Research Of The Preparation Technology And Quality Standard Of Xihuang Drapping Pill

Objective:To develop secondly Xihuang dropping pills based on the Xihuang Wan, and study the preparation technology and quality standard of Xihuang dropping pill, compare the new formulations with the original formulation, and establish the quality standard of Xihuang dripping pill.Methods:The orthogonal tests were used to optimize supercritical CO2extraction technology from Olibanum and Myrrha with extraction yield and content of octyl acetate as indexes and to optimize forming technology of Xihuang dropping pills with dissolved time, appearance quality and weight difference as indexes. The qualitative analysis and quantitative analysis of Xihuang dropping pills were studied by HPLC and GC methods. The results compared with Xihuang Wan on the above basis.Results:The fat-soluble components were considered as the main antitumor active component of Xihuang Wan, and ethanol extracts had the strongest antitumor effect. Optimal supercritical CO2extraction technology conditions were as follows:extraction pressure of35MPa, extraction temperature of55, extraction time of2h, and30%ethanol as entrainer. The optimal forming technology conditions were as follows: PEG8000:PEG10000(1:1) were used as matrix, the ratio of drug and matrix was1:1.5, dimethyl silicone oil was refrigerant, temperature of liquid was75℃, temperature of refrigerant was gradual (30℃as upper temperature and0～5℃as lower temperature), dropping velocity was20～25drops per minute, dropping distance was4cm. The HPLC fingerprint of Xihuang dripping pill was established with bilirubin as the reference peak and the GC fingerprint of Xihuang dripping pill was established with octyl acetate as the reference peak. Ten batches of Xihuang dripping pill samples showed a better similarity. The method was used to determine the content of bilirubin, octyl acetate and Muscone in Xihuang dripping pill.There was the relationship between Xihuang dripping pill and raw materials and intermediates based on the above analyses. Compared with Xihuang Wan, the HPLC and GC fingerprint of Xihuang dripping pill had a more decidedly characteristic point,the contents of three marker components was increased.The quality standard draft of Xihuang dripping pill was established.Conclusion:This thesis has established the preparation technology and quality standard of Xihuang dropping pill. New formulations were primarily compared with the original formulation.The results were definitely helpful for further research on this medicine.