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产后补丸质量标准的研究
引用本文:黄丹莹. 产后补丸质量标准的研究[J]. 中国药品标准, 2010, 11(1): 35-39
作者姓名:黄丹莹
作者单位:广东省惠州市药品检验所,惠州,516003
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。

关 键 词:产后补丸  质量标准  TLC  HPLC  黄芩苷

Studies on Quality Standard of Chanhoubu Pills
Huang Dan-ying. Studies on Quality Standard of Chanhoubu Pills[J]. , 2010, 11(1): 35-39
Authors:Huang Dan-ying
Affiliation:Huang Dan-ying( Huizhou Institute for Drug Control of Guangdong Province ,Huizhou 516003 )
Abstract:
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
Keywords:TLC  HPLC
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