酒丹参标准汤剂的质量评价

Quality Evaluation of Standard Decoction of Wine-processing Salviae Miltiorrhizae Radix et Rhizoma

目的:建立酒丹参标准汤剂的质量控制方法,为酒丹参配方颗粒及其他酒丹参相关产品的质量评价提供参考。方法:收集具有代表性的酒丹参饮片15批,制备酒丹参标准汤剂,建立HPLC指纹图谱,测定5种酚酸类(丹参素钠、咖啡酸、迷迭香酸、紫草酸、丹酚酸B)成分含量;采用已知对照品为参照,对指纹图谱主要色谱峰进行归属,明确酒丹参标准汤剂中的主要化学成分;计算出膏率,5种丹酚酸类成分转移率和溶液p H,建立综合评价指标来评价酒丹参标准汤剂制备工艺的稳定性。结果:酒丹参标准汤剂的主要成分为酚酸类成分,5种酚酸类(丹参素钠、咖啡酸、迷迭香酸、紫草酸、丹酚酸B)成分质量分数分别为0. 21%~0. 37%,0. 03%~0. 10%,0. 08%~0. 18%,0. 07%~0. 13%,2. 68%~4. 34%,转移率分别为71. 8%~85. 4%,50. 0%~71. 4%,68. 2%~81. 0%,66. 7%~84. 6%,67. 5%~79. 6%;出膏率45. 1%~55. 3%;p H 5. 91~6. 05;15批酒丹参标准汤剂HPLC指纹图谱与对照图谱相比,相似度均> 0. 98,图谱显示有12个共有峰,其中7个指认为丹参素钠、原儿茶醛、咖啡酸、阿魏酸、迷迭香酸、紫草酸和丹酚酸B。结论:建立的系统评价酒丹参标准汤剂的质量方法稳定可行,为酒丹参水煎剂相关制剂的质量控制提供参考。

Objective:To establish the quality control method of the wine-processing Salviae Miltiorrhizae Radix et Rhizoma standard decoction,in order to provide reference for the quality evaluation of the wine-processing Salviae Miltiorrhizae Radix et Rhizoma formula granules and other related products.Method:Totally 15 batches of representative wine-processing Salviae Miltiorrhizae Radix et Rhizoma pieces were collected to prepare the standard decoction,establish the HPLC fingerprint and determine the content of five components(sodium danshensu,caffeic acid,rosmarinic acid,lithospermic acid,salvianolic acid B).The main common peaks in fingerprint were identified to define the main chemical constituents in the standard decoction,the parameters,such as dry extract rate,transfer rate of index components and pH of the standard decoction were calculated,and the comprehensive evaluation index was established to evaluate the stability of the preparation process.Result:The main component standard decoction was phenolic acids.The concentrations of five components(sodium danshensu,caffeic acid,rosmarinic acid,lithospermic acid,salvianolic acid B)in the standard decoction were 0.21%-0.37%,0.03%-0.10%,0.08%-0.18%,0.07%-0.13%,2.68%-4.34%,the dry extract rates of standard decoction were71.8%-85.4%,50.0%-71.4%,68.2%-81.0%,66.7%-84.6%,67.5%-79.6%,the transfer rates were between 45.1%-55.3%,and pH value was between 5.91-6.05.The fingerprint similarities of the 15 batches of standard decoction with reference fingerprints were>0.98,the fingerprint showed 12 common peaks,7 of which were considered to be sodium danshensu,protocatechuic aldehyde,caffeic acid,ferulic acid,rosmarinic acid,lithosperic acid and salvianolic acid B.Conclusion:The established systematic evaluation for the quality of wineprocessing Salviae Miltiorrhizae Radix et Rhizoma standard decoction is stable and feasible,and provides a reference for the quality control of relevant preparations of wine-processing Salviae Miltiorrhizae Radix et Rhizoma decoction.