Research Of The Preparation Technology And Quality Standard Of Xihuang Dropping Pill Based On The Antitumor Active Component Selection

Objective:To develop Xihuang dropping pill based on the antitumor active component selection of Xihuang Wan, and the preparation technology and quality standard of Xihuang dropping pill were studied.Methods:The MTT assay on human tumor cell and anti-angiogenesis on zebrafish were applied to select the antitumor active component of Xihuang Wan. 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 pill with dissolved time, appearance quality and weight difference as indexes. The qualitative and quantitative analysis of Xihuang dropping pill were studied by HPLC and GC methods. The MTT assay on human tumor cell and anti-angiogenesis on zebrafish were also applied to evaluate the antitumor active of Xihuang dropping pill and the results were compared with Xihuang Wan.Results:The fat-soluble components were considered as the main antitumor active component of Xihuang Wan, and ethanol extracts had the strongest antitumor effect. The 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 quality standard draft of Xihuang dripping pill was established. Xihuang dripping pill showed a better antitumor effect than Xihuang Wan.Conclusion:This thesis has established the preparation technology and quality standard of Xihuang dropping pill. The results were definitely helpful for the further research on this medicine.