CN102389743A - Formula of medical bacteriostatic humidifying solution - Google Patents
Formula of medical bacteriostatic humidifying solution Download PDFInfo
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- CN102389743A CN102389743A CN2011101608595A CN201110160859A CN102389743A CN 102389743 A CN102389743 A CN 102389743A CN 2011101608595 A CN2011101608595 A CN 2011101608595A CN 201110160859 A CN201110160859 A CN 201110160859A CN 102389743 A CN102389743 A CN 102389743A
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- 230000003385 bacteriostatic effect Effects 0.000 title abstract 2
- 229960003255 natamycin Drugs 0.000 claims abstract description 26
- NCXMLFZGDNKEPB-FFPOYIOWSA-N natamycin Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/C[C@@H](C)OC(=O)/C=C/[C@H]2O[C@@H]2C[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 NCXMLFZGDNKEPB-FFPOYIOWSA-N 0.000 claims abstract description 26
- 108010039918 Polylysine Proteins 0.000 claims abstract description 24
- 235000010298 natamycin Nutrition 0.000 claims abstract description 24
- 239000004311 natamycin Substances 0.000 claims abstract description 24
- 239000012530 fluid Substances 0.000 claims description 34
- 230000000844 anti-bacterial effect Effects 0.000 claims description 12
- 239000007864 aqueous solution Substances 0.000 claims description 10
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- 230000003750 conditioning effect Effects 0.000 claims description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 abstract description 24
- 239000001301 oxygen Substances 0.000 abstract description 24
- 229910052760 oxygen Inorganic materials 0.000 abstract description 24
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- KDXKERNSBIXSRK-RXMQYKEDSA-N D-lysine Chemical compound NCCCC[C@@H](N)C(O)=O KDXKERNSBIXSRK-RXMQYKEDSA-N 0.000 description 1
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- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
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- 229920000729 poly(L-lysine) polymer Polymers 0.000 description 1
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- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
The invention relates to a formula of a medical bacteriostatic humidifying solution, which is mainly used for clinical oxygen uptake, breathing machine treatment, neonate warming box and air passage moistening. The formula is a solution mainly comprising the components of epsilon-polylysine, natamycin and water, and belongs to the category of clinically-used medicines and medical apparatuses and instruments. The formula can effectively ensure that a moistening solution is not polluted by bacteria in a clinical use process, and has high safety and no toxic and side effects after entering a human body. The formula has the advantages of simple preparation process, low cost and better clinical value and popularization and use social significance.
Description
A kind of medical humidification fluid that uses during the confession that technical field the present invention relates to field of medicaments clinical cares such as oxygen inhalation therapy, respirator treatment, the warm case of neonate and air flue be moistening clinically with bacteria resistance function; Main component is the aqueous solution that contains epsilon-polylysine and Natamycin composition, belongs to medicine and medicine equipment category that clinical care is used.
Be used in the clinical care of background technology medical humidification fluid general reference that oxygen humidification, lung ventilator humidification, the warm case of neonate are preserved moisture, tracheae (artificial airway) is moistening and humidification is used during other clinical cares liquid.The general requirement of the humidification fluid that clinical care is used is aqua sterilisa or distilled water, and because of itself does not have bacteria resistance function, in long-time clinical care process, humidification fluid brings the nosocomial infection risk very easily by germ contamination to the patient.
Oxygen inhalation therapy or respirator treatment are one of the most frequently used rescue of hospital or treatment means; Because the humidity of oxygen itself is very low; Long-time oxygen uptake meeting causes that the patient respiratory road is dry, dry and cracked hemorrhage, the sputum of schneiderian membrane is difficult for adverse consequences such as expectoration, generally wants to carry out humidifying to oxygen earlier when therefore carrying out the mechanical ventilation nursing clinically and handles.Domestic also have in the lot of documents report oxygen uptake process humidification fluid easily by germ contamination, thereby cause nosocomial infection.For example stone Lan Ping etc. " the pollution situation analysis and the countermeasure of oxygen humidifying liquid " (nursing research; The 19th the 5th phase of volume of 2005 the 5th phases), " monitoring of Daliang City's oxygen humidifying liquid germ contamination degree " (Chinese infection control magazine of Xu Dan etc.; The 3rd the 2nd phase of volume of April in 2004) and " the Bacteria Culture investigation of oxygen humidifying liquid " tens pieces of articles such as (Chinese hospital infection magazine, 2006 the 16th the 7th phases of volume) of Tong Jianhua all bacterial infection and nosocomial infection problem that existing oxygen humidifying liquid causes have been carried out the argumentation of system.
Infant incubator is the special place that premature and ewborn infant are received treatment, nursed.Humidity suitable in the warm case all need be regulated through the humidification fluid in the tank, if tank germ contamination seriously then can cause hospital-acquired infection.Ji County, Tianjin healthcare hospital for women & children 6 routine neonate's nosocomial infections of first affiliated hospital, 8 routine neonatal deaths of Shanghai Communications University, Xi'an and in March, 2009 generation take place in October, 2008, and one of its main induced factor is that the warm case water filling port bacterium of neonate exceeds standard.
The air flue nursing is one of main nursery work of patients accepted tracheotomy; But after the tracheotomy; Because the humidity deficit of suction gas is prone to cause air flue mucosa injury, ciliary movement and is obstructed, and therefore needs often carry out the humidifying nursing to gas port, humidification fluid pollutes and very easily causes patient's pulmonary infection.
In addition, be used for the humidification fluid that a lot of other links such as ICU ward air humidification are used during clinical care, all have pollution hidden trouble inevitably, cause institute's sense and take place.
For this reason, the present invention proposes a kind of antibacterial medical humidification fluid prescription, and its main component is the solution of epsilon-polylysine, Natamycin and water proportioning, can solve the humidification fluid pollution hidden trouble well.
Epsilon-polylysine (ε-PL, molecular formula C
180H
362N
60), claim poly-D-lysine again, be Janpanese sake well flat one and clear two doctors screening in island and synthetic auxotype bacteriostatic agent, it is a kind of poly-l-lysine that leans on peptide bond to connect carboxyl and amino group, is a kind of polypeptide with bacteriostasis efficacy.It is a kind of external bacteriostatic agent of wide spectrum, gets into nutrition amino acid---the lysine that can be decomposed into needed by human behind the human body, and the lysine eight necessary seed amino acids that are human body, therefore, epsilon-polylysine has high security.Japan 1989 lists epsilon-polylysine in the food in and allows the natural additive that adds, has also listed the food additives scope at US and European.
Epsilon-polylysine has strong bacteriostasis, and the membrane structure that it can destroy microorganisms causes that material, energy and the information transmission of cell interrupted, and finally causes cell death.It all has good fungistatic effect to gram-positive bacteria, Gram-negative bacteria, saccharomycete, mould; And it is very good to difficult Escherichia coli, the salmonella fungistatic effect that suppresses of other bacteriostatic agents; Hear resistance bacillus and some viruses also there is inhibitory action; Hiraki tests result such as following table to the minimal inhibitory concentration (MIC) of epsilon-polylysine different microorganisms:
Table 1 epsilon-polylysine suppresses the minimal inhibitory concentration of growth of microorganism
But epsilon-polylysine is relatively poor to the fungistatic effect of mould, so compatibility Natamycin antipathogenic composition is formed compound preparation in the prescription of the present invention.
Natamycin (natamycin); Have another name called: pimaricin (pimaricin), natamycin are by filamentous fungi inhibitor polyene antibiotics such as the saccharomycete of synthetic natural, the wide spectrum of his streptomycete (Streptomyces natalensis) secondary metabolism, highly effective and safe and moulds.Natamycin is extremely low to the toxicity of mammalian cell; Can be widely used on the fresh-keeping and antifungal therapy of food antiseptic; Have the antibacterial activity identical nearly all saccharomycete and mould all had antibacterial activity with nystatin,, and have antitrichomonal effect; But to bacterium protozoan or sick plain invalid.In June nineteen eighty-two, united states drug and food control office (FDA) official approval Natamycin are as food preservative, and Natamycin is present unique in the world antimycotic microbiological antiseptic.China Ministry of Public Health official approval Natamycin was as food preservative in 97 years.
The Natamycin security is high, and is harmless, be difficult to absorbed by human body alimentary canal, and microorganism is difficult to its generation resistance is mainly used in the production and the preservation of food such as dairy products, meat products, fermented wine, beverage at present.
Summary of the invention the present invention aim to provide a kind of when being used for oxygen uptake oxygen humidification, lung ventilator oxygen humidification, the warm case of neonate preserve moisture, the antibacterial medical humidification fluid prescription of tracheae (artificial airway) humidification; Its meaning is to guarantee effectively that not only humidification fluid does not receive germ contamination in the clinical use; Simultaneously safe, have no side effect behind the entering human body.Prescription adopts epsilon-polylysine and Natamycin compatibility, not only can make bacteriostatic agent produce better synergy, enlarges the antimicrobial spectrum of medical humidification fluid, and fungistatic effect is better, and reduces the bacteriostatic agent consumption.Preparation technology of the present invention is simple, and is with low cost, has the social effect that good clinical is worth and promotes the use of.
The present invention is specific as follows:
The main active ingredient of a kind of antibacterial medical humidification fluid that 1, the present invention relates to comprises the solution that epsilon-polylysine, Natamycin and water are formed.
2, a kind of antibacterial medical humidification fluid that the present invention relates to, the concentration of epsilon-polylysine in the aqueous solution are 1 μ g/ml～200000 μ g/ml, Natamycin 1 μ g/ml～500 μ g/ml; Preferred version is that the concentration of epsilon-polylysine in the aqueous solution is 150 μ g/ml, Natamycin 20 μ g/ml.
3, because epsilon-polylysine is that fungistatic effect is best in 5～8 the solution at pH value, and the Natamycin aqueous solution receives the influence of pH hardly to mould and saccharomycetic activity, but is lower than 3 or be higher than at 9 o'clock at pH, and the aqueous solution of Natamycin is with regard to less stable.Therefore in the antibacterial medical humidification fluid that the present invention relates to, can also add medicinal pH value conditioning agent, humidification fluid is remained between 6～7.
4, because epsilon-polylysine and alcohol, organic acid (acetic acid, malic acid, maleic acid etc.), glyceride, glycine have good synergy, in the antibacterial medical humidification fluid that the present invention relates to, can also add above synergist; According to the content ratio of epsilon-polylysine, addition is respectively: between the alcohol 30%～70%, between the organic acid 0.5%～5%, between the glyceride 0.01%～5.0%, between the glycine 0.01～10%.
4, the medical humidification fluid with bacteria resistance function that the present invention relates to can directly use the aqueous solution of this humidification fluid when clinical use; Also can use hydrophilic substances such as absorbent materials such as sponge, nonwoven or gelatin to supply clinical use as the storage carrier of this aqueous solution.
Jiangxi Province hospital Neurology is chosen sanity when being admitted to hospital, is continued inpatient 100 examples of oxygen uptake 24 hours, oxygen flow 2-5L/min; 39～94 years old age; 61 years old mean age, the male sex's 65 examples wherein, women's 35 examples; Successively number by being admitted to hospital, be divided into two groups of each 50 people of AB at random by odd or even number.A group is experimental group, and the B group is control group, two groups of oxygen sources, oxygen uptake flow no difference of science of statistics.The humidification fluid of experimental group use prescription of the present invention extracted residual liquid censorship in the bag by the sterile working rules after 24 hours, capable again Bacteria Culture; Control group uses the humidification bottle adding distil water humidifying oxygen uptake behind the conventional cleaning and sterilizing, falls to remove residual water after 24 hours, scrapes the humidification bottle inwall with aseptic cotton balls by the sterile working rules, and sample send Bacteria Culture.The result: experimental group 51 routine sample Bacteria Culture total negatives, pollution rate are zero; There are 8 examples to detect Pseudomonas in the control group 50 routine samples, Serratia, Escherichia coli, staphylococcus aureus, pollution rate is 16%.P＜0.05 difference has statistical significance.See table 1:
Table 1: two kinds of humidification fluid bacterial bearing rates
X
2＝8.696，P＝0.003
Above description of test, the humidification fluid that adopts the present invention to prepare can extensively suppress pathogenic microorganism field planting in humidification fluid and oxygen hose such as bacterium, fungi, guarantees the cleaning of oxygen terminal pipeline, can effectively avoid oxygen uptake patient's cross pollution.
Preparation method of the present invention sees the specific embodiment.
Specific embodiment the present invention can use following embodiment to explain
The preparation of embodiment 1 product 10000ml medical humidification fluid of the present invention, artificial air flue humidification usefulness requires humidification fluid aseptic.
Prescription:
The preparation method:
1, takes by weighing epsilon-polylysine raw material 1.5 grams, Natamycin 0.3 gram in above prescription ratio precision.
2, epsilon-polylysine is put in the 10000ml distilled water, be stirred to dissolving fully, regulate between pH value to 5.5～7.0 with acetic acid.
3, according to every bottle of 100ml can, sealing, 115 ℃ of high temperature wet heating were sterilized 30 minutes.
5, detect deposit after qualified subsequent use.
The preparation of embodiment 2 product 10000ml medical humidification fluids of the present invention, oxygen humidification usefulness, requiring humidification fluid is aqua sterilisa, and total number of bacterial colonies is answered≤20cfu/ml, and pathogenic bacteria must not detect.
Prescription:
The preparation method:
1, takes by weighing epsilon-polylysine raw material 1.5 grams, Natamycin 0.3 gram, glycine 0.2 gram in above prescription ratio precision.
2, epsilon-polylysine, Natamycin, glycine are put in the 10000ml distilled water, be stirred to dissolving fully, regulate between pH value to 5.5～7.0.
3, with 0.3um filtering with microporous membrane humidification fluid.
4, according to every bottle of 100ml can, sealing.
5, detect deposit after qualified subsequent use.
The invention is not restricted to above practical implementation method.
Claims (3)
1. the prescription of an antibacterial medical humidification fluid is characterized in that the main component of medical humidification fluid is the solution that epsilon-polylysine, Natamycin and compatible are processed, and can also add synergist or pH value conditioning agent in the prescription.
2. the prescription of a kind of antibacterial medical humidification fluid according to claim 1 is characterized in that the concentration of epsilon-polylysine in the aqueous solution is that 1 μ g/ml～200000 μ g/ml, the concentration of Natamycin in the aqueous solution are 1 μ g/ml～500 μ g/ml.
3. the prescription of a kind of antibacterial medical humidification fluid according to claim 1 and 2, its characteristic is that also preferred version is that the concentration of epsilon-polylysine in the aqueous solution is 150 μ g/ml, Natamycin 20 μ g/ml.
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102941034A (en) * | 2011-11-18 | 2013-02-27 | 曹青春 | Medical humidification liquid having bacteriostasis function |
| CN103205771A (en) * | 2013-03-15 | 2013-07-17 | 胡鸣若 | Preserving method and application method for self-breathing type electrochemical oxygen generator |
| CN103990414A (en) * | 2014-05-27 | 2014-08-20 | 浙江康德药业集团有限公司 | Oxygen humidifying solution with bacteriostasis function and preparation method thereof |
| 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 |
| CN106390852A (en) * | 2016-11-14 | 2017-02-15 | 西安汇智医疗集团有限公司 | Antibacterial moisturizing liquid for respiratory ventilation treatment |
| CN107638573A (en) * | 2016-07-22 | 2018-01-30 | 上海宝阳医疗器械有限公司 | A kind of antibacterial medical ultrasound compounding agent and preparation method thereof |
| CN108184873A (en) * | 2018-01-29 | 2018-06-22 | 吴元华 | A kind of medicament composition of the prevention phytobacterial disease containing epsilon-polylysine |
| CN108552193A (en) * | 2018-04-11 | 2018-09-21 | 程其明 | Biological antibacterial liquid of cavity drainage and its preparation method and application |
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| CN102941034A (en) * | 2011-11-18 | 2013-02-27 | 曹青春 | Medical humidification liquid having bacteriostasis function |
| CN103205771A (en) * | 2013-03-15 | 2013-07-17 | 胡鸣若 | Preserving method and application method for self-breathing type electrochemical oxygen generator |
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| CN103990414A (en) * | 2014-05-27 | 2014-08-20 | 浙江康德药业集团有限公司 | Oxygen humidifying solution with bacteriostasis function and preparation method thereof |
| 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 |
| CN105145597B (en) * | 2015-08-26 | 2017-06-30 | 浙江康德药业集团股份有限公司 | A kind of oxygen humidifying liquid of Efficient antibacterial and preparation method thereof |
| CN107638573A (en) * | 2016-07-22 | 2018-01-30 | 上海宝阳医疗器械有限公司 | A kind of antibacterial medical ultrasound compounding agent and preparation method thereof |
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| CN106390852A (en) * | 2016-11-14 | 2017-02-15 | 西安汇智医疗集团有限公司 | Antibacterial moisturizing liquid for respiratory ventilation treatment |
| CN108184873A (en) * | 2018-01-29 | 2018-06-22 | 吴元华 | A kind of medicament composition of the prevention phytobacterial disease containing epsilon-polylysine |
| CN108552193A (en) * | 2018-04-11 | 2018-09-21 | 程其明 | Biological antibacterial liquid of cavity drainage and its preparation method and application |
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