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In-vitro release detection method of ripdicaine emulsifiable paste

A technology of risprocaine and detection method, which is applied in the field of in vitro release detection of risprocaine cream, can solve the problems of affecting the discrimination of release methods and low repeatability of in vitro release, so as to reduce the difficulty of quality control, The effect of precise monitoring

Pending Publication Date: 2022-04-29
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problem in the prior art that the repeatability of in vitro release is low and affects the discrimination of the release method, the present invention provides an in vitro release detection method of Liprocaine cream with high repeatability and strong discrimination

Method used

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  • In-vitro release detection method of ripdicaine emulsifiable paste
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  • In-vitro release detection method of ripdicaine emulsifiable paste

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Using SOTAX CE7 flow cell, Merck Express PLUS PES filter membrane.

[0039]A flow cell method for measuring the in vitro release of lipradicaine emulsifiable paste comprises the following steps. The in vitro release of the original preparation and the generic preparations from two manufacturers were measured respectively.

[0040] (1) The SOTAX CE7 flow cell is used as the experimental device, and the system is set as a closed-loop system. The experimental temperature is 32°C, the flow rate is 16mL / min, and the sampling time is 15 / 30 / 60 / 120 / 240 / 360 / 480 / 600 / 720min.

[0041] (2) Pre-saturate the Merck Express PLUS PES filter membrane with freshly prepared PBS6.8 buffer solution for 30 minutes, add the sample into a 0.4mL cream pool (sample weight 350-400mg), scrape off the excess sample on the surface with a scraper, and put The pre-saturated membrane is taken out and the surface moisture is removed with absorbent paper, the filter membrane is put into the fixing ring,...

Embodiment 2

[0049] Using SOTAX CE7 flow cell, Merck Express PLUS PES filter membrane.

[0050] A flow cell method for measuring the in vitro release of lipradicaine emulsifiable paste comprises the following steps. This method was used to investigate the in vitro release behavior of the trial preparation obtained by changing the emulsifier in the formulation.

[0051] (1) The SOTAX CE7 flow cell is used as the test device, the system is set as a closed-loop system, the test temperature is 32°C, the flow rate is 16mL / min, and the sampling time is 15 / 30 / 60 / 120 / 240 / 360 / 480 / 600 / 720min.

[0052] (2) Pre-saturate the Merck Express PLUS PES filter membrane with newly prepared PBS6.8 buffer solution for 30 minutes, add the sample into a 0.4mL cream pool (the weighing sample size is 350-400 mg), and scrape off the excess on the surface with a scraper. For the sample, take out the pre-saturated membrane and remove the surface moisture with absorbent paper, put the filter membrane into the fixing...

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Abstract

The invention discloses an in-vitro release detection method of ripdicaine emulsifiable paste, and belongs to the technical field of biological medicines. According to the method, a flow cell is adopted as an experimental device, a to-be-detected riprodicaine emulsifiable paste sample is placed in an emulsifiable paste pool, then a release film is placed in a fixing ring, the fixing ring and the emulsifiable paste pool are assembled to obtain an adapter, a release medium is added into a medium bottle, the flow speed and the water bath temperature of the flow cell are set, and sampling is carried out at fixed time for detection. According to the method, the quality difference of the ripdicaine emulsifiable paste is efficiently and accurately monitored through an in-vitro evaluation method, and the quality control difficulty of an imitated preparation is reduced.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to an in vitro release detection method of risprocaine cream. Background technique [0002] Liprocaine cream is an oil-in-water cream made from 2.5% lidocaine and 2.5% prilocaine by forming a eutectic mixture. This product is a superficial analgesic commonly used in clinical practice, and is often used for analgesia in venous catheterization, venipuncture and various minor surgical operations. However, the characteristics of prescriptions and preparations are complicated, and the control of process parameters is difficult. Minor changes in the formulation process may lead to significant differences in product quality. It is a complex preparation that is difficult to develop and requires individualized consideration of specific varieties during review. It can distinguish between different prescriptions and processes. And the in vitro release study with the possibilit...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/54G01N30/74
CPCG01N30/02G01N30/06G01N30/54G01N30/74
Inventor 涂家生宁保明罗婷婷孙春萌
Owner CHINA PHARM UNIV
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