藏药智托日嘎丸质量标准研究

Quality Control of Zang Medicine Zhituoriga Pills

目的:首次对智托日嘎丸的质量标准开展研究,达到质控目的。方法:对来源不同厂家的5批智托洁白丸样品进行显微鉴别、理化鉴别、薄层色谱鉴别、水分和重量差异进行考察。结果:建立了以寒水石结晶、矮紫堇淀粉粒、矮紫堇花瓣薄壁细胞、诃子石细胞、兔耳草根皮层薄壁组织、川木香纤维为鉴别特征的显微鉴定方法和以正己烷-醋酸乙酯(6∶1);甲苯-乙酸乙酯-甲酸(6∶3∶1)为展开剂,硅胶G薄层板为载体的薄层层析方法。测得智托日嘎丸的水分含量为4.9%~8.6%,平均水分含量为7.4%,重量差异为5.6%~6.9%,符合药典规定的要求。结论:本研究实验中所选用的试剂无毒/低毒,方法操作性强,结果直观,重现性好,能够有效地控制藏药智托日嘎丸质量,可为智托日嘎丸的规范化生产和临床应用提供简便可依的质量控制依据。

To study the quality standard of Zhituo Riga Pills for the first time,so as to achieve the purpose of quality control.Methods Five batches of Zhituo Jiebai pills from different manufacturers were identified by microscopic identification,physical and chemical identification,TLC identification,moisture and weight differences.Results A microscopic identification method was established,which was characterized by crystal of mirabilite,starch granules of Corydalis humilis,petal parenchyma cells of Corydalis humilis,Chebula cells,cortex parenchyma of rabbit ears and fiber dimension of Radix Aucklandiae,and hexane-ethyl acetate(6∶1)was used.Thin layer chromatography with toluene-ethyl acetate-formic acid(6∶3∶1)as developing agent and silica gel G as carrier.The moisture content of Zhituo Riga Pills is 4.9%-8.6%,the average moisture content is 7.4%,and the weight difference is 5.6%-6.9%,which meets the requirements of Pharmacopoeia.Conclusion The reagents selected in this research experiment are nontoxic/low toxic,the method is easy to operate,the results are intuitive,and the reproducibility is good,which can effectively control the quality of Zhituo Riga pills,and can provide a simple and reliable quality control basis for the standardized production and clinical application of Zhituo Riga pills.