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Consistency evaluation and detection method for amoxicillin capsules

A technology of amoxicillin capsules and amoxicillin, which is applied in the field of consistency evaluation and detection of amoxicillin capsules, can solve the problems of low accuracy and sensitivity, incomplete detection, etc.

Pending Publication Date: 2021-06-18
HAINAN HAILI PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The invention provides a consistency evaluation and detection method for amoxicillin capsules, which is used to solve the technical problems that the existing detection methods for consistency evaluation of amoxicillin capsules have low accuracy and sensitivity and incomplete detection

Method used

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  • Consistency evaluation and detection method for amoxicillin capsules
  • Consistency evaluation and detection method for amoxicillin capsules
  • Consistency evaluation and detection method for amoxicillin capsules

Examples

Experimental program
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Embodiment 1

[0031] An embodiment of the consistency evaluation and detection method of amoxicillin capsules provided by the present invention includes comparing the crystal forms and impurities of the amoxicillin capsules to be tested and the reference preparation;

[0032] The crystal form comparison includes detecting the crystal form of the amoxicillin capsule to be tested and the reference preparation by X-ray diffraction method. The parameters set before the crystal form comparison test are: X-ray tube voltage is 37kV, tube current is 22mA and scanning speed 0.3deg. / min, check whether the characteristic peaks and diffraction angles of the crystal form spectrum are consistent;

[0033] The impurity comparison includes the detection of impurities in the amoxicillin capsules to be tested and the reference preparation by high performance liquid chromatography. The high performance liquid chromatography includes gradient elution with mobile phase A and mobile phase B, and mobile phase A is...

Embodiment 2

[0040] An embodiment of the consistency evaluation and detection method of amoxicillin capsules provided by the present invention, the X-ray diffraction method adopts a DX-2500 type X-ray diffractometer, equipped with a DWS-3 type curved graphite crystal monochromator, and the crystal form ratio The parameters set before the test are: the X-ray tube voltage is 37kV, the tube current is 22mA and the scanning speed is 0.3deg. / min.

[0041] It is necessary to select the corresponding scanning speed and intensity according to the crystal form characteristics of the amoxicillin capsule to be tested. The crystal form comparison spectrum of the amoxicillin capsule to be tested and the reference preparation is as follows: figure 1 As shown, the crystal form comparison results are as follows:

[0042]

[0043] Depend on figure 1 As can be seen from the above table, the characteristic peaks and diffraction angles in the X-ray diffraction patterns of the amoxicillin capsule to be te...

Embodiment 3

[0048] An embodiment of the consistency evaluation and detection method of amoxicillin capsules provided by the present invention, the detection wavelength of high performance liquid chromatography is 254nm; the flow rate is 1.5mL / min; the column temperature is 35°C; the injection volume is 10 μL . High performance liquid chromatography includes gradient elution with mobile phase A and mobile phase B, mobile phase A is potassium dihydrogen phosphate solution, the optional concentration is 0.05mol / L, and the pH value is 5; mobile phase B is acetonitrile solution, A combination of one or more of formamide solution or isopropanol solution, preferably mobile phase B is a mixed solution of 90% acetonitrile solution and 10% formamide solution, so that the elution effect is better and the accuracy of the detection result is improved and sensitivity.

[0049] In order to speed up the detection and strengthen the elution effect, the gradient elution sequence and the ratio of mobile ph...

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Abstract

The invention discloses a consistency evaluation and detection method for amoxicillin capsules. The method systematically and comprehensively investigates and evaluates the consistency between the to-be-detected amoxicillin capsule and the reference preparation of the original research medicine by comparing crystal forms and impurities of the to-be-detected amoxicillin capsule and the reference preparation. The corresponding scanning speed and intensity are selected according to the crystal form characteristics of the to-be-detected amoxicillin capsule, the detection of the crystal form characteristic peaks of the to-be-detected amoxicillin capsule and the reference preparation is sensitive, and the crystal form diffraction angles of the two drugs are accurately detected. Gradient elution is carried out by adopting a solution of a combination of a monopotassium phosphate solution and one or more of an acetonitrile solution, a formamide solution or an isopropanol solution as a mobile phase, so that the elution effect is better, and the accuracy and the sensitivity of a detection result are improved. The method is used for solving the technical problems that an existing amoxicillin capsule consistency evaluation detection method is low in accuracy and sensitivity and incomplete in detection.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a consistency evaluation and detection method for amoxicillin capsules. Background technique [0002] Amoxicillin (Amoxicillin, Amixil, amoxycillin) is a penicillin antibiotic, which is effective against aerobic gram-positive cocci such as Streptococcus pneumoniae, hemolytic streptococcus, non-penicillinase-producing Staphylococcus, Enterococcus faecalis, and large intestine. Escherichia, Proteus mirabilis, Salmonella, Haemophilus influenzae and Neisseria gonorrhoeae and other aerobic Gram-negative bacteria that do not produce β-lactamase and Helicobacter pylori have good antibacterial activity. Amoxicillin exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls, and can rapidly dissolve and rupture bacteria into spheroids. [0003] In response to national requirements, drug manufacturers should evaluate the quality consis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N23/20G01N30/02G01N30/34G01N30/88G01N30/74G01N30/06G01N30/14G01N30/04G01N30/86
CPCG01N23/20G01N30/02G01N30/34G01N30/88G01N30/74G01N30/06G01N30/14G01N30/04G01N30/8634G01N2030/8872G01N2030/146G01N2030/047G01N2223/056G01N2223/1016
Inventor 许丹青余国新耿亮朱亚东
Owner HAINAN HAILI PHARMACEUTICAL CO LTD
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