Method for evaluating clinical compatibility of injections
A compatibility and injection technology, applied in the field of evaluating the clinical compatibility of injections, can solve the problems of low sensitivity, low universality, and inability to take into account physical and chemical information at the same time.
Active Publication Date: 2013-08-14
THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL
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[0003] The purpose of the present invention is to overcome the limitations of existing detection methods for clinical compatibility of injections, which are complicated to operate, cannot be monitored on-line in real time, cannot take into account physical and chemical information at the same time, and have low sensitivity and poor universality. Isothermal Titration Calorimetry (ITC) in the field of physical chemistry is tried to apply to evaluate the clinical compatibility of injections, in order to establish a rapid, sensitive and universal detection method
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[0049] In order to facilitate the understanding of the technical solutions of the present invention, the following will be introduced in conjunction with specific implementation manners.
[0050] In the experiment, Yiqi Fumai freeze-dried powder injection (YQFM) was used as the model drug, vitamin C injection (Vc) and 5% glucose injection (5% GS) were selected as combined injections according to its commonly used clinical combination drugs, and the ITC method was used to control the After the two combined injections are fused with the Yiqi Fumai freeze-dried powder injection aqueous solution, the thermal characteristic information is collected to obtain the reaction activity spectrum, obtain the corresponding thermodynamic parameters, and determine the type of reaction, which is verified by high performance liquid chromatography (HPLC). .
[0051] Experimental instruments and materials:
[0052] NANO ITC 2GIsothermal titration calorimeter (US TA company). The minimum detect...
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The invention discloses a method for evaluating the clinical compatibility of injections. The method comprises the following steps of: preparing a sample solution; carrying out titration; generating a reaction activity spectrum; calculating corresponding thermodynamic parameters, such as enthalpy change Delta H, reaction constant K, entropy change Delta S and the like; judging whether the reaction type is an enthalpy drive reaction or an entropy drive reaction according to the relation between Delta H and the T Delta S, wherein T is the reaction temperature; and further judging the clinical compatibility of the injections. Compared with the prior art, the method disclosed by the invention has the advantages of strong universality, high sensitivity, simpleness and convenience for operation, less interference factors and good repeatability; the system can rapidly reach a basic line balance during online titration by adopting an instrument isothermal power compensating system, so as to adapt to continuous titration and increase the measurement accuracy; the reaction type can be judged by parameters without the need of knowing all ingredients in the solution, therefore the method is especially suitable for Chinese medicine injections of which the material bases are undefined; and the method disclosed by the invention can be used for effectively remedying the limitation of incapability of detection of the conventional chemical analysis method caused by no comparison products and difficulty in determining ingredient characteristic absorption spectrum or absorption wavelength andhas better universality and reaction activity fingerprint spectrum characteristics.
Description
technical field [0001] The invention relates to a method for evaluating clinical compatibility of injections, and belongs to the technical field of clinical drug safety evaluation. Background technique [0002] Injections are widely used in clinical practice. In order to meet the treatment needs of basic diseases and complications, etc., combination drugs are often required. However, due to the differences in the properties of different drugs, the combination of drugs may lead to changes in the original material basis, decreased drug efficacy, and even adverse reactions. The methods currently used to detect the safety of drug combinations mainly include visual observation, insoluble particles, pH value, osmotic pressure, and high performance liquid chromatography (HPLC). Using these methods to detect the physical and chemical properties of drugs before and after combined use provides reference value for clinical safety medication, but these methods are complex to operate, c...
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IPC IPC(8): G01N25/48
Inventor 鄢丹肖小河冯雪任永申陈龙虎闫琰
Owner THE FIFTH MEDICAL CENT OF CHINESE PLA GENERAL HOSPITAL