益肾清利颗粒的质量标准研究

Quality Standard of Yishen Qingli Granule

目的摸索和建立益肾清利颗粒的质量控制方法。方法采用高效液相色谱法以及薄层色谱鉴定法,对益肾清利颗粒组方中的药味黄芪、山茱萸、泽泻、三七进行定性鉴别;对益肾清利颗粒组方中的有效成分马钱苷进行含量测定。结果定性鉴别薄层斑点清晰,测定3批制剂马钱苷的含量;系统耐用性试验、专属性试验、线性范围、精密度试验、重复性试验、加样回收率试验均符合要求。结论该方法安全、可靠、可用于益肾清利颗粒的质量控制。

Objective Establish the quality standards of kidney clear the granule. To better control the quality of the kidney clean the granule. Methods By thin layer chromatography （TLC）, the kidney pellet formula ingredients of astragalus membranaceus, dogwood, alisma, notoginseng for qualitative identification;Using high performance liquid chromatography（HPLC ） method for kidney clear the granule characteristics of effective composition content of loganin horse money. Results Qualitative identify the contents of the TLC spots were clear, determine the content of three groups of agents loganin were 0.81 mg, 0.82 mg/g and 0.79 mg/g/g; System durability test, the specificity test, linear range, precision test, repeatability test, sample recovery rate test conform to the requirements. Conclusion This method is safe, reliable, and can be used for kidney clear quality control of the granule.