| The Goupi Gao originating from the experience preparation in Ming dynasty is the drug preparation recorded in Chinese Pharmacopoeia 2010 (volume one) and the representative preparation of black plaster; the prescription of the Goupi Gao mainly consists of 29 kinds of traditional Chinese medicines, such as unprocessed radix aconite, unprocessed radix aconiti kusnezoffii, notopterygium root, etc.; the Goupi Gao is capable of relieving rheumatism and cold invigorating blood circulation and stopping pains; said traditional Chinese medicines are prepared for treating rheumatism, traumatic injury, limb numbness and lumbago with obvious effect in clinical treatment; the Goupi Gao can be widely applied clinically; aiming at the situation that the safety study on the traditional extracorporeal black plaster is not complete yet, the Goupi Gao is selected to be the study object in this thesis; by looking up some documents, the possible toxic ingredients in the preparation are defined to be aconitum di-ester alkaloid and heavy metal lead; via the study on the Goupi Gao, the following main study contents and results are obtained:1.detection to aconitum di-ester alkaloidA high performance liquid chromatography for detecting ingredients of aconitine, hypaconitine and mesaconitine is established; the lowest detection limits of three toxic ingredients are set to 0.056 micro-grams,0.100 micro-grams and 0.039 micro-grams; the feeding slices (unprocessed radix aconite), the medicine oil, the medicine dregs and the drug preparation in the preparation process of the Goupi Gao are detected; showing by the detection, all of three di-ester alkaloid ingredients are not detected from the medicine oil, the medicine dregs or the Goupi Gao, which proves that the toxic ingredients in the slices are damaged by high-temperature frying operation, and the unsafe factors during the medication can be reduced.2.study on determination to lead content in Guopi GaoWith the EDTA complexometry and two pre-treatment methods of ignition method and dissolving method, the lead contents of 11 kinds of Goupi Gao are determined; the lead contents are 17%-24% determined with the ignition method and the lead contents are 15%-24% determined with the dissolving method; the lead content determined with the dissolving method is only the lead content of the fatty acid lead salt in the preparation, and the lead content determined with the ignition method comprises the lead content of the fatty acid lead salt and the lead content of red lead without being completely chemically combined with the plant oil during the plaster refining operation; with the difference between the lead contents determined with two methods, the chemical combination reaction degree between the oil and fat and the red lead can be judged as one of the quality control foundations of the Goupi Gao.3.study on extracorporeal percutaneous absorption of lead in Goupi GaoThe microwave digestion-graphite oven atomic absorption spectrometry for determining the lead content of receiver in extracorporeal percutaneous absorption experiment is established; with a Franz diffusion cell, the affections of different receivers and temperatures to the accumulated permeability of unit lead area are considered; the study suggests that the lead in the Goupi Gao permeates through the skin in zero-level release equation so as the prompt that the amount of the lead permeating through the skin is increasing as time goes on when the Goupi Gao is being used.The extracorporeal percutaneous absorption data is fitted and predicted with a GM (1,1) model; a short-term prediction value (12h) has high accuracy with the relative error of 1.04%; the relative errors of the long-term prediction values (20, 24h) are increased, to be 78.18% and 99.31%. |
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