Method for determining etomidate emulsion injection in-vitro release curve

A technology for etomidate and a determination method is applied in the field of determination of the external release curve of etomidate emulsion injection, which can solve the problem of not establishing a determination method for etomidate emulsion injection, and achieves reduction of research and development risks, reliable quality control, and high reliability. The effect of improving the test pass rate

Pending Publication Date: 2021-10-19
WUHAN DOCAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The prior art has not established a method for measuring the in vitro release curve of etomidate emulsion injection, and failed to provide a safe and effective evaluation method for etomidate emulsion injection

Method used

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  • Method for determining etomidate emulsion injection in-vitro release curve
  • Method for determining etomidate emulsion injection in-vitro release curve
  • Method for determining etomidate emulsion injection in-vitro release curve

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Embodiment 1: Adopt basket method-dynamic dialysis method

[0048] Using the device in the four appendices of the Chinese Pharmacopoeia 2020 edition, prepare 500 mL of phosphate buffer saline PBS containing 30% absolute ethanol at pH 7.4 as the release medium at a speed of 100 rpm / min and a temperature of 37°C±0.5°C. Put the dialysis bag (molecular weight cut-off 8kD-15kD) containing 5mL of etomidate emulsion injection into the rotating basket, immerse in the release medium, absorb 1mL of the drug release solution at each sampling point, and supplement the isothermal release medium at the same time.

[0049]Utilize above-mentioned method, assay batch number is the etomidate emulsion injection of self-made sample 1, self-made sample 2, self-made sample 3 and reference preparation 1, and the results are shown in Table 1 below.

[0050] Table 1 basket method-dynamic dialysis method release test results

[0051]

[0052] The results in Table 1 show that using the method...

Embodiment 2

[0053] Embodiment 2: adopt paddle method-reverse dialysis method

[0054] Using the dissolution apparatus of the four appendices of the Chinese Pharmacopoeia 2020 edition, prepare 500mL of phosphate buffer saline PBS containing 30% absolute ethanol at pH 7.4 as the release medium, the speed is 100r / min, and the temperature is 37°C±0.5°C. The dialysis bag (molecular weight cut-off 8kD-15kD) filled with 2mL release medium was immersed in the release medium for 2h to equilibrate. Precisely measure 5 mL of etomidate emulsion injection and directly add it to the release medium outside the dialysis bag, take 0.5 mL of the release medium outside the dialysis bag at 0 min as the total drug solution, add 0.5 mL of tetrahydrofuran, mix and filter. Take out the dialysis bag at each sampling point, pour out the solution in the bag, take 0.5 mL of the solution as the drug release solution, add 0.5 mL of tetrahydrofuran, mix to 1 mL, and filter.

[0055] Utilize above-mentioned method, ass...

Embodiment 3

[0061] Embodiment 3: adopt flow cell method-dynamic dialysis method

[0062] Adopt the United States Pharmacopoeia dissolution test flow cell closed system device, 22.6mm flow cell, prepare 200mL of phosphate buffer saline PBS containing 30% absolute ethanol at pH 7.4, as the release medium, the flow rate is 8mL / min, and the temperature is 36 ~37.7°C. A dialysis bag (molecular weight cut-off 8kD-15kD, diameter 8mm) containing 2mL of etomidate emulsion injection was placed in a cuvette, and 1mL of the drug release solution was drawn at each sampling point, and an equal amount of isothermal release medium was added at the same time.

[0063] Utilize above-mentioned method, assay batch number is the etomidate emulsion injection of self-made sample 1, self-made sample 2, self-made sample 3 and reference preparation 1, and the results are shown in Table 3 below.

[0064] Table 3 flow cell method-dynamic dialysis method release test results

[0065]

[0066] The results in Tabl...

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Abstract

The invention relates to a method for determining an etomidate emulsion injection in-vitro release curve, which comprises the following steps: pumping a release medium with the temperature of 36-37.7 DEG C into a flow cell; adding an etomidate emulsion injection into a dialysis bag, and placing the dialysis bag in the flow cell; taking a sample outside the dialysis bag at different time points to obtain a drug release solution, and detecting the drug release solution to obtain the concentration of the etomidate emulsion injection; and calculating the release degree of the etomidate emulsion injection, and drawing a release curve. According to the method, the distribution and absorption process of etomidate in blood can be objectively simulated, the quality of etomidate emulsion injections of different prescription processes can be distinguished, the etomidate BE test passing rate is increased, and the research and development risk is reduced.

Description

technical field [0001] The application relates to the technical field of drug analysis, in particular to a method for measuring the release curve of etomidate emulsion injection liquid. Background technique [0002] Etomidate Emulsion Injection is used as an intravenous drug. When injected, etomidate is rapidly separated from oil particles. The plasma protein binding rate of etomidate is about 75%, which is mainly combined with albumin; in renal insufficiency Or in patients with chronic liver damage, the protein binding rate decreased. Etomidate is rapidly distributed in the brain and other tissues, with a total volume of distribution of about 4.5l / kg. [0003] Etomidate emulsion injection belongs to O / W type special injection, its quality and the behavior of active ingredients in the body are greatly affected by the prescription and process. After the special injection enters the body, there are usually factors such as the drug release process and the absorption of body f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N21/33
CPCG01N30/02G01N21/33
Inventor 黄岭向文殿宋婷胡金涛朱墨吴俊
Owner WUHAN DOCAN PHARMA
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