机构地区:[1]湖南中医药大学药学院,湖南长沙410208 [2]中药药性与药效国家中医药管理局重点实验室,湖南长沙410208 [3]湖南中医药大学现代中药制技术与评价实验室,湖南长沙410208 [4]中南大学临床药理研究所,湖南长沙4100078 [5]湖南中医药大学第一附属医院,湖南长沙410007
出 处:《中成药》2011年第8期1292-1298,共7页Chinese Traditional Patent Medicine
基 金:国家自然科学基金项目(81073142;30901971);湖南省科技厅项目(2010SK3019);教育厅重点项目(09A068)
摘 要:目的建立中药材群体指纹图谱信息量及一次投料量数学模型并进行实验验证。方法运用信息熵及遗传统计学原理,建立数学模型,以大黄醇提物及鱼腥草挥发油进行验证。结果建立了中药群体指纹图谱信息量及制剂稳态质量控制的一次投料量数学模型。大黄醇提物采用HPLC测定,在4.189μg进样量时指纹图谱的绝对和相对信息量较大,指纹图谱绝对信息量为1.535×109μV.s,RSD为37.23%,相对信息量为5.360×108μV.s.μg-1,RSD为19.42%;稳态质量控制一次投料量共需80 836 g。鱼腥草挥发油采用GC测定,指纹图谱的绝对信息量为2.472×107 mV.s,RSD为90.46%,相对信息量为5.353×106 mV.s.μg-1,RSD为80.96%;稳态质量控制一次投料量共需43 600 g(合9 544株)。结论中药的质量受中药遗传多态性影响,体现Hardy-weiberg群体平衡质量。大黄、鱼腥草平衡质量(一次投料量)远大于中国药典规定,其斗谱给药不能反映其遗传多态性要求。AIM To establish and validate the once sampling capacity mathematical model for the Chinese materia medica(CMM) with chromatgraphic fingerpingt information power by Rhei Radix et Rhizoma extract and Houttuyniae Herba.METHODS The mathematical model has been established by way of the statistical genetics,and validated by Rhei Radix et Rhizoma extract and Houttuyniae Herba.RESULTS The model has been elucidated and established at pharmaceutical quality control levels for the CMM.The experiments have been carried out by HPLC chromatographic fingerprint of Rhei Radix et Rhizoma extract and GC chromatographic fingerprint of Houttuyniae Herba.The most of absolute and relative information powers were obtained at sampling capacities of 3.251-4.189 μg.The absolute and relative information powers of HPLC chromatographic fingerprint of Rhei Radix et Rhizoma extract were on average 1.535×109 μV·s with RSD of 37.23% and 5.360×108 μV·s·μg-1 with RSD of 19.42%,respectively.The once sampling capacities for Rhei Radix et Rhizoma were 80 836 g at pharmaceutical stable quality control levels.The absolute and relative information powers of GC chromatographic fingerprint of Houttuyniae Herba were on average 2.472×107 mV·s with RSD of 90.46% and 5.353×106 mV·s·μg-1 with RSD of 80.96%,respectively.The once sampling capacities for Houttuyniae Herba were 43 600 g(equal to 9 544 stocks) at pharmaceutical stable quality control levels.CONCLUSION The quality controls for the CMM were influenced by their own genetic polymorphism,with the Hardy-weiberg population equilibrium property.The once sampling capacities for Rhei Radix et Rhizoma and Houttuyniae Herba for information powers were more than that regulated by pharmaceutical stable quality control levels from ’China pharmacopiea’.The administration of the orders of piece arrangement for them were not accordant with the genetic polymorphisms.
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