CN103301501B - Medical liquid dressing and preparation method thereof - Google Patents
Medical liquid dressing and preparation method thereof Download PDFInfo
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- CN103301501B CN103301501B CN201310240323.3A CN201310240323A CN103301501B CN 103301501 B CN103301501 B CN 103301501B CN 201310240323 A CN201310240323 A CN 201310240323A CN 103301501 B CN103301501 B CN 103301501B
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- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses medical liquid dressing and a preparation method thereof, and aims at providing the medical liquid dressing which has long-acting antibacterial effects, the capability of reducing formed scars and has a good treatment effect on wound healing. The medical liquid dressing is characterized by containing 0.02-1% of solid ingredients and the balance of water; the solid ingredients include 10-80% of chitosan quaternary ammonium salt, 20-90% of organosilicon quaternary ammonium salt, and 6-30% of auxiliary materials. The preparation method comprises the steps of adding water to an agitating tank, setting the agitating speed of the agitator to 30-35 r/min; firstly, adding chitosan quaternary ammonium salt to agitate and completely dissolve for about 2-3 hours; adding an organosilicon quaternary ammonium salt solution and a chlorhexidine gluconate solution when agitating, fully agitating for 1-2 hours to obtain a mixing solution; filtering the mixing solution in a container; removing air bubbles over a night; determining a semi-finished product of which the solid content is 0.02-1% and the PH value is 4.1-7.5 in the next day; and sub-charging in bottles to form the finished product after a sterile test is qualified. The medical liquid dressing belongs to the technical field of preparation of medicaments.
Description
Technical field
The present invention discloses a kind of dressing and preparation method thereof, specifically, is a kind of medical use liquid dressing and preparation method thereof, belongs to technical field of medicine preparation.
Background technology
Wound healing is a complicated process, and by the impact of many factors, as infection, wound surface pollution, autoimmunity etc., wherein infecting is modal factor, and infection is the main cause affecting wound healing.Therefore, create good wound healing environment, prevent traumatic infection to be very important, adopt local topical " antibacterials " and " dressing " treatment at present clinically." antibacterials " cause a more and more serious clinical resistance difficult problem and " dressing " without clear and definite antibacterial effect, wound surface easily to be infected, heal slow and form cicatrix.
Traditional medicine is clinically to various skin injuries such as burn, wound, scald and decubital ulcers, and in order to protect wound surface, reduce and infect, accelerating wound healing typically uses sterile gauze as drug administration carrier, is covered in the method on wound surface surface after band medicine.But sterile gauze is easy to wound adhesion, cause and often can damage newborn epithelium and granulation tissue when changing dressings, Principle of Pain unbearably.Simultaneously sterile gauze itself does not have antibiotic property, and often in wound surface nursing exists because because making moist, patient's adhesive plaster of perspiring occurs that gauze displacement need be changed repeatedly, and too much closed adhesive plaster easily causes skin allergy, pruritus, blister; When temperature is low (as winter), adhesive plaster differences in viscosity, the not easily effective problem such as wound closure.These problems all make wound surface easily infect.
In urinary system and anorectum department, anus, rectum belong to permanent infected area as gastral end in the digestion activity of human body, so clinical to be difficult to accomplish truly aseptic in urinary system and anorectum department, and the wound surface easy infection at urinary system and anorectal position, the course of disease is long, and complication is many.And traditional medicine dressing is clinically difficult to these positions of land, use quite inconvenient, the nursing of wound surface seems and bothers very much.
These factors easily increase patient suffering and extend the hospital stays above, bring thought and economic double burden to patient.
Summary of the invention
For the problems referred to above, the object of the present invention is to provide a kind of long-acting broad-spectrum antibacterial, reduce and form cicatrix, and wound healing is had to the medical use liquid dressing of good therapeutic effect.
For solving the problems of the technologies described above, last technical scheme provided by the invention is such: this medical use liquid dressing is containing the solid constituent of 0.02-1%, and surplus is water; Wherein: described solid content comprises the component of following mass percent: chitosan quaternary ammonium salt 10-80%, organosilicon quaternary ammonium salt 20-90%, adjuvant 6-30%, each component sum of solid content is 100%.
Above-mentioned medical use liquid dressing, described liquid dressing is containing the solid constituent of 0.04-0.08%, and surplus is water; Wherein: described solid content comprises the component of following mass percent: chitosan quaternary ammonium salt 30-60%, organosilicon quaternary ammonium salt 40-70%, adjuvant 12-20%, each component sum of solid content is 100%.Above-mentioned a kind of medical use liquid dressing, described adjuvant is chlorhexidine gluconate.
For preparing above-mentioned medical use liquid dressing, the present invention also provides the preparation method of this liquid dressing: 1) take each solid constituent and water;
2) be configured to 5% organosilicone quaternary ammonium saline solution by water-soluble for organosilicon quaternary ammonium salt, chlorhexidine gluconate is water-soluble is configured to 20% chlorhexidine gluconate solution,
3) in agitator tank, fill with the water adding step 1) and take, setting blender mixing speed is 30-35 rev/min, and first add chitosan quaternary ammonium salt and stir, make it dissolve completely, the time is about 2-3 hour; Add step 2 while stirring again) the organosilicone quaternary ammonium saline solution prepared and chlorhexidine gluconate solution, fully stir 1-2 hour, obtain mixed solution;
4) filtered by the mixed solution of step 3) gained and put in container, overnightly eliminate bubble, next day measures, and solids content is at 0.02-1%, and the semi-finished product of pH value 4.1-7.5, after aseptic test is qualified, bottle subpackage, is finished product.
Compared with prior art, technical scheme provided by the invention, there is due to cation type organic silicon quaternary ammonium salt and chitosan quaternary ammonium salt the characteristics such as good water solublity, film property, antibiotic property, wound healing, biocompatibility and biodegradability, when solution spraying is in skin surface, solidify very soon after adhesion, form the stealthy antibacterial film of molecule level, skin is cationic layer, and film is firmly connected in chemical bond mode by the macromolecule organic silicon with skin surface.Cationic layer has strong adsorption effect to pathogenic microorganisms such as electronegative antibacterial, fungus, viruses, the ineffective and death by suffocation of the respiratory enzyme that pathogenic microorganism is depended on for existence.Therefore there is long-acting broad-spectrum antibacterial, reduce and form cicatrix, and have good therapeutic effect to wound healing.
Through experiment confirm, medical use liquid dressing of the present invention to various operative incision, empyrosis wound surface, various traumatic wound surface, ulcer in body surface wound surface, and the healedmyocardial chronic ulcer of various difficulties etc. all has the curative effect of highly significant, and be applicable to the wound of arbitrary shape and each position of human body.Medical use liquid dressing of the present invention is simultaneously that doctor adds new physical antibacterial weapon, the topical application of alternative antibacterials, alleviates a difficult problem for clinical drug-resistant.
Detailed description of the invention
Below in conjunction with detailed description of the invention; claim of the present invention is described in further detail; but do not form any limitation of the invention, the amendment of anyone limited number of time made within the scope of the claims in the present invention, still in claims of the present invention.
Embodiment 1
In agitator tank, pour into the pure water of 170000ml, setting blender mixing speed is 30-35 rev/min of stirring, first adds chitosan quaternary ammonium salt and (is produced by Ke Rui bio tech ltd, Jiaxing.) 87.5g stir make it dissolve completely, process about needs 2-3 hour.Bi Hou, more slowly add 5% organosilicon quaternary ammonium salt respectively and (produced by Ke Rui bio tech ltd, Jiaxing.) solution 5250ml and 20% chlorhexidine gluconate solution 437.5ml, limit edged stir about 30 minutes, then fully stir, the time is about 1-2 hour, obtains mixed solution.Filtration is put in container, overnightly eliminates bubble, and be semi-finished product, measuring solids content next day is 0.22%, and pH value is 4.8, and bottle subpackage carries out sterility test, is finished product after qualified.
Embodiment 2
In agitator tank, pour into the pure water of 170000ml, setting blender mixing speed is 30-35 rev/min of stirring, and first add chitosan quaternary ammonium salt 138.3g stirring and make it dissolve completely, process about needs 2-3 hour.Bi Hou, more slowly add 5% organosilicone quaternary ammonium saline solution 5250ml and 20% chlorhexidine gluconate solution 437.5ml respectively, limit edged stir about 30 minutes, then fully stir, the time is about 1-2 hour, obtains mixed solution.Filtration is put in container, overnightly eliminates bubble, and be semi-finished product, measuring solids content next day is 0.47%, and pH value is 4.3, and bottle subpackage carries out sterility test, is finished product after qualified.
Embodiment 3
In agitator tank, pour into the pure water of 170000ml, setting blender mixing speed is 30-35 rev/min of stirring, first inserts in agitator tank by chitosan quaternary ammonium salt 52.7g, and then stir and make it dissolve completely, process about needs 2-3 hour.Bi Hou, more slowly add 5% organosilicone quaternary ammonium saline solution 5250ml and 20% chlorhexidine gluconate solution 437.5ml respectively, limit edged stir about 30 minutes, then fully stir, the time is about 1-2 hour, obtains mixed solution.Filtration is put in container, overnightly eliminates bubble, and be semi-finished product, measuring solids content next day is 0.13%, and pH value is 5.2, and bottle subpackage carries out sterility test, is finished product after qualified.
Embodiment 4
In agitator tank, pour into the pure water of 170000ml, setting blender mixing speed is 30-35 rev/min of stirring, first inserts in agitator tank by chitosan quaternary ammonium salt 87.5g, and then stir and make it dissolve completely, process about needs 2-3 hour.Bi Hou, more slowly add 5% organosilicone quaternary ammonium saline solution 6250ml and 20% chlorhexidine gluconate solution 437.5ml respectively, limit edged stir about 30 minutes, then fully stir, the time is about 1-2 hour, obtains mixed solution.Filtration is put in container, overnightly eliminates bubble, and be semi-finished product, measuring solids content next day is 0.32%, and pH value is 5.8, and bottle subpackage carries out sterility test, is finished product after qualified.
Embodiment 5
In agitator tank, pour into the pure water of 170000ml, setting blender mixing speed is 30-35 rev/min of stirring, first inserts in agitator tank by chitosan quaternary ammonium salt 87.5g, and then stir and make it dissolve completely, process about needs 2-3 hour.Bi Hou, more slowly add 5% organosilicone quaternary ammonium saline solution 3750ml and 20% chlorhexidine gluconate solution 437.5ml respectively, limit edged stir about 30 minutes, then fully stir, the time is about 1-2 hour, obtains mixed solution.Filtration is put in container, overnightly eliminates bubble, and be semi-finished product, measuring solids content next day is 0.18%, and pH value is 4.9, and bottle subpackage carries out sterility test, is finished product after qualified.
In order to effect of the present invention is better described, provide clinical observation result of the present invention below:
1, patient source
With voluntarily for principle, the patient of the fresh surgical otch selecting surgical operation to produce, totally 132 examples.
Inclusion criteria
Operative incision patient; Age 18-65 year; Signature Informed Consent Form;
Subject Exclusion Criteria
The women of current gestation or suckling; Suffer from diabetes or other several chronic diseases; Within nearly three months, once used antibiotic more than 1 week person continuously; Nearest March participated in other clinical trial persons; Merge intentionally, brain, liver, the serious primary disease such as kidney and hemopoietic system, psychotic; Allergic constitution or to multi-medicament allergy sufferers; Researcher is thought and should not be participated in clinical trial person;
Two groups totally 132 example, experimental group 66 example, man 37 example, female 29 example, 42.76 years old mean age; Matched group 66 example, man 34 example, female 22 example, 40.47 years old mean age, relatively goes up no significant difference in the mean age, has comparability for two groups, incision length 14-20cm, average 15.90cm.
The sick kind data of table 1-1
| Case load | Treatment group (example) | Matched group (example) | |
| Thyroid is extractd | 20 | 11 | 9 |
| Appendectomy | 15 | 8 | 7 |
| Cancer of pancreas excises | 10 | 5 | 5 |
| Splenectomy | 13 | 6 | 7 |
| Hernia repair | 16 | 8 | 8 |
| Humeral fracture | 15 | 6 | 9 |
| Fracture of femur | 9 | 5 | 4 |
| Gallbladder removal | 14 | 8 | 6 |
| Cesarean operation | 20 | 10 | 10 |
| Add up to | 132 | 66 | 66 |
2, experiment material:
Medical use liquid dressing prepared by embodiment one
3, test method:
Clinical testing procedure
Patient is divided into test group at random and matched group carries out clinical observation.Test group uses medical use liquid dressing, and after myometrial suture, by this product direct spraying in incision, coating widths is each 4 ~ 5mm in operative incision both sides.After this product is applied to operative incision, automatically can form protecting film.Generally need wrapping early stage, as the wound surface that need wrap up or cover, the wrapping face of gauze should be squirted thoroughly, then row wrapping.After postoperative 3 days, if wound is without obviously red and swollen or ooze out, then do not need to bind up a wound, the dressing of this medical use liquid of direct spraying, each 2-3 spray, every day 3 times, can increase according to patient's practical situation or reduce each consumption.When changing dressings, dip normal saline or povidone iodine with cotton balls, repeatedly wiping 3-5 time, wound surface is removed totally substantially, then smears this product by spray, processes by above-mentioned wrapping as wrapped up.After operative incision is sewed up, within postoperative 2nd day or the 3rd day, change dressings once.Matched group is changed dressings according to Clinical practice modified chitin biological dressing (trade name: An Pushu), until wound healing, other processing method is consistent with treatment group.
Three, diagnostic criteria
1, wound healing standard
Wound healing by first intention: with " first " representative, refer to that healing is excellent, do not have the initial stage of untoward reaction to heal.
Second class heals: with " second " representative, refer to that healing is not good enough, healing place has inflammatory reaction, does not suppurate as redness, scleroma, hematoma, hydrops etc.
Third class heals: with " third " representative, refer to that otch suppurates, need incision and drainage.
2, wound healing time standard
Comparison parallel with matched group, after wound healing, judges healing time, and it is effective, effective, invalid to divide.
Effective: to propose a few days ago above time healing than matched group
Effective: to propose the healing of above time the previous day than matched group
Invalid: identical with matched group, or postpone healing.
3, PAIN CRITERIA
(1) painless: not bitterly;
(2) mild pain: mild pain, can nonuser intermittent pain;
(3) moderate pain: moderate pain, the lasting pain that impact is had a rest, need use analgesic;
(4) severe pain: severe pain, the lasting pain that non-medication can not be alleviated;
(5) pole severe pain: serious pain, the change of the pain continued companion blood pressure, pulse etc.;
5, cicatrix standard
(1) good: refer to smooth cicatrix, its trend is parallel with skin slope stricture of vagina, and color is identical with normal skin tone;
(2) slight: cicatrix is emblem protuberance slightly, and color is darker than normal skin tone;
(3) obvious: to refer to the exhausted trace swelled, color is darker, and can itch, bitterly, but the degree of protuberance can not exceed the scope of wound, and can flatten after a period of time;
Five, the statistical method adopted and evaluation methodology
Statistical procedures: two groups of analysis of comparable, qualitative data adopts X 2 test, Wilcoxon rank test.Quantitative data meets normal distribution t and checks, and does not meet normal distribution Wilcoxon rank test.Testing of hypothesis is unified uses two-sided test, and provide the P value of statistic of test and correspondence thereof, significance level a gets 0.05.Filter out qualified clinical observation table, machine system is analyzed by statistics requirement, is added up and research as calculated, results all for clinical trial is carried out statistical procedures and evaluation, and makes corresponding conclusion.
Clinical indexes is as follows:
A, effectiveness observation index: wound healing time, healing rank, pain condition, minimizing cicatrix and incision complication situation.
B, safety observations index: whether skin irritation, local anaphylaxis phenomenon, otch infect and other untoward reaction.
Evaluation methodology: clinical efficacy, nosetiology curative effect, total effects and safety four aspects judge
Six, clinic trial data analysis
1, the wound healing time
The situation analysis of table 2-1 curative effect index
Statistical analysis, comparing difference between wound healing time group has statistical significance (FAS:t=-4.8352, P=0.0000; PPS:t=-4.6721, P=0.0000), test group healing time is lower than matched group.The credibility interval of further calculating test group and matched group wound healing time difference 95% is (FAS:(0.8111 ,+∞); PPS:(0.7788 ,+∞)), be the standard of 2 days according to non-bad effect dividing value set in scheme, can think the non-bad and matched group of the general curative effect of test group.
2, pain healing curative effect index
Table 3 pain healing curative effect index
Whether the pain measurement (testing front/rear) of two groups of experimenters test, wound healing rank, otch ftracture and the equal not statistically significant of group difference (P > 0.05) of infection of incisional wound situation, and the curative effect of illustrative experiment group is non-is inferior to matched group.
Reduce cicatrix curative effect index
Table 4 reduces cicatrix curative effect index
Because cicatrization is according to the difference of individual physique and otch wound surface, forms cicatrix and also have nothing in common with each other; Therefore, cannot concluding evaluation be carried out to minimizing cicatrix curative effect, only be inferior to matched group by the curative effect of comparative illustration experimental group is non-.
4. safety indexes
Table 5 safety indexes
In sum, test products and reference product are to promoting that the healing of operative incision, analgesia, minimizing cicatrix etc. have good curative effect, and safety is high.
Four, clinical trial conclusion and discussion
Compare difference between wound healing time group and have statistical significance (FAS:t=﹣ 4.8352, P=0.0000; PPS:t.=﹣ 4.6721, P=0.0000), test group healing time is lower than matched group.The credibility interval of further calculating test group and matched group wound healing time difference 95% be [FAS:(0.8111 ,+∞); PPS(0.7788 ,+∞)], be the standard of 2 days according to non-bad effect dividing value set in scheme, can think that the general curative effect of test group is non-and be inferior to matched group
Whether the pain measurement (testing front/rear) of two groups of subject, wound healing rank, otch ftracture and the equal not statistically significant of group difference (P > 0.05) of infection of incisional wound situation, and the curative effect of illustrative experiment group is non-is inferior to matched group.
Safety results shows, and have no any adverse events or serious adverse events generation during this research, therefore, test products and reference product all have good safety
In sum, to obtain conclusion as follows in this clinical trial:
Test products and reference product are to promoting that the healing of postoperative surgical otch, analgesia, minimizing cicatrix etc. all have good curative effect, safe, reliable.
This medical use liquid dressing is external.Mainly be applicable to the treatment of various mucocutaneous or traumatic infection, be more suitable for the position that Post operation is difficult to wrap up position.Only have and promote wound healing reparation, analgesia, hemostasis, minimizing cicatrix, anti-infective effect.
Embodiment two
Medical use liquid dressing is used for the postoperative clinical observation of anorectum department
One, clinical data
Patient 40 example of this product in April, 2012 to June after the various anal-surgery of hospital's anorectum department ward Randomized treatment.Male 16 people in 40 routine patients, female 24 people; Age: 18-74 year, Qi Zhongnan: 19-72 years old, female: 18-74 year; Institute's row operation has anal fistula seton drainage 3 person-times, anal fistula, anal abscess otomy 8 person-times, and mixed hemorrhoids is cut and pricked art 13 person-times, mixed hemorrhoid procedure 8 person-times, anal sphincterotomy 11 person-times, and anal polyp, adenoma are removalled by ligature art 5 person-times, thrombosed external hemorrhoid decollement; 1 person-time.40 patients once accept above-mentioned binomial operator 11 person-times.
Two, observational technique
L, (1) double blind random.(2) observation group 20 is listed in by sequence number odd number person, the easypro externally used antimicrobial ion stock solution group of spray that), even numbers person lists matched group 20 in, route dressing change group).
2, diagnostic criteria
(1) surgical patient is hospitalized by anorectum department conventional treatment from outpatient service.(2) rejecting suffers from cancer, diabetes etc. or should not affect this patient observed.(3) spray you to relax the using method of chitosan long acting antibiotic material: directly spray in right amount to exposure wound, deep wound medication is sprayed at embedding on sterilization Cotton Gossypii bar applying, every day early, evening respectively once.(4) matched group is by anorectum department route dressing change method, and morning every day, evening are respectively once.
3, wound surface observation index is
(1) red and swollen: be evident as+, not obviously be ±, do nothing-; (2) hemorrhage: be evident as+, only have a small amount of blood stains for ±, inaction-; (3) pain: be evident as+, be slightly ±, inaction-; (4) wound secretion: mostly be most+, be slightly ±, inaction-; (5) pruritus: be unbearably+, be slightly ±, inaction-; (6) organization healing degree: wound is unchanged is+, slightly more for ±, heal for-; (7) observation of side effect and untoward reaction: observe with or without general malaise, erythra etc. in time, and other untoward reaction, and judge that whether this reaction is relevant with checking medication, by 5 grade standards: I is certainly relevant; II may be relevant; III is certainly irrelevant; IV may have nothing to do; V cannot judge.Give record.(8) course for the treatment of: all transfer "-" to above-mentioned symptom, without occurring as terminating the course for the treatment of in hospital stay.
Three, result
L, two groups of data distributions
Observation group: male 8 people, female 12 people; Age is from 18-72 year; Wherein institute's underwent operative: anal fistula seton drainage 1 person-time, anal fistula (anal abscess) otomy 3 person-times, mixed hemorrhoids is cut and is pricked art 6 person-times, mixed hemorrhoid procedure 4 person-times, anal sphincterotomy 4 person-times, anal polyp, adenoma are removalled by ligature art 3 person-times, thrombosed external hemorrhoid decollement 1 person-time.
Matched group: male 8 people, female 12 people; Age is from 21-74 year; Wherein institute's underwent operative: anal fistula seton drainage 2 person-times, anal fistula (anal abscess) otomy 5 person-times, mixed hemorrhoids is cut and is pricked art 7 person-times, mixed hemorrhoid procedure 4 person-times, anal sphincterotomy 7 person-times, and anal polyp, adenoma are removalled by ligature art 2 person-times.Upper two groups of data have comparability.
The natural law that table 1 wound surface redness disappears compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 1 | 9 | 2 | 3 | 2 | 2 | 2 | ||||||||
| Matched group (number) | 1 | 1 | 2 | 2 | 3 | 3 | 2 | 4 | 1 | 1 |
Two groups are compared and have notable difference (P < 0.01)
The natural law of the hemorrhage disappearance of table 2 wound surface compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 5 | 7 | 2 | 1 | 1 | 3 | 1 | ||||||||
| Matched group (number) | 1 | 4 | 1 | 5 | 3 | 2 | 1 | 1 | 2 |
Two groups are compared and have notable difference (P < 0.01)
The natural law that table 3 wound pain disappears compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 3 | 3 | 3 | 2 | 2 | 2 | 4 | 1 | |||||||
| Matched group (number) | 2 | 1 | 1 | 1 | 2 | 6 | 4 | 2 | 1 |
Two groups are compared and have notable difference (P < 0.01)
The natural law that table 4 wound secretion disappears compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 4 | 3 | 4 | 2 | 2 | 1 | 2 | 1 | 1 | ||||||
| Matched group (number) | 1 | 3 | 3 | 3 | 4 | 3 | 1 | 1 | 1 |
Two groups are compared and have notable difference (P < 0.01)
The natural law that table 5 wound surface pruritus disappears compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 12 | 1 | 2 | 4 | 1 | ||||||||||
| Matched group (number) | 1 | 2 | 2 | 1 | 4 | 3 | 3 | 3 |
Two groups are compared and have notable difference (P < 0.01)
Needed for table 6 wound healing, natural law compares
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 1 | 3 | 7 | 3 | 1 | 2 | 2 | 1 | |||||||
| Matched group (number) | 1 | 1 | 1 | 3 | 6 | 3 | 4 | 1 |
Two groups are compared and have notable difference (P < 0.01)
3, every whole comparison disappearing, terminate required natural law the course for the treatment of that observes the symptoms
Table 7
| Natural law | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
| Observation group's (number) | 1 | 1 | 5 | 4 | 4 | 2 | 1 | 1 | 1 | ||||||
| Matched group (number) | 1 | 1 | 1 | 2 | 2 | 5 | 5 | 5 |
Two groups are compared and have notable difference (P < 0.01)
Medical use liquid dressing examining report of the present invention
In sum, medical use liquid dressing of the present invention is the external dressing of a kind of safety advanced person, all can play certain long acting antibiotic, isolation wound surface at anus, rectum, perineal position and buttocks wound and reduce the various pathological reactions that wound surface causes, the effect accelerating wound healing extremely significantly, there is good compliance.
Anorectum department clinical treatment anus, anal canal and anal skin local wound one are directly subordinate to a professional difficult problem.Due to podex at fetal development as ectoderm and endoblastic boundary, finally develop into 1. body internal organs joint; 2. mucocutaneous and subcutaneous tissue, comprises various connective tissue, nerve, muscle, lymph etc. extremely abundant, complicated; 3. anatomical structure is complicated; 4. anal orifice and rectal intestine is as gastral end, permanent infected area is belonged in the digestion activity of people, so it is aseptic to be difficult to accomplish truly in anorectum department is clinical, the pathology at anorectal position or the healing of artificial wound more difficult than general surgical wound, complication is many, the course for the treatment of is long.
Medical use liquid dressing of the present invention for biopolymer active material is sprayed in anorectal local wound by this test, observe and whether can play isolation wound surface, long acting antibiotic and promotion wound healing, alleviate the various reactions of wound phase and wait effect, result shows, all observation index are that observation group and matched group all have extremely significantly difference through statistical conclusions, wherein pruritis alleviate particularly evident, and as main observation item, the shortening of the course for the treatment of is also obvious, in addition whole observation process has no adverse reaction and side effect generation, tested patient reaction is comfortable by medicine, display compliance is good, achieve challenging achievement.The conclusion of this observation is: medical use liquid dressing of the present invention is the external dressing of a kind of safety advanced person, when it is sprayed to skin, mucosa or wound surface, the ion reticular membrane that can form " non-drug " and " non-macroscopic view " has the double effects of " physical antibacterial " and " stealthy gauze " concurrently and strong adhesion, not only can long acting antibiotic, can also infection be isolated simultaneously.The spray-type of its uniqueness, be specially adapted to the human body (position such as hands, foot, genitals, perineum, anus, movable joint) that conventional medicament and dressing are not easily fixed, medical use liquid dressing of the present invention demonstrates good adaptive capacity, and relative traditional dressing, does not have dirt.Medical use liquid dressing materials of the present invention all can play certain long acting antibiotic, isolation wound surface at anus, rectum, perineal position and buttocks wound and reduce the various pathological reactions (red and swollen, hemorrhage, pain, secretion, pruritus etc.) that wound surface causes and accelerate wound healing extremely significantly, Shorten the Treatment Process, not only have no side effect with untoward reaction but also be easy to operation, show good compliance, therefore clinic is promoted the use of.
Claims (1)
1. a preparation method for medical use liquid dressing, is characterized in that, this medical use liquid dressing is containing the solid constituent of 0.02 ?1%, and surplus is water;
Wherein: described solid content comprises the component of following mass percent: chitosan quaternary ammonium salt 10 ?80%, organosilicon quaternary ammonium salt 20 ?90%, adjuvant 6 ?30%, each component sum of solid content is 100%;
Comprise the steps: successively
1) each solid constituent and water is taken by above-mentioned mass percent;
2) be configured to 5% organosilicone quaternary ammonium saline solution by water-soluble for organosilicon quaternary ammonium salt, chlorhexidine gluconate is water-soluble is configured to 20% chlorhexidine gluconate solution,
3) fill with in agitator tank add step 1) water that takes, setting blender mixing speed be 30 ?35 revs/min, first add chitosan quaternary ammonium salt and stir, make it dissolve completely, the time be 2 ?3 hours; Add step 2 while stirring again) the organosilicone quaternary ammonium saline solution prepared and chlorhexidine gluconate solution, fully stir 1 ?2 hours, obtain mixed solution;
4) by step 3) mixed solution of gained filters and puts in container, overnightly eliminates bubble, next day measures, solids content 0.02 ?1%, pH value 4.1 ?7.5 semi-finished product, after aseptic test is qualified, bottle subpackage, is finished product.
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| CN103800939B (en) * | 2014-02-14 | 2015-09-02 | 武汉烺祺生物科技有限公司 | A kind of antibacterial healing functional dressing and preparation method thereof |
| CN104162184B (en) * | 2014-05-26 | 2016-06-15 | 北京鼎瀚恒海生物科技股份有限公司 | A kind of based composite dressing for medical use and its preparation method |
| CN104307032B (en) * | 2014-11-05 | 2016-11-16 | 天津工业大学 | A kind of pain relieving, antibacterial, stop blooding and promote the liquid dressing of wound healing |
| CN105169455B (en) * | 2015-08-25 | 2018-06-01 | 东莞市达庆医疗器械有限公司 | A kind of burn and scald external application first aid medical dressing and preparation method thereof |
| CN107773635A (en) * | 2016-08-31 | 2018-03-09 | 瑞普（天津）生物药业有限公司 | A kind of animal skin composite disinfectant and preparation method |
| CN108969795B (en) * | 2018-08-29 | 2019-09-10 | 海南一鸿实业发展有限公司 | One kind is for difficult healedmyocardial surface of a wound functional liquid dressing and preparation method thereof |
| CN109010907B (en) * | 2018-08-29 | 2019-10-29 | 海南鸿翼医疗器械有限公司 | A kind of functionality Wound-protection liquid body dressing and preparation method thereof |
| CN110559475A (en) * | 2019-09-19 | 2019-12-13 | 广州博民生物科技有限公司 | Compound liquid dressing and preparation method thereof |
| CN111991612A (en) * | 2020-08-29 | 2020-11-27 | 山东百多安医疗器械股份有限公司 | Preparation method of liquid dressing with analgesic and antibacterial functions |
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