阅读说明：本技术 一种用于外科手术的抗菌性电解质冲洗液及其制备方法 (Antibacterial electrolyte flushing fluid for surgical operation and preparation method thereof ) 是由 甘旭华 崔海栋 刘大林 于 2019-05-04 设计创作，主要内容包括：本发明公开了一种用于外科手术的抗菌性电解质冲洗液及其制备方法,属于外科手术用液体制品技术领域。每1L电解质冲洗液由如下重量分的原料组分：氯化钠4.00-8.00g、磷酸氢二钠1.20-8.00g、磷酸二氢钾0.10-11.60g。本发明还提供了上述电解质冲洗液的制备方法。溶液经过电解工艺,形成300-1200mV氧化还原电位；增加了一对磷酸盐缓冲对,达到了维持冲洗液酸碱平衡、维持渗透压和增加溶液稳定性的作用。本发明公开的一种用于外科手术的抗菌性电解质冲洗液,解决了现有技术中手术冲洗液共同存在的抑菌和抗菌功效弱的缺陷,避免了手术冲洗液中抗生素的使用,大大降低了了耐药菌出现的几率,有利于创面愈合和病患身体的恢复。(The invention discloses an antibacterial electrolyte flushing fluid for a surgical operation and a preparation method thereof, and belongs to the technical field of liquid products for the surgical operation. Each 1L of electrolyte flushing fluid comprises the following raw material components in parts by weight: 4.00-8.00g of sodium chloride, 1.20-8.00g of disodium hydrogen phosphate and 0.10-11.60g of monopotassium phosphate. The invention also provides a preparation method of the electrolyte flushing fluid. The solution is subjected to an electrolysis process to form 300-1200mV oxidation-reduction potential; a pair of phosphate buffer pairs is added, so that the effects of maintaining acid-base balance of flushing fluid, maintaining osmotic pressure and increasing solution stability are achieved. The antibacterial electrolyte flushing fluid for the surgical operation disclosed by the invention overcomes the defect that the common antibacterial and antibacterial effects of the flushing fluid in the prior art are weak, avoids the use of antibiotics in the flushing fluid, greatly reduces the occurrence probability of drug-resistant bacteria, and is beneficial to wound healing and recovery of a patient body.)

1. An antibacterial electrolyte flushing fluid for surgical operation, which is characterized in that: each 1L of the electrolyte flushing fluid is prepared from the following raw materials in parts by weight:

4.00-8.00g of sodium chloride, 1.20-8.00g of disodium hydrogen phosphate and 0.10-11.60g of monopotassium phosphate.

2. The antibacterial electrolyte irrigating solution for surgical use according to claim 1, wherein:

the pH value of the antibacterial electrolyte flushing fluid is 6.0-8.0, the oxidation-reduction potential of the antibacterial electrolyte flushing fluid is 300-1200mV, and the osmotic pressure of the antibacterial electrolyte flushing fluid is 280-300 mOsmol/L.

3. The method for preparing an antibacterial electrolyte irrigating solution for surgical use according to any one of claims 1 to 2, comprising the steps of:

1) respectively dissolving excessive sodium chloride, disodium hydrogen phosphate and potassium dihydrogen phosphate in water for injection to form a saturated sodium chloride solution, a saturated disodium hydrogen phosphate solution and a saturated potassium dihydrogen phosphate solution;

2) adding medicinal active carbon with the weight of 0.1-0.3% of the volume of the corresponding solution into the sodium chloride solution, the disodium hydrogen phosphate solution and the potassium dihydrogen phosphate solution obtained in the step 1), stirring, performing heat preservation and adsorption for 15-20min, removing carbon, and conveying to a primary liquid storage tank;

3) circulating and refluxing the sodium chloride, disodium hydrogen phosphate and potassium dihydrogen phosphate solution obtained in the step 2) for 20-30min through 5-micrometer filter elements and 0.45-micrometer filter elements and a reflux pipeline respectively, and finally, filtering through 0.22-micrometer filter elements and conveying to a secondary liquid storage tank;

4) injecting the saturated sodium chloride solution obtained in the step 3) and injection water into an oxidation-reduction potential water generation device simultaneously to prepare sodium chloride oxidation-reduction potential water, and measuring the content of sodium chloride;

5) in the oxidation-reduction potential water obtained in the step 4), according to the sodium chloride content measured in the step 4), adding the sodium chloride, disodium hydrogen phosphate and potassium dihydrogen phosphate solution obtained in the step 3) according to the prescription amount, so that the pH value and osmotic pressure of the solution meet the prescription value;

6) filling the solution obtained in the step 5).

4. The method for producing an antibacterial electrolyte irrigating solution for surgical use according to claim 3, wherein:

in the step 4), the sodium chloride solution and the water for injection are simultaneously injected into the oxidation-reduction potential water generating device for electrolysis treatment to prepare the sodium chloride oxidation-reduction potential water.

5. The method for producing an antibacterial electrolyte irrigating fluid for surgical use according to claim 4, wherein the obtained oxidation-reduction potential water is:

the physicochemical indexes of the acidic oxidation-reduction potential water are as follows: the pH value is 3.0-5.5, the available chlorine is 50-400mg/L, and the oxidation-reduction potential ORP 300-1200 mV;

or near neutral oxidation-reduction potential water, the physical and chemical indexes are as follows: the pH value is 5.5-7.8, the available chlorine is 50-400mg/L, and the oxidation-reduction potential ORP is 300-1200 mV.

6. The formulation of claims 1-5, wherein a pair of phosphate buffer pairs is added to maintain the pH of the solution stable.

7. The method for producing an antibacterial electrolyte irrigating solution for surgical use according to claim 3, wherein: the sodium chloride content of the solution can be adjusted flexibly according to the requirement within the range of the prescription value according to the measured result of the step 4).

8. The method for producing an antibacterial electrolyte irrigating solution for surgical use according to claim 3, wherein: the pH value of the solution can be adjusted flexibly according to the measurement result of the sodium chloride content in the step 4) and the requirement of the prescription osmotic pressure value within the range of the prescription value according to the requirement.

Technical Field

The invention belongs to the technical field of liquid products for surgical operations, and particularly relates to an antibacterial electrolyte flushing fluid for surgical operations and a preparation method thereof.

Background

In the process of surgical operation, in order to ensure the effect of the operation and obtain a clearer operation visual field, the lavage and washing of visceral organs or tissues are needed in the operation; after the surgery is completed, the surgical area also needs to be washed. On one hand, irrigation can remove residual tissue fluid, blood stains and the like; on the other hand, the washing liquid is also often used as a carrier of antibiotics to achieve the purpose of locally preventing infection; in addition, variable amounts of irrigation fluid are absorbed into the systemic circulation during irrigation and lavage, and therefore irrigation and lavage can also be used as a treatment to maintain electrolyte balance in the body.

At present, the commonly used surgical irrigation solution at home and abroad comprises mannitol irrigation solution, glycine irrigation solution, normal saline, sodium lactate ringer and the like. These conventional surgical irrigation solutions have various advantages and disadvantages, such as: 5% mannitol water solution is isotonic with blood plasma, has diuretic and dehydrating effects, and can reduce tissue edema of wound surface; however, it is likely to cause water electrolyte disturbance, and hyponatremia or hyperkalemia and osmotic nephropathy are likely to occur.

These commonly used surgical irrigation solutions have a common defect, and have weak bacteriostatic and antibacterial effects, and are easy to cause surgical incision infection. According to the research of relevant clinical practice, the infection rate of the operation part of the general surgery department is 8.09 percent; the infection probability of the craniocerebral operation part is 3.34-9.65%; the hospital infection rate of the oral, maxillofacial and malignant tumor surgical patients is 9.10%. Therefore, in clinical practice, antibiotics such as cephalosporin, gentamicin, vancomycin and the like are often applied in a preventive manner in a surgical washing solution so as to reduce the occurrence of postoperative incision infection; even so, there is still a certain postoperative infection rate, and the situation that the abuse of antibiotics and the occurrence rate of drug-resistant bacteria are increased inevitably is caused.

Disclosure of Invention

The invention provides an antibacterial electrolyte flushing fluid for surgical operation and a preparation method thereof, which overcome the defect that the common antibacterial and antibacterial effects of the flushing fluid in the prior art are weak, avoid the use of antibiotics in the flushing fluid, greatly reduce the occurrence probability of drug-resistant bacteria, and are beneficial to wound healing and recovery of patients.

The invention relates to an antibacterial electrolyte flushing fluid for surgical operation, which comprises the following raw material components in 1L of the operation flushing water solution by weight: 4.00-8.00g of sodium chloride, 1.20-8.00g of disodium hydrogen phosphate and 0.10-11.60g of monopotassium phosphate.

The invention relates to an antibacterial electrolyte flushing fluid for surgical operation, which is characterized in that: the pH value of the antibacterial electrolyte flushing fluid is 6.0-8.0, the oxidation-reduction potential of the antibacterial electrolyte flushing fluid is 300-1200mV, and the osmotic pressure of the antibacterial electrolyte flushing fluid is 280-300 mOsmol/L.

The invention relates to a preparation method of an antibacterial electrolyte flushing fluid for a surgical operation, which is mainly realized by the following technical scheme:

1) respectively drying sodium chloride, disodium hydrogen phosphate and potassium dihydrogen phosphate crystal powder at 180 ℃ for 2 hours, and cooling for later use;

2) dissolving the sodium chloride obtained in the step 1) in water for injection to prepare a saturated sodium chloride solution;

3) injecting the saturated sodium chloride solution obtained in the step 2) and injection water into an oxidation-reduction potential water generation device at the same time to prepare sodium chloride oxidation-reduction potential water, and measuring the content of sodium chloride;

4) in the oxidation-reduction potential water obtained in the step 3), according to the sodium chloride content measured in the step 3), adding the sodium chloride, the disodium hydrogen phosphate and the potassium dihydrogen phosphate obtained in the step 1) according to the prescription amount, so that the pH value and the osmotic pressure of the solution meet the prescription values;

5) filling the solution obtained in the step 4).

In the present invention, as described in step 3), after the raw material sodium chloride is dissolved in the water for injection to form a saturated sodium chloride solution, the saturated sodium chloride solution and the water for injection are simultaneously injected into the oxidation-reduction potential water generating apparatus, and the electrolysis treatment is performed to obtain the sodium chloride oxidation-reduction potential water. The sodium chloride content of the oxidation-reduction potential water is 4.0-8.0 g/L.

Furthermore, the sodium chloride oxidation-reduction potential water can be acidic oxidation-reduction potential water, and the physicochemical indexes are as follows: the pH value is 3.0-5.5, the available chlorine is 50-400mg/L, and the oxidation-reduction potential ORP 300-1200 mV; or the water can be near neutral oxidation-reduction potential water, and the physical and chemical indexes are as follows: the pH value is 5.5-7.8, the available chlorine is 50-400mg/L, and the oxidation-reduction potential ORP is 300-1200 mV.

The antibacterial electrolyte flushing fluid for surgical operation is added with a pair of disodium hydrogen phosphate-monopotassium phosphate buffer pairs, and the existence of phosphate buffer salt achieves the effect of maintaining acid-base balance of the flushing fluid and also plays a role of maintaining osmotic pressure.

The invention is a sterile, pyrogen-free, colorless and transparent isotonic electrolyte washing liquid which has super-strong sterilization efficiency. In the operation process, the antibacterial electrolyte flushing fluid can be used for flushing in stock solution, or can be used for flushing in operation after being diluted by 2-5 times with a normal saline injection, the diluted flushing fluid still keeps extremely high sterilization efficiency, the use of antibiotics in the flushing fluid is avoided, the occurrence probability of drug-resistant bacteria is greatly reduced, and the wound healing and the recovery of a patient body are facilitated.

Detailed Description

The present invention will be described in detail with reference to specific examples, but the embodiments, the use and the purpose of which are illustrated only by way of example, and are not intended to limit the actual scope of the present invention in any way. All other embodiments of the invention as claimed are within the scope of the invention.

The invention relates to an antibacterial electrolyte flushing fluid for surgical operation, wherein each 1L of the antibacterial electrolyte flushing fluid is prepared from the following raw materials in parts by weight: 4.00-8.00g of sodium chloride, 1.20-8.00g of disodium hydrogen phosphate and 0.10-11.60g of monopotassium phosphate.

The invention relates to a preparation method of an antibacterial electrolyte flushing fluid for a surgical operation, which comprises the following steps: 1) respectively drying sodium chloride, disodium hydrogen phosphate and potassium dihydrogen phosphate crystal powder at 180 ℃ for 2 hours, and cooling for later use; 2) dissolving the sodium chloride obtained in the step 1) in water for injection to prepare a saturated sodium chloride solution; 3) injecting the saturated sodium chloride solution obtained in the step 2) and injection water into an oxidation-reduction potential water generation device at the same time to prepare sodium chloride oxidation-reduction potential water, and measuring the content of sodium chloride; 4) in the oxidation-reduction potential water obtained in the step 3), according to the sodium chloride content measured in the step 3), adding the sodium chloride, the disodium hydrogen phosphate and the potassium dihydrogen phosphate obtained in the step 1) according to the prescription amount, so that the pH value and the osmotic pressure of the solution meet the prescription values; 5) filling the solution obtained in the step 4).

As a preferred embodiment, the antibacterial electrolyte flushing fluid for surgical operation of the present invention is prepared from the following raw materials in parts by weight per 1L of the antibacterial electrolyte flushing fluid: 8.2g of sodium chloride, 1.44g of disodium hydrogen phosphate and 0.24g of monopotassium phosphate.

Further, the pH value of the antibacterial electrolyte flushing fluid is 7.0-7.4, the oxidation-reduction potential of the antibacterial electrolyte flushing fluid is 300-1200mV, and the osmotic pressure of the antibacterial electrolyte flushing fluid is 280-300 mOsmol/L.