消渴健脾胶囊质量标准研究

目的建立消渴健脾胶囊的质量标准。方法采用显微镜鉴别制剂中直接以粉末入药的白术、葛根、大黄、茯苓、车前子5味中药材的显微特征;采用薄层色谱(TLC)法定性鉴别栀子、土茯苓、大黄、茯苓、莱菔子、葛根6味药材的特征斑点;采用高效液相色谱(HPLC)法测定制剂中栀子苷的含量,色谱柱为Cosmosil C₁₈柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(9∶91,V/V),流速为1 mL/min,柱温为35℃,检测波长为238 nm,进样量为10μL。结果显微鉴别可有效检出制剂中白术、葛根、大黄、茯苓和车前子5种以粉末入药中药材的特征性结构;栀子等6味中药材的TLC图谱斑点清晰,分离度好,阴性对照无干扰;栀子苷质量浓度在8.652~173.040μg/mL范围内与峰面积线性关系良好(r=0.999 6,n=5);栀子苷平均加样回收率为100.15%,RSD为2.02%(n=6)。结论该方法操作简单,重复性好,结果准确,可用于消渴健脾胶囊的质量控制。

Quality Standard of Xiaokejianpi Capsules

Objective To establish the quality standard of Xiaokejianpi Capsules.Methods Five kinds of Chinese medicinal materials including Atractylodis Macrocephalae Rhizoma,Puerariae Lobatae Radix,Rhei Radix et Rhizoma,Poria and Plantaginis Semen directly used as powder in the preparation were identified by the microscope.The characteristic spots of six kinds of Chinese medicinal herbs including Gardeniae Fructus,Smilacis Glabrae Rhizoma,Rhei Radix et Rhizoma,Poria,Raphani Semen and Puerariae Lobatae Radix were identified by the thin-layer chromatography(TLC) method.The content of geniposide in the preparation was determined by the high-performance liquid chromatography(HPLC) method.The chromatographic column was Cosmosil C₁₈column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-water(9:91,V/V),the flow rate was 1 mL/min,the column temperature was 35℃,the detection wavelength was 238 nm,and the injection volume was 10μL.Results Microscopic identification could effectively detect the characteristic structures of Atractylodis Macrocephalae Rhizoma,Puerariae Lobatae Radix,Rhei Radix et Rhizoma,Poria and Plantaginis Semen directly used as powder in the preparation.The TLC chromatograms of six kinds of Chinese medicinal herbs such as Gardeniae Fructus had clear spots,good separation,and the negative samples had no interference.The mass concentration of geniposide showed a good linear relationship with the peak area in the range of 8.652-173.040μg/mL(r=0.999 6,n=5),and the average recovery of geniposide was 100.15% with an RSD of2.02%(n=6).Conclusion The method is simple,repeatable and accurate,which can be used for the quality control of Xiaokejianpi Capsules.