中药整体质量控制标准体系构建和中药一致性评价步骤
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摘要
阐述中药整体质量控制标准体系构建方法和中药一致性评价核心方法,提出中药拉平投料基本操作方法;阐述中药标准制剂概念和构建方法,剖析中药5种质量控制模式基本内涵,指出中药标准制剂控制模式的优越性和先进性;增加【定量指纹检查】项是控制中药整体质量批间一致性的关键;用宏定性相似度(Sm)> 0.90,宏定量相似度(Pm)在80%～120%作为整体控制方法是提升我国中药整体质量的首要前提;用中药紫外全指纹溶出度测定法监控中药主组分化学指纹的整体溶出行为的一致性。可见,基于系统指纹定量法的标准制剂控制模式和拉平投料技术是实现中药整体质量批间一致性控制的保证和检验中药主组分物质的整体质量平衡传输的有效方法,可实现中药整体质量批间一致性的控制;基于三固色谱柱和指纹系统定量校正因子校正,采用《中国药典》指标成分的精准定量和标准指纹图谱整体定量检查法可实现中药整体质量批间一致性的宏观定量的精准控制;中药紫外全指纹溶出度测定法能代表中药所有主组分的溶出度,其在中药固体制剂工艺一致性评价中具有高效、便捷、准确和可靠的特点。
To construct the standard overall quality control system for traditional Chinese medicine(TCM),establish TCM quality consistency evaluation, and to introduce the basic operation of leveling the input of TCM materials. We expounded the basic concept of TCM standard preparation and construction method, analyzed the basic connotation of 5 quality control models of TCM, and stated the superiority and advancement of the control mode of TCM standard preparation. Quantitative fingerprint was added as one of the check items in TCM standard and was the key to the consistency control of inter-batch quality. The macro qualitative similarity(Sm) of the profiling of samples no less than 0.90 and the macro quantitative similarity(Pm) within 80%-120% were used as the control method, and also the prerequisites for improving the overall quality level of TCM. The UV full fingerprint dissolution test was used to monitor the consistency of the whole dissolution behaviors of fingerprint of TCM main components. The control mode of TCM standard preparation and the leveling feed technology,which were based on the Systematically Quantified Fingerprint Method, were the most effective ways to control the quality consistency between batches of the overall quality of TCM. From the macro-strategic perspective, the Chinese Pharmacopoeia used both the quantitative profiling to check and control the overall amplitude of chemical fingerprints of the main components in TCM and the precise quantitative control of the marker components for modernization. The control mode of TCM standard preparation and the leveling loading technology for TCM raw materials, help achieve the quality consistency of the overall quality between batches of TCM. Both are effective methods to ensure and test the overall mass balance transmission of the main components in TCM. Based on the three-solid chromatographic column and the calibration of correction factors of fingerprint system, the macroscopic and quantitative control of the overall quality consistency of TCM between batches may be achieved with both the precise quantitative method for the marker components in Chinese Pharmacopoeia and the overall quantitative method of standard fingerprint. The dissolution of all the main components in TCM may be represented by the UV full fingerprint dissolution test of TCM, characterized by high efficiency, convenience, accuracy and reliability in the quality consistency evaluation for TCM solid preparation process.
To construct the standard overall quality control system for traditional Chinese medicine(TCM),establish TCM quality consistency evaluation, and to introduce the basic operation of leveling the input of TCM materials. We expounded the basic concept of TCM standard preparation and construction method, analyzed the basic connotation of 5 quality control models of TCM, and stated the superiority and advancement of the control mode of TCM standard preparation. Quantitative fingerprint was added as one of the check items in TCM standard and was the key to the consistency control of inter-batch quality. The macro qualitative similarity(Sm) of the profiling of samples no less than 0.90 and the macro quantitative similarity(Pm) within 80%-120% were used as the control method, and also the prerequisites for improving the overall quality level of TCM. The UV full fingerprint dissolution test was used to monitor the consistency of the whole dissolution behaviors of fingerprint of TCM main components. The control mode of TCM standard preparation and the leveling feed technology,which were based on the Systematically Quantified Fingerprint Method, were the most effective ways to control the quality consistency between batches of the overall quality of TCM. From the macro-strategic perspective, the Chinese Pharmacopoeia used both the quantitative profiling to check and control the overall amplitude of chemical fingerprints of the main components in TCM and the precise quantitative control of the marker components for modernization. The control mode of TCM standard preparation and the leveling loading technology for TCM raw materials, help achieve the quality consistency of the overall quality between batches of TCM. Both are effective methods to ensure and test the overall mass balance transmission of the main components in TCM. Based on the three-solid chromatographic column and the calibration of correction factors of fingerprint system, the macroscopic and quantitative control of the overall quality consistency of TCM between batches may be achieved with both the precise quantitative method for the marker components in Chinese Pharmacopoeia and the overall quantitative method of standard fingerprint. The dissolution of all the main components in TCM may be represented by the UV full fingerprint dissolution test of TCM, characterized by high efficiency, convenience, accuracy and reliability in the quality consistency evaluation for TCM solid preparation process.
引文
[1]孙国祥,陈新新,孙万阳,等.中药标准制剂控制模式发展历程和构建全质量关控制中药质量模式[J].中南药学,2014,12(1):1-9.
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[11]孙国祥,史香芬,张静娴,等.指纹定量法测定中药复方指纹归属度和药效物质工艺收率[J].药学学报,2008,43(10):1047-1052.
[12]Liu Y,Liu Z,Sun G,et al. Monitoring and evaluating the quality consistency of compound bismuth aluminate tablets by a simple quantified ratio fingerprint method combined with simultaneous determination of five compounds and correlated with antioxidant activities[J]. PLoS One,2015,10(3):e0118223
[13]Yang L,Sun G,Guo Y,et al. Holistic evaluation of quality consistency of Ixeris sonchifolia(Bunge)Hance Injectables by quantitative fingerprinting in combination with antioxidant activity and chemometric methods[J].PLoS One,2016,11(2):e0148878.
[14]Yang LP,Xie XM,Zhang J,et al. Microemulsion electrokinetic chromatography in combination with chemometric methods to evaluate the holistic quality consistency and predict the antioxidant activity of Ixeris sonchifolia antioxidant activity of Ixeris sonchifolia(Bunge)Hance injection[J]. PLoS One,2016,11(6):e0157601.
[15]谢元超,巩丽萍,徐晓洁,等.自身对照法测定复方黄连素片溶出度[J].药物分析杂志,2012,32(8):1486-1489.
[16]Sun GX,Song YQ,Li LF,et al. Quickly quantifying the dissolution fingerprints of compound Danshen dropping pill by HPLC[J].Ann Trans Med,2013,1(2):16.
[2]孙国祥,张玉静,孙万阳,等.中药一致性评价关键问题——中药标准制剂控制模式和定量指纹图谱检查项[J].中南药学,2016,14(10):1026-1032.
[3]孙国祥,孙万阳,张晶,等.中药质量一致性评价体系-基于定量指纹图谱检查的中药标准制剂控制模式的解析[J].中南药学,2018,16(1):2-13.
[4]孙国祥,智雪枝,张春玲,等.中药色谱指纹图谱超信息特征数字化评价系统[J].中南药学,2007,5(6):549-555.
[5]孙国祥,胡玥珊,毕开顺.系统指纹定量法评价牛黄解毒片质量[J].药学学报,2009,44(4):401-405.
[6]孙国祥,张静娴.系统指纹定量法鉴别龙胆泻肝丸质量[J].分析化学,2009,37(8):1183-1187.
[7]孙国祥,任培培,毕雨萌,等.双定性双定量相似度法评价银杏达莫注射液的高效液相色谱指纹图谱[J].色谱,2007,25(4):518-523.
[8]孙国祥,王玲娇.基于双波长HPLC指纹谱的一级系统指纹定量法鉴定木香顺气丸质量[J].化学学报,2010,68(18):1903-1908.
[9]孙国祥,侯志飞,张春玲,等.色谱指纹图谱定性相似度和定量相似度的比较研究[J].药学学报,2007,42(1):75-80.
[10]Sun GX,Zhi XZ,Bi KS. Overall qualitative and overall quantitative assessment of compound liquoric tablets using HPLC fingerprints[J]. Anal Sci,2009,25(4):529-534.
[11]孙国祥,史香芬,张静娴,等.指纹定量法测定中药复方指纹归属度和药效物质工艺收率[J].药学学报,2008,43(10):1047-1052.
[12]Liu Y,Liu Z,Sun G,et al. Monitoring and evaluating the quality consistency of compound bismuth aluminate tablets by a simple quantified ratio fingerprint method combined with simultaneous determination of five compounds and correlated with antioxidant activities[J]. PLoS One,2015,10(3):e0118223
[13]Yang L,Sun G,Guo Y,et al. Holistic evaluation of quality consistency of Ixeris sonchifolia(Bunge)Hance Injectables by quantitative fingerprinting in combination with antioxidant activity and chemometric methods[J].PLoS One,2016,11(2):e0148878.
[14]Yang LP,Xie XM,Zhang J,et al. Microemulsion electrokinetic chromatography in combination with chemometric methods to evaluate the holistic quality consistency and predict the antioxidant activity of Ixeris sonchifolia antioxidant activity of Ixeris sonchifolia(Bunge)Hance injection[J]. PLoS One,2016,11(6):e0157601.
[15]谢元超,巩丽萍,徐晓洁,等.自身对照法测定复方黄连素片溶出度[J].药物分析杂志,2012,32(8):1486-1489.
[16]Sun GX,Song YQ,Li LF,et al. Quickly quantifying the dissolution fingerprints of compound Danshen dropping pill by HPLC[J].Ann Trans Med,2013,1(2):16.