CN100420446C - Surgical flush fluid and its preparing process and application - Google Patents
Surgical flush fluid and its preparing process and application Download PDFInfo
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- CN100420446C CN100420446C CNB2006100422403A CN200610042240A CN100420446C CN 100420446 C CN100420446 C CN 100420446C CN B2006100422403 A CNB2006100422403 A CN B2006100422403A CN 200610042240 A CN200610042240 A CN 200610042240A CN 100420446 C CN100420446 C CN 100420446C
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- flushing liquor
- flushing liquid
- flushing
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Abstract
The present invention relates to a flushing fluid for surgery, which is characterized in that the flushing liquid is composed of solute and solvent, wherein the solute comprises one or two kinds of carboxymethyl cellulose, carboxymethyl chitosan and carboxymethyl chitin; the solvent comprises water for injection, physiological saline, Ringer's solution flushing liquid, mannitol flushing liquid, dextrose flushing liquid, chlorhexidine flushing liquid, gentamicin physiological saline flushing liquid, active iodine flushing liquid, bromogeramine flushing liquid, Jie'eryin flushing liquid, glycine flushing liquid and metronidazole flushing liquid or physiological equilibrium solution. The total concentration of the solute in the flushing liquid for the surgery is 0.1 to 50 g/L. The physiological equilibrium liquid is composed of phosphate buffer, NaHCO3, sodium gluconate and mannitol. In the present invention, the flushing liquid for the surgery simultaneously has the functions of surgical wash and surgical adherence prevention, and has the advantages of good effect, high stability and no side effect.
Description
Technical field
The present invention relates to a kind of surgical flush fluid and its production and application, particularly relate to a kind of surgical flush fluid that prevents surgical adhesions and its production and application.
Background technology
The inventor has disclosed a kind of carboxymethyl chitosan in the patent No. is the patent of ZL92106578.7, it is a kind of milky or light yellow powdery thing, and is soluble in water, and water-soluble back is transparent viscous colloidal solution.In the patent No. is the patent of ZL01107718.2, further disclosed the feasibility of carboxymethyl chitosan, be sure of that it has the effect of treatment gastritis, gastric ulcer as a kind of medicine as treatment gastritis, gastric ulcer medicine.The inventor has disclosed water soluble medical chitose preparation and preparation method in the patent No. is the patent of ZL00111646.0.In application number is the patent application of 200510045472.X, disclosed hydrogel that carboxymethyl chitosan and/or carboxymethyl chitin make in preparation treatment skin trauma medicine application and in the preparation protection with repair application in the skin trauma dressing.On above-mentioned development basis, the inventor has further tested the surgical flush fluid that contains carboxymethyl cellulose and/or carboxymethyl chitosan and/or carboxymethyl chitin again.The flushing liquor that uses clinically can only be used for the operative site flushing at present, does not prevent the effect of surgical adhesions, and the surgical flush fluid with surgery washing and prevention surgical adhesions function does not appear in the newspapers as yet.
Summary of the invention
The purpose of this invention is to provide a kind of surgical flush fluid and its production and application, to overcome the above-mentioned deficiency of existing flushing liquor with prevention surgical adhesions.
A kind of surgical flush fluid, it is characterized in that being formed by solute and solvent, solute is one or both in carboxymethyl cellulose, carboxymethyl chitosan, the carboxymethyl chitin, and solvent is water for injection, normal saline, ringer's solution flushing liquor, mannitol flushing liquor, glucose flushing liquor, hibitane flushing liquor, gentamycin normal saline flushing liquid, povidone iodine flushing liquor, bromo geramine flushing liquor, JIEERYIN flushing liquor, glycine flushing liquor, metronidazole flushing liquor or physiological balance liquid; The total concentration of described solute in surgical flush fluid is 0.1～50g/L; Described physiological balance liquid is by phosphate buffer, NaHCO
3, gluconic acid sodium salt, mannitol form; Described phosphate buffer is made up of sodium hydrogen phosphate, sodium dihydrogen phosphate or dipotassium hydrogen phosphate, potassium dihydrogen phosphate or sodium hydrogen phosphate, potassium dihydrogen phosphate or dipotassium hydrogen phosphate, sodium dihydrogen phosphate and water, its total mol concentration is 0.005M～0.2M, NaHCO in the physiological balance liquid
3, gluconic acid sodium salt, mannitol concentration range be respectively 0.3～1.4g/L, 10～25g/L, 10～25g/L; The pH of this physiological balance liquid is 7.0～7.5.
The preparation method of above-mentioned surgical flush fluid is characterized in that taking by weighing in carboxymethyl cellulose, carboxymethyl chitosan, the carboxymethyl chitin one or both, and it is dissolved in the above-mentioned solvent, carries out moist heat sterilization or membrane filtration degerming then.
The application of above-mentioned surgical flush fluid in the clinical operation flushing.
Surgical flush fluid of the present invention has the function of surgery washing and prevention surgical adhesions simultaneously, effective, good stability, has no side effect.
The specific embodiment
Embodiment 1
Contain the preparation of the flushing liquor of carboxymethyl chitosan: take by weighing carboxymethyl chitosan 3.0g, place clean normal saline bottle, add solvent normal saline 100ml, stirring and dissolving, in 121 ℃ of following moist heat sterilization 20min, must contain the surgical flush fluid (A) of carboxymethyl chitosan.
Embodiment 2
Contain the preparation of the flushing liquor of carboxymethyl cellulose: take by weighing sodium hydrogen phosphate (Na
2HPO
42H
2O) 0.0162 mole (analytical pure, down together), sodium dihydrogen phosphate (NaH
2PO
42H
2O) 0.0038 mole, put in the beaker, add sterile distilled water 1000ml, stirring and dissolving, getting total mol concentration is the phosphate buffer of the pH7.4 of 0.02M.Take by weighing NaHCO
30.84g, gluconic acid sodium salt 21.05g, mannitol 16.04g adds in the above-mentioned buffer stirring and dissolving respectively.Carry out membrane filtration (Φ 0.22 μ m) under the aseptic condition to aseptic pyrogen-free normal saline bottle, the degerming depyrogenation gets the solvent physiological balance liquid.Take by weighing aseptic pyrogen-free carboxymethyl cellulose 0.5g, place clean aseptic pyrogen-free normal saline bottle, aseptic condition adds physiological balance liquid 100ml down, stirring and dissolving, pH value is 7.4 the surgical flush fluid that contains carboxymethyl cellulose (B).
The sodium hydrogen phosphate of physiological balance liquid, sodium dihydrogen phosphate can be used dipotassium hydrogen phosphate, potassium dihydrogen phosphate or dipotassium hydrogen phosphate, sodium dihydrogen phosphate or sodium hydrogen phosphate, potassium dihydrogen phosphate instead in the present embodiment, two kinds of phosphatic molar ratios can be 1.5-5.2: 1, and its total concentration can be 0.005M～0.2M; NaHCO
3Concentration can be 0.3～1.4g/L, gluconic acid sodium salt can be 10～25g/L, mannitol can be 10～25g/L.Change carboxymethyl cellulose in carboxymethyl cellulose, carboxymethyl chitosan, the carboxymethyl chitin one or both, the total concentration of solute is that 0.1～50g/L all can reach same effect in the surgical flush fluid that makes.The surgical flush fluid pH value that makes can be 7.0～7.5.
Embodiment 3
Contain the preparation of the surgical flush fluid of carboxymethyl cellulose and carboxymethyl chitin: take by weighing aseptic carboxymethyl cellulose 0.5g and aseptic carboxymethyl chitin 0.5g respectively, place clean physiological saline solution bottle, aseptic condition adds aseptic solvent ringer's solution 250ml down, stirring and dissolving must contain the surgical flush fluid (C) of carboxymethyl cellulose and carboxymethyl chitin.
Change carboxymethyl cellulose, carboxymethyl chitin in carboxymethyl cellulose, carboxymethyl chitosan, the carboxymethyl chitin any two kinds, also can reach same effect.
In above-mentioned 3 embodiment, the solute that is used for preparing surgical flush fluid is any one of carboxymethyl cellulose, carboxymethyl chitosan, carboxymethyl chitin three, or two kinds combination among the three, all can reach same effect.Employed solvent can be water for injection, normal saline, ringer's solution flushing liquor, mannitol flushing liquor, glucose flushing liquor, hibitane flushing liquor, gentamycin normal saline flushing liquid, povidone iodine flushing liquor, bromo geramine flushing liquor, JIEERYIN flushing liquor, glycine flushing liquor or metronidazole flushing liquor; Also can be the physiological balance liquid among the embodiment 2, all can reach same effect.The surgical flush fluid of Film with Preventing Adhesion of the present invention is liquid form or gel form, is aseptic pyrogen-free.
Embodiment 4
Contain carboxymethyl chitosan flushing liquor (A), contain carboxymethyl cellulose flushing liquor (B), contain the surgery washing effect and the Film with Preventing Adhesion effect test of the flushing liquor (C) of carboxymethyl cellulose and carboxymethyl chitin:
Select for use body weight to be 40 of the Wistar rat of 200 ± 20g, female, be divided into 4 groups at random, 10 every group.4 groups are respectively: contain the flushing liquor (A group) of carboxymethyl chitosan, the flushing liquor (B group) that contains carboxymethyl cellulose, the flushing liquor (C group) that contains carboxymethyl cellulose and carboxymethyl chitin, normal saline flushing liquid matched group (D group).All animals all adopts the pentobarbital sodium intraperitoneal injection of anesthesia, and dosage is 30mg/Kg.Get the abdominal part center and cut the otch that is about 3cm, open the abdominal cavity, carry out bilateral oophorectomy under the aseptic condition, and find out caecum, its content is extruded cap end,, impaired on the caecum surface until the serous coat skin with the continuous scouring of dry gauze, on the caecum surface pearl oozing of blood is arranged, then caecum is put back to the abdominal cavity.Get the flushing liquor to be tried of 10ml respectively and pour the abdominal cavity into, respectively the perform the operation operative site of animal of flushing, and with dry sterile gauze with flushing liquor sucking-off gently, observe surgical field of view flushing situation, and carry out myometrial suture.Postoperative animal sub-cage rearing was put to death all animals after 14 days, opened the abdomen check.The intestinal adhesion degree is adopted the Pyatyi classification method, and determine following grade scale: (1) 0 grade: do not have adhesion fully, the reparation of intestinal serosal surface is good; (2) I level: a small amount of adhesion of caecum and surrounding tissue, loose easily branch, no oozing of blood; (3) II level: caecum and surrounding tissue gently arrive the moderate adhesion, and there is oozing of blood the part during separation; (4) III level: the extensive adhesion of intestinal tube and surrounding tissue, difficult separation, no intestinal obstruction; The IV level: the tight adhesion of intestinal tube and surrounding tissue is agglomerating, and separation difficulty causes intestinal obstruction.
Result of the test shows, contain carboxymethyl chitosan flushing liquor, contain carboxymethyl cellulose flushing liquor, contain the flushing liquor of carboxymethyl cellulose and carboxymethyl chitin, each group is similar to the developing result of normal saline flushing liquid to the developing result of operative site, and different flushing liquors do not have than big-difference the developing result of operative site.But various flushing liquor is to the preventive effect difference of the intestinal adhesion of operation animal, contain carboxymethyl chitosan flushing liquor, contain carboxymethyl cellulose flushing liquor, contain the flushing liquor of carboxymethyl cellulose and carboxymethyl chitin, the Film with Preventing Adhesion effect of each group all is better than normal saline flushing liquid, the flushing liquor Film with Preventing Adhesion effect that wherein contains carboxymethyl cellulose and carboxymethyl chitin is best, and the serous coat reparation is better.Experimental result sees the following form.
The surgical flush fluid of prevention surgical adhesions of the present invention can be applied in the operation of all position flushings that need undergo surgery clinically, as surgical operation, thoracic surgery, bone surgery, gynecilogical operation, obstetric operation, ent surgery, department of stomatology operation, body surface operation wound.Before the flushing of operative site comprises operation, in the operation, postoperative operative site flushing.
Above result of the test proves, contain a kind of among carboxymethyl cellulose, carboxymethyl chitosan, the carboxymethyl chitin three, or any two kinds combination among the three, all has operative site developing result preferably, and have simultaneously the prevention surgical adhesions effect, surgical flush fluid as a kind of novel Film with Preventing Adhesion is developed, and market prospect is wide.
Claims (1)
1. surgical flush fluid, it is characterized in that being formed by solute and solvent, solute is a carboxymethyl chitin, and solvent is normal saline, ringer's solution flushing liquor, mannitol flushing liquor, glucose flushing liquor, hibitane flushing liquor, gentamycin normal saline flushing liquid, povidone iodine flushing liquor, bromo geramine flushing liquor, JIEERYIN flushing liquor, glycine flushing liquor, metronidazole flushing liquor or physiological balance liquid; The concentration of described solute in surgical flush fluid is 0.1～50g/L; Described physiological balance liquid is by phosphate buffer, NaHCO
3, gluconic acid sodium salt and mannitol forms, the concentration range of back three in described physiological balance liquid is respectively 0.3～1.4g/L, 10～25g/L, 10～25g/L; Described phosphate buffer is by sodium hydrogen phosphate, sodium dihydrogen phosphate and water, or dipotassium hydrogen phosphate, potassium dihydrogen phosphate and water, or potassium dihydrogen phosphate, sodium hydrogen phosphate and water, or dipotassium hydrogen phosphate, sodium dihydrogen phosphate and water forms, and the mole total concentration of solute is 0.005M～0.2M in the phosphate buffer; The pH of this physiological balance liquid is 7.0～7.5.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2006100422403A CN100420446C (en) | 2006-01-27 | 2006-01-27 | Surgical flush fluid and its preparing process and application |
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|---|---|---|---|
| CNB2006100422403A CN100420446C (en) | 2006-01-27 | 2006-01-27 | Surgical flush fluid and its preparing process and application |
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| CN1839875A CN1839875A (en) | 2006-10-04 |
| CN100420446C true CN100420446C (en) | 2008-09-24 |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101961505A (en) * | 2010-09-28 | 2011-02-02 | 北京纺织科学研究所 | Methods for preparing medical anti-adhesion hemostatic material and medical anti-adhesion hemostatic washing fluid |
| CN103275802B (en) * | 2013-05-27 | 2015-01-14 | 江苏理工学院 | Water-based lubricant and preparation method thereof |
| CN105030667A (en) * | 2015-08-26 | 2015-11-11 | 南京天纵易康生物科技股份有限公司 | Operation irrigating solution and preparation method thereof |
| CN105148328B (en) * | 2015-08-29 | 2018-01-26 | 北京诺康达医药科技有限公司 | A kind of medical tissue protection cleaning fluid and its preparation method and application |
| CN105687236A (en) * | 2016-03-14 | 2016-06-22 | 中山大学附属第医院 | Medical artificial inner ear perilymphatic fluid and preparing method and application thereof |
| CN107753509A (en) * | 2016-08-19 | 2018-03-06 | 华仁药业股份有限公司 | A kind of electrolyte solution for surgery washing and preparation method thereof |
| CN108744026A (en) * | 2018-06-09 | 2018-11-06 | 江苏海尔滋生物科技有限公司 | Instant-matching type chitin polysaccharide frozen dried powder |
| CN111053785A (en) * | 2019-12-09 | 2020-04-24 | 徐州辉朗医疗科技有限公司 | Surgical flushing fluid and preparation method thereof |
| CN111012792B (en) * | 2019-12-30 | 2022-04-19 | 江苏开源康达医疗器械有限公司 | Biological polysaccharide flushing fluid suitable for orthopedic surgery and preparation method thereof |
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| US5292532A (en) * | 1990-12-21 | 1994-03-08 | Felice Bombart | Aqueous antifungal vaginal douche |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5292532A (en) * | 1990-12-21 | 1994-03-08 | Felice Bombart | Aqueous antifungal vaginal douche |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Hangzhou Singclean Medical Products Co., Ltd. Assignor: Liu Wanshun Contract record no.: 2010330001938 Denomination of invention: Surgical flush fluid and its preparing process and application Granted publication date: 20080924 License type: Exclusive License Open date: 20061004 Record date: 20100925 |
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| C17 | Cessation of patent right | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20080924 Termination date: 20110127 |