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A local anesthetic preparation for external use and a method for improving the stability of the local anesthetic preparation

A technology for local anesthesia and external preparations, which is applied in the field of local anesthetic preparations and amide local anesthetics. It can solve the problems of reducing drug efficacy, drug safety threats, and waste of raw materials for preparations, so as to improve stability and prolong drug storage. and shelf life, the effect of easy operation

Active Publication Date: 2020-06-19
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the packaging of local anesthetic preparations for external use on the market mostly contains ethylene, polyethylene or polyacrylonitrile composite aluminum films. Waste, reduce drug efficacy, and pose a great threat to the safety of drugs

Method used

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  • A local anesthetic preparation for external use and a method for improving the stability of the local anesthetic preparation
  • A local anesthetic preparation for external use and a method for improving the stability of the local anesthetic preparation
  • A local anesthetic preparation for external use and a method for improving the stability of the local anesthetic preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Product name: Debaian

[0027] Drug Name: Flurbiprofen Babu Ointment

[0028] Packaging material: Packaging material 5 paper / thermoplastic polyester / / aluminum / vinyl (PAPER / PET / AL / PE, Fujimori Industry Co., Ltd.)

[0029] Table 2 stability test:

[0030] serial number Influencing factors Dibaian (preparation content%) 1 Freeze at -30°C for 5 days 105.5％ 2 Freeze at -30°C for 10 days 105.0％ 3 Freeze at -30°C for 12 days 104.3％ 4 40℃ high temperature for 10 days 105.2％ 5 40°C high temperature for 12 days 104.3％ 6 60℃ high temperature for 3 days 105.3％ 7 60℃ high temperature for 5 days 105.1％ 8 60℃ high temperature for 10 days 104.7％ 9 60℃ high temperature for 12 days 104.5％ 10 60℃ high temperature for 30 days 103.4％ 11 5 days of light 105.1％ 12 10 days of light 104.9％ 13 92.5% high humidity for 5 days 104.5％

[0031] The results show that flurbiprofen uses paper / the...

Embodiment 2

[0033] The raw material of lidocaine is unstable and has a certain sublimation property, so the packaging material of lidocaine patch needs better insulation and low adsorption to the main drug. In the present invention, the prepared lidocaine patches are packaged with different packaging materials. The packaging materials are shown in Table 3, and they are set out under different influencing factors. The stability test was carried out by setting out samples under high humidity and light conditions. By detecting the content changes of lidocaine patch samples under various packaging materials, the most suitable packaging material for lidocaine patches was selected. The test results are shown in Table 3. :

[0034] Table 3 The impact of the type of lidocaine patch packaging material on the content of the preparation

[0035]

[0036]

[0037] The content of lidocaine in the lidocaine patch was 104.4% on the 0 day of stakeout. The results in Table 2 show that the content ...

Embodiment 3

[0044] The selection of embodiment 3 bupivacaine paste packaging materials

[0045] Since both bupivacaine and lidocaine can be used as local anesthetics, bupivacaine samples were used to carry out screening experiments on packaging materials. The stability test was carried out under the conditions of -30°C freezing, 40°C high temperature, 60°C high temperature, 92.5% high humidity and light conditions. By detecting the content changes of ropivacaine patch samples under various packaging materials, ropivacaine was selected The most suitable packaging material for patches, the test results are shown in Table 5

[0046] Table 5 The impact of the type of bupivacaine patch packaging material on the content of the preparation

[0047]

[0048]

[0049] The content of bupivacaine in the bupivacaine patch was 104.9% at day 0 of stakeout. The results in Table 5 show that the impact trend of the packaging material of the bupivacaine patch is similar to that of lidocaine and rop...

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Abstract

The invention relates to the field of pharmaceutical preparations and discloses a topical preparation of a local anesthetic drug and a method for improving the stability of the preparation of the local anesthetic drug. A local anesthetic external preparation comprises a local anesthetic and a packaging material, wherein that packaging material is a polyester / aluminum / cycloolefin composite aluminumfilm. The polyester / aluminum / cycloolefin composite aluminum film is a novel composite low-absorption packaging material. A method for improving that stability of a local anesthetic drug preparation comprises packaging the local anesthetic drug preparation with a polyester / aluminum / cycloolefin composite aluminum film as a packaging material. The method of the invention does not need to add any antioxidant or nitrogen filling, and the vacuum pumping operation is simple and convenient. Experiments show that the polyester / aluminum / cycloolefin composite aluminum film is used for packaging of topical preparations of local anesthetic drugs, the content of active drugs in the preparations can be ensured, and the stability of local anesthetic drugs can be effectively improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an external preparation of local anesthetics and a method for improving the stability of local anesthetic preparations, especially amide local anesthetics. Background technique [0002] Drug packaging is in direct contact with drugs, and packaging materials play an important role in ensuring the stability of drugs, thus directly affecting drug safety. Choosing the right packaging material can protect the integrity of the quality of the drug, it will not be affected by environmental conditions, it will not react with the drug, it will not pollute the drug, and it is non-toxic. Unsuitable packaging materials may cause migration, adsorption, adsorption, and even chemical reactions of active pharmaceutical ingredients, leading to drug failure and sometimes serious toxic side effects. [0003] Local anesthetics are a class of drugs that can reversibly block the generation a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/445A61K31/167A61K31/381A61P23/02B32B27/36B32B15/20B32B15/09B32B9/00B32B9/04B32B33/00
CPCA61K9/0014A61K31/167A61K31/381A61K31/445B32B9/00B32B9/041B32B15/09B32B15/20B32B27/36B32B33/00
Inventor 孙立欣卢迪申桂芬纪明文张林林
Owner BEIJING TIDE PHARMA
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