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Compound lidocaine medicine composition and preparation method thereof

A lidocaine and composition technology, applied in the field of medicine, can solve problems such as unsatisfactory stability, influence on product quality, decreased stability, etc., and achieve the effects of enhancing percutaneous penetration effect, shortening operation time, and high stability

Active Publication Date: 2016-07-20
SHANXI YUANYANG PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] However, the microemulsion prepared by the traditional method has unsatisfactory stability to a certain extent, which usually shows as stratification, floc and precipitation after standing for a period of time, especially when the temperature is high, the stability At the same time, there are generally other additives such as chemical penetration enhancers, traditional preservatives and ion polymers in traditional microemulsions, which not only affect product quality, but also have large side effects and low safety

Method used

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  • Compound lidocaine medicine composition and preparation method thereof
  • Compound lidocaine medicine composition and preparation method thereof
  • Compound lidocaine medicine composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] [Recipe] Lidocaine 2g, prilocaine 3g, peppermint oil 2g, caprylic capric macrogolglyceride 18g, polyethylene glycol 4006g and water 80g.

[0034] [Preparation method] Weigh the oil phase, surfactant, co-surfactant, lidocaine and prilocaine according to the formula and stir to form a mixed drug solution, then add dropwise the water weighed according to the formula, using The pharmaceutical composition is prepared by adding water dropwise.

Embodiment 2

[0036] [Recipe] Lidocaine 3g, prilocaine 2g, oleic acid 9g, Tween-8013g, ethanol 9g and water 60g.

[0037] [Preparation method] Weigh the oil phase, surfactant, co-surfactant, lidocaine and prilocaine according to the formula and stir to form a mixed drug solution, then add dropwise the water weighed according to the formula, using The pharmaceutical composition is prepared by adding water dropwise.

Embodiment 3

[0039] [Recipe] Lidocaine 2.5g, prilocaine 2.5g, ethyl oleate 5.5g, polyoxyethylene castor oil 15.5g, polyethylene glycol 4007.5g and water 70g.

[0040] [Preparation method] Weigh the oil phase, surfactant, co-surfactant, lidocaine and prilocaine according to the formula and stir to form a mixed drug solution, then add dropwise the water weighed according to the formula, using The pharmaceutical composition is prepared by adding water dropwise.

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Abstract

The invention provides a compound lidocaine medicine composition. The composition is prepared from lidocaine, prilocaine, an oil phase, a surfactant, a cosurfactant and water. According to the method, a hydrophilic drug prilocaine and a lipophilic drug lidocaine are introduced into a microemulsion system in a reasonable proportion. The system can be used for enhancing the transdermal permeation effect of the two drugs at the same time and greatly shortening the effect of local anaesthesia, can be applied to local cortex before injection to reduce patient pain and improve compliance, and can be applied to patients requiring operation as soon as possible to greatly reduce the waiting time of anaesthesia and shorten the operation time. Furthermore, the pharmaceutical composition has high stability, can be stored for 9 months at 25 DEG C and 40 DEG C, does not contain penetration enhancer, preservative, ionic polymer or other additives, and is simple in composition, high in quality, small in side effect and high in safety.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a compound lidocaine pharmaceutical composition and a preparation method thereof. Background technique [0002] Compound lidocaine cream is a compound cream prepared from two local anesthetics, lidocaine and prilocaine. Abroad, it was first listed in the 1980s by the Swedish company Astra (trade name EMLA), and now it has been listed in more than a dozen countries including China and the United States. The drug is mainly aimed at the problem that existing anesthetics (including injections, latex and solutions) are difficult to penetrate the stratum corneum and epidermis of the intact skin, enter the dermis where the nerve endings that feel pain are located, and exert an analgesic effect. An effective topical anesthetic capable of penetrating intact skin. [0003] At present, the most widely used dosage form of compound lidocaine is emulsifiable paste or patch, suc...

Claims

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Application Information

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IPC IPC(8): A61K31/167A61K9/107A61K9/06A61K9/12A61K47/10A61K47/32A61K47/44A61P23/02
CPCA61K9/0014A61K9/06A61K9/107A61K9/12A61K31/167A61K47/10A61K47/32A61K47/44A61K2300/00
Inventor 贺琴
Owner SHANXI YUANYANG PHARMA TECH
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