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目的:优选盆炎康栓的制备工艺,为该制剂的临床应用提供参考。方法:以绿原酸、丹酚酸B提取量及干膏收率为综合评价指标,通过正交试验考察提取次数、加水量和煎煮时间对盆炎康栓水提工艺的影响;以延胡索乙素提取量及干膏收率的综合评分为指标,通过正交试验考察加醇量、提取时间和乙醇体积分数对醇提工艺影响。以栓剂成型后的外观、硬度、熔点及溶出度为指标,通过单因素试验优选盆炎康栓的成型工艺。结果:最佳水提工艺为加8倍量水提取2次,每次1 h;绿原酸、丹酚酸B平均提取量分别为2.778,30.314 mg·g-1。最佳醇提工艺为加4倍量60%乙醇提取2次,每次1.5 h;延胡索乙素提取量0.758 mg·g-1。优选的成型工艺为以36型混合脂肪酸甘油酯为基质,聚山梨酯-80加入量1.5%,水浴50℃制栓。结论:优选的提取工艺和成型工艺稳定可行,适合盆炎康栓的工业化生产。
Objective: To optimize the preparation technology of Pan Yan Kang suppository to provide a reference for the clinical application of the preparation. Methods: The chlorogenic acid, salvianolic acid B extraction yield and dry paste yield as a comprehensive evaluation index, through orthogonal test to examine the extraction times, water and boiling time on the Penyankangshui extraction process; Corydalis B extract volume and dry extract yield as a comprehensive assessment of the indicators through orthogonal test to examine the amount of alcohol, extraction time and ethanol volume fraction of alcohol extraction process. The suppository appearance, hardness, melting point and dissolution as an index, through the single factor test preferred basin Yan Kang bolt forming process. Results: The best water extraction process was extracted twice with 8 times of water for 1 h each time. The average extraction rates of chlorogenic acid and salvianolic acid B were 2.778 and 30.314 mg · g-1, respectively. The best alcohol extraction process was 4 times the amount of 60% ethanol extracted twice, each 1.5 h; tetrahydropalmatine extraction amount 0.758 mg · g-1. The preferred molding process is based on the type 36 mixed fatty acid glyceride as a substrate, polysorbate-80 added in an amount of 1.5% and water bath at 50 ° C. Conclusion: The optimal extraction process and molding process are stable and feasible, which is suitable for the industrial production of Penyankang suppository.