Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium

A technology of amoxicillin sodium clavulanate potassium and clavulanate potassium is applied in the detection field of new compound amoxicillin sodium clavulanate potassium for injection, which can solve the problems of drug resistance and the like

Inactive Publication Date: 2010-07-14
XIANGBEI WELMAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to the continuous and widespread emergence of lactamase-producing pathogen...

Method used

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  • Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium
  • Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium
  • Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0007] Embodiment one, preliminary detection of preparation

[0008] The experiment uses "amoxicillin sodium and clavulanate potassium for injection", the ratio is 7:1, and the specification is 1.6g. The test sample is white, off-white or slightly yellowish white powder, and the following various tests are carried out.

[0009] 1. Identification test:

[0010] The two components, amoxicillin in sodium salt form and clavulanic acid in potassium salt form, should present the flame reaction of sodium salt when burning. Take platinum wire, moisten it with hydrochloric acid, dip it into this product, burn it in a colorless flame, the flame is bright yellow, and mixed with lavender.

[0011] The two components, amoxicillin sodium and clavulanate potassium, have different polarities and can be separated by HPLC and identified by reference substances. Get the standard product of this product and amoxicillin sodium and clavulanate potassium, respectively use the mobile phase to make...

Embodiment 2 3

[0012] 2. Detection test

[0013] Test sample acidity inspection: take the test sample and add water for injection to make a solution containing 150mg per ml, measure it with an acidity meter, the result is that the pH of the test sample is between 8.0-10.0, which is a qualified product.

[0014] Clarity inspection of the test sample solution: take 5 bottles of the test sample, add water to make a solution containing about 0.1g of amoxicillin per 1ml, compare it with No. 2 turbidity standard solution, and check the clarity. Results The test sample was a clear liquid, which did not exceed the No. 2 turbidity standard solution, and the clarity met the relevant regulations, so it was a qualified sample.

[0015] The water content of the test sample is checked. Take 1g of the test sample and measure it according to the water detection method. As a result, the water content of the test sample is about 2% and meets the standard, which is a qualified sample.

Embodiment 2

[0016] Embodiment two, the analysis of preparation and quality control method

[0017] In order to control the quality of the product, it is necessary to analyze and study the possible impurities in the product. Because there is no experience of mixing two substances together before, the existing mature method is only aimed at the detection method of the relevant impurities in a single amoxicillin sodium (or clavulanate potassium).

[0018] Although such an inspection method is effective for the inspection of a single substance, it is not clear whether it can inspect the relevant impurities in the mixture, because whether the two main components will affect each other's detection after being prepared into a mixed preparation, and whether the two impurities will also affect the detection of the other. There are many uncertain factors in the detection of the other party, and a large number of experiments are required to verify. Therefore, we have established a corresponding det...

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Abstract

The invention provides a novel high-efficiency liquid chromatography (HPLC) method capable of synchronously detecting the contents of two single ingredients and relevant impurities in injection use compound amoxicillin sodium and clavulanate potassium. Compared with the existing detection method, the invention has higher precision on the 7/1 compound preparation with relatively low clavulanic acid content, and has better separation degree on the injection preparation with higher purity requirement, in addition, the two ingredients of the amoxicillin and the clavulanic acid can not be mutually interfered or influenced in the detection process. The method has the advantages of simple operation, easy implementation, strong specificity, high sensitivity, large linear range, good stability and good repetitiveness, and can be used for detecting compound sterile injection preparations and raw materials.

Description

Background of the invention [0001] Amoxicillin / clavulanic acid was created by British researchers working in Beecham between 1977 and 1978 and received a US patent in 1984 (US4,441,609). [0002] In this compound, amoxicillin (or sodium salt) belongs to lactam antibiotics, which has the characteristics of broad antibacterial spectrum, strong bactericidal ability in vivo, good absorption (75-90%), and short peak time (1-2 hours) (HandsfieldHH, Clark H, Wallace JF, Holmes KK, Turck M., etc., 1973), since it was listed in the 1960s, it has been widely used clinically. However, due to the continuous and widespread emergence of lactamase-producing pathogens, the lactam ring in amoxicillin is hydrolyzed and inactivated, resulting in drug resistance. Potassium clavulanate is an oxypenicillane compound isolated from the culture medium of streptomycin. Lactam antibiotics that are not resistant to enzymes can prevent them from being inactivated by enzymes produced by bacteria, thereby...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N30/02G01N21/72
Inventor 王霆邓桂兴马宏强孙明杰
Owner XIANGBEI WELMAN PHARMA CO LTD
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