藏药赞丹杰巴丸质量标准研究

Quality Control of Tibetan Medicine Zandan Jieba Pill

目的:建立和完善赞丹杰巴丸的质量标准体系。方法:对来源不同厂家的4批赞丹杰巴丸样品进行显微鉴别、理化鉴别及薄层色谱(TLC)鉴别研究,并对4个不同厂家样品的水分和重量差异进行考察。结果:建立了以檀香纤维束、紫檀纤维束、石灰华碳酸钙方晶、红花分泌细胞、红花花粉粒及丁香花粉粒为鉴别特征的显微鉴定方法和以乙酸乙酯-甲醇(6∶1)、乙酸乙酯∶甲酸∶水(9∶2∶2)、环己烷∶乙酸乙酯∶甲酸(8∶2∶0.5)及三氯甲烷∶甲醇(9∶1)为展开剂,硅胶G薄层板为载体的薄层层析方法。测得赞丹杰巴丸的水分含量为6.75%~7.53%,平均水分含量为6.53%,重量差异为0.86%~3.91%,符合药典规定的要求。结论:该研究为赞丹杰巴丸的规范化生产和临床应用提供了简便可依的质量控制依据。且所选用的试剂无毒/低毒,价格低廉,操作性强,结果直观,重现性好,能够有效地控制藏药赞丹杰巴丸质量。

Objective:To establish and improve the quality standard system of Tibetan Zandan Jieba Pill,Four batches of Tibetan Zandan Jieba Pill samples from different manufacturers were identified by microscopic identification,physical and chemical identification and thin layer chromatography(TLC).Methods:And the moisture and weight differences of samples from four different manufacturers were also investigated.Results:Microscopic identification was established with the identification characteristics of sandalwood fiber bundles,red sandalwood fiber bundles,tufa calcium carbonate square crystals,safflower secretory cells,safflower pollen grains and clove pollen grains;TLC was set up with from ethyl acetate-methanol(6∶1)to ethyl acetate-formic acid-Water(9∶2∶2),cyclohexane-ethyl acetate-formic acid(8∶2∶0.5)and trichloromethane-methanoll(9∶1)as developing agents and silica gel G thin layer plate as carrier.The measured moisture content of Tibetan Zandan Jieba Pill is 6.75%~7.53%,the average moisture content is 6.53%,and the weight difference is 0.86%~3.91%,which meets the requirements of the pharmacopoeia.Conclusion:This study can provide a simple and reliable quality control basis for the standardized production and clinical application of Zandan Jieba Pill.Moreover,the reagents selected in the establishment method of this study are non-toxic/low-toxic,low price,strong operability,intuitive results,good reproducibility,and can effectively control the quality of Tibetan medicine Zanden Jeba Pill.