CN107801732B - Gas humidifying liquid and preparation method thereof - Google Patents
Gas humidifying liquid and preparation method thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
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- A01N59/08—Alkali metal chlorides; Alkaline earth metal chlorides
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- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/36—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a singly bound oxygen or sulfur atom attached to the same carbon skeleton, this oxygen or sulfur atom not being a member of a carboxylic group or of a thio analogue, or of a derivative thereof, e.g. hydroxy-carboxylic acids
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- A01N37/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids
- A01N37/44—Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having three bonds to hetero atoms with at the most two bonds to halogen, e.g. carboxylic acids containing at least one carboxylic group or a thio analogue, or a derivative thereof, and a nitrogen atom attached to the same carbon skeleton by a single or double bond, this nitrogen atom not being a member of a derivative or of a thio analogue of a carboxylic group, e.g. amino-carboxylic acids
- A01N37/46—N-acyl derivatives
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
- A01N43/02—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms
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- A01N43/14—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms with one hetero atom six-membered rings
- A01N43/16—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atoms with one hetero atom six-membered rings with oxygen as the ring hetero atom
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N43/00—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds
- A01N43/90—Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having two or more relevant hetero rings, condensed among themselves or with a common carbocyclic ring system
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Abstract
The invention discloses a gas humidifying liquid and a preparation method thereof. The gas humidifying liquid is an aqueous solution at least containing epsilon-polylysine and sodium dehydroacetate as effective components, wherein the concentration of the epsilon-polylysine is 3-60 mu g/mL, and the concentration of the sodium dehydroacetate is 50-440 mu g/mL. The preparation method of the gas humidifying liquid comprises the following steps: dissolving other effective components except the epsilon-polylysine in purified water at normal temperature, heating to 45-85 ℃, adding the epsilon-polylysine, stirring for dissolving, supplementing the purified water to the required concentration, and sterilizing to obtain the humidifying solution. The humidifying liquid has good storage stability and is not easy to generate precipitate; the humidifying liquid has excellent antibacterial broad spectrum and effect, and effectively ensures that the humidifying liquid is not polluted by bacteria in the clinical use process; in addition, the preparation method is simple, convenient and quick, and the effective components are easier to dissolve, thereby having good clinical value and social significance for popularization and use.
Description
Technical Field
The invention discloses a gas humidifying liquid and a preparation method thereof, in particular to a high-stability gas humidifying liquid with an excellent bacteriostatic function. The invention belongs to the field of clinical care products.
Background
Oxygen inhalation therapy is the most common nursing technology and rescue treatment means in hospitals, and patients in Intensive Care Units (ICU) are critically ill and mostly need frequent or long-time oxygen inhalation. Because oxygen humidity itself is very low, long-time oxygen uptake can cause bad consequences such as patient's respiratory tract is dry, nasal mucosa is dry to split bleeding, the difficult expectoration of sputum, consequently, in the oxygen therapy process, need gaseous humidifying liquid to carry out the humidification to oxygen to avoid dry oxygen to produce the stimulation to the respiratory tract mucosa, and then improve patient's comfort level, improve the oxygen therapy effect.
The gas humidifying liquid is liquid for humidifying oxygen in clinical care. The humidifying liquid used for clinical care generally requires sterile water or distilled water, and because the humidifying liquid does not have the bacteriostatic function per se, the humidifying liquid is extremely easy to be polluted by bacteria in the long-time clinical care process, so that the nosocomial infection risk is brought to patients. It is reported that: respiratory tract infection accounts for the first place in hospital infection cases in China, and pulmonary complications caused by infection of various treatment instruments such as diagnosis and treatment operations and medical equipment are non-negligible factors. The incidence rate of foreign mechanical ventilation related infection is 21-77%, and the fatality rate is 20.0-61.7%. A great deal of domestic literature reports that the humidifying liquid is easily polluted by bacteria in the oxygen inhalation process, thereby causing nosocomial infection. For example, dozens of articles such as "study of flora of oxygen humidified fluid contamination causing lung infection" (nursing research, ten days of 21 st of 7 th of 2007) of liujin et al, "analysis and countermeasure of contamination condition of oxygen humidified fluid" (nursing research, 19 th of 5 th of 2005) of delavay, "monitoring of bacterial contamination degree of oxygen humidified fluid of Dalian City" (Chinese journal of infection control, 3 rd of 4 th of 2004) of xudan et al, and "study of bacterial culture of oxygen humidified fluid" of childhood (Chinese journal of infection, 16 th of 2006) of the present gas humidified fluid have systematically discussed the problem of bacterial infection and nosocomial infection.
Epsilon-polylysine (epsilon-PL, molecular formula C)180H362N60) The nutritional bacteriostatic agent is screened and synthesized by Nippon Jijing Pingyi and Shiwo, is poly L-lysine with carboxyl and amino groups connected by peptide bonds, and is a polypeptide with bacteriostatic effect. It is a broad-spectrum external bacteriostatic agent, after it is fed into human body, it can be decomposed into lysine which is a nutrient amino acid necessary for human body, and the lysine is eight amino acids necessary for human body, so that epsilon-polylysine possesses high safety. In 1989, epsilon-polylysine was listed as a natural additive to food products, and food additives were also listed in the U.S. and europe.
Epsilon-polylysine has strong bacteriostatic ability, and can destroy the cell membrane structure of microorganisms, cause the interruption of the substance, energy and information transmission of cells, and finally cause the cell death. The antibacterial agent has good antibacterial effects on gram-positive bacteria, gram-negative bacteria, saccharomycetes and mould, has good antibacterial effects on escherichia coli and salmonella which are difficult to inhibit by other antibacterial agents, and also has an inhibiting effect on heat-resistant bacillus and some viruses.
Chinese patent ZL200910135422.9 discloses a medical humidification fluid of an aqueous solution of which the main component is epsilon-polylysine, and chinese patent CN201110160859.5 discloses a medical humidification fluid of which the main component is an aqueous solution of epsilon-polylysine and natamycin. However, when the existing wetting liquid mainly containing epsilon-polylysine is stored in a damp and hot environment (particularly in the plum rain season in the south), precipitates are easy to be separated out, and the wetting liquid may be infected with bacteria. If the potential safety hazards cannot be found in time, medical accidents are likely to happen. In view of this, it is urgently needed to develop a gas humidification liquid with good stability, broad bacteriostatic spectrum and better effect.
Disclosure of Invention
Therefore, the present invention is to overcome the above-mentioned drawbacks of the prior art and to provide a highly stable gas humidification liquid with excellent bacteriostatic function and without precipitation of precipitates during storage.
The invention also aims to provide a preparation method of the gas humidifying liquid.
In order to achieve the purpose, the invention adopts the following technical scheme:
the high-stability gas humidifying liquid with the excellent bacteriostatic function is an aqueous solution with effective components at least comprising epsilon-polylysine and sodium dehydroacetate, wherein the concentration of the epsilon-polylysine is 3-60 mu g/mL, and the concentration of the sodium dehydroacetate is 50-440 mu g/mL.
Furthermore, the concentration of the epsilon-polylysine is 5-50 mu g/mL, and the concentration of the sodium dehydroacetate is 100-350 mu g/mL; more preferably, the concentration of epsilon-polylysine is 10-25 mu g/mL, and the concentration of sodium dehydroacetate is 200-300 mu g/mL.
In the invention, the effective component of the gas humidifying liquid can also comprise natamycin.
Further, the amount of natamycin should not exceed the total mass of epsilon-polylysine and sodium dehydroacetate, and is preferably 30 to 300. mu.g/mL, more preferably 60 to 100. mu.g/mL.
In the invention, the effective component of the gas humidification liquid can also contain a bacteriostatic synergist, and when the effective component does not contain natamycin, the dosage of the bacteriostatic synergist is not more than 10% of the total mass of epsilon-polylysine and sodium dehydroacetate, and preferably not more than 5% of the total mass of epsilon-polylysine and sodium dehydroacetate; when the effective component contains natamycin, the dosage of the antibacterial synergist should not exceed 10% of the total mass of epsilon-polylysine, sodium dehydroacetate and natamycin, and preferably not exceed 5% of the total mass of epsilon-polylysine, sodium dehydroacetate and natamycin. The bacteriostatic synergist is one or a mixture of more than two of organic acid and sodium chloride.
Further, the organic acid may be selected from acetic acid, citric acid, malic acid, tartaric acid, lactic acid, glycine, lysine, serine, and the like.
In a preferred embodiment of the invention, the bacteriostatic builder is selected from citric acid, malic acid and sodium chloride.
Here, the total concentration of the effective components of the wetting liquid is preferably 105 to 300. mu.g/mL.
The preparation method of the high-stability gas humidifying liquid with the excellent bacteriostatic function comprises the following steps:
1) weighing other raw materials except epsilon-polylysine and water, adding the raw materials into a clean sterile container, adding a proper amount of purified water, and stirring and dissolving the mixture at normal temperature to form a uniform solution;
2) heating the solution obtained in the step 1) to 45-85 ℃, adding epsilon-polylysine, and stirring and dissolving to obtain a uniform solution;
3) adding purified water into the solution obtained in the step 2) to reach the required concentration, and then sterilizing to obtain a gas humidification liquid;
4) and packaging and sealing the obtained gas humidification liquid to obtain a humidification liquid finished product.
Further, the sterilization is performed for 20-60 minutes under the high-temperature damp-heat condition of 116-125 ℃, or the sterilization is performed through a sterilization filter.
The effective components of the high-stability gas humidification liquid with the bacteriostatic function comprise epsilon-polylysine and sodium dehydroacetate, and the sodium dehydroacetate is added according to a certain proportion, so that the separation of epsilon-polylysine precipitates is inhibited, namely the storage stability of the humidification liquid is improved by the mutual synergy of the two active components; meanwhile, the synergistic bacteriostasis of the wetting liquid enables the bacteriostasis broad spectrum and the effect of the wetting liquid to be better. Preferably, the mass ratio of sodium dehydroacetate to epsilon-polylysine in the gas humidification fluid is not less than 0.1, otherwise the synergy is minimal. In order to ensure better synergistic stability and antibacterial effect, the concentration of epsilon-polylysine is 5-50 mu g/mL, and the concentration of sodium dehydroacetate is 100-350 mu g/mL; more preferably, the concentration of epsilon-polylysine is 10-25 mu g/mL, and the concentration of sodium dehydroacetate is 200-300 mu g/mL.
The humidifying liquid can also contain natamycin, the addition of the natamycin can further improve the broad spectrum of bacteriostasis, the using amount of the natamycin should not exceed the total mass of the epsilon-polylysine and the sodium dehydroacetate, and the synergistic effect of the epsilon-polylysine and the sodium dehydroacetate can be influenced when the using amount is larger.
The humidifying liquid can also be added with a bacteriostatic synergist according to the requirement, the dosage of the bacteriostatic synergist is not more than 10 percent of the total mass of the epsilon-polylysine, the sodium dehydroacetate and the natamycin, and the adverse effects such as biological stimulation and the like can be generated when the dosage is too high. The antibacterial synergist is one or more of organic acid and sodium chloride, and the organic acid is selected from acetic acid, citric acid, malic acid, tartaric acid, lactic acid, glycine, lysine, serine, etc. The bacteriostatic synergist not only can improve the bacteriostatic effect integrally, but also can obviously improve the bacteriostatic effect of different bacteriostatic synergists on certain strains, and can be selected according to different requirements. For example, citric acid can significantly improve the inhibition effect on bacillus subtilis and escherichia coli when used as a bacteriostatic synergist, and malic acid can significantly improve the inhibition effect on aspergillus niger when used as a bacteriostatic synergist. The bacteriostatic synergist is preferably one of citric acid, malic acid and sodium chloride.
The gas humidifying liquid is not limited to oxygen humidification during oxygen inhalation, and can also be used for oxygen humidification of a breathing machine, moisture preservation of a newborn incubator, humidification of an air pipe (an artificial air passage) and the like.
The gas humidifying liquid can be directly used in clinical care by adopting the water solution thereof, and also can be used as a storage carrier of the humidifying liquid by using water absorbing materials such as sponge, non-woven fabric and the like or hydrophilic substances such as gelatin and the like.
According to the preparation method of the gas humidification liquid, firstly, effective components except the epsilon-polylysine are dissolved at room temperature, and then the epsilon-polylysine is dissolved by heating, so that a uniform solution is more easily obtained.
The invention has the beneficial effects that: the gas humidifying liquid has good storage stability and is not easy to generate precipitate; the gas humidifying liquid has better antibacterial broad spectrum and effect due to the synergistic effect of the epsilon-polylysine and the sodium dehydroacetate, and more effectively ensures that the humidifying liquid is not polluted by bacteria in the clinical use process; in addition, the preparation method of the humidifying liquid is simple, convenient and quick, the effective components are easier to dissolve, and the humidifying liquid has good clinical value and social significance for popularization and use.
Detailed Description
The invention will now be further illustrated by reference to specific examples, which are given by way of illustration only, without limiting the scope of the invention thereto.
Examples 1 to 9
The formulations and preparation processes of examples 1-9 are detailed in Table 1, with the following steps:
1) weighing other raw materials except the epsilon-polylysine and the water, adding the raw materials into a clean container, adding a proper amount of purified water, and stirring and dissolving the mixture at normal temperature to form a uniform solution;
2) heating the solution obtained in the step 1) to 45-85 ℃, adding epsilon-polylysine, and stirring and dissolving to obtain a uniform solution;
3) adding purified water into the solution obtained in the step 2) to reach the required concentration, and then sterilizing to obtain a wetting solution;
4) and packaging and sealing the obtained gas humidification liquid to obtain a humidification liquid finished product.
Table 1 formulations and processes of the examples
Comparative examples 1 to 3
Comparative examples 1-3 similar procedures were used as in the examples, and the specific formulations and procedures are detailed in Table 2.
Comparative example 4
Only epsilon-polylysine is used as an active ingredient to be dissolved at 50 ℃ to prepare the wetting liquid, and the specific formula and the process are detailed in the table 2.
Comparative example 5
Comparative example 5 the same procedure as in example 1 was followed, but the active ingredients were epsilon-polylysine and natamycin, and the specific formulation and procedure are detailed in table 2.
TABLE 2 respective proportional formulations and Processes
Test analysis
1) Storage stability test of humidification fluid
The samples of the wetting liquid prepared in the above examples and comparative examples, which were respectively sealed in the same transparent container, were placed in an environment at a temperature of 40 ± 2 ℃ for accelerated examination and the stability of the samples was observed. The shorter the time, in units of time, at which precipitation occurs, the poorer the stability. The evaluation criteria are as follows:
① is excellent in that no visible foreign matter is observed for 12 months under accelerated conditions;
② good, visible foreign matter is observed in 10-12 months under accelerated condition;
③ if qualified, observing visible foreign matter in 7-9 months under accelerated condition;
④ failed, visible foreign bodies were observed within 6 months under accelerated conditions.
The stability results for the examples and comparative examples are as follows:
table 3 stability results of examples and comparative examples
TABLE 4 results of determining the content of epsilon-polylysine in each sample before and after the accelerated test
| Sample source | Results in 0 day (mg/L) | Accelerated at 40 ℃ for 6 months to obtain a result (mg/L) |
| Example 1 | 49.90 | 49.50 |
| Example 2 | 3.00 | 2.96 |
| Example 3 | 29.97 | 29.85 |
| Example 4 | 15.02 | 14.88 |
| Example 5 | 14.97 | 14.94 |
| Example 6 | 15.00 | 14.97 |
| Example 7 | 14.96 | 14.96 |
| Example 8 | 10.01 | 9.91 |
| Example 9 | 19.98 | 19.92 |
| Comparative example 1 | 50.05 | 44.05 |
| Comparative example 2 | 0.29 | 0.29 |
| Comparative example 3 | 17.80 | 16.50 |
| Comparative example 4 | 50.00 | 38.65 |
| Comparative example 5 | 49.90 | 37.30 |
As can be seen from the experimental results in tables 3 and 4, the gas humidification fluids prepared in examples 1 to 9 and comparative example 2 of the present invention were examined by accelerated experiments, and epsilon-polylysine was not precipitated and the concentration was substantially unchanged; in the gas humidifying liquid of the comparative examples 1 and 3 to 5, epsilon-polylysine is separated out, particularly, the concentration of the comparative examples 4 and 5 is greatly reduced, and the epsilon-polylysine is separated out due to the interaction of the epsilon-polylysine and heavy metal ions, so that the storage stability is poor.
2) Bacteriostatic test of humidifying liquid
Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Morganella, Serratia fraudulenta, Klebsiella pneumoniae, Serratia marcescens, and Bacillus subtilis were quantitatively inoculated into the nutrient broth and the nutrient broth containing the wetting solutions (amount of 2% by volume of broth) of examples 1-9 and comparative examples 1-5, respectively, and incubated at 35 deg.C for 48 hours.
The results are as follows:
the nutrient broth control group is obviously turbid and has good bacterial growth;
the nutrient broth containing the wetting fluid of examples 1-9 was clear and transparent, indicating that bacterial growth was inhibited;
in a nutrient broth containing the humidified liquid of comparative example 1, wherein the broth of Morganella and Citrobacter freudenreichii is turbid;
in a nutrient broth containing the humidified fluid of comparative example 2, wherein the broth of escherichia coli and bacillus subtilis is turbid;
the nutrient broth containing the wetting fluid of comparative example 3 was clear and transparent, indicating that bacterial growth was inhibited;
in the nutrient broth containing the humidified liquid of comparative example 4, wherein the broth of Morganella and Citrobacter freudenreichii is turbid;
in a nutrient broth containing the humidified fluid of comparative example 5, the broth was turbid with serratia marcescens.
Claims (12)
1. The gas humidifying liquid is characterized by being an aqueous solution at least containing epsilon-polylysine and sodium dehydroacetate as active ingredients, wherein the concentration of the epsilon-polylysine is 3-60 mu g/mL, and the concentration of the sodium dehydroacetate is 100-350 mu g/mL.
2. The gas humidification fluid as claimed in claim 1, wherein the concentration of the epsilon-polylysine is 5-50 μ g/mL.
3. The gas humidifying liquid as claimed in claim 1, wherein the concentration of epsilon-polylysine is 10-25 μ g/mL, and the concentration of sodium dehydroacetate is 200-300 μ g/mL.
4. The gas humidification fluid of claim 1, wherein the active ingredient further comprises natamycin.
5. The gas humidification fluid of claim 4, wherein the natamycin is used in an amount not exceeding the total mass of epsilon-polylysine and sodium dehydroacetate; the concentration of the natamycin is 30-300 mug/mL.
6. The gas humidification fluid of claim 4, wherein the natamycin concentration is 60-100 μ g/mL.
7. The gas humidification fluid as claimed in any one of claims 1 to 4, wherein the active ingredient further comprises a bacteriostatic synergist, and when the active ingredient does not comprise natamycin, the bacteriostatic synergist is used in an amount of not more than 10% of the total mass of epsilon-polylysine and sodium dehydroacetate; when the effective component contains natamycin, the dosage of the antibacterial synergist is not more than 10% of the total mass of epsilon-polylysine, sodium dehydroacetate and natamycin; and the bacteriostatic synergist is one or a mixture of more than two of organic acid and sodium chloride.
8. The gas humidification fluid of claim 7, wherein the organic acid is selected from the group consisting of acetic acid, citric acid, malic acid, tartaric acid, lactic acid, glycine, lysine and serine.
9. The gas humidification fluid of claim 7, wherein the bacteriostasis synergist is selected from the group consisting of citric acid, malic acid, and sodium chloride.
10. The gas humidification fluid as claimed in claim 1, wherein the total concentration of the active ingredients is 105-300 μ g/mL.
11. A method of producing a humidification fluid for a gas as claimed in any one of claims 1 to 10, comprising the steps of:
1) weighing other raw materials except the epsilon-polylysine and the water, adding the raw materials into a clean container, adding a proper amount of purified water, and stirring and dissolving the mixture at normal temperature to form a uniform solution;
2) heating the solution obtained in the step 1) to 45-85 ℃, adding epsilon-polylysine, and stirring and dissolving to obtain a uniform solution;
3) adding purified water into the solution obtained in the step 2) to reach the required concentration, and then sterilizing to obtain a gas humidification liquid;
4) and packaging and sealing the obtained gas humidification liquid to obtain a humidification liquid finished product.
12. The method for preparing the humidified gas fluid as claimed in claim 11, wherein the sterilization is performed by sterilizing at a high temperature of 116-125 ℃ for 20-60 minutes or filtering through a sterilization filter.
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| CN101658705A (en) * | 2009-04-23 | 2010-03-03 | 陈旭良 | Medical humidification fluid with bacteria resistance function |
| CN105145597A (en) * | 2015-08-26 | 2015-12-16 | 浙江康德药业集团股份有限公司 | Efficient and antibacterial oxygen humidification fluid and method for preparing same |
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| CN101658705A (en) * | 2009-04-23 | 2010-03-03 | 陈旭良 | Medical humidification fluid with bacteria resistance function |
| CN105145597A (en) * | 2015-08-26 | 2015-12-16 | 浙江康德药业集团股份有限公司 | Efficient and antibacterial oxygen humidification fluid and method for preparing same |
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