| Objective:By Cuscuta chinensis Lam.total flavonoids from pharmacokinetic trial,I discussion pharmacokinetic study of traditional Chinese medicine ideas and methods.Method:1.Orthogonal design experimental Optimal extraction Cuscuta chinensis Lam.total flavonoids craft。2.The healthy volunteer takes Cuscuta chinensis Lam.total flavonoids.at 0,0.5,1.0,2.0,3.0,4.0,8.0,12.0,24.0,48.Ohour, Draws blood to freeze the preservation 2ml to the heparin antifreeze tube in testing.Will extract blood plasma room temperature melting;Sets at 1ml in the centrifuge tube; Joins ethyl acetate 0.6 ml precisely;On turbulent flow liquid mixer vortex 2min;Centrifugal 5 min(3000 r/min-1);Absorption supernate;37℃the water bath nitrogen air current wields does;The residual dissolves with 40μl the methyl alcohol。HPLC determination content,Specimen handling 10μl; The record peak area carries on the quantitative analysis。3.The use of 3p97 software analysis pharmacokinetic data;Calculate the number of different atrioventricular,Weight coefficient,Goodness of fit value;obtained relevant pharmacokinetic parameters.4.To the problems encountered during the experiment:Dodder lack of standard components and component complex, active ingredient is not clear, difficult to control the quality of test operationOther issues.Discussion solution countermeasure, how does conduct the traditional Chinese medicine medicine generation of dynamics research under the Chinese medicine theory instruction.Results:1.Orthogonal design experimental result:The extraction process is A1B1C3D3,Ethyl alcohol density 50% adds 10 time of quantity ethyl alcohol to withdraw 90min, withdraws 3 times. The ethyl alcohol density has the remarkable influence to the Hyperoside content(P<0.05).Ethyl alcohol quantity, extraction time,extraction number of times to Hyperoside content not remarkable significance(P>0.05).It is that factor A has the significance influence to the test result, Factor B, C, D to test result non-significance influence.The influence Hyperoside glucoside factor's order is A>D>C>B in turn.The ethyl alcohol density>withdraws the number of times>to withdraw the time>the ethyl alcohol quantity. Therefore in the production and the experiment process must guarantee the ethyl alcohol density. Best preparation craft is A1B3C3D3,the ethyl alcohol density 50%, add 10 time of quantity ethyl alcohol,withdraws 90min,withdraws 3 times.2.Pharmacokinetics Test:the pharmacokinetic analysis of data software 3p97, the hyperin In total flavonoids sbsorption metabolism in the body consistent with one compartment model.T(peak)3.26h,t1/2(ka)1.55h, t1/2(ke)3.48h,Shows hyperin Cuscuta in vivo absorption and elimination in the time gap.3.In the experiment faces question and countermeasure:3.1 the chemical composition of traditional Chinese medicine complex and diverse。first:to develop a large number of standards,Traditional Chinese medicine standard substance and establish fingerprint.Since the chemical composition of traditional Chinese medicine complex and diverse,.Development of standard also require substantial human,material.in the short term can not be resolved.second, Tracer technique.Using radioisotope or stable isotope labeled drug, and determine the in absorption, distribution,excretion dynamic process,with good sensitivity, high accuracy, wide applicability, but the radioactive pollution of the environment law, Stable isotope's tracer manufacture cost is high,the difficulty to be big.Third, PK/PD union.to "effect" on the "certificate",the establishment of efficacy-time, Some scholars put forward the "Pharmacokinetics and Treatment" of compound.In this respect, need medicine "certificate" and "efficacy evaluation" standards.Combination of the two to see, Need to develop a series of standards, The standard of Chinese medicine, Chinese medicine quality standards, including standards for Chinese medicine products, fingerprinting, diagnostic criteria for traditional Chinese medicine, TCM clinical efficacy evaluation criteria.Pharmacokinetics of traditional Chinese medicine the key issues is a standard problem,traditional Chinese medicine, including standards and criteria.3.2 Chinese medicine treatment technology process.,need standardization,information.Establish standards for Chinese medicine clinics. Methodology, using the syndrome information science, mathematics,science scale, syndromes evaluation.TCM Syndrome informatics is as a medical information,The use of modern information technology to collect, analyze and deal with.Clinical data acquisition is collected and stored procedure.in the diagnosis and treatment the amount of information(including symptoms, signs, laboratory tests, etc.).The syndrome of objective, standardized and digital is the foundation and the key of integration the syndrome and information science.The standardization of Chinese medicine,first determine the standard system framework. Standard System of Traditional Chinese Medicine, promote the standardization of Chinese medicine, has great practical significance and role for standardization in Chinese medicine,create the conditions and standards of support provided for the modernization and internationalization of Chinese medicine.3.3 The quality of clinical trials can be controlled The traditional Chinese medicine clinical trial has not suited own complete detailed guiding principle. the traditional Chinese medicine has its own characteristic.The traditionalChinese medicine clinical trial copy western medicine to have the unreasonable place inevitably.the question which the solution traditional Chinese medicine clinical trial faces, first formulates manifests the Chinese medicine characteristic the traditional Chinese medicine clinical trial guiding principle and the standard.On this basis, we establishes suits the Chinese medicine clinical operation the detailed operation standard regulations.It is advantageous for the operators to understand the execution.the quality is controllable in the management.The key question is the CRF standardization,computerization improves the traditional Chinese medicine clinical research quality.To construct a suitable the traditional Chinese medicine the medicine clinical trial information system,to monitor entire experimental process,not only we may control the clinical research the quality result, but may also reduce researcher's work and the convenient superintendent manages.The CRF standardization,the computerization key is the Chinese medicine diagnosis standard,the curative effect evaluation criteria establishment.4.In the traditional Chinese medicine medicine generation of research mentality,it is separated from the Chinese medicine theory the instruction question.It Should adhere to the guiding principles theory of the Chinese medicine, the total perspective of the Chinese medicine, follows the group side rule of the traditional Chinese medicine.From the whole function condition to seek the superiority of the Chinese medicine diagnosing and treating characteristic as well as to conform to own rule clinical curative effect assessment method.It is the main objective to resolve the qusetion of the Chinese medicine academic systematic and complex.The new technology and the new method are developed suitable for the complex life system research and the quantitative analysis.To promotes the Chinese medicine pharmacy theory and Chinese medicine research ability systematically. Conclusion:1.Cuscuta chinensis Lam extraction process for ethyl alcohol density 50%, Adds 6 time of quantity ethyl alcohol, Withdraws 90min,Withdraws 3 times.After the Cuscuta chinensis Lam extraction oral administration gives the medicine, Hyperoside conforms to the one room of model in vivo in vivo process.Reaches peak time 3.26h, Distributed half-life 1.55h,Eliminates half-life 3.48h.The cuscuta eliminates quickly,takes for a long time is not easy to produce stores up the phenomenon,the security is high.2.The pharmacokinetics of traditional Chinese medicine as a close contact with the bridge disciplines of Chinese medicine, the key issues currently facing is the standard.That demand not only the standard of Chinese medicine, but also the standard of Chinese medicine.On this basis, it provides the objective basis for the Chinese medicine clinical curative effect validity, the security.the traditional Chinese medicine action mechanism research,the instruction clinical reasonable medication.3.Pharmacokinetics of traditional Chinese medicine ideas, it adhere to the principles of Traditional Chinese Medicine Theory. |