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223322p: 金币+200, 基金HEPI+1, ★★★★★最佳答案, xiexie 2017-02-19 18:07:02
223322p: 金币+200, 基金HEPI+1, ★★★★★最佳答案, xiexie 2017-02-19 18:07:02
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申请书摘要 国家食品药品监督管理局于2004年明文规定，经硫磺熏蒸的药材按劣药处理。然而由于缺少详细的科学数据，作为传统药材和饮片的加工方法，硫磺熏蒸在药材和饮片加工领域仍被广泛使用。本研究基于硫磺熏蒸中药材和饮片可能在成分、药效和毒性上发生变化，选取7种具有代表性的中药材和饮片（不同的化学类型和生物活性）- - -金银花（环烯醚萜，抗菌）、白芍（单萜苷，抗炎、镇痛）、贝母（生物碱，止咳）、人参（皂苷，免疫调节）、白芷（香豆素，止咳）、菊花（黄酮，抗氧化）、当归（苯酞，活血化瘀），运用现代色谱分析技术，结合药理和毒理方法，开展硫磺熏蒸前后中药材和饮片成分、药效和毒性的比较研究，探讨中药材和饮片经硫磺熏蒸后成分、药效和毒性的变化规律，建立硫磺熏蒸中药材和饮片的快速检测技术。本研究可客观地评价硫磺熏蒸中药材和饮片的优劣，保证临床用药的安全、有效，同时为执法部门制定中药材及饮片加工的相关法规提供科学依据。 申请书主题词 硫磺熏蒸，中药材和饮片，快速检测，安全性评价 结题中文摘要 本课题系统考察了硫磺熏蒸对白芍和白芷化学成分、药效、毒性及无机元素等各个方面的影响。通过对硫熏前后药材的HPLC、HPLC-MS定性分析和HPLC定量分析，结果表明硫熏使白芍和白芷的主要化学成分发生了质和量的改变，并产生了新的化学成分。采用ICP-AES分析方法测定了硫熏前后白芍和白芷中有害重金属、硫及主要微量元素，结果显示硫熏导致其中残留大量的硫，并引起As、Hg、Pb等重金属残留，同时会改变某些微量元素的含量。采用红外光谱法建立了硫熏药材的快速检测技术。通过抗炎和镇痛实验考察了硫熏对白芍和白芷的药效学影响，结果显示在抗炎实验中硫熏组较未熏组效应明显降低。通过急性毒性和长期毒性实验对硫熏药材的毒性进行考察，急性毒性的实验结果显示硫熏白芍的毒性强于未熏白芍，而未熏白芷的毒性强于硫熏白芷；长期毒性的血液生化指标检查结果显示硫熏药材灌服对大鼠肌酐、尿素氮、总胆红素以及各种无机盐离子影响较大，反映出硫熏药材可能对肝肾功能以及排泄和代谢有一定的影响；长期毒性的病理组织学结果显示，在所设剂量下，硫熏白芍对大鼠肾脏的毒性作用可能具有可逆性，而硫熏白芷对大鼠肝脏、肾脏的毒性作用可能具有不可逆性。 结题英文摘要 This work was carried out systematically to investigate the affects of chemical constituents, afficacy,toxicity and inorganic elements of RADIX PAEONIAE ALBA and RADIX ANGELICAE DAHURICAE by sulfur-fumigated process. The results showed that the main chemical constituents changed in quality and quantity and new chemical constituents appeared in RADIX PAEONIAE ALBA and RADIX ANGELICAE DAHURICAE before and after sulfur-fumigated process through HPLC,HPLC-MS qualitative and HPLC quantitative analyses. The results suggested that sulfur-fumigated process could result in the residues of sulfur,and some heavy metals, such as As,Hg,Pb, and meantime the content changes of some trace elements by using ICP-AES analytical method to determine the harmful heavy metals, sulfur and the main trace elements in RADIX PAEONIAE ALBA and RADIX ANGELICAE DAHURICAE before and after sulfur-fumigated process. A rapid detection method coupled with IR spectroscopy for distinguishing the sulfur-fumigated medicinal materials was established. The results showed that the afficacies in sulfur-fumigated groups were decreased compare to that in non sulfur-fumigated groups in anti-inflammatory experiment by anti-inflammatory and analgesic investigations to the sulfur-fumigated affects in RADIX PAEONIAE ALBA and RADIX ANGELICAE DAHURICAE. Through the experimental investigations of acute and chronic toxicities to sulfur-fumigated medicinal materials, the results of acute toxicity showed that the toxicity of sulfur-fumigated RADIX PAEONIAE ALBA was stronger than that of non sulfur-fumigated one, and the toxicity of non sulfur-fumigated RADIX ANGELICAE DAHURICAE was stronger than that of sulfur-fumigated one. The blood biochemical indexes of chronic toxicity showed that the administrations of sulfur-fumigated medicinal materials had great affects to creatinine, urea nitrogen, total Bilirubin and all kinds of inorganic salt ions in rats, suggested that sulfur-fumigated medicinal materials might affect excretion ,metabolism and the functions of liver and kidney. The results of histopathology of chronic toxicity showed that the toxicity to rats' kidneys with sulfur-fumigated RADIX PAEONIAE ALBA might be reversible, and the toxicity to rats' livers and kidneys with sulfur-fumigated RADIX ANGELICAE DAHURICAE might be irreversible under given dosages. |
2楼2017-02-19 16:34:42