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目的采用星点设计-效应面法优选茯苓皮总三萜液固压缩片处方,以提高其体外溶出度。方法通过预试验和单因素考察初步确定所选辅料及比例,以溶出度为考察指标,采用星点设计-效应面法进一步优化处方,对最优处方的茯苓皮总三萜液固粉末、茯苓皮总三萜原料、液固压缩片辅料混合粉末进行差示扫描量热分析(DSC),考察药物与辅料之间是否存在相互作用以及药物在液固压缩制剂中的存在形式。结果茯苓皮总三萜液固压缩片的最优处方为药液比1∶1.67,载体材料与涂层材料的比值(R值)为18.25,崩解剂加入量为8%,PVP-XL 10与CMS-Na的比值为1.27,压制硬度为40~50 N。DSC分析表明辅料与茯苓皮总三萜不存在相互作用,药物在液固粉末中是以非晶型形式存在的。结论茯苓皮总三萜液固压缩片处方合理,可提高茯苓皮总三萜的体外溶出度,并将药物从结晶状态转化为分子或无定形状态。
Objective To optimize the dissolution of triterpenoids in tuckahoe by the combination of star point design and response surface methodology. Methods The pre-test and single-factor study were carried out to determine the selected adjuvants and their proportions. Dissolution was taken as the index of study. The optimal design was further optimized by using the star-point design-response surface method. The total triterpene liquid-solid powder and Poria cocos The total triterpene raw material and the liquid-solid compressed tablet auxiliary powder were subjected to differential scanning calorimetry (DSC) to examine the interaction between the drug and the excipients and the existence of the drug in the liquid-solid compression preparation. Results The optimum formulation of total triterpene liquid-solid compressed tablets of Poria cocos from the ratio of liquid to solid was 1:1.67, the ratio of carrier material to coating material was 18.25, the disintegrating agent was 8%, PVP-XL 10 The ratio to CMS-Na is 1.27 and the press hardness is 40 to 50 N. DSC analysis showed that excipient and tuckahoe triterpenes there is no interaction, the drug in the liquid-solid powder is amorphous form. Conclusion The total triterpene fluid-compressed tablets of Poria cocos were reasonable and could improve the dissolution rate of Triterpen peculiar triterpenoids in vitro and convert the drugs from crystalline state to molecular or amorphous state.