CN105796596A - Balanced salt flushing fluid for surgery and preparation method thereof - Google Patents
Balanced salt flushing fluid for surgery and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/717—Celluloses
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/734—Alginic acid
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/42—Phosphorus; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Abstract
The invention discloses a balanced salt flushing fluid for surgery. The balanced salt flushing fluid comprises 0.1-0.5g/L potassium chloride, 0.1-0.5g/L magnesium chloride, 1-20g/L sodium chloride, 1-10g/L sodium acetate, 1-20g/L sodium gluconate, 0.5-2g/L disodium hydrogen phosphate, 0.5-1.5g/L mannitol, 0.1-1g/L sodium alginate, 0.1-1g/L sodium carboxymethylcellulose, 1-5g/L cyclodextrin, 0.1-0.5g/L starch sodium octenylsuccinate, 1-5g/L sorbitol, 0.5-1g/L cocamidopropyl propyl betaine and 1-10g/L citric acid. The invention also discloses a method for preparing the balanced salt flushing fluid, which comprises the steps of thick fluid preparation, thin fluid preparation, filtering, filling, sterilization and packaging. The flushing fluid disclosed by the invention can obviously reduce the degree of irritation to the human body, prevent postoperative tissue bonding and accelerate wound healing.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, be specifically related to a kind of surgical operation balanced salt flushing liquor and preparation method thereof.
Background technology
China is populous, has every day substantial amounts of patient to accept surgical operation, in surgical procedures, makes the tissue of internal organs expose to air because operating on, and causes tissue to dry, aoxidizes, and causes that Post operation produces tissue adhesion, extends wound healing time.According to statistics, the problem that the surgical operation of more than 90% all can relate to postoperative tissue adhesion, tissue adhesion is in medical circle as a kind of common pathological reaction, and it is the anomalous structure making connective fiber be combined together to form with adjacent tissue or organ due to the wound of tissue in surgical operation.Postoperative tissue adhesion all occur in the operations such as abdomen operation on pelvis, bone surgery, Urology Surgery, gynecological, can cause serious post-operative complication, such as abdomen pelvic pain, intestinal obstruction, sterility and infertility etc., serious adhesion causes difficulty often to operation again.Therefore, the surgical adhesions problem thorny problem that to be always up in surgical operation common.
It addition, when surgical operation, in order to obtain the apparent visual field, it is often necessary to internal organs or tissue are carried out lavation, flushing by operation process.And after having performed the operation, it is also desirable to it is rinsed operative region processing, to clear out of the microorganisms such as residual blood in field of operation and antibacterial.Additionally, flushing liquor is alternatively arranged as antibiotic etc carrier, thus preventing to infect, reduce postoperative complication.The amount having turned out flushing liquor entrance body circulation is relatively large, and therefore, these flushing liquors must be regarded as the medicine of a kind of general, it is desirable to has high safety and the compatibility.Surgical flush fluid used by current domestic surgical operation is more, but has prevention of postoperative tissue adhesion concurrently and can promote that the product of wound healing is few.And existing disclosed flushing liquor still suffers from certain defect, for instance, there is many defects such as certain toxic and side effects, poor stability, function singleness.
Summary of the invention
An object of the present invention is to provide a kind of surgical operation balanced salt flushing liquor, it is possible to reduce the stimulation to human body, reduces patient suffering, decreases postoperative tissue bonding, accelerates wound healing.
For reaching above-mentioned purpose, the technical solution adopted in the present invention is: provide a kind of surgical operation balanced salt flushing liquor, including following component by weight:
Potassium chloride 0.1g/L～0.5g/L；Magnesium chloride 0.1g/L～0.5g/L；
Sodium chloride 1g/L～20g/L；Sodium acetate 1g/L～10g/L；
Sodium gluconate 1g/L～20g/L；Disodium hydrogen phosphate 0.5g/L～2g/L；
Mannitol 0.5g/L～1.5g/L；Sodium alginate 0.1g/L～1g/L；
Sodium carboxymethyl cellulose 0.1g/L～1g/L；Cyclodextrin 1g/L～5g/L；
Starch sodium octenyl succinate 0.1g/L～0.5g/L；Sorbitol 1g/L～5g/L；
Cocamido propyl betaine 0.5g/L～1g/L；Citric acid 1g/L～10g/L.
Preferably, surgical operation balanced salt flushing liquor includes following component by weight:
Potassium chloride 0.2g/L～0.4g/L；Magnesium chloride 0.1g/L～0.3g/L；
Sodium chloride 10g/L～15g/L；Sodium acetate 5g/L～8g/L；
Sodium gluconate 5g/L～10g/L；Disodium hydrogen phosphate 0.8g/L～1.2g/L；
Mannitol 0.5g/L～1g/L；Sodium alginate 0.3g/L～0.8g/L；
Sodium carboxymethyl cellulose 0.2g/L～0.4g/L；Cyclodextrin 1g/L～2g/L；
Starch sodium octenyl succinate 0.3g/L～0.5g/L；Sorbitol 1g/L～5g/L；
Cocamido propyl betaine 0.5g/L～1g/L；Citric acid 1g/L～10g/L.
Preferably, surgical operation balanced salt flushing liquor includes following component by weight:
Potassium chloride 0.3g/L；Magnesium chloride 0.3g/L；
Sodium chloride 10g/L；Sodium acetate 6g/L；
Sodium gluconate 6g/L；Disodium hydrogen phosphate 1g/L；
Mannitol 1g/L；Sodium alginate 0.5g/L；
Sodium carboxymethyl cellulose 0.2g/L；Cyclodextrin 2g/L；
Starch sodium octenyl succinate 0.5g/L；Sorbitol 2g/L；
Cocamido propyl betaine 0.6g/L；Citric acid 4g/L.
It is a further object to provide the method preparing surgical operation balanced salt flushing liquor, comprise the following steps:
(1) raw material accurately weighing formula ratio puts in dense preparing tank, add water for injection and at 75 DEG C～85 DEG C stirring and dissolving, obtain concentrated wiring liquid；
(2) in concentrated wiring liquid, add activated carbon stirring and adsorbing, and at 75 DEG C～85 DEG C, be incubated 10min～20min；Being cooled to 50 DEG C～60 DEG C after insulation, circulation decarburization pumps into dilute preparing tank after filtering, and obtains rare dosing；
(3) in rare dosing add water for injection to full dose, stirring and adjusting pH value to 6.9～7.4, circulating filtration 20min～30min after adjustment；
(4) fill, sterilizing, inspection.
Preferably, activated carbon addition is the 0.01% of concentrated wiring liquid weight.
Preferably, also include using water for injection to clean dense preparing tank, and cleanout fluid is pumped into the step in dilute preparing tank.
Preferably, the step of 0.45 μm of filter circulating filtration is used including in step (3).
Preferably, step (1) to the operating time of step (4) less than 8 hours.
In sum, the invention have the advantages that
Its preparation of the flushing liquor of the present invention is very close with human plasma composition, it is possible to substantially reduces the stimulation degree to human body, it is prevented that postoperative tissue bonds, accelerates wound healing.
Detailed description of the invention
The content of each raw material such as table 1 in embodiment 1～embodiment 6.
Table 1: the formula of embodiment 1～embodiment 6: unit g/L.
Flushing liquor in embodiment 1～embodiment 6 can prepare in accordance with the following methods:
(1) raw material accurately weighing formula ratio puts in dense preparing tank, add water for injection and at 80 DEG C stirring and dissolving, obtain concentrated wiring liquid；
(2) in concentrated wiring liquid, add the activated carbon stirring and adsorbing of concentrated wiring liquid quality 0.01%, and at 80 DEG C, be incubated 15min；It is cooled to 55 DEG C after insulation, filters after circulation decarburization 20min and pump into dilute preparing tank, use water for injection to clean dense preparing tank simultaneously, and cleanout fluid is pumped into dilute preparing tank, obtain rare dosing；
(3) adding water for injection in rare dosing to full dose, the content being arranged in prescription each component, stirring and adjusting pH value, to 6.9～7.4, uses 0.45 μm of filter circulating filtration 30min after adjustment；
(4) fill, sterilizing, inspection；Step (1) to operating time of step (4) less than 8 hours.
Concrete step is:
Fill
A prepares: open the high efficiency particulate air filter of bag-making loading sealing gear equipment B3, device interior carries out local A level clean by laminar flow；Check set heat seal, bag, capping heater operation parameter whether meet regulation:
B installs PP TYPE, interface and sealing lid is separately added in the agitator of bag-making loading sealing gear.
C opens the conveying → lettering → interface conveying → bag forming station of the transport membrane → print media running bag-making loading sealing gear successively, checks whether bag forming, interface heat seal, trimming presentation quality meet the requirements；
D is separately turned on equipment subsequent work stations: fill → sealing lid conveying → seal lid heat seal → output；Start liquid drug.
Filling process requires:
In pouring process, extract output product respectively from 4 filling exits, converted each bag inner liquid medicine loading amount by weight method, regulate loading amount and make up to regulation loading amount；Checking visible foreign matters, foreign can fill.Liquid drug temperature controls at 45 DEG C～55 DEG C, and filling speed is approximately 1000 bags/h.
Sterilizing
Entrucking: product elder generation manual sorting that filling and sealing is qualified is (sack printing surface upward, the back side faces down, mouth envelope is respectively in the same direction), again through conveyer belt through automatic swing bag machine according to every dolly be 1056 bags=neat for product be placed in pallet by the load mode of horizontally-arranged (12 bags) × vertical setting of types (4) × 22 (dish), the cabinet that often goes out loads 7 cars altogether.
Sterilization method: adopt overheated water-bath type back-pressure sterilizing cabinet to carry out sterilizing.
Before starting sterilizing, open machine power and related process medium (industrial steam, compression air, purified water, cooling water), check whether industrial steam reaches 0.4～0.6Mpa, whether compression air reaches 0.4～0.7Mpa, whether cooling water pressure reaches 0.3～0.4Mpa, open sterilizing cabinet automatic rolling door, by by specifying that the vehicle of sterilization (amounting to 7 cars) placing soft bag pushes in sterilizing cabinet.
Arranging sterilizing program parameter: sterilising temp is 121 DEG C, the 10 minutes time (the F0 value > 12 of sterilizing), equipment starts automatic operation.
Technological requirement: drug solution preparing is complete to start to must not exceed 16 hours to sterilizing.
Test example
One, the anti experiment of surgical flush fluid
Experimental subject: male rat 700, is randomly divided into 7 groups and often organizes 100 rats.File method sets up postoperative abdominal adhesions model: after animal fasting 12 hours, use 10% chloral hydrate anesthesia, take front median incision 1.5cm under sterile working after cropping, sterilization and enter abdomen, repeatedly rub placenta percreta to tip-like petechia, surface at ileocecus right flank key files, form about 5cm2Include abdominal cavity in after air exposure 5min after impaired wound surface, successively close abdominal cavity.
Matched group does not use any drug treating, and first group uses the drug irrigation in embodiment 1～embodiment 6 respectively to the 7th group.The postoperative normal raising of matched group, does not use any medicine；All the other 6 groups is administration group, before complete closedown abdominal cavity of performing the operation, rinses wound surface with the flushing liquor of preparation in 10ml embodiment 1～embodiment 7 respectively.
Within postoperative 15th day, adopting cervical dislocation to put to death animal, xiphoid-process lower cut enters abdomen, and according to Phillips grade scale, observation adhesion situation, respectively record adhesion score.
Phillips grade scale is as follows:
0 grade: entirely without being adhered, caecum serosal surface reparation is good；
I grade: caecum and surrounding tissue are adhered on a small quantity, loose easily separated, without oozing of blood；
II grade: caecum and surrounding tissue gently arrive moderate and be adhered, and intestinal tube can be " U "-shaped, during separation, there is oozing of blood local；
III grade: intestinal tube and surrounding tissue are extensively adhered, it is more difficult to separate, without intestinal obstruction；
IV grade: intestinal tube and surrounding tissue are closely adhered agglomerating, separation difficulty causes incomplete or complete intestinal obstruction.
The appraisal result of 7 groups of rats is as shown in table 2.
Table 2: rat grade form
| Group | Average score |
| Matched group | 6.52 |
| Embodiment 1 | 1.25 |
| Embodiment 2 | 2.59 |
| Embodiment 3 | 3.24 |
| Embodiment 4 | 2.13 |
| Embodiment 5 | 2.19 |
| Embodiment 6 | 4.88 |
As can be seen from Table 2, the average score of the flushing liquor of the embodiment of the present invention 1 is minimum, it is substantially less than the evaluation of matched group, illustrate that the flushing liquor of the present invention can substantially reduce the adhesion degree of postoperative tissue, the average ratings of embodiment 6 is apparently higher than embodiment 2～embodiment 5, but compare matched group and also have significance advantage, it is possible to learn that the flushing liquor of embodiment 6 has certain effect, but can continue to optimize.Embodiment 2～embodiment 5 is separately added into different material relative to embodiment 6, it is also possible to significantly reduce adhesion degree, has illustrated that the component of corresponding increase is also the effect having and improving drug effect.
Two, irritation test
Flushing liquor in embodiment 1～embodiment 5 is carried out irritation test, investigates medicine to whether tissue causes the irritations such as redness, hyperemia, degeneration, necrosis, to judge the local toxicity size of preparation.Experimental subject uses rabbit, adopts existing experimental technique to carry out, and its experimental results of examples 1～embodiment 5 is serious adverse reaction occurs, and the zest of tissue is relatively low, and safety is high.
Claims (8)
1. a surgical operation balanced salt flushing liquor, including following component by weight:
Potassium chloride 0.1g/L～0.5g/L；Magnesium chloride 0.1g/L～0.5g/L；
Sodium chloride 1g/L～20g/L；Sodium acetate 1g/L～10g/L；
Sodium gluconate 1g/L～20g/L；Disodium hydrogen phosphate 0.5g/L～2g/L；
Mannitol 0.5g/L～1.5g/L；Sodium alginate 0.1g/L～1g/L；
Sodium carboxymethyl cellulose 0.1g/L～1g/L；Cyclodextrin 1g/L～5g/L；
Starch sodium octenyl succinate 0.1g/L～0.5g/L；Sorbitol 1g/L～5g/L；
Cocamido propyl betaine 0.5g/L～1g/L；Citric acid 1g/L～10g/L.
2. surgical operation balanced salt flushing liquor as claimed in claim 1, including following component by weight:
Potassium chloride 0.2g/L～0.4g/L；Magnesium chloride 0.1g/L～0.3g/L；
Sodium chloride 10g/L～15g/L；Sodium acetate 5g/L～8g/L；
Sodium gluconate 5g/L～10g/L；Disodium hydrogen phosphate 0.8g/L～1.2g/L；
Mannitol 0.5g/L～1g/L；Sodium alginate 0.3g/L～0.8g/L；
Sodium carboxymethyl cellulose 0.2g/L～0.4g/L；Cyclodextrin 1g/L～2g/L；
Starch sodium octenyl succinate 0.3g/L～0.5g/L；Sorbitol 1g/L～5g/L；
Cocamido propyl betaine 0.5g/L～1g/L；Citric acid 1g/L～10g/L.
3. surgical operation balanced salt flushing liquor as claimed in claim 1, including following component by weight:
Potassium chloride 0.3g/L；Magnesium chloride 0.3g/L；
Sodium chloride 10g/L；Sodium acetate 6g/L；
Sodium gluconate 6g/L；Disodium hydrogen phosphate 1g/L；
Mannitol 1g/L；Sodium alginate 0.5g/L；
Sodium carboxymethyl cellulose 0.2g/L；Cyclodextrin 2g/L；
Starch sodium octenyl succinate 0.5g/L；Sorbitol 2g/L；
Cocamido propyl betaine 0.6g/L；Citric acid 4g/L.
4. the method for any described surgical operation balanced salt flushing liquor in preparation claims 1 to 3, comprises the following steps:
(1) raw material accurately weighing formula ratio puts in dense preparing tank, add water for injection and at 75 DEG C～85 DEG C stirring and dissolving, obtain concentrated wiring liquid；
(2) in concentrated wiring liquid, add activated carbon stirring and adsorbing, and at 75 DEG C～85 DEG C, be incubated 10min～20min；Being cooled to 50 DEG C～60 DEG C after insulation, circulation decarburization pumps into dilute preparing tank after filtering, and obtains rare dosing；
(3) in rare dosing add water for injection to full dose, stirring and adjusting pH value to 6.9～7.4, circulating filtration 20min～30min after adjustment；
(4) fill, sterilizing, inspection.
5. method as claimed in claim 4, it is characterised in that: described activated carbon addition is the 0.01% of concentrated wiring liquid weight.
6. method as claimed in claim 4, it is characterised in that: also include using water for injection to clean dense preparing tank, and cleanout fluid is pumped into the step in dilute preparing tank.
7. method as claimed in claim 4, it is characterised in that: including in described step (3) uses the step of 0.45 μm of filter circulating filtration.
8. method as claimed in claim 4, it is characterised in that: described step (1) to operating time of step (4) less than 8 hours.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107375326A (en) * | 2017-09-12 | 2017-11-24 | 苏州工业园区旭太生物工程有限公司 | One kind balance salt flushing liquor and preparation method 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 |
| CN110075118A (en) * | 2018-01-25 | 2019-08-02 | 波士顿生物服务实验室公司 | A kind of Multifunctional surgical flushing liquor and preparation method and application |
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| CN1981881A (en) * | 2005-12-14 | 2007-06-20 | 四川琢新生物材料研究有限公司 | Materials against bonding after surgical operation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| CN107375326A (en) * | 2017-09-12 | 2017-11-24 | 苏州工业园区旭太生物工程有限公司 | One kind balance salt flushing liquor and preparation method thereof |
| CN110075118A (en) * | 2018-01-25 | 2019-08-02 | 波士顿生物服务实验室公司 | A kind of Multifunctional surgical flushing liquor and preparation method and application |
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