不同厂家复方丹参片物质组溶出度研究

Study on dissolution of multi-components in Compound Danshen Tablets from different manufacturers

目的建立测定复方丹参片三组物质组(多指标物质组、指纹物质组、有效部位物质组)溶出度检测方法,并考察不同厂家复方丹参片物质组溶出度的情况。方法按照《中国药典》2010年版二部附录XC溶出度测定第三法,以200mL水为溶出介质进行溶出实验,并采用高效液相及紫外分别检测三组物质组的体外溶出度,绘制累积溶出曲线,且对各曲线进行相似因子的比较。结果测定结果显示在60min内除物质组一中丹参酮ⅡA的溶出仅为23.41%外,其他物质组均能溶出95%以上,且不同厂家复方丹参片物质组溶出曲线相似因子f2值大多小于50。结论复方丹参片三组物质组的溶出度总体呈良好的相关性,故可作为质量检测的标准之一。不同厂家复方丹参片物质组的溶出度存在显著性差异,这可能是由于各厂家生产工艺不尽相同所致,因此建议中成药的质量控制应增加主成分或适宜物质组的溶出度检测。

Objective To establish the methods for determining the dissolution of three material groups（multi-index material group,fingerprint substance group,and effective parts group） of Compound Danshen Tablets（CDT,）,and study the dissolution condition of CDT from different manufacturers.Methods According to the appendix XC of Chinese Pharmacopoeia 2010,200 mL water was used as dissolution medium.HPLC and UV were used to detect the in vitro dissolution in the three groups of substances,respectively,cumulative dissolution curves were drawn and similar factors of the curves were compared.Results In addition to the first group of tanshinone IIA,the dissolution was only 23.41%,dissolution in the other groups were all over 95% within 60min.Furthermore,the similarity factor（f2） values of the dissolution profile from different manufacturers were mostly less than 50.Conclusion The dissolution in the three groups of substances totally shows the good correlation,so it can be used as a criterion for quality testing.The material group dissolution of CDT from different manufacturers has significant differences,which may be due to the different production process,so the dissolution testing of main components or appropriate groups of substances should be included in the quality control of Chinese patent medicine.