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目的:优选清宫消炎栓最佳制备工艺条件。方法:采用高效液相色谱法以栓剂外观、硬度及苦参碱、氧化苦参碱含量为考察指标,在加速试验条件下,对栓剂外观及硬度进行考察;并对苦参中苦参碱、氧化苦参碱进行含量测定,优选最佳制剂成型工艺。结果:清宫消炎栓栓重为3.00 g/粒,经加速试验(1个月)外观及硬度适宜,栓剂重量未发生明显变化;苦参碱、氧化苦参碱含量最高,说明栓重为3.00 g/粒;药粉加甘油比例为0.5%时栓剂稳定性最好。结论:栓剂稳定性好,适合工业化生产。
Objective: To optimize the preparation of anti-inflammatory suppository Qing process conditions. Methods: The appearance and hardness of suppositories were investigated by HPLC. The contents of matrine, matrine and oxymatrine were investigated under accelerated test conditions. Oxymatrine for determination of content, preferably the best preparation molding process. Results: The weight of anti-inflammatory suppository of Qing Yan was 3.00 g / tablet. After accelerated test (1 month), appearance and hardness were suitable, the weight of suppository did not change obviously. The content of matrine and oxymatrine was the highest, / Tablets; suppository stability is best when the ratio of powder to glycerol is 0.5%. Conclusion: The suppository has good stability and is suitable for industrialized production.