Method for identifying human blood albumin products
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A technology for human albumin and products, applied in the field of human albumin, can solve the problems of unsuitability for on-site detection, high technical requirements, long inspection period, etc. Effect
Inactive Publication Date: 2008-07-16
广东省药品检验所
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[0003] The current national standard identification method of human serum albumin ("Chinese Pharmacopoeia" 2005 edition three appendices VIII C, VIII D) includes immune double diffusion method and immunoelectrophoresis method, and its advantage is that the accuracy rate is high, but these two methods have great influence on the experiment. The technical requirements for personnel are high, specific instruments and fixed sites are required, and the inspection cycle is long, so it is not suitable for on-site inspections with high mobility
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Embodiment 1
[0030] Embodiment 1 Operation method
[0031] 0.2mol / L citric acid buffer (pH4.2): Mix 0.2mol / L citric acid and 0.2mol / L sodium citrate at a volume ratio of 12.3:7.7, add 100mg of sodium azide per liter of buffer , adjust the pH to 4.2 with 0.2mol / L citric acid and 0.2mol / L sodium citrate.
[0032] BCG reagent (0.15mmol / L): Weigh 105mg of bromocresol green, dissolve it in 2.5ml of 0.1mol / L NaOH (heating to aid dissolution), then add 0.2mol / LpH4.2 citrate buffer 1000ml , plus Tween-801 ~ 2ml.
[0033] Take 2ml of BCG reagent, add 1 drop of the test product, and shake well.
[0034] If the test product is 5% to 25% genuine human serum albumin, the color of the solution should immediately change from yellow to green, otherwise the test product is a counterfeit product.
Embodiment 2
[0035] Embodiment 2 Sensitivity experiment
[0036] Such as figure 1 , six test tubes are equipped with 2ml BCG reagent, the first tube on the left is a blank control, and the remaining tubes are added dropwise from left to right with human serum albumin concentrations of 0.2%, 1%, 5%, 10%, and 20% respectively. %. It can be seen from the results that the higher the concentration of albumin, the darker the green color of the solution after reaction. Judging by naked eyes, the detection sensitivity of this identification method to human serum albumin is 1% albumin concentration.
[0037] Compared with the national standard identification method ("Chinese Pharmacopoeia" 2005 edition three appendices VIII C, VIII D), using this identification method can obtain 80 batches of human serum albumin authentic products and 16 batches of human serum albumin counterfeit products sampled in the market. The correct test conclusion is drawn, and the accuracy rate of the test conclusion is...
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Abstract
The invention discloses a method for identifying human blood albumin products, comprising the following steps: (1) a citric acid buffer solution is prepared: 0.2mol/L of citric acid and 0.2mol/L of sodium citrate are taken and mixed according to the volume proportion of 12.3: 7.7, and each liter of buffer solution is added with 100mg of sodium azide, then the pH is adjusted to 4.2 by using 0.2mol/L of citric acid and 0.2mol/L of sodium citrate; (2) a BCG reagent is prepared: 105mg of bromocresol green is weighed and firstly dissolved in 2.5ml of 0.1mol/L NaOH (water-jacket heating for dissolution enhancement), then the mixture is added with 1000ml of 0.2mol/L citric acid buffer solution with the pH of 4.2, and 1 to 2ml of Tween minus 80 is added; (3) 2ml of BCG reagent is taken to be added with one drop of human serum albumin product which is ready to be detected, and an even shaking is carried out. If the color of the solution turns green from yellow, the product is an authentic product; otherwise, the product is a schlock. The identification method of the invention has low analysis cost, no need of special equipment, stronger specificity and high correct rate of the inspection results; the invention is applicable to the rapid inspection method of human blood albumin at the scene, and meets the needs of the basic pharmaceutical supervision and inspection.
Description
technical field [0001] The present invention relates to human serum albumin, in particular, relates to a method for identifying human serum albumin products. Background technique [0002] Human albumin is a biological product, which is obtained from the veins of healthy people and prepared through a series of strict extraction, purification and sterilization processes. It is used to treat shock, cerebral edema and cerebral edema caused by severe blood loss, trauma and burns. Increased brain pressure caused by injury is a veritable "life-saving medicine" for the prevention and treatment of edema or ascites caused by hypoproteinemia, liver cirrhosis, and kidney disease, so this product is also called "life product". Since human serum albumin is generally used in critically ill patients in clinical practice, the requirements of the State Food and Drug Administration are particularly strict, and a batch release system is implemented for the production and sales of human serum al...
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