超滤在痰热清注射液制备中的应用研究

Ultrafiltration of Tanreqing Injection

目的选择适用于痰热清注射液(黄芩、熊胆粉、山羊角、金银花、连翘)制备的超滤膜及超滤参数。方法通过超滤前后细菌内毒素检测,脱色效果、指标性成分(黄芩苷、熊去氧胆酸、氨基酸、总固体)透过率和指纹图谱相似度评价,对超滤膜进行筛选;并以膜通量为指标,对超滤参数进行优选。结果用灵敏度0.25 EU/mL的鲎试剂检查,饮用水通过10 kDa、8 kDa、5 kDa、3 kDa的膜后均符合注射用水内毒素标准要求,不同孔径超滤膜对药液色泽和黄芩苷、熊去氧胆酸、总固体透过率影响较大,对氨基酸透过率和指纹图谱相似度影响较小;泵转速250 r/min、操作压力193.06 kPa、药液温度40℃时膜通量最大。结论选择5 kDa超滤膜能有效去除细菌内毒素,改善痰热清注射液颜色,对注射液整体化学成分影响不大,指标性成分含量及指纹图谱相似度符合痰热清注射液质量标准。

AIM To select the uhrafiltration membrane and its parameters for production process of Tanreqing Injection （Scutellariae Radix, Lonicerae japonicae Flos , Forsythiae Fructus ） . METHODS The bacterial endotoxin, decolorizing efficiency, filterability of markers （ baicalin, ursodeoxycholic acid, amino acids, total solid） and fingerprint chromatogram similarity were evaluated for pore size of membrane. The processing condition of the membrane was screened based on membrane flux. RESULTS LAL with the sensitivity of 0.25 EU/mL was used in the membrane examination. The drink water was changed up to the standard of injection water after passing through the membrane of 10 kDa, 8 kDa, 5 kDa and 3 kDa. The pore size of membrane played a key role in color filterability of baicalin, ursodeoxycholic acid, total solid, but had little influence on the filterability of amino acids and fingerprint cbromatogram similarity. The ultrafihration membrance had high membrane flux at the injection temperature of 40 ℃ , 250 r/min pump speed, 193.06 kPa working pressure. CONCLUSION The 5 kDa ultrafiltration membrance can be used to eliminate bacterial endotoxin from Tanreqing Injection effectively, and improves injection color. Indicative medicinal ingredients and fingerprint chromatogram similarity meet the quality standard of Tanreqing Injection.