川芎茶调散及其4种改型制剂的质量分析

Quality Analysis of Chuanxiong Mixture and Its Four Modified Forms of Preparation

目的：考察川芎茶调散改型制剂的质量，分析影响质量的工艺因素。方法：按中国药典检测方法对各制剂所含挥发油及浸出物进行定量分析，并用ＴＬＣ法对各制剂进行川芎、白芷的主成分鉴别。结果：挥发油含量最高为０．４％（散剂、片剂），最低为０．０８５％（袋泡剂）；醇溶性浸出物最高为１５．７６％（散剂），最低为１０．２３％（冲剂）；水溶性浸出物最高为２４．８９％（散剂），最低为１８．４３％（袋泡剂）；袋泡剂中川芎、白芷的ＴＬＣ鉴别为阴性。结论：与散剂相比，４种改型制剂均存在不同程度的质量问题，其中冲剂、袋泡剂各项指标最低。

OBJECTIVE:To investigate into the quality of the modified preparations of Chuanxiong Mixture and factors affecting the quality.METHOD:Based on the methods described in the Chinese Pharmacopeia,quantitative analysis of volatile oil and extractives from the various preparations was made and the chief constituents in Rhizoma Ligustici chuanxiong and Radix Angelicae dahuricae were identified with TLC method.RESULT:The highest content of volatile oil was 0.4% (in powder and tablets) and the lowest,0.085%(in small bag form).The highest content of alcohol soluble extractive was 15.76%(in powder)and the lowest,10.23%(in granule).The highest content of water soluble extractives was 24.89%(in powder) and the lowest,18.43%(in small bag form).In the small bag form,Rhizoma Ligustici chuanxiong and Radix Angelicae dehuriae Was negative with TLC identification.CONCLUSION:Compared with powder form,all the 4 modified forms have different degrees of quality problem,indicating the unreasonableness of the techniques in the modification of the form of the preparation.