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CN-121987555-A - Paracetamol ointment and preparation method thereof

CN121987555ACN 121987555 ACN121987555 ACN 121987555ACN-121987555-A

Abstract

The invention provides a acetaminophen ointment and a preparation method thereof. The ointment combination of the invention can better exert the function of locally positioning and treating arthralgia and neuralgia diseases, and can avoid the side effect of liver injury of oral medicines. The ointment provided by the invention has the advantages of good spreadability, basically no granular feel, heat resistance, stability, simple preparation method and low production cost, and is especially suitable for large-scale industrial production.

Inventors

  • TAN RONG
  • LIU XUANTONG
  • YIN YONGMEI

Assignees

  • 南开大学

Dates

Publication Date
20260508
Application Date
20241101

Claims (7)

  1. 1. A acetaminophen ointment comprising acetaminophen, an ointment base, a solvent, an emulsifier, a preservative, and water, wherein the ointment comprises the following components in weight percent: 2.5 percent of acetaminophen, 5 to 25 percent of ointment matrix, 1 to 10 percent of solvent, 1 to 8 percent of emulsifier, 0.05 to 0.15 percent of preservative and the balance of water.
  2. 2. An ointment according to claim 1, comprising, by weight, 2.5% acetaminophen, 10% -16% ointment base, 1% -5% solvent, 2% -5% emulsifier, 0.05% -0.15% preservative and the balance water.
  3. 3. An ointment as claimed in claim 1, comprising, by weight, 2.5% acetaminophen, 15.4% ointment base, 3.6% solvent, 4.5% emulsifier, 0.15% preservative and the balance water.
  4. 4. An ointment according to claim 1, wherein the ointment base is selected from one or more of white vaseline, liquid paraffin, paraffin wax, beeswax, cetyl alcohol, stearyl alcohol, the solvent is selected from one or more of dimethyl sulfoxide, ethanol, glycerol, propylene glycol, the emulsifier is selected from one or more of glyceryl monostearate, sodium dodecyl sulfate, span, tween, and the preservative is selected from one or more of methylparaben, ethyl ester, propyl ester, butyl ester, and other parabens.
  5. 5. An ointment according to claim 1, wherein the ointment base is preferably a mixture of white vaseline and stearyl alcohol, the solvent is preferably glycerol, the emulsifier is preferably a mixture of glycerol monostearate and tween-80, and the preservative is preferably ethylparaben.
  6. 6. A method of preparing an ointment as claimed in claim 1, comprising the steps of: (1) Heating and melting ointment matrix and emulsifier in an evaporation dish in water bath at 70-80deg.C to obtain oil phase; (2) Heating solvent, antiseptic and calculated amount of purified water in another evaporating dish to 70-80 for dissolving; (3) Adding the liquid (2) into the liquid (1) in a trickle mode at the same temperature, stirring while adding, and homogenizing to obtain paste; (4) Slowly adding the ground acetaminophen into the paste, uniformly mixing, continuously homogenizing and stirring, and cooling to room temperature step by step.
  7. 7. The process for preparing the ointment of claim 1, which comprises the following steps: (1) Heating and melting white vaseline, stearyl alcohol and glyceryl monostearate in an evaporation vessel in water bath, and keeping the temperature at 70-80deg.C to obtain oil phase; (2) Heating glycerin, ethylparaben and calculated amount of purified water to 70-80 ℃ in another evaporation pan to dissolve the glycerin and the ethylparaben; (3) Adding the liquid (2) into the liquid (1) in a trickle mode at the same temperature, stirring while adding, and homogenizing to obtain a paste; (4) Slowly adding the ground acetaminophen into the paste, uniformly mixing, continuously homogenizing and stirring, and gradually cooling to room temperature.

Description

Paracetamol ointment and preparation method thereof Technical Field The invention relates to the field of pharmaceutical preparations, in particular to a acetaminophen ointment and a preparation method thereof. Background Acetaminophen is a antipyretic analgesic, which is white crystalline or crystalline powder, odorless and slightly bitter in taste. Can be widely used for treating common cold, fever, headache, arthralgia, neuralgia, dysmenorrhea and the like clinically. However, the dosage forms of acetaminophen commonly used in the market are mainly taken orally, are metabolized by the liver to produce systemic effects, and are easy to cause liver injury when taken excessively, so that the acetaminophen has been widely paid attention to at home and abroad. Therefore, research on new dosage forms of acetaminophen and reduction of adverse reactions is urgently needed. Disclosure of Invention In view of the above, the present invention proposes a method for preparing a acetaminophen ointment, which solves the above-mentioned problems. The technical scheme of the invention is realized by that the acetaminophen ointment is prepared from acetaminophen, stearyl alcohol, white vaseline, glyceryl monostearate, tween-80, ethylparaben, glycerol and distilled water. The prescription is further characterized by comprising 1-2 parts of acetaminophen, 2-4 parts of stearyl alcohol, 4-6 parts of white vaseline, 1-2 parts of glyceryl monostearate, 1-2 parts of tween-80, 0.04-0.1 part of ethylparaben and 1-2 parts of glycerin. The prescription is further characterized by comprising 1 part of acetaminophen, 2 parts of stearyl alcohol, 4 parts of white vaseline, 1 part of glyceryl monostearate, 1 part of tween-80, 0.04 part of ethylparaben and 1.4 parts of glycerin. The preparation method of the acetaminophen ointment comprises the following steps: s1, taking 1.0 g g of stearyl alcohol, 2.0 g g of white vaseline and 0.5g of glyceryl monostearate, placing the materials into an evaporation vessel, heating and melting the materials in a water bath at 70 ℃, uniformly stirring the materials, keeping the temperature at 70-80 ℃ and keeping the materials as an oil phase; S2, taking 0.7 g g of glycerin, 0.4 g of tween-80 and 0.02g of ethylparaben, adding 14.9 mL distilled water into another evaporation dish, heating and melting in a 70 ℃ water bath, uniformly stirring, and keeping the temperature at 70-80 ℃ to be used as a water phase; s3, adding aqueous phase liquid into the oil phase liquid in a trickle mode at the temperature of 70 ℃ and stirring uniformly while adding; S4, condensing to obtain an emulsion matrix; S5, taking and slowly adding the ground acetaminophen 0.5g into the paste for three times, uniformly mixing, continuously stirring until the powder is uniformly mixed with the paste, adding the complete medicine, and cooling to room temperature to obtain the O/W type emulsion matrix. Compared with the prior art, the acetaminophen ointment has the beneficial effects that the acetaminophen ointment is prepared by uniformly mixing an aqueous phase matrix, an oil phase matrix and a preservative, the acetaminophen ointment prepared by the invention is beneficial to avoiding liver injury caused by the traditional acetaminophen oral dosage form during liver metabolism, greatly reducing adverse reaction, better improving the medication safety of acetaminophen, and simultaneously being beneficial to exerting the drug effect and accurately exerting the curative effect. The acetaminophen ointment prepared by the invention has strong spreadability, no obvious granular feel when being smeared, good heat resistance, no layering after centrifugation, good stability, proper emulsion grain size, uniform distribution and no obvious granules and bubbles. Drawings FIG. 1 shows a milk particle size distribution diagram. Detailed Description In order to better understand the technical content of the present invention, the following provides specific examples to further illustrate the present invention. The experimental methods used in the embodiment of the invention are conventional methods unless otherwise specified. Materials, reagents, and the like used in the examples of the present invention are commercially available unless otherwise specified. Examples TABLE 1 Paracetamol ointment prescription 。 The preparation method of the acetaminophen ointment comprises the following steps: S1, taking 1.0 g g of stearyl alcohol, 2.0 g g of white vaseline and 0.5g of glyceryl monostearate, placing the materials into an evaporation vessel, heating and melting the materials in a water bath at 70 ℃, uniformly stirring the materials, keeping the temperature at 70-80 ℃ and keeping the materials as an oil phase; S2, taking 0.7 g g of glycerin, 0.4 g of tween-80 and 0.02g of ethylparaben, adding 14.9 mL distilled water into another evaporation dish, heating and melting in a 70 ℃ water bath, uniformly stirring, and keeping the temperature at 70-80 ℃ to be us