Surgical flushing fluid and preparation method thereof

Abstract

The invention belongs to the technical field of medical drugs, and particularly relates to flushing fluid for surgical operation and a preparation method of the flushing fluid. The flushing fluid for the surgical operation is formed by taking sodium hyaluronate, hydroxyethyl cellulose, trehalose and D-panthenol as active ingredients and sodium chloride and phosphate as buffer solutions, and has good moisture retention, lubricity, biocompatibility and biodegradability; in the abdominal and pelvic cavity operation process, the effect of keeping exposed visceral organs and tissue surfaces wet is achieved, and visceral tissues can be effectively prevented from being dry and losing water. By generating a layer of protective water film on the surfaces of visceral organs, the flushing fluid for the surgical operation can prevent the conditions of visceral organ serous membrane injury and tissue adhesion during and after the operation. Meanwhile, sodium hyaluronate and D-panthenol contained in the flushing fluid for the surgical operation have the anti-inflammatory characteristic, the wound healing process can be accelerated, and the occurrence rate of postoperative complications is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical pharmaceutical technology, specifically relating to a surgical irrigation solution and its preparation method. Background Technology

[0002] Surgical procedures are medical operations that use instruments and techniques to diagnose, treat, or correct living tissue. They aim to treat diseases in patients through physical intervention. However, surgical procedures inevitably create wounds for patients. Minimizing patient trauma and eliminating adverse factors during surgery are key factors affecting the success rate of a surgical procedure.

[0003] During abdominal and pelvic surgeries, the lesions and surrounding organs and tissues inside the patient's body are often exposed, allowing medical staff to obtain a clear surgical field to the greatest extent possible. However, these surgeries are time-consuming, and if the patient's body cavity is exposed to air for an extended period, the surfaces of organs and tissues will dry out, causing serous membrane damage and increasing the risk of complications such as mechanical tissue injury and adhesions. This can lead to postoperative sequelae such as abdominal pain, pelvic pain, and intestinal obstruction, affecting postoperative recovery and increasing patient suffering.

[0004] In addition, tissue fragments and blood leakage often occur during surgery. In order to ensure good sterile conditions and surgical field, it is necessary to promptly remove contaminants from the cavity through irrigation.

[0005] To address these issues, appropriate surgical irrigation solutions can be used during open surgery to lubricate and protect the surfaces of exposed organs and surgical wounds, prevent the intestines and organs from drying out during surgery, and reduce organ damage.

[0006] The commonly used surgical irrigation solution is physiological saline containing 0.9% sodium chloride, which has advantages such as good fluidity, cleanliness and sterility, and low price. However, it has shortcomings in terms of moisturizing and lubrication performance.

[0007] In recent years, surgical irrigation solutions with carboxymethyl chitosan as the main component have been widely used in clinical practice. As a derivative of chitosan, carboxymethyl chitosan has advantages such as good water solubility, easy biodegradability, and good tissue compatibility. Patents CN104095876B and CN105030815B respectively propose irrigation solutions containing carboxymethyl chitosan as a component, which have good anti-adhesion properties and can be used in surgical procedures. However, currently, the precursor of chitosan, chitin, is mainly derived from animal-derived raw materials such as shrimp shells and crab shells. These raw materials may contain allergens such as tropomyosin or pollutants such as heavy metal ions, posing potential risks to human health.

[0008] In light of the above issues, a suitable surgical irrigation solution for clinical application should possess excellent moisturizing properties, fluidity, biocompatibility, and biodegradability. It should adequately lubricate the surfaces of exposed organs during surgery, prevent tissue adhesion, and facilitate the timely removal of residual abdominal material. Furthermore, the surgical irrigation solution should avoid the addition of animal-derived ingredients to enhance its safety. Summary of the Invention

[0009] The present invention aims to provide a surgical irrigation solution and its preparation method to solve the problem that the use of surgical irrigation solutions containing animal-derived ingredients may cause allergies in patients, while keeping the wound moist and lubricated, and having good irrigation and anti-adhesion functions.

[0010] To achieve the above-mentioned objectives, the present invention is implemented through the following technical solution: A surgical irrigation solution, by weight percentage, comprises 0.1-0.3% sodium hyaluronate, 0.1-0.5% hydroxyethyl cellulose, and further comprises trehalose, D-panthenol, sodium chloride, phosphate buffer, and water; wherein the weight-average molecular weight of the sodium hyaluronate is 500,000 to 1,500,000 Da, and the weight-average molecular weight of the hydroxyethyl cellulose is 80,000 to 200,000 Da.

[0011] This invention introduces a synergistic and complementary effect between hydroxyethyl cellulose and sodium hyaluronate in a specific ratio (0.1-0.3% by weight of sodium hyaluronate and 0.1-0.5% by weight of hydroxyethyl cellulose). Sodium hyaluronate primarily forms a protective film on the organ surface, providing long-lasting hydration, while hydroxyethyl cellulose enhances the lubricity and stability of the solution, preventing sedimentation. Furthermore, excessively high weight-average molecular weight can lead to an overly viscous solution, hindering hydrodynamics during irrigation and reducing contaminant removal capacity; conversely, excessively low weight-average molecular weight, while easily soluble, results in poor film-forming properties and short hydration time. Therefore, this invention intentionally controls the weight-average molecular weight of sodium hyaluronate to 500,000-1,500,000 Da and the weight-average molecular weight of hydroxyethyl cellulose to 80,000-200,000 Da, ensuring optimal performance balance of the surgical irrigation solution in complex surgical environments.

[0012] This invention further enhances the moisturizing and anti-inflammatory properties by adding trehalose and D-panthenol. Trehalose, as a natural sugar, helps maintain cellular hydration, while D-panthenol promotes tissue repair and reduces inflammatory responses. This invention also ensures that the osmotic pressure and pH of the solution are compatible with the human physiological environment by adding sodium chloride and phosphate buffer, thus avoiding tissue irritation.

[0013] This invention utilizes the synergistic film-forming effect of sodium hyaluronate and hydroxyethyl cellulose to create a durable water film on the surface of organs, significantly delaying moisture evaporation and effectively preventing dryness damage. This helps prolong the moisturizing time, reduces the need for repeated intraoperative irrigation, improves surgical efficiency, and significantly enhances clinical applicability. Furthermore, by controlling the molecular weight range, this invention maintains a suitable solution viscosity, ensuring good fluidity and efficiently removing blood and tissue debris from the surgical area. Additionally, by completely avoiding animal-derived components, this invention significantly reduces the risk of allergic reactions, helping to improve patient tolerance.

[0014] Preferably, the content, by weight percentage, includes: 0.1-0.3% sodium hyaluronate, 0.1-0.5% hydroxyethyl cellulose, 0.5-2.5% trehalose, 1.5-3.0% D-panthenol, 0.7-1.0% sodium chloride, 0.15% phosphate buffer, and the balance being water.

[0015] Preferably, the sodium hyaluronate is produced by fermentation of Streptococcus veterinaria.

[0016] The sodium hyaluronate of this invention, as a non-animal-derived component, is produced through microbial fermentation (such as Streptococcus vesicularis), which helps to fundamentally eliminate the harm of animal allergens, while also possessing good biocompatibility and biodegradability.

[0017] Preferably, the sodium hyaluronate has a weight-average molecular weight of 800,000 to 1,200,000 Da.

[0018] Preferably, the molecular weight distribution coefficient of the sodium hyaluronate is 1.0 to 3.0.

[0019] A high molecular weight of sodium hyaluronate can lead to excessively high liquid viscosity, affecting the flowability of the rinse, while a low molecular weight weakens the moisturizing effect.

[0020] Preferably, the molecular weight distribution coefficient of the hydroxyethyl cellulose is 2.0 to 5.0.

[0021] Preferably, the pH value of the surgical irrigation solution is 6.8 to 7.5.

[0022] Preferably, the osmotic pressure of the surgical irrigation solution is 220~330 mOsmol / kg.

[0023] Preferably, the phosphate buffer solution comprises sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dodecahydrate.

[0024] Preferably, the phosphate buffer solution contains sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dodecahydrate in a mass ratio of 1:13~16.

[0025] As a further preferred embodiment, the phosphate buffer solution contains sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dodecahydrate in a mass ratio of 1:14.

[0026] The method for preparing a surgical irrigation solution as described above includes the following steps: S1: Weigh each component according to the formula and dissolve hydroxyethyl cellulose, trehalose, D-panthenol, sodium chloride, and phosphate buffer in water, stir evenly, filter to remove bacteria, and obtain a mixed buffer solution. S2: Add sodium hyaluronate to the mixed buffer solution obtained in step S1, stir at room temperature until dissolved, fill and sterilize by moist heat, cool to obtain surgical irrigation solution.

[0027] Preferably, the temperature for the moist heat sterilization process in step S2 is 115~125℃, and the processing time is 10~15min.

[0028] As a further preferred option, the temperature for the moist heat sterilization process in step S2 is 121°C and the processing time is 12 min.

[0029] Preferably, a 0.22μm microporous filter membrane is used for filtration and sterilization in step S1.

[0030] Therefore, the present invention has the following beneficial effects: The surgical irrigation solution of this invention uses sodium hyaluronate, hydroxyethyl cellulose, trehalose, and D-panthenol as active ingredients, and sodium chloride and phosphate as buffer solutions. It possesses excellent moisturizing, lubricating, biocompatible, and biodegradable properties, effectively keeping exposed organs and tissue surfaces moist during abdominal and pelvic surgeries, preventing organ and tissue dehydration. By forming a protective water film on the organ surface, the surgical irrigation solution of this invention can prevent intraoperative and postoperative organ serous membrane damage and tissue adhesion. Simultaneously, the sodium hyaluronate and D-panthenol contained in the surgical irrigation solution have anti-inflammatory properties, which can accelerate wound healing and reduce the incidence of postoperative complications. Detailed Implementation

[0031] The present invention will be further described below with reference to specific embodiments. Those skilled in the art will be able to implement the present invention based on these descriptions. Furthermore, the embodiments of the present invention described below are generally only some, not all, of the embodiments of the present invention. Therefore, all other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort should fall within the scope of protection of the present invention.

[0032] The sodium hyaluronate used in the following examples is produced by fermentation with Streptococcus veterinaria.

[0033] Example 1 This embodiment provides a surgical irrigation solution and its preparation method.

[0034] A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight-average molecular weight approximately 1 million Da), 0.6g hydroxyethyl cellulose (weight-average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, 500mL water for injection.

[0035] The method for preparing a surgical irrigation solution as described above includes the following steps: S1: In a cleanroom environment, accurately weigh sodium hyaluronate, hydroxyethyl cellulose, trehalose, D-panthenol, sodium chloride, sodium dihydrogen phosphate, and disodium hydrogen phosphate according to the above formula. Add the weighed trehalose, hydroxyethyl cellulose, D-panthenol, sodium chloride, sodium dihydrogen phosphate, and disodium hydrogen phosphate to approximately 80% of the total prepared solution volume of water for injection, stir until completely dissolved, and obtain a homogeneous mixed buffer solution. Filter the solution through a 0.22 μm microporous membrane for sterilization.

[0036] S2: Under continuous stirring, add the weighed sodium hyaluronate to the mixed buffer solution obtained in step S1. After the addition is complete, increase the stirring speed and continue stirring until the sodium hyaluronate is completely dissolved and no visible particles remain. Then, add water for injection to the total volume (500 mL) and continue stirring for 30 minutes to ensure complete homogeneity. Dispense the solution into medical-grade polypropylene rinse bottles, sterilize them at 121°C for 12 minutes, and allow them to cool to room temperature to obtain the finished surgical irrigation solution. The osmotic pressure of the surgical irrigation solution is 287 mOsmol / kg.

[0037] Example 2 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 1.5g sodium hyaluronate (weight-average molecular weight approximately 1.2 million Da), 0.5g hydroxyethyl cellulose (weight-average molecular weight approximately 100,000 Da), 2.7g trehalose, 10.0g D-panthenol, 4.3g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0038] Example 3 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 0.5g sodium hyaluronate (weight-average molecular weight approximately 1.5 million Da), 1.0g hydroxyethyl cellulose (weight-average molecular weight approximately 120,000 Da), 5.0g trehalose, 10.0g D-panthenol, 4.5g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0039] Example 4 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight average molecular weight approximately 800,000 Da), 1.2g hydroxyethyl cellulose (weight average molecular weight approximately 150,000 Da), 7.0g trehalose, 9.0g D-panthenol, 4.5g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0040] Example 5 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 1.2g sodium hyaluronate (weight-average molecular weight approximately 1 million Da), 2.0g hydroxyethyl cellulose (weight-average molecular weight approximately 180,000 Da), 4.5g trehalose, 12.0g D-panthenol, 4.5g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0041] Example 6 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight-average molecular weight approximately 1.4 million Da), 1.5g hydroxyethyl cellulose (weight-average molecular weight approximately 80,000 Da), 10g trehalose, 7.5g D-panthenol, 3.5g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection.

[0042] The method for preparing a surgical irrigation solution as described above includes the following steps: in step S2, after dispensing, the solution is sterilized by moist heat at 115°C for 10 minutes (minimum temperature and time values ​​are required here); the osmotic pressure of the surgical irrigation solution is 220 mOsmol / kg. All other steps are the same as in Example 1.

[0043] Example 7 The difference between this embodiment and Embodiment 1 is that: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight-average molecular weight approximately 500,000 Da), 2.5g hydroxyethyl cellulose (weight-average molecular weight approximately 200,000 Da), 12.5g trehalose, 15.0g D-panthenol, 5.0g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, 500mL water for injection.

[0044] The method for preparing a surgical irrigation solution as described above includes the following steps: in step S2, after dispensing, the solution is sterilized by moist heat at 125°C for 15 minutes (maximum temperature and time values ​​are specified here); the osmotic pressure of the surgical irrigation solution is 330 mOsmol / kg. All other aspects are the same as in Example 1.

[0045] Comparative Example 1 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 0.5g sodium hyaluronate (weight-average molecular weight approximately 300,000 Da), 0.6g hydroxyethyl cellulose (weight-average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0046] Comparative Example 2 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1g sodium hyaluronate (weight average molecular weight approximately 2 million Da), 0.5g hydroxyethyl cellulose (weight average molecular weight approximately 80,000 Da), 2.5g trehalose, 7.5g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0047] Comparative Example 3 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 0.5g hydroxyethyl cellulose (weight average molecular weight approximately 100,000 Da), 2.5g trehalose, 7.5g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0048] Comparative Example 4 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0049] Comparative Example 5 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight-average molecular weight approximately 1 million Da), 0.6g hydroxyethyl cellulose (weight-average molecular weight approximately 50,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0050] Comparative Example 6 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight average molecular weight approximately 1 million Da), 0.6g hydroxyethyl cellulose (weight average molecular weight approximately 250,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0051] Comparative Example 7 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 0.25g sodium hyaluronate (weight average molecular weight approximately 1 million Da), 0.6g hydroxyethyl cellulose (weight average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0052] Comparative Example 8 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1.75g ​​sodium hyaluronate (weight-average molecular weight approximately 1 million Da), 0.6g hydroxyethyl cellulose (weight-average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0053] Comparative Example 9 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight average molecular weight approximately 1 million Da), 0.25g hydroxyethyl cellulose (weight average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0054] Comparative Example 10 The difference between this comparative example and Example 1 is as follows: A surgical irrigation solution has the following formulation: 1.0g sodium hyaluronate (weight-average molecular weight approximately 1 million Da), 2.75g hydroxyethyl cellulose (weight-average molecular weight approximately 80,000 Da), 2.5g trehalose, 8.0g D-panthenol, 4g sodium chloride, 0.049g sodium dihydrogen phosphate, 0.68g disodium hydrogen phosphate, and 500mL water for injection. Everything else is the same as in Example 1.

[0055] [Performance Testing and Analysis] Surgical irrigation solutions were prepared according to the methods in Examples 1-7 and Comparative Examples 1-10, and their pH value, osmotic pressure, shear viscosity and protein content were measured. The specific results are shown in Table 1 below.

[0056] Table 1: Results of parameter measurements for surgical irrigation fluid Example number pH value Osmotic pressure (mOsmol / kg) Shear viscosity (mPa·s) Protein content (w / w) Example 1 7.32 287 23 0.001% Example 2 7.30 305 41 0.001% Example 3 7.22 312 38 0.002% Example 4 7.16 315 27 0.001% Example 5 7.19 313 30 0.002% Example 6 7.20 265 33 0.001% Example 7 7.18 322 25 0% Comparative Example 1 7.28 270 19 0.001% Comparative Example 2 7.17 273 212 0.003% Comparative Example 3 7.28 272 10 0% Comparative Example 4 7.36 266 1 0% Comparative Example 5 7.22 270 24 0.001% Comparative Example 6 7.24 272 83 0% Comparative Example 7 7.31 267 16 0.001% Comparative Example 8 7.30 271 234 0.002% Comparative Example 9 7.27 268 22 0.001% Comparative Example 10 7.30 276 77 0.002% .

[0057] Surgical irrigation solutions were prepared according to the methods described in Examples 1-7 and Comparative Examples 1-10, respectively. To verify the moisturizing effect of the surgical irrigation solutions of the present invention, 100g of each irrigation solution was weighed as a sample solution, dispensed into 200mL glass beakers, and placed in a constant temperature and humidity chamber at a temperature of 37℃±1℃ and a humidity of 45±2RH%. The mass of the sample solution was weighed at 2, 4, 8, and 24 hours, and the moisturizing rate was calculated. The specific results are shown in Table 2 below.

[0058] Table 2: Results of Moisturizing Effect Measurement of Surgical Irrigation Solution Example number Mass of solution before heating (g) 2 hours after heating (%) 4 hours after heating (%) 8 hours after heating (%) 24 hours after heating (%) Example 1 100.0 73.0% 49.3% 27.0% 3.5% Example 2 100.1 78.2% 58.7% 36.9% 4.4% Example 3 100.1 72.8% 57.5% 29.3% 4.1% Example 4 100.0 79.4% 53.2% 30.0% 4.6% Example 5 100.1 75.5% 50.9% 29.2% 4.4% Example 6 100.0 78.5% 60.2% 34.4% 4.8% Example 7 100.0 77.0% 47.7% 29.2% 6.3% Comparative Example 1 99.9 63.7% 30.4% 12.2% 3.3% Comparative Example 2 100.1 80.1% 57.6% 30.7% 3.1% Comparative Example 3 100.0 54.9% 28.1% 9.1% 2.5% Comparative Example 4 100.2 51.0% 23.0% 6.2% 1.0% Comparative Example 5 100.1 65.2% 32.2% 17.0% 3.2% Comparative Example 6 100.0 77.5% 56.0% 26.6% 3.5% Comparative Example 7 99.9 60.4% 27.0% 10.3% 3.1% Comparative Example 8 100.0 77.0% 55.6% 31.1% 2.9% Comparative Example 9 100.0 72.9% 30.1% 25.5% 3.0% Comparative Example 10 100.1 75.5% 56.0% 33.3% 3.1% .

[0059] The results showed that all examples had certain moisturizing properties, while the moisturizing effects of Comparative Examples 1, 3, 4, 5, 7, and 9 were poor. The moisturizing rates of Comparative Examples 1, 3, and 7 were slightly higher than those of Comparative Examples 3 and 4, indicating that sodium hyaluronate was the main moisturizing component in the rinsing solution. However, low concentrations or low molecular weight sodium hyaluronate would reduce the moisturizing effect of the rinsing solution. The evaporation rates of the solutions in Comparative Examples 5 and 9 were slower than those in Comparative Examples 1, 3, and 7, indicating that low concentrations or low molecular weight hydroxyethyl cellulose slightly reduced the moisturizing effect, but this was not the main factor.

[0060] Surgical irrigation solutions were prepared according to the methods described in Examples 1-7 and Comparative Examples 1-10, respectively. To verify the irrigation ability of the surgical irrigation solutions of the present invention, a bacterial suspension containing 100-200 CFU / mL of Saccharomyces cerevisiae was prepared. Twenty-one yeast agar plates were prepared and divided into seven groups. 1 mL of bacterial suspension was evenly added to the plates and spread evenly until the bacterial suspension was absorbed. The plates were incubated upside down at 30°C for 24-48 hours until white circular colonies appeared on the culture medium. One group of plates was reserved as a blank control. The plates were rinsed with 100 mL of each surgical irrigation solution. After rinsing, 10 mL of sterile distilled water was used to rinse the surface of the plates, and 1 mL of the liquid was transferred to another sterile culture medium plate. After incubation for 24-48 hours, the colony count was observed and recorded. The specific results are shown in Table 3 below.

[0061] Table 3: Results of Irrigation Capacity Measurement of Surgical Irrigation Fluids Example number Colony count Example 1 23 Example 2 37 Example 3 44 Example 4 20 Example 5 24 Example 6 40 Example 7 35 Comparative Example 1 17 Comparative Example 2 192 Comparative Example 3 18 Comparative Example 4 14 Comparative Example 5 27 Comparative Example 6 83 Comparative Example 7 12 Comparative Example 8 183 Comparative Example 9 31 Comparative Example 10 62 sterile distilled water 11 Blank control 293 .

[0062] The results showed that, except for Comparative Examples 2 and 8, all examples and comparative examples retained good rinsing ability, with some examples showing rinsing effects comparable to physiological saline. However, Comparative Examples 2 and 8 showed poor rinsing effects, indicating that liquid viscosity significantly affects the rinsing ability of surgical irrigation solutions. Adding excessively high concentrations or large molecular weights of sodium hyaluronate should be avoided when preparing surgical irrigation solutions. Meanwhile, Comparative Examples 6 and 10 showed slightly worse rinsing effects than the examples, indicating that adding high concentrations or large molecular weights of hydroxyethyl cellulose also negatively impacts rinsing ability, but the impact is less than that of sodium hyaluronate.

[0063] The above description is merely a detailed explanation of preferred embodiments and principles of the present invention. For those skilled in the art, there may be changes in specific implementation methods based on the ideas provided by the present invention, and these changes should also be considered within the scope of protection of the present invention.

Claims

1. A surgical irrigant, characterized by, The sodium hyaluronate is 0.1-0.3% by weight percentage, the hydroxyethyl cellulose is 0.1-0.5% by weight percentage, and the trehalose, D-panthenol, sodium chloride, phosphate buffer and water are further included.

2. A surgical irrigant as defined in claim 1, wherein, The sodium hyaluronate is 0.1-0.3% by weight percentage, the hydroxyethyl cellulose is 0.1-0.5% by weight percentage, the trehalose is 0.5-2.5% by weight percentage, the D-panthenol is 1.5-3.0% by weight percentage, the sodium chloride is 0.7-1.0% by weight percentage, the phosphate buffer is 0.15% by weight percentage, and the water is the rest.

3. The surgical irrigant of claim 1 wherein, The raw material of the sodium hyaluronate is derived from the fermentation method of Streptococcus zooepidemicus.

4. The surgical irrigant of claim 1 wherein, The weight average molecular weight of the sodium hyaluronate is 80-120 million Da.

5. The surgical irrigant of claim 1 wherein, The pH value of the surgical flushing solution is 6.8-7.

5.

6. The surgical irrigant of claim 1 wherein, The osmotic pressure of the surgical flushing solution is 220-330 mOsmol / kg.

7. The surgical irrigant of claim 1 wherein, The phosphate buffer includes sodium dihydrogen phosphate monohydrate and disodium hydrogen phosphate dodecahydrate.

8. A surgical irrigant according to claim 7, wherein, The mass ratio of the sodium dihydrogen phosphate monohydrate to the disodium hydrogen phosphate dodecahydrate in the phosphate buffer is 1:13-16.

9. A method for preparing a surgical irrigation solution as described in any one of claims 1 to 8, characterized in that, The method comprises the following steps: S1: ingredients are weighed according to the formula, and the hydroxyethyl cellulose, trehalose, D-panthenol, sodium chloride and phosphate buffer are dissolved in water, stirred uniformly, filtered and sterilized to obtain a mixed buffer solution; S2: the sodium hyaluronate is added to the mixed buffer solution obtained in step S1, stirred at room temperature until dissolved, wet heat sterilized after filling, cooled, and a surgical flushing solution is obtained.

10. The method of claim 9, wherein the surgical irrigant is prepared by, The processing temperature of the wet heat sterilization process in step S2 is 115-125 DEG C, and the processing time is 10-15 min.