川芎配方颗粒的制备及量值传递研究

Study on preparation and law of quality value transmitting of Chuanxiong Dispensing Granules

[目的]研究川芎配方颗粒的制备工艺及量值传递过程,确定川芎饮片、标准汤剂、配方颗粒的相关性,保证配方颗粒与标准汤剂的等效性。[方法]制备18批川芎标准汤剂,测定出膏率。建立特征图谱,标定特征峰,对特征峰进行归属。测定原料饮片和标准汤剂中阿魏酸的含量,计算转移率。以标准汤剂所得的质量指标为依据,进行制备工艺研究,制备川芎配方颗粒。以出膏率、阿魏酸含量及转移率、特征峰传递数量为指标,进行川芎配方颗粒量值传递研究。[结果]通过对18批川芎饮片的标准汤剂进行研究,最终确定出膏率范围为26%~37%。特征图谱共标定8个特征峰,对其中3个成分进行指认,分别为阿魏酸、洋川芎内酯A和藁本内酯。阿魏酸含量范围为0.28%~0.52%,平均转移率为37.7%。[结论]川芎饮片、标准汤剂及配方颗粒中的阿魏酸转移稳定,均呈现8个特征峰,说明川芎饮片中化学成分基本全部转移至配方颗粒,川芎配方颗粒与标准汤剂基本等效。

[Objective]Study on preparation and law of quality value transmitting of Chuanxiong Dispensing Granules,the correlation of Rhizoma Chuanxiong decoction pieces,standard decoction and dispensing granules was determined to ensure the equivalence of dispensing granules and standard decoction.[Methods]Eighteen batches of Rhizoma Chuanxiong standard decoction were prepared and the extraction rate was determined.The specific chromatogram was established and the characteristic peaks were identified.The content of ferulic acid in decoction pieces and standard decoction was determined and the transfer rate was calculated.Based on the quality index obtained from the standard decoction,the preparation process was studied to prepare Chuanxiong Dispensing Granules.Taking the paste yield,ferulic acid content,transfer rate and characteristic peak as indexes,the value transfer of Chuanxiong Dispensing Granules was studied.[Results]Through the study of standard decoction of 18 batches of Rhizoma Chuanxiong decoction pieces,the range of extraction rate was determined:26%~37%;a total of 8 characteristic peaks were assessed,and three components wereferulic acid,ligustilide A and ligustilide.Ferulic acid content range was 0.28%~0.52%and the average transfer rate was 37.7%.[Conclusion]There were 8 characteristic peaks in Rhizoma Chuanxiong decoction pieces,standard decoction and dispensing granules,ferulic acid transfer stability.The results showed that all the chemical components in Rhizoma Chuanxiong decoction pieces were basically transferred to dispensing granules,and the Chuanxiong Dispensing Granules were basically equivalent to standard decoction.