CN104324049A - Method for preparing balanced salt flushing liquid used for joint operation - Google Patents

Method for preparing balanced salt flushing liquid used for joint operation Download PDF

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Publication number
CN104324049A
CN104324049A CN201410500260.5A CN201410500260A CN104324049A CN 104324049 A CN104324049 A CN 104324049A CN 201410500260 A CN201410500260 A CN 201410500260A CN 104324049 A CN104324049 A CN 104324049A
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China
Prior art keywords
balanced salt
water
flushing liquor
injection
weight
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CN201410500260.5A
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Chinese (zh)
Inventor
崔友
李伟
王恒彩
夏小秋
高余芬
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ZHEJIANG TIANRUI PHARMACEUTICAL CO Ltd
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ZHEJIANG TIANRUI PHARMACEUTICAL CO Ltd
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Priority to CN201410500260.5A priority Critical patent/CN104324049A/en
Publication of CN104324049A publication Critical patent/CN104324049A/en
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    • A—HUMAN NECESSITIES
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a method for preparing balanced salt flushing liquid used for joint operation. The method includes following steps: adding water for injection accounting for 25-35% of total volume of the water for injection in a formula into a concentrating-preparation pot; adding 8-12 parts by weight of sodium chloride, 8-12 parts by weight of sodium gluconate, 6-9 parts by weight of sodium acetate, 0.6-0.9 parts by weight of potassium chloride, 0.4-0.8 parts by weight of magnesium chloride and 0.4-0.6 parts by weight of acetic acid with stirring for 13-17 min; adding needle-use activated carbon with stirring uniformly; performing adsorption for 13-17 min; removing the activated carbon through titanium bars; filtering the mixed solution into a diluting-preparation pot with addition of the water for injection to total amount; adjusting the pH value to between 6.8-7.4; performing refined filtration and encapsulation to an end after the liquid being qualified through intermediate detection; performing sterilization in a water bath at 110-120 DEG C for 35-45 min; and performing leakage test, light test, packaging and a storage process to obtain the balanced salt flushing liquid used for joint operation. The balanced salt flushing liquid does not cause acidosis and can prevent and treat the acidosis.

Description

A kind of method preparing operation on joint balanced salt flushing liquor
Technical field
The present invention relates to medicine technology field, particularly relate to a kind of method preparing operation on joint balanced salt flushing liquor.
Background technology
In order to obtain the visual field more clearly during operation on joint, often need to carry out lavation, flushing to joint in operation process, and after having performed the operation, also need to carry out flushing process to operative region, to clear out of the microorganisms such as the residual blood in field of operation, broken bone and antibacterial, and flushing liquor also can be used as the carrier of antibiotic etc, thus prevention infection, reduce postoperative complication.
Current domestic specially for surgical operation and Minimally Invasive Surgery flushing liquor used less, the substitute is clinically and replace flushing liquor to use with various injection, as 0.9% sodium chloride, 5% glucose injection etc.And in these injection description, do not have the indication for flushing liquor, and be therefore all at Use overrun, extremely lack of standardization, and China is populous, has every day a large amount of patient to accept surgical operation, clinical demand amount is very large; In addition along with the progressively accumulation of micro-wound surgical operation experience and being gradually improved and maturation of surgical technic, increasing operation is able to complete under the mirror of chamber, and in micro-wound surgical operation process, use a large amount of flushing liquors to be inevitable, therefore the development of flushing liquor seems extremely important for meeting clinical needs.
Current domestic special Surgical irrigating fluid, mainly contains: glycine flushing liquor (2000ml:30g), mannitol flushing liquor (2000ml:100g), balanced salt flushing liquor (500ml); In Clinical practice process, also useful 0.9% sodium chloride injection and 5% glucose injection substitute flushing liquor use.
(1) 5% mannitol: aqueous solution and the blood plasma of 5.07% are isotonic, have diuresis and dehydration.The tissue edema that can reduce surgical wound surface in operation process can improve surface tension of liquid, reduces intravesical liquid foam and bubble in art, is conducive to the situation of observing intravesical visual area.Can be used for Transurethral prostatic electroresection A clinically; Per urethra prostatic secretions; Underwent transurethral resection of bladder tumor; Urethral stricture oulectomy etc.
(2) 0.9% normal saline: be isotonic electrolyte solution, chloride 154mmol/L, containing sodium 154mmol/L.For the flushing of wound surface, prevent the frozen plug of clot, keep the clear of surgical field of view.Can be used for gallbladder excision, appendectomy, hernia repair etc. under peritoneoscope camera system; Arthroscopy of knee and the excision of knee arthroscope inferior synovial membrane; Lithotrity under Fetching Calculi Operation Under Ureter Mirror and cystoscope; Lithotomy etc. under PCN; Adenoid dectomy and maxillary cyst, nasal polyp extirpation etc. under conchoscope.But its easy conductive; Clinical data shows, and extensive application can cause water intoxication.
(3) 5% glucoses (G.S): non-electrolyte, isosmotic solution.Non-conductive.For the flushing of wound surface, prevent clot frozen plug, keep visual area clear.Can be used for Laparoscopic Ovarian cyst excision, per womb excise, infertility detect.Because gynecological laparoscopic operation uses flushing liquor only as washing wound surface during separation focus or after removal of lesions tissue, consumption is less, and needs the auxiliary flushing of washer, and diabetic, can not use 5%G.S solution.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of method preparing operation on joint balanced salt flushing liquor, operation on joint balanced salt flushing liquor prepared by the method is consistent with the pH of extracellular fluid, and composition is also close with blood plasma with osmotic pressure, open that electrolyte solution comparative advantages are obvious, the compatibility good with other grades commonly used clinically.
For solving the problems of the technologies described above, technical scheme of the present invention is: a kind of method preparing operation on joint balanced salt flushing liquor, comprises step:
1) in dense preparing tank, add the water for injection of 25 ~ 35% of formula water for injection cumulative volume;
2) add the sodium chloride of 8 ~ 12 weight portions, the gluconic acid sodium salt of 8 ~ 12 weight portions, the sodium acetate of 6 ~ 9 weight portions, the potassium chloride of 0.6 ~ 0.9 weight portion, the magnesium chloride of 0.4 ~ 0.8 weight portion, the acetic acid of 0.4 ~ 0.6 weight portion, stir 13 ~ 17min;
3) needle-use activated carbon is added, after stirring, absorption 13 ~ 17min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 110 ~ 120 DEG C of water-bath sterilization 35 ~ 45min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
As preferred technical scheme, select the magnesium chloride hexahydrate of the potassium chloride of the Sodium acetate trihydrate of the gluconic acid sodium salt of the sodium chloride of 10.52kg, 10.04kg, 7.36kg, 0.74kg, 0.6kg, the acetic acid of 0.5kg.
As preferred technical scheme, described step 3) in needle-use activated carbon addition be 0.08 ~ 0.12% of water for injection weight in dense preparing tank.
As preferred technical scheme, described in be adsorbed on 70 ~ 75 DEG C at insulation absorption.
As preferred technical scheme, described titanium rod is 0.45 μm of titanium rod.
As preferred technical scheme, described adjustment pH adopts 0.1mol/L sodium hydroxide solution or hydrochloric acid solution to regulate.
As preferred technical scheme, described filter element is 0.22 μm of filter element.
When carrying out operation on joint, operation balanced salt flushing liquor is cooled to 4 ~ 8 DEG C of uses, effect is better, can be prepared into the flushing liquor of the plurality of specifications such as 500mL, 1000mL, 1500mL, 2000mL according to demand.
Owing to have employed technique scheme, a kind of method preparing operation on joint balanced salt flushing liquor, comprises step: the water for injection 1) adding 25 ~ 35% of formula water for injection cumulative volume in dense preparing tank; 2) add the sodium chloride of 8 ~ 12 weight portions, the gluconic acid sodium salt of 8 ~ 12 weight portions, the sodium acetate of 6 ~ 9 weight portions, the potassium chloride of 0.6 ~ 0.9 weight portion, the magnesium chloride of 0.4 ~ 0.8 weight portion, the acetic acid of 0.4 ~ 0.6 weight portion, stir 13 ~ 17min; 3) needle-use activated carbon is added, after stirring, absorption 13 ~ 17min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection; 4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 110 ~ 120 DEG C of water-bath sterilization 35 ~ 45min; 5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor; Obtained joint operation balanced salt flushing liquor is consistent with the pH of extracellular fluid, and composition is also close with blood plasma with osmotic pressure, to open electrolyte solution comparative advantages obvious with other conventional clinically grades: chlorine ion concentration, within the normal range of blood plasma, not containing lactate, can not cause acidosis; Acetate and glucose acid group are metabolized to bicarbonate in vivo, can prevention and therapy acidosis.
Operation on joint balanced salt flushing liquor prepared by the present invention compares with the plasma fraction of human body and sees the following form:
As seen from the above table, operation on joint balanced salt flushing liquor prepared by the present invention is consistent with the pH of extracellular fluid, and composition is also close with blood plasma with osmotic pressure, to open electrolyte solution comparative advantages obvious with other conventional clinically grades: chlorine ion concentration, within the normal range of blood plasma, high chlorine metabolic acidosis can not occur; Acetate and glucose acid group are metabolized to bicarbonate in vivo, can prevention and therapy acidosis; Because it is not containing lactate, a large amount of supplementing unlikelyly causes lacticemia; Electrolytical component is similar to extracellular fluid, simultaneously not calcium ions, and the compatibility is good.
Detailed description of the invention
Below in conjunction with embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.In addition should be understood that those skilled in the art can make various changes or modifications the present invention, and these equivalent form of values fall within the application's appended claims limited range equally after the content of having read the present invention's instruction.
Prepare a method for operation on joint balanced salt flushing liquor, comprise step:
1) in dense preparing tank, add the water for injection of 25 ~ 35% of formula water for injection cumulative volume;
2) add the sodium chloride of 8 ~ 12 weight portions, the gluconic acid sodium salt of 8 ~ 12 weight portions, the sodium acetate of 6 ~ 9 weight portions, the potassium chloride of 0.6 ~ 0.9 weight portion, the magnesium chloride of 0.4 ~ 0.8 weight portion, the acetic acid of 0.4 ~ 0.6 weight portion, stir 13 ~ 17min;
3) needle-use activated carbon is added, after stirring, absorption 13 ~ 17min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 110 ~ 120 DEG C of water-bath sterilization 35 ~ 45min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
Described step 3) in needle-use activated carbon addition be 0.08 ~ 0.12% of water for injection weight in dense preparing tank.
Described be adsorbed on 70 ~ 75 DEG C at insulation absorption.
Described titanium rod is 0.45 μm of titanium rod.
Described adjustment pH adopts 0.1mol/L sodium hydroxide solution or hydrochloric acid solution to regulate.
Described filter element is 0.22 μm of filter element.
When carrying out operation on joint, operation balanced salt flushing liquor is cooled to 4 ~ 8 DEG C of uses, effect is better.
Embodiment one:
1) in dense preparing tank, add the water for injection of 25% of formula water for injection cumulative volume;
2) add the sodium chloride of 8kg, the gluconic acid sodium salt of 8kg, the sodium acetate of 6kg, the potassium chloride of 0.6kg, the magnesium chloride of 0.4kg, the acetic acid of 0.4kg, stir 13min;
3) needle-use activated carbon is added, after stirring, absorption 13min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 110 DEG C of water-bath sterilization 3min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
Described step 3) in needle-use activated carbon addition be 0.08% of water for injection weight in dense preparing tank.
Described be adsorbed on 70 DEG C at insulation absorption.
Described titanium rod is 0.45 μm of titanium rod.
Described adjustment pH adopts 0.1mol/L sodium hydroxide solution to regulate.
Described filter element is 0.22 μm of filter element.
When carrying out operation on joint, operation balanced salt flushing liquor is cooled to 4 DEG C of uses, effect is better.
Embodiment two:
1) in dense preparing tank, add the water for injection of 30% of formula water for injection cumulative volume;
2) add the sodium chloride of 10.52kg, the gluconic acid sodium salt of 10.04kg, the Sodium acetate trihydrate of 7.36kg, the potassium chloride of 0.74kg, the magnesium chloride hexahydrate 0.5kg of 0.6kg two acetic acid stir 15min;
3) needle-use activated carbon is added, after stirring, absorption 15min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 115 DEG C of water-bath sterilization 40min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
Described step 3) in needle-use activated carbon addition be 0.1% of water for injection weight in dense preparing tank.
Described be adsorbed on 702 DEG C at insulation absorption.
Described titanium rod is 0.45 μm of titanium rod.
Described adjustment pH adopts 0.1mol/L hydrochloric acid solution to regulate.
Described filter element is 0.22 μm of filter element.
When carrying out operation on joint, operation balanced salt flushing liquor is cooled to 6 DEG C of uses, effect is better
Embodiment three:
1) in dense preparing tank, add the water for injection of 35% of formula water for injection cumulative volume;
2) add the sodium chloride of 12kg, the gluconic acid sodium salt of 12kg, the sodium acetate of 9kg, the potassium chloride of 0.9kg, the magnesium chloride of 0.8kg, the acetic acid of 0.6kg, stir 17min;
3) needle-use activated carbon is added, after stirring, absorption 17min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 120 DEG C of water-bath sterilization 45min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
Described step 3) in needle-use activated carbon addition be 0.12% of water for injection weight in dense preparing tank.
Described be adsorbed on 75 DEG C at insulation absorption.
Described titanium rod is 0.45 μm of titanium rod.
Described adjustment pH adopts 0.1mol/L sodium hydroxide solution to regulate.
Described filter element is 0.22 μm of filter element.
When carrying out operation on joint, operation balanced salt flushing liquor is cooled to 8 DEG C of uses, effect is better
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and description just illustrates principle of the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.Application claims protection domain is defined by appending claims and equivalent thereof.
All all drop within protection scope of the present invention without the reconfiguration done by creative work from the present invention is to devise.

Claims (7)

1. prepare a method for operation on joint balanced salt flushing liquor, it is characterized in that, comprise step:
1) in dense preparing tank, add the water for injection of 25 ~ 35% of formula water for injection cumulative volume;
2) add the sodium chloride of 8 ~ 12 weight portions, the gluconic acid sodium salt of 8 ~ 12 weight portions, the sodium acetate of 6 ~ 9 weight portions, the potassium chloride of 0.6 ~ 0.9 weight portion, the magnesium chloride of 0.4 ~ 0.8 weight portion, the acetic acid of 0.4 ~ 0.6 weight portion, stir 13 ~ 17min;
3) needle-use activated carbon is added, after stirring, absorption 13 ~ 17min, through the de-charcoal of titanium rod, filter to dilute preparing tank, benefit adds to the full amount of water for injection;
4) regulate between pH to 6.8 ~ 7.4, intermediate detect qualified after, end through filter element fine straining, embedding, 110 ~ 120 DEG C of water-bath sterilization 35 ~ 45min;
5) leak detection, lamp inspection, packaging, warehouse-in, obtains described operation on joint balanced salt flushing liquor.
2. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 1, it is characterized in that: select the magnesium chloride hexahydrate of the potassium chloride of the Sodium acetate trihydrate of the gluconic acid sodium salt of the sodium chloride of 10.52kg, 10.04kg, 7.36kg, 0.74kg, 0.6kg, 0.5kg acetic acid.
3. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 1, it is characterized in that: described step 3) in needle-use activated carbon addition be 0.08 ~ 0.12% of water for injection weight in dense preparing tank.
4. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 3, it is characterized in that: described in be adsorbed on 70 ~ 75 DEG C at insulation absorption.
5. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 3, it is characterized in that: described titanium rod is 0.45 μm of titanium rod.
6. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 1, it is characterized in that: described adjustment pH adopts 0.1mol/L sodium hydroxide solution or hydrochloric acid solution to regulate.
7. prepare the method for operation on joint balanced salt flushing liquor as claimed in claim 1, it is characterized in that: described filter element is 0.22 μm of filter element.
CN201410500260.5A 2014-09-26 2014-09-26 Method for preparing balanced salt flushing liquid used for joint operation Pending CN104324049A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
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
CN113533632A (en) * 2021-08-30 2021-10-22 西安乐析医疗科技有限公司 Method for measuring total chlorine content in balanced salt solution for perfusion

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010894A2 (en) * 2002-07-30 2004-02-05 Omeros Corporation Ophthalmologic irrigation solutions and method
CN101693039A (en) * 2009-10-14 2010-04-14 北京普瑞博思投资有限公司 Medical composition for surgery washing
CN102836171A (en) * 2012-09-17 2012-12-26 北京金康驰医药投资有限公司 Solution for surgery and endoscope washing and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004010894A2 (en) * 2002-07-30 2004-02-05 Omeros Corporation Ophthalmologic irrigation solutions and method
CN101693039A (en) * 2009-10-14 2010-04-14 北京普瑞博思投资有限公司 Medical composition for surgery washing
CN102836171A (en) * 2012-09-17 2012-12-26 北京金康驰医药投资有限公司 Solution for surgery and endoscope washing and preparation method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN113533632A (en) * 2021-08-30 2021-10-22 西安乐析医疗科技有限公司 Method for measuring total chlorine content in balanced salt solution for perfusion

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Application publication date: 20150204