生地黄炭饮片质量标准研究

Quality Standard of Shengditan Tablet

目的:测定生地黄炭饮片中水分、灰分、浸出物及毛蕊花糖苷、梓醇的含量,并进行性状与薄层定性鉴别,为制定其质量标准提供依据。方法:根据2010年版《中华人民共和国药典》附录方法检测生地黄炭饮片水分、灰分、浸出物含量,运用薄层色谱方法进行定性鉴别。结果:10批生地黄炭饮片水分平均值为5.22%,总灰分平均值为4.66%、酸不溶性灰分平均值为1.32%、水浸出物含量平均值为53.06%、醇浸出物含量平均值为10.52%、毛蕊花糖苷含量平均值为0.022 3%;梓醇含量平均值为0.020 3%;薄层鉴别可以检出毛蕊花糖苷、梓醇。结论:本实验方法准确可靠,以上检测指标和参数可以为制定生地黄炭饮片质量标准提供依据。

Objective：Determine the content of moisture,ash,extract and verbascoside,catalpol,and characters and TLC of Shengditan Tablet to provide the basis for the establishment of its quality standard. Methods：According to the 2010 edition of＆quot;Pharmacopoeia ap-pendix Chinese＆quot; method to detect the moisture,ash and extract content of Shengditan Tablet,using TLC method for qualitative identifi-cation. Result：In the ten batch of Shengditan Tablet,the average value of water was 5. 22%,the average value of total ash was 4. 66%, the average value of acid insoluble ash was 1. 32%,the average value of water extracts was 53. 06%,the average value of alcohol extract content was 10. 52%,the average value of Verbascoside content was 0. 022 3%,the average value of Catalpol content was 0. 020 3%. Verbascoside and Catalpol can be detected by TLC. Conclusion：The experimental method is accurate and reliable,the above detection index and parameters can provide basis for the formulation of quality standards of Shengditan Tablet.