CN111973629A - Wound disinfection flushing fluid and preparation method thereof - Google Patents

Wound disinfection flushing fluid and preparation method thereof Download PDF

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Publication number
CN111973629A
CN111973629A CN202010679960.0A CN202010679960A CN111973629A CN 111973629 A CN111973629 A CN 111973629A CN 202010679960 A CN202010679960 A CN 202010679960A CN 111973629 A CN111973629 A CN 111973629A
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Prior art keywords
hydrogen peroxide
wound
release agent
stirring
slow
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CN202010679960.0A
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Inventor
李华
何卫华
邹昌勇
李从明
沈赞
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Jiangsu Huaguan Biotechnology Joint Stock Co ltd
Hubei Huaguan Zhongke Biological Pharmaceutical Co ltd
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Jiangsu Huaguan Biotechnology Joint Stock Co ltd
Hubei Huaguan Zhongke Biological Pharmaceutical Co ltd
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Priority to CN202010679960.0A priority Critical patent/CN111973629A/en
Publication of CN111973629A publication Critical patent/CN111973629A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/40Peroxides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics

Abstract

The invention provides a wound disinfection flushing fluid and a preparation method thereof, the wound disinfection flushing fluid comprises 20-30% of hydrogen peroxide slow-release agent, 2-4% of chlorhexidine acetate, 0.1-0.5% of thickening agent and the balance of water by mass percent of 100%, wherein the hydrogen peroxide slow-release agent is prepared by mixing hydroxypropyl methylcellulose and hydrogen peroxide, and can slowly release the hydrogen peroxide at a wound, so that the long-acting sterilization and bacteriostasis effects are achieved.

Description

Wound disinfection flushing fluid and preparation method thereof
Technical Field
The invention relates to the technical field of disinfection cleaning agents, and particularly relates to a wound disinfection flushing fluid and a preparation method thereof.
Background
The skin is an important organ of the human body, has an important biological barrier function, covers the surface of the human body, and prevents the interior of the human body from directly contacting with the external environment, but the skin is mostly contacted with the external environment, so the skin surface is often injured. The conventional wound treatment means is surface cleaning and disinfection and then bandaging, and the purpose of self-healing is achieved through self-repair of a human body. However, for some special care situations, such as deep wounds or operation wounds, the conventional cleaning and disinfecting liquid can only clean and disinfect the surface of the wound, cannot reach the deep layer, has poor disinfection effect, and the deep wound is also easily infected with specific pathogenic bacteria, such as anaerobic bacteria like tetanus bacillus, clostridium tetani, clostridium botulinum and the like, and once the pathogenic bacteria are not cleared in time, serious harm or even death is caused to the human body.
Disclosure of Invention
In view of the above, the invention provides a wound disinfection irrigation fluid capable of slowly releasing a bactericide at a wound, creating an aerobic environment and avoiding propagation of anaerobic pathogenic bacteria and a preparation method thereof.
The technical scheme of the invention is realized as follows: the invention provides a wound disinfection washing fluid, which comprises the following components in percentage by mass of 100:
Figure BDA0002585470110000011
Figure BDA0002585470110000021
on the basis of the technical scheme, preferably, each component comprises the following components in percentage by mass of 100 percent:
Figure BDA0002585470110000022
on the basis of the technical scheme, preferably, each component comprises the following components in percentage by mass of 100 percent:
Figure BDA0002585470110000023
on the basis of the above technical scheme, preferably, the water is purified water.
On the basis of the technical scheme, preferably, the thickening agent comprises sodium alginate and sodium carboxymethyl cellulose, wherein the sodium alginate: the mass ratio of the sodium carboxymethylcellulose is 1: (2.5-4).
Still preferably, the preparation method of the hydrogen peroxide sustained release agent comprises the following steps: mixing hydroxypropyl methylcellulose with 3% hydrogen peroxide, heating to 50-60 deg.C under sealed condition, stirring for 10-20min under heat preservation, and cooling to 20-30 deg.C to obtain hydrogen peroxide sustained release agent, wherein the hydroxypropyl methylcellulose: the mass ratio of 3% hydrogen peroxide is 1: (4-8).
On the basis of the technical scheme, preferably, the methoxyl content of the hypromellose is 28-30%.
In the technical scheme, the hydrogen peroxide sustained release agent can slowly release hydrogen peroxide with the sterilization and disinfection functions at the wound for a long time, meanwhile, the hydrogen peroxide is decomposed to generate oxygen, an aerobic environment is created for the wound, the reproduction of anaerobic bacteria is inhibited, and the hydroxypropyl methylcellulose is used as a sustained release carrier, so that the rapid release of the hydrogen peroxide is effectively prevented.
In the technical scheme, the chlorhexidine acetate is used as the sterilizing disinfectant which is directly contacted with the wound, and plays a role in broad-spectrum sterilization.
The invention also adopts the composition compounded by sodium alginate and sodium carboxymethylcellulose as the thickening agent, on one hand, the sodium alginate and connective tissue at the wound interact to form a net structure, thereby retaining the hydrogen peroxide slow-release agent, so that the long-acting slow-release sterilization and disinfection effect is achieved, meanwhile, the sodium carboxymethylcellulose has certain thixotropy, the macromolecules of the sodium alginate slow-release agent generate a recovery effect, a three-dimensional structure can be formed, the effective components in the disinfectant can be retained and stored, and a protective film can be formed on the surface of the mucous membrane, thereby playing a further protective role.
The invention also provides a preparation method of the wound disinfection washing fluid, which comprises the following steps:
step one, mixing a thickening agent and water, heating to 40-50 ℃, keeping the temperature, stirring for 1 +/-0.5 h, cooling to 20-30 ℃, sequentially adding a hydrogen peroxide slow-release agent and chlorhexidine acetate, and stirring for 1-2h to obtain a first mixed solution;
and step two, adjusting the pH value of the first mixed solution to 6.0-7.0 to obtain the wound disinfection washing solution.
On the basis of the above technical solution, preferably, boric acid or borax is used to adjust the pH value of the first mixed solution in the second step.
Compared with the prior art, the wound disinfection irrigation solution has the following beneficial effects:
(1) the wound disinfection flushing fluid can be used for flushing and disinfecting the surface of a wound, and after flushing, the disinfection flushing fluid can stay at the wound, hydrogen peroxide with a sterilization and disinfection effect is continuously released by utilizing the slow release effect of the hydrogen peroxide slow release agent, and oxygen can be released after the hydrogen peroxide is decomposed, so that the wound is in an aerobic environment for a long time, the propagation of highly pathogenic anaerobic bacteria is effectively inhibited, the time is won for the subsequent wound treatment, and the infection risk is reduced;
(2) the thickening agent in the disinfection flushing fluid can enable a wound to form a network-shaped protective layer more easily, and the hydrogen peroxide slow-release agent is convenient to stay in the network-shaped structure, so that external bacteria are prevented from continuously invading, further infection of the wound can be prevented, meanwhile, long-acting hydrogen peroxide can be provided, and the effects of sterilization and bacteriostasis are achieved.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
Example 1
Respectively weighing 10g of hydroxypropyl methylcellulose 2910 and 40g of 3% hydrogen peroxide, mixing, adding into a high-pressure glass reaction bottle, heating to 50 ℃, keeping the temperature and stirring for 10min, and cooling to 20 ℃ to obtain 48g of hydrogen peroxide sustained release agent.
Weighing 0.03g of sodium alginate, 0.07g of sodium carboxymethylcellulose and 77.9g of water, mixing and heating to 40 ℃ in a three-necked bottle, preserving heat and stirring for 30min, cooling to 20 ℃, sequentially adding 20g of hydrogen peroxide slow-release agent and 2g of chlorhexidine acetate, stirring for 1h to obtain a first mixed solution, and slowly adding trace boric acid to adjust the pH value of the first mixed solution to 6.0 to obtain the wound disinfection flushing fluid.
Example 2
Respectively weighing 10g of hydroxypropyl methylcellulose 2910 and 80g of 3% hydrogen peroxide, mixing, adding into a high-pressure glass reaction bottle, heating to 60 ℃, keeping the temperature, stirring for 20min, and cooling to 20 ℃ to obtain 96g of hydrogen peroxide sustained release agent.
Weighing 0.1g of sodium alginate, 0.4g of sodium carboxymethylcellulose and 65.5g of water, mixing and heating to 50 ℃ in a three-necked bottle, preserving heat and stirring for 90min, cooling to 30 ℃, sequentially adding 30g of hydrogen peroxide slow-release agent and 4g of chlorhexidine acetate, stirring for 2h to obtain a first mixed solution, and slowly adding trace borax to adjust the pH value of the first mixed solution to 7.0 to obtain the wound disinfection flushing fluid.
Example 3
Respectively weighing 10g of hydroxypropyl methylcellulose 2910 and 50g of 3% hydrogen peroxide, mixing, adding into a high-pressure glass reaction bottle, heating to 55 ℃, keeping the temperature and stirring for 15min, and cooling to 25 ℃ to obtain 58g of hydrogen peroxide sustained release agent.
Weighing 0.05g of sodium alginate, 0.15g of sodium carboxymethylcellulose and 73.8g of water, mixing and heating to 45 ℃ in a three-necked bottle, preserving heat and stirring for 60min, cooling to 25 ℃, sequentially adding 24g of hydrogen peroxide slow-release agent and 2g of chlorhexidine acetate, stirring for 1.5h to obtain a first mixed solution, and slowly adding trace boric acid to adjust the pH value of the first mixed solution to 6.5 to obtain the wound disinfection flushing fluid.
Example 4
Respectively weighing 10g of hydroxypropyl methylcellulose 2910 and 70g of 3% hydrogen peroxide, mixing, adding into a high-pressure glass reaction bottle, heating to 58 ℃, keeping the temperature, stirring for 12min, and cooling to 25 ℃ to obtain 76g of hydrogen peroxide sustained release agent.
Weighing 0.09g of sodium alginate, 0.31g of sodium carboxymethylcellulose and 67.6g of water, mixing and heating to 48 ℃ in a three-necked bottle, preserving heat and stirring for 90min, cooling to 25 ℃, sequentially adding 28g of hydrogen peroxide slow-release agent and 4g of chlorhexidine acetate, stirring for 2h to obtain a first mixed solution, and slowly adding trace borax to adjust the pH value of the first mixed solution to 6.0 to obtain the wound disinfection flushing fluid.
Example 5
Respectively weighing 10g of hydroxypropyl methylcellulose 2910 and 60g of 3% hydrogen peroxide, mixing, adding into a high-pressure glass reaction bottle, heating to 54 ℃, keeping the temperature, stirring for 16min, and cooling to 25 ℃ to obtain 69g of hydrogen peroxide sustained release agent.
Weighing 0.075g of sodium alginate, 0.225g of sodium carboxymethylcellulose and 71.7g of water, mixing and heating to 55 ℃ in a three-necked bottle, preserving heat and stirring for 80min, cooling to 25 ℃, sequentially adding 25g of a hydrogen peroxide slow-release agent and 3g of chlorhexidine acetate, stirring for 1.5h to obtain a first mixed solution, and slowly adding trace boric acid to adjust the pH value of the first mixed solution to 6.8 to obtain the wound disinfection flushing fluid.
Examples 1-5 and a commercially available wound irrigation solution were each subjected to experimental comparison.
Anaerobic bacteria disinfection test:
according to the requirements of the disinfection technical specification, the bactericidal logarithm value of the tubercle bacillus, the clostridium tetani and the clostridium perfringens is respectively determined, and the determination result is as follows:
log sterilization value Example 1 Example 2 Example 3 Example 4 Example 5 Comparative example
Mycobacterium tuberculosis 5.24 5.42 5.36 5.38 5.51 5.11
Clostridium tetani 5.44 5.58 5.41 5.50 5.58 5.06
Clostridium perfringens 5.32 5.31 5.44 5.25 5.51 5.05
Slow-release anaerobic bacteria disinfection test:
the rinse solutions of examples 1 to 5 and the comparative example were exposed to air, left standing for 4 hours, and then the bactericidal log values of tubercle bacillus, clostridium tetani and clostridium perfringens were measured according to the requirements of disinfection specifications, and the measurement results were as follows:
log sterilization value Example 1 Example 2 Example 3 Example 4 Example 5 Comparative example
Mycobacterium tuberculosis 5.12 5.15 5.12 5.13 5.14 4.23
Clostridium tetani 5.08 5.18 4.99 5.05 5.06 4.15
Clostridium perfringens 5.01 5.12 5.15 4.89 5.08 4.33
In conclusion, the wound disinfection irrigation solution has a good disinfection effect on anaerobic bacteria, and after a certain period of exposure, the wound disinfection irrigation solution still has a good disinfection effect on the anaerobic bacteria, while the sterilization performance of the commercially available irrigation solution is greatly reduced.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims (6)

1. The wound disinfection washing fluid is characterized by comprising the following components in percentage by mass of 100 percent:
20 to 30 percent of hydrogen peroxide slow release agent
Chlorhexidine acetate 2-4%
0.1 to 0.5 percent of thickening agent
The balance being water.
2. The wound disinfecting washing solution as claimed in claim 1, wherein the thickener is a combination of sodium alginate and sodium carboxymethylcellulose, and the ratio of sodium alginate: the mass ratio of the sodium carboxymethylcellulose is 1: (2.5-4).
3. The wound disinfecting washing solution as claimed in claim 1, wherein the preparation method of the hydrogen peroxide slow-release agent comprises: mixing hydroxypropyl methylcellulose with 3% hydrogen peroxide, heating to 50-60 ℃ under a closed condition, keeping the temperature, stirring for 10-20min, and cooling to 20-30 ℃ to obtain a hydrogen peroxide slow release agent, wherein the hydroxypropyl methylcellulose: the mass ratio of 3% hydrogen peroxide is 1: (4-8).
4. A wound disinfecting irrigant according to claim 3 wherein the hydroxypropyl methylcellulose has a methoxyl content of 28-30%.
5. A method of preparing a wound disinfecting irrigant solution according to claim 1, comprising the steps of:
step one, mixing a thickening agent and water, heating to 40-50 ℃, keeping the temperature, stirring for 1 +/-0.5 h, cooling to 20-30 ℃, sequentially adding a hydrogen peroxide slow-release agent and chlorhexidine acetate, and stirring for 1-2h to obtain a first mixed solution;
and step two, adjusting the pH value of the first mixed solution to 6.0-7.0 to obtain the wound disinfection washing solution.
6. The method of preparing a wound-disinfecting rinse solution according to claim 5, wherein boric acid is used to adjust the pH of the first mixture in the second step.
CN202010679960.0A 2020-07-15 2020-07-15 Wound disinfection flushing fluid and preparation method thereof Pending CN111973629A (en)

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CN108938614A (en) * 2017-05-17 2018-12-07 王�锋 A kind of compound and its preparation method and application for treating open injury
CN107582737A (en) * 2017-10-17 2018-01-16 山东新华医疗器械股份有限公司 A kind of compound chlorohexidene oral-cavity disinfectant and preparation method thereof

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Application publication date: 20201124