产舒康颗粒的制备及质量标准研究  

Study on Preparation and Quality Standard of Chanshukang Granules

作　　者：崔秀君[1] 程立方[2] 

机构地区：[1]济南市妇幼保健院,济南市250001 [2]山东省中医药研究院,济南市250014

出　　处：《中国药房》2007年第6期433-436,共4页China Pharmacy

摘　　要：目的：制备产舒康颗粒并建立其质量标准。方法：以胎盘超微粉碎技术进行颗粒制备，通过氨基酸分析、薄层色谱法和高效液相色谱法进行质量控制。色谱柱为C18（200mm×4．6mm，5μm），流动相为甲醇-2％冰醋酸溶液（40：60），检测波长为324nm。结果：胎盘超微粉粒度、色泽、味道、分散程度较好，经薄层鉴别、氨基酸分析与普通粉无显著差异。本品中用薄层色谱检出当归、川芎、胎盘、甘草；阿魏酸含量在0．625～3．750μg范围内线性关系良好；3批颗粒中阿魏酸含量分别为0．054％、0．037％、0．042％，平均回收率为96．2％（RSD=2．37％）。结论：可将胎盘制成超微粉用于产舒康颗粒，质控方法专属性强。OBJECTIVE： To prepare Chanshukang granules and establish a quality standard thereof. METHODS： To prepare the granules by Placenta ultramicronization technique, and control the quality through amino acid analysis, TLC and HPLC, using Kromasil C,8 （200mm× 4.6mm, 5μm） as column, ethanol - 2% glacial acetic acid （40 ： 60） as mobile phase, with the wavelength at 324nm. RESULTS： Placenta ultramicron is superior in granularity, color, taste and distribution, with no obvious difference from ordinary powder, as shown by TLC identification and amino acid analysis. Angelicae Sinensis, Rhizoma Chuanxiong, Placenta and Glycyrrhizae Praeparata were also identified, with the content of ferulic acid having a linear calibration curve ranging 0. 625-3. 750μg. The content of ferulic acid in the three batches was 0.054%, 0.037%, and 0.042% respectively. The average recovery was 96.2% （RSD=2.37% ） .CONCLUSION： Placenta can be made into ultramicron powder for use in Chanshukang granules. This method of quality control is specifically applicable.

关 键 词：产舒康颗粒 胎盘超微粉碎技术 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R283[医药卫生—中药学] R944.27[医药卫生—中医学]