the quality of the product.
文摘目的系统评价复方丹参滴丸辅助羟苯磺酸钙治疗糖尿病性视网膜病变(DR)的临床效果。方法检索中国知网、万方数据知识服务平台、维普网、中国生物医学文献服务系统、PubMed、Embase、Web of Science和Cochrane Library建库至2023年7月复方丹参滴丸联合羟苯磺酸钙治疗DR的临床随机对照试验。结果共纳入11项临床随机对照试验,共848例患者,观察组425例,对照组423例。meta分析结果显示,与对照组比较,试验组视野灰度值[均值差(MD)(95%CI):-0.92(-0.96,-0.88),P<0.00001]、血管瘤体积[MD(95%CI):-3.11(-3.33,-2.89),P<0.00001]、出血斑面积[MD(95%CI):-0.76(-0.85,-0.67),P<0.00001]、黄斑厚度[MD(95%CI):-55.62(-62.59,-48.65),P<0.00001]、血管内皮生长因子水平[MD(95%CI):-17.63(-21.6,-13.59),P<0.00001]、肿瘤坏死因子-α水平[MD(95%CI):-13.3(-16.09,-10.68),P<0.00001]更低,视力[MD(95%CI):0.13(0.05,0.20),P<0.00001]更好。无明显不良反应或事件发生。敏感性分析检验证实模型稳定性高,结论可信度高。结论根据目前临床证据,复方丹参滴丸与羟苯磺酸钙联用可提高DR的临床疗效。