黄芪胃漂浮片制备工艺和质量标准研究
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摘要
目的:研究黄芪胃漂浮片的提取和成型工艺,制备成适应临床应用的新制剂,建立质量标准。
方法:(1)根据黄芪主要成分的理化性质,选择适宜的提取方法,并运用正交实验设计的方法优选最佳提取工艺。
(2)根据辅料性质及制剂质量要求,用单因素考察选择适宜的辅料,用正交实验优选辅料的最佳用量;考察颗粒干燥时间、片重、片剂硬度对漂浮性能的影响;根据拟定的制剂处方确定完成制备工艺制粒压片,得到黄芪胃漂浮片。
(3)对漂浮片中黄芪进行TLC鉴别,通过方法学考察建立黄芪甲苷和黄芪多糖的含量测定方法。
(4)应用自制浮力测定装置对制剂漂浮性能进行考察,拟合漂浮曲线,预测漂浮时间。
结果:(1)确定黄芪的提取工艺为:用12倍量水提取3次,每次1.5h。
(2)筛选出辅料及用量为:HPMC E50 16.5g/100片、Na2CO3 3.3g/100片、HEC 3.3g/100片,以湿法制颗粒压片,干燥时间为24h,片剂硬度在3～5kg。
(3)建立黄芪胃漂浮片的质量标准,方法学考察结果表明:精密度、稳定性、重现性以及加样回收率均符合要求,实验数据稳定可靠。
(4)浮力-时间曲线拟合为对数曲线,方程显著,95%置信区间起浮时间为5～9分钟。
结论:黄芪提取工艺合理,数据可靠;成型工艺达到了漂浮片的要求。制成的黄芪胃漂浮片符合药典片剂项下规定,完成了黄芪胃漂浮片的质量标准拟定,为将中药提取物制备成漂浮片提供了依据。
Objective:To study Huang Qi floating tablets extraction and the confectioning technology,as well as its new preparation suitable for clinical practice,and the establishment of its quality specification.
Methods:(1)According to the physico-chemical properties of the active ingredients in Astragalus,chose eligible extraction method,and optimized the extraction process by orthogonal experiment.(2)According to nature of the excipients and the need for floating,appropriate excipients were chosen by single factor consideration,whose proportion is later optimized by orthogonal experiment.The desiccation time and pressure of the preparation were evaluated by vitro floatation performance.Then on the basis of the determined prescription and preparation technics,Huang Qi floating tablets were obtained by wet granulation,tabletting.(3)TLC qualitative distinction was used;the content determination of astragalosideⅣand astragalus polysaccharides were established through methodology investigation. (4)A new apparatus was used to evaluate vitro floatation performance,and the datas were simulated to equation,which could forecast the floationg time.
Results:(1)Extraction process of Astragalus was determined:to extract with 12-time water for 3 times,each time for 1.5h.(2)The eligible dosage was:HPMC E50 16.5g/100 tablets,Na2CO3 3.3g/100 tablets,HEC 3.3g/100 tablets. The desiccation time was 24h.The pressure of the preparation was 3～5Kg.(3)Quality specification of Huang Qi floating tablets was established.The methodology consideration result indicated that:the precision,the stability,the reproduction quality and application of sample recovery rate can meet the requirement. (4)Curve regression for test data showed the change of buoyancy by time was logarithmic linear equation,which is significant.Floating time was 5～9 minutes by 95% confidence interval.
Conclusion:Extraction process of each ingredients in a prescription was reasonable,the data was reliable;the confectioning process improved the vitro floatation performance.Huang Qi floating tablets conformed to regulations of the tablet item in 2005 edition of Chinese Pharmacopoeia.The experiment provided experiences for the preparation of floating tablets with TCM extraction.
方法:(1)根据黄芪主要成分的理化性质,选择适宜的提取方法,并运用正交实验设计的方法优选最佳提取工艺。
(2)根据辅料性质及制剂质量要求,用单因素考察选择适宜的辅料,用正交实验优选辅料的最佳用量;考察颗粒干燥时间、片重、片剂硬度对漂浮性能的影响;根据拟定的制剂处方确定完成制备工艺制粒压片,得到黄芪胃漂浮片。
(3)对漂浮片中黄芪进行TLC鉴别,通过方法学考察建立黄芪甲苷和黄芪多糖的含量测定方法。
(4)应用自制浮力测定装置对制剂漂浮性能进行考察,拟合漂浮曲线,预测漂浮时间。
结果:(1)确定黄芪的提取工艺为:用12倍量水提取3次,每次1.5h。
(2)筛选出辅料及用量为:HPMC E50 16.5g/100片、Na2CO3 3.3g/100片、HEC 3.3g/100片,以湿法制颗粒压片,干燥时间为24h,片剂硬度在3～5kg。
(3)建立黄芪胃漂浮片的质量标准,方法学考察结果表明:精密度、稳定性、重现性以及加样回收率均符合要求,实验数据稳定可靠。
(4)浮力-时间曲线拟合为对数曲线,方程显著,95%置信区间起浮时间为5～9分钟。
结论:黄芪提取工艺合理,数据可靠;成型工艺达到了漂浮片的要求。制成的黄芪胃漂浮片符合药典片剂项下规定,完成了黄芪胃漂浮片的质量标准拟定,为将中药提取物制备成漂浮片提供了依据。
Objective:To study Huang Qi floating tablets extraction and the confectioning technology,as well as its new preparation suitable for clinical practice,and the establishment of its quality specification.
Methods:(1)According to the physico-chemical properties of the active ingredients in Astragalus,chose eligible extraction method,and optimized the extraction process by orthogonal experiment.(2)According to nature of the excipients and the need for floating,appropriate excipients were chosen by single factor consideration,whose proportion is later optimized by orthogonal experiment.The desiccation time and pressure of the preparation were evaluated by vitro floatation performance.Then on the basis of the determined prescription and preparation technics,Huang Qi floating tablets were obtained by wet granulation,tabletting.(3)TLC qualitative distinction was used;the content determination of astragalosideⅣand astragalus polysaccharides were established through methodology investigation. (4)A new apparatus was used to evaluate vitro floatation performance,and the datas were simulated to equation,which could forecast the floationg time.
Results:(1)Extraction process of Astragalus was determined:to extract with 12-time water for 3 times,each time for 1.5h.(2)The eligible dosage was:HPMC E50 16.5g/100 tablets,Na2CO3 3.3g/100 tablets,HEC 3.3g/100 tablets. The desiccation time was 24h.The pressure of the preparation was 3～5Kg.(3)Quality specification of Huang Qi floating tablets was established.The methodology consideration result indicated that:the precision,the stability,the reproduction quality and application of sample recovery rate can meet the requirement. (4)Curve regression for test data showed the change of buoyancy by time was logarithmic linear equation,which is significant.Floating time was 5～9 minutes by 95% confidence interval.
Conclusion:Extraction process of each ingredients in a prescription was reasonable,the data was reliable;the confectioning process improved the vitro floatation performance.Huang Qi floating tablets conformed to regulations of the tablet item in 2005 edition of Chinese Pharmacopoeia.The experiment provided experiences for the preparation of floating tablets with TCM extraction.
引文
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