扶正救肺颗粒成型工艺的均匀设计优选
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摘要
目的优选复方扶正救肺颗粒成型工艺的条件。方法考察不同辅料(预胶化淀粉、麦芽糊精、微晶纤维素、聚维酮、甘露醇)对浸膏粉吸湿性的影响;用均匀设计试验优选制粒工艺条件,以成型率和吸湿率为指标对辅料与浸膏粉的比例、辅料之间的比例、润湿剂(乙醇)的浓度及其用量等主要因素进行考察,并结合实际情况得出最佳成型工艺。结果 4种辅料均能明显降低浸膏粉的吸湿性,其中预胶化淀粉+麦芽糊精的效果最优,最佳成型工艺条件为辅料与浸膏粉比为1∶1,乙醇体积分数为95%,乙醇用量是浸膏粉的0.75倍,预胶化淀粉与麦芽糊精的比为0.8。结论所选辅料合理,成型制备工艺可行,为扶正救肺颗粒制粒工艺条件的确定及生产环境的控制提供了科学的实验依据。
Objective To optimize the processing conditions of compound Fuzheng Jiufei granules. Methods The influence of different excipients(including pregelatinized starch, malt dextrin, avicel, povinone, mannitol) to hygroscopicity of powdered extract were investigated; processing conditions were optimized by uniform design test, the main factors such as the ratio of excipients to extract powder, the ratio between excipients, the concentration of wetting agent(ethanol) and their dosage were investigated by formability and hygroscopicity, and the best formulation process was obtained according to the actual situation.Results The four kinds of excipients can significantly reduce the hygroscopicity of the extract powder, and the effect of pregelatinized starch + maltodextrin is the best. The best forming process is that the ratio of excipient to extract powder is 1∶1, and the volume fraction of ethanol is 95%. The amount of ethanol is 0.75 times that of the main drug, and the ratio of pregelatinized starch to maltodextrin is 0.8. Conclusion The selected excipients in Fuzheng Jiufei granule is reasonable and forming process is feasible. This research provides the basis for the establishment of forming technique and control of production environment of Fuzheng Jiufei granule.
Objective To optimize the processing conditions of compound Fuzheng Jiufei granules. Methods The influence of different excipients(including pregelatinized starch, malt dextrin, avicel, povinone, mannitol) to hygroscopicity of powdered extract were investigated; processing conditions were optimized by uniform design test, the main factors such as the ratio of excipients to extract powder, the ratio between excipients, the concentration of wetting agent(ethanol) and their dosage were investigated by formability and hygroscopicity, and the best formulation process was obtained according to the actual situation.Results The four kinds of excipients can significantly reduce the hygroscopicity of the extract powder, and the effect of pregelatinized starch + maltodextrin is the best. The best forming process is that the ratio of excipient to extract powder is 1∶1, and the volume fraction of ethanol is 95%. The amount of ethanol is 0.75 times that of the main drug, and the ratio of pregelatinized starch to maltodextrin is 0.8. Conclusion The selected excipients in Fuzheng Jiufei granule is reasonable and forming process is feasible. This research provides the basis for the establishment of forming technique and control of production environment of Fuzheng Jiufei granule.
引文
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[2] 王佩,刘晓昱,徐红.复方芪苓无糖颗粒剂成型工艺的研究[J].中华中医药学刊,2014,32(2):354.
[3] 李铜铃,贾玉蓉,魏波.不同辅料对中药冲剂吸湿性的影响[J].华西药学杂志,1993,8(2):80.
[4] 崔福德.药剂学,第6版[M].北京:人民卫生出版社,2009:123.
[5] 王秀良,向大雄,赵绪元.不同赋形剂及配方对中药喷雾干燥浸膏粉制粒的影响[J].中成药,2002,24(2):90.
[6] 韩来敏,刘宏,盛惟.沏其日甘颗粒剂成型工艺的研究[J].中国民族医药杂志,2005,11(3):35.
[7] 刘金城,杭清,楼云雁,等.复方茵柏颗粒剂成型工艺的研究[J].中华中医药学刊,2010,28(3):646.
[8] 方开泰.均匀设计及均匀设计表[M].北京:科学出版社,1994:69.
[9] 侯小涛,刘鹏,邓家刚,等.均匀设计优选甘蔗叶多糖颗粒制备工艺[J].中成药,2014,36(12):2636.
[10] 董玉秀,宋珍鹏,崔素娟.对休止角测定方法的讨论[J].中国药科大学学报,2008,39(4):317.
[11] 王娟,刘汉清.通脉颗粒的成型工艺研究[J].中药材,2006,29(7):724.