正交设计结合药效学实验优选桂栀助眠胶囊提取工艺研究
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摘要
目的优选桂栀助眠胶囊最佳提取工艺。方法在单因素实验结果基础上,采取正交试验法,以干膏得率和栀子苷转移率为指标,考察加水量、提取时间、提取次数3个因素,优选桂栀助眠胶囊最佳水提工艺;以药液浓度、药液含醇量、醇沉时间为考察因素,优选桂栀助眠胶囊最佳醇沉工艺;通过改善睡眠药效学实验对醇沉前后提取物进行比较。结果桂栀助眠胶囊最佳水提工艺为加10倍量水煎煮3次,每次0.5 h;最佳醇沉工艺为水提滤液浓缩至1 mL药液相当于原药材1 g,药液含醇量为80%,醇沉时间为12 h。与阴性对照组比较,桂栀助眠胶囊水提取物能延长戊巴比妥钠小鼠睡眠时间(P<0.01),且能增加戊巴比妥钠阈下剂量小鼠入睡率(P<0.05);水提醇沉物有延长巴比妥钠小鼠睡眠时间,增加小鼠入睡率的趋势,但差异无显著性(P>0.05)。结论醇沉前后提取物药效存在差异,为不影响药效,最终选择水提工艺作为制剂的最佳提取工艺。
Objective To optimize the extraction technology of Guizhi Zhumian Capsules(GZC). Methods Based on the analysis of the single factor experiment results, the orthogonal test method was adopted to study the three factors including the amount of water added, extraction time, and extraction frequency by taking the dry extract yield of the medicinal materials and transfer rate of geniposide as indicators to optimize the water extraction process of GZC. To optimize the alcohol precipitation process of GSC, these factors including the concentration of the medicinal materials, alcohol content, and time of alcohol precipitation were investigated. The extracts before and after alcohol precipitation were compared by improving sleep pharmacodynamics. Results The best water extraction technology of GZC was decocted three times with 10 times of water, 0.5 h each time. The optimal alcohol precipitation process was to concentrate the filtrate of water extraction to 1 mL, which was equivalent to 1 g of the original medicinal materials, with 80% alcohol content and 12 h alcohol precipitation time. Compared with the negative control group, the water extract group of GZC could prolong the sleep time of pentobarbital sodium mice and increase the sleep rate of mice under the lower dose of pentobarbital sodium valve(P < 0.05). The water extract group and the water extract and alcohol precipitation showed a trend of shortening the sleep latent period of the mice with barbiturate sodium, but there was no significant difference(P > 0.05). Conclusion The pharmaceutical efficacy of the extract before and after alcohol precipitation was different. In order not to affect the drug effect, the water extraction process was finally selected as the best extraction process.
Objective To optimize the extraction technology of Guizhi Zhumian Capsules(GZC). Methods Based on the analysis of the single factor experiment results, the orthogonal test method was adopted to study the three factors including the amount of water added, extraction time, and extraction frequency by taking the dry extract yield of the medicinal materials and transfer rate of geniposide as indicators to optimize the water extraction process of GZC. To optimize the alcohol precipitation process of GSC, these factors including the concentration of the medicinal materials, alcohol content, and time of alcohol precipitation were investigated. The extracts before and after alcohol precipitation were compared by improving sleep pharmacodynamics. Results The best water extraction technology of GZC was decocted three times with 10 times of water, 0.5 h each time. The optimal alcohol precipitation process was to concentrate the filtrate of water extraction to 1 mL, which was equivalent to 1 g of the original medicinal materials, with 80% alcohol content and 12 h alcohol precipitation time. Compared with the negative control group, the water extract group of GZC could prolong the sleep time of pentobarbital sodium mice and increase the sleep rate of mice under the lower dose of pentobarbital sodium valve(P < 0.05). The water extract group and the water extract and alcohol precipitation showed a trend of shortening the sleep latent period of the mice with barbiturate sodium, but there was no significant difference(P > 0.05). Conclusion The pharmaceutical efficacy of the extract before and after alcohol precipitation was different. In order not to affect the drug effect, the water extraction process was finally selected as the best extraction process.
引文
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[13]雷鹏,刘韶,李新中,等.对《中国药典》2005年版一部栀子药材中栀子苷含量测定方法的探讨[J].中药新药与临床药理, 2007, 18(3):225-227.
[14]贺康洪,侯佳宁,张紫东,等.HPLC法测定肝血管瘤活血胶囊中栀子苷的含量[J].解放军药学学报,2014,30(6):530-534.
[15]田香,玉华,白玉霞.HPLC法测定蒙药如达七味散中栀子苷的含量[J].内蒙古民族大学学报:自然科学版, 2016, 31(2):152-155.
[16]冯华,聂明华,邹孔强,等.高效液相色谱法测定连朴饮不同煎液中栀子苷的含量[J].中国医院用药评价与分析, 2012, 12(9):809-811.
[17]侯小涛,郝二伟,秦健峰,等.肉桂的化学成分、药理作用及质量标志物(Q-marker)的预测分析[J].中草药, 2018, 49(1):20-34.
[18]李卿,梁旭明,杜洪飞,等.正交试验法优化痛风消颗粒水提醇沉工艺[J].中国药房,2016,27(4):518-521.
[19]陈恒文,张翠英,任伟光,等.多指标综合评分法优化宣痹安痛方的水提醇沉工艺[J].中国中药杂志,2016,41(1):70-74.
[2]李智欣,肖韦华,何计国,等.栀子中改善睡眠成分的研究[J].农产品加工(学刊), 2006, 73(8):79-82.
[3]王雅琪,杨园珍,伍振峰,等.中药挥发油传统功效与现代研究进展[J].中草药, 2018, 49(2):455-461.
[4]吴明侠,王淑美,梁生旺,等.交泰丸的配伍化学成分研究[J].中成药, 2005, 27(9):1119-1121.
[5]盛亚男.交泰丸镇静催眠的有效成分研究[D].广州:广州中医药大学, 2010.
[6]中国药典[S].一部. 2015.
[7]王虹玉,喇孝瑾,白素芬,等.正交试验法优选栀子豉汤的水提工艺[J].中国实验方剂学杂志, 2012, 18(22):36-38.
[8]郝博,杜守颖,洪燕龙,等.中药栀子提取工艺的实验研究[J].中国新药杂志, 2004, 13(8):715-717.
[9]毕宏生,郭俊国,解孝锋.正交试验优选栀子的水提醇沉工艺[J].中国实验方剂学杂志, 2014, 20(1):19-23.
[10]保健食品检验与评价技术规范[S]. 2003.
[11]谢松,卞晓岚,陈敬贤,等.葛芪颗粒水提醇沉工艺的优化[J].中成药, 2017, 39(8):1723-1726.
[12]李天辰,沈侃,韩伟.益气散聚方的水提醇沉工艺研究[J].中成药, 2012, 34(11):2257-2261.
[13]雷鹏,刘韶,李新中,等.对《中国药典》2005年版一部栀子药材中栀子苷含量测定方法的探讨[J].中药新药与临床药理, 2007, 18(3):225-227.
[14]贺康洪,侯佳宁,张紫东,等.HPLC法测定肝血管瘤活血胶囊中栀子苷的含量[J].解放军药学学报,2014,30(6):530-534.
[15]田香,玉华,白玉霞.HPLC法测定蒙药如达七味散中栀子苷的含量[J].内蒙古民族大学学报:自然科学版, 2016, 31(2):152-155.
[16]冯华,聂明华,邹孔强,等.高效液相色谱法测定连朴饮不同煎液中栀子苷的含量[J].中国医院用药评价与分析, 2012, 12(9):809-811.
[17]侯小涛,郝二伟,秦健峰,等.肉桂的化学成分、药理作用及质量标志物(Q-marker)的预测分析[J].中草药, 2018, 49(1):20-34.
[18]李卿,梁旭明,杜洪飞,等.正交试验法优化痛风消颗粒水提醇沉工艺[J].中国药房,2016,27(4):518-521.
[19]陈恒文,张翠英,任伟光,等.多指标综合评分法优化宣痹安痛方的水提醇沉工艺[J].中国中药杂志,2016,41(1):70-74.