产后补丸质量标准的研究  

Studies on Quality Standard of Chanhoubu Pills

作　　者：黄丹莹[1] 

机构地区：[1]广东省惠州市药品检验所,惠州516003

出　　处：《中国药品标准》2010年第1期35-39,共5页Drug Standards of China

摘　　要：目的：建立产后补丸的质量标准。方法：采用TLC法对处方中木香，延胡索，血竭，黄芩进行定性鉴别；并用HPLC法对处方中黄芩进行含量测定，采用phenomenexLuna5μC18 4．6mm×250mm；以甲醇-2％冰醋酸（53：47）为流动相；检测波长为318nm；流速为1．0mL·min^-1。结果：薄层色谱斑点清晰，易于识别，专属性强；在4．3-215mg·L^-1的范围内呈良好线性关系（r=0．9998）；平均回收率为100．0％，RSD=1．2％（n=9）。结论：该方法准确灵敏、简便、重复性好，提高后的质量标准更有效的控制该制剂的质量。Objective：To determine the quality standard of Chanhoubu Pills. Methods： Radix aucklandiae, Rhizoma corydalis, Sanguis draconis, Radix scutellariae in Chanhoubu Pills were identified by TLC. The content of Baicalin was determined by HPLC. The chromatographic conditions were ： phenomenex Luna C18 column （4. 6 mm × 250 μm, 5 μm） ; mobile phase ： methanol-2% HAC （ 53： 47 ）, and the detection wavelength at 318 nm. Results： The qualitative identification with TLC were specific. Baicalin showed a good linearity within the range of 4.3 -215 mg· L^-1 ,r =0. 999 8. The average recovery was 100. 0% ,and RSD was 1.2%. Conclusion： This method can be used for the quality control of Chanhoubu Pills

关 键 词：产后补丸 质量标准 TLC HPLC 黄芩苷 

分 类 号：R286.0[医药卫生—中药学]