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目的:研究艾纳香挥发油栓的制备工艺,考察其体外溶出效果。方法:建立艾纳香挥发油栓的含量测定及方法学考察方法,采用正交试验优化艾纳香挥发油的提取工艺,通过融变时限、外观及溶出度等指标优化对栓剂基质的考察,多指标考察栓剂最佳的成型温度、基质及辅料用量的选择,确定最佳的处方工艺。考察不同溶出方法及转速对制剂溶出度的影响,建立溶出度测定方法。结果:制备的艾纳香挥发油栓工艺稳定,正交试验最佳工艺为药材加6倍量的水、加2.5%氯化钠,提取8 h,栓剂最佳成型温度60~65℃,在45 min及3 h的累积溶出度分别达到70%,90%以上。结论:艾纳香挥发油栓处方合理,制备工艺简单可靠,稳定性良好。
Objective: To study the preparation process of Anemone volatile oil suppository and investigate its in vitro dissolution effect. Methods: The content of volatile oil suppository of Anemarrhena asphodeloides and methodological method were established. The orthogonal experiment was used to optimize the extraction process of volatile oil of Anemarrhena asphodeloides, the optimization of the matrix of suppository was studied by means of such indicators as time of thawing, appearance and dissolution. Investigate suppository the best molding temperature, the choice of matrix and auxiliary materials to determine the best prescription process. Investigate different dissolution methods and speed on the dissolution of the preparation, the establishment of dissolution assay. Results: The technology of volatile oil suppository was stable. The optimal orthogonal test was 6 times the amount of water, 2.5% sodium chloride and extraction for 8 hours. The optimum forming temperature of suppository was 60 ~ 65 ℃, The cumulative dissolution rates at min and 3 h reached 70% and 90%, respectively. Conclusion: The prescription of Anemone volatile oil suppository is reasonable, the preparation process is simple and reliable, and the stability is good.