CN115177871A - Ergonomic equivalent tissue compensator and preparation process thereof - Google Patents

Abstract

The present invention provides an equivalent tissue compensator based on ergonomics and a preparation process thereof. The ergonomic equivalent tissue compensator is mainly made from the following raw materials in parts by weight: 8-20 parts of natural polymer materials, 0.01-1 parts of water-soluble cellulose, and 0.01-1 parts of water-soluble polymer parts, 25-65 parts of polyol, 0.1-1 part of inorganic salt, 0.01-1 part of antibacterial agent, 0.1-2 part of cross-linking agent, and purified water to make up to 100 parts by weight. The equivalent tissue compensator based on ergonomics of the present invention can simulate tissue parameters such as constituent elements, physical density and its uniformity, moisture content, thickness and its uniformity, and fit (number of cavities and cavities and its uniformity) at the same time. Volume), antibacterial properties, and biocompatibility are used as the quality control standards of products, so as to realize superficial tumors such as breast cancer, skin cancer and other special locations such as tumor thyroid tumor, vulvar cancer, testicular cancer, etc. during superficial radiotherapy , to improve the uniformity of the surface radiation dose, thereby improving the radiation effect.

Description

An ergonomic equivalent tissue compensator and its preparation process

technical field

The invention relates to the technical field of medical materials, in particular to an ergonomic equivalent tissue compensator and a preparation process thereof.

Background technique

Cancer is a disease caused by excessive proliferation of cells in the body out of normal regulation. Radiotherapy, as the three main means of tumor treatment, has been widely used in clinical practice. With the development of intensity modulated technology, precise control of radiotherapy dose is one of the core contents of modern radiotherapy. However, due to various particles used in radiotherapy: photons/electron beams/protons/heavy ions, etc., there is a dose-building effect. For the superficial (tumor) target area, whether it is the traditional electron beam irradiation technique or the conformal intensity modulated X-ray irradiation technique, when the rays pass through the superficial tissue, the superficial target area is caused by the existence of the dose build-up area. The radiation dose is extremely uneven, which affects the effect of radiation therapy. When the tumor invades the skin or is close to the skin in some patients, the skin dose will be insufficient and the cancer cells cannot be completely killed. For example, in the case of head and neck cancer with skin invasion, and in the case of breast cancer requiring chest wall irradiation, the problem of insufficient skin dose will seriously affect the treatment effect. Breast cancer diagnosis and treatment guidelines (2018 edition) pointed out that no matter what irradiation technique is used in breast cancer radiation therapy, attention should be paid to adding tissue compensator on the surface of the chest wall to ensure sufficient skin dose. In addition to breast cancer, other superficial organs and irregular organ surfaces will also use some special materials or methods for radiotherapy tissue compensation. By increasing the tissue equivalent compensator with an appropriate thickness, the dose to the skin surface and subcutaneous tissue can be increased while the dose to the front edge of the heart and lung can be reduced, so that the dose distribution in the superficial layer can be uniform, thereby improving the effect of radiotherapy.

In clinical procedures, tissue compensators are usually used to modify the superficial target area to ensure accurate and uniform radiation dose. According to the clinical use scenarios of equivalent tissue compensators, the first-generation equivalent tissue compensators are represented by wet gauze, paraffin, and petrolatum. These materials need to be made repeatedly and repeatedly during use, and the thickness of the compensators is not uniform. This affects the effect of radiation therapy.

The second-generation equivalent tissue compensators represented by polyurethane, polystyrene, and silica gel have solved the clinical defects of the first-generation products, but still have the following problems:

1) The density is not uniform. When the TPS system is used for planning, the dose of the tumor target area will be lower than expected, which will seriously affect the effect of radiotherapy. Due to the uneven addition and distribution of the curing agent in the thermoplastic polymer material during the molding process, the density inside the product is uneven; in order to meet the mechanical properties and clinical use of the product, it is necessary to add 20 mesh nylon mesh during the molding process. Further resulting in uneven density of the product.

2) The thickness gradually decreases. When high-energy rays penetrate medical plastics, the energy absorption will easily lead to a decrease in the degree of polymerization of the polymer material, which in turn leads to a decrease in the thickness of the product. When used, the dose of the tumor target area will be lower than expected, which will seriously affect radiotherapy. Effect.

3) The adhesion of the polymer material is too strong due to its own characteristics, and it is easy to damage the epidermis due to the tearing force during the clinical application and removal process, aggravating the radiation damage.

4) The composition of the product is different from that of human tissue, and the theoretically calculated target dose in the TPS system is not equivalent to the actual target dose, which leads to unpredictable therapeutic effects.

SUMMARY OF THE INVENTION

In order to solve the defects of the products in the prior art and the inaccurate radiation target dose due to errors in the clinical use process, the treatment effect is not as expected. The present invention provides an ergonomic equivalent tissue compensator and a preparation process thereof.

The technical scheme of the present invention is as follows:

In a first aspect of the present invention, there is provided an equivalent tissue compensator based on ergonomics, which is made from the following raw materials in parts by weight:

Wherein, the natural macromolecular material, water-soluble cellulose and water-soluble macromolecular polymer are used as gel skeleton;

The natural polymer material is selected from one or more of type I collagen, type II collagen, III collagen, gelatin, carrageenan, xanthan gum, agar, and sodium alginate. Preferably, the natural polymer material is gelatin, wherein the gelatin can be A-type gelatin, B-type gelatin or enzymatic gelatin. More preferably, the natural polymer material is A-type medicinal gelatin, and the parts by weight are 9-15 parts. In the present invention, the role of the natural polymer material is to form the network skeleton of the gel.

The water-soluble cellulose is selected from one or more of microcrystalline cellulose, carboxymethyl cellulose, hydroxymethyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, and chitosan. kind. Preferably, the water-soluble cellulose is carboxymethyl cellulose, and the parts by weight are 0.05-0.5 parts by weight. In the present invention, the role of the water-soluble cellulose is to form the network backbone of the gel.

The water-soluble high molecular polymer is selected from one or more of polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, and polyacrylate. Preferably, the water-soluble macromolecular polymer is polyvinyl alcohol, and the parts by weight are 0.05-0.5 parts by weight. In the present invention, the role of the water-soluble high molecular polymer is to form the network skeleton of the gel.

The polyol is selected from one or more of propylene glycol, ethylene glycol, glycerol, polyethylene glycol and sorbitol. Preferably, the polyols are ethylene glycol and glycerol, wherein the weight fraction of ethylene glycol in the equivalent tissue compensation material is 5-15 parts, and the weight of glycerol in the equivalent tissue compensation material is 5-15 parts by weight. The parts by weight are 20 to 50 parts. More preferably, the weight part of ethylene glycol is 8-15 parts; the weight part of glycerol is 20-40 parts. In the present invention, the function of the polyol is to form a hydrogen bond with the network skeleton of the gel to stabilize the mechanical properties of the gel.

The inorganic salt is selected from one or more of hydrochloride, sulfate, phosphate and carbonate. Hydrochloride salts such as sodium chloride, potassium chloride, magnesium chloride, calcium chloride. Sulfates, such as sodium sulfate, magnesium sulfate. Phosphates, such as sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate. Carbonates, such as sodium carbonate, sodium bicarbonate. Preferably, the inorganic salt is sodium chloride, and the parts by weight are 0.5 to 1 part by weight. In the present invention, the action of the inorganic salt modulates the dielectric constant of the equivalent tissue compensator

The antibacterial agent is selected from one or more of quaternary ammonium salts, PHMB, PHMG, octenidine, potassium sorbate, phenoxyethanol, sodium benzoate, and paraben. Preferably, the antibacterial agent is PHMB, and the parts by weight are 0.01 part-0.1 part by weight. In the present invention, the function of the antibacterial agent prevents the product from being polluted by microorganisms and avoids secondary pollution of the irradiated field by the microorganisms carried by the product during secondary use.

The cross-linking agent is one or more combinations of pentanediol, genipin, glutamine aminotransferase, alanine aminotransferase, aspartate aminotransferase, and the like. Preferably, the cross-linking agent is transglutaminase, and the parts by weight are 0.1-0.5 parts by weight. At the same time, it is also possible to use ultraviolet rays with a power of 10mW to irradiate for 15-20 minutes, or to give cobalt 60 rays or electron rays at a dose of 1-2kGy for physical cross-linking. In the present invention, the function of the crosslinking agent is to promote the formation of various chemical bonds such as hydrogen bonds and covalent bonds among the components of the gel, stabilize the structure of the product, and improve the mechanical properties of the product.

Described water is purified water, according to the weight parts of other components of the product, make up to the total weight parts to be 100 parts.

The inventors of the present invention take the tissue anatomical structure and composition of the radiotherapy target area as a reference, and design a hydrogel-type tissue compensator that satisfies the equivalent. Among them, the hydrogel uses natural polymer materials, water-soluble cellulose, and water-soluble polymer as the gel skeleton, supplemented by polyols, purified water, inorganic salts, antibacterial agents, etc. to adjust the density, electrical conductivity and antibacterial properties of the product , adding a small amount of cross-linking agent to further improve the mechanical properties of the product.

In a second aspect of the present invention, there is provided an ergonomic equivalent tissue compensator and a preparation process thereof as described in the first aspect, and the specific steps are as follows:

1) Weigh water-soluble cellulose, water-soluble polymer, inorganic salt and an appropriate amount of purified water to fully dissolve in a vacuum emulsifier;

2) Weigh the natural polymer material to fully swell in a vacuum emulsifier, heat up to 65°C until it is completely melted, and stir uniformly at 20-200 rpm, this is solution A;

3) adding polyol and antibacterial agent under vacuum; stirring uniformly at 20-100rpm, this is solution B;

4) Weigh the cross-linking agent and dissolve it in an appropriate amount of purified water for later use, this is solution C;

5) Transfer the completely dissolved solution C into the upper solution B, keep the constant temperature at 65°C, and keep the vacuum state and stir at 50-200rpm for 10-40min;

6) The fully reacted product is poured into molds of different shapes according to different uses, covered with polyethylene film, left for 12-36 hours to release the mold, and then packed into boxes. The form of the mold is shown in Figure 1. You can choose: neck tumor equivalent tissue compensator casting model, breast equivalent tissue compensator casting mold or lower abdomen and genital organ tumor equivalent tissue compensator casting mold.

Preferably,

The described ergonomic equivalent tissue compensator and its preparation process, the specific steps are as follows:

1) Weigh 0.05-0.5 part of carboxymethyl cellulose, 0.05-0.5 part of PVA, 0.5-1 part of sodium chloride and an appropriate amount of purified water to fully dissolve in a vacuum emulsifier;

2) Weigh 9-15 parts of A-type medicinal gelatin to fully swell in a vacuum emulsifying machine, heat up to 65° C. to melt completely, and uniformly stir at 20-200 rpm, this is solution A;

3) under vacuum state, add 20-50 parts of glycerol, 5-15 parts of ethylene glycol, 0.01-0.1 part of PHMB; stir uniformly at 20-100 rpm, this is solution B;

4) Weigh 0.1-0.5 part of transglutaminase, dissolve it in an appropriate amount of purified water for later use, and this is solution C;

5) Transfer the completely dissolved solution C into the upper solution B, keep the constant temperature at 65°C, and keep the vacuum state and stir at 50-200rpm for 10-40min;

6) The fully reacted product is poured into molds of different shapes according to different uses, covered with polyethylene film, left for 12-36 hours to release the mold, and then packed into boxes. Among them, the mold form is shown in Figure 1.

The present invention has the following technical effects:

1) The ergonomic equivalent tissue compensator of the present invention takes the tissue anatomy and composition of human organs and radiotherapy target areas as reference objects, and simulates tissue parameters such as constituent elements, physical density and its uniformity, and moisture content at the same time. Supplemented by thickness and its uniformity, fit (number of cavities and volume of cavities), antibacterial properties, and biocompatibility as quality control standards for products, to achieve superficial tumors such as breast cancer, skin cancer and other When superficial radiotherapy is performed for special locations such as thyroid tumors, vulvar cancer, and testicular cancer, the uniformity of the surface radiotherapy dose can be improved, thereby improving the radiotherapy effect. The above effects are verified in Tables 1-3 in the specific embodiment.

2) The equivalent compensator manufactured by the present invention is soft and skin-friendly, can fit seamlessly with the part, ensures the uniformity of the radiation dose, can effectively prevent the formation of air gaps, and reduce the secondary formation of high-energy rays in the gaps. Second, the product made by the invention has good biocompatibility and can further meet the needs of clinical use. The above effects are verified in Tables 1-3 in the specific embodiment.

Description of drawings

Figure 1 shows the equivalent tissue compensator casting abrasive.

Among them, A is the casting model of the equivalent tissue compensation for neck tumors; B is the casting mold for the equivalent tissue compensation of the breast; C is the casting mold for the equivalent tissue compensation of the lower abdomen and reproductive organs.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present invention clearer and clearer, the present invention will be described in further detail below with reference to the accompanying drawings and embodiments. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. example.

Example 1 Preparation of Equivalent Tissue Compensation (equivalent A)

1. Weigh 0.5g of carboxymethyl cellulose, 0.5g of PVA, 5g of sodium chloride and 562.9g of purified water into a vacuum emulsifier, and stir at 100rpm until the dissolution is uniform.

2. Weigh 90g of medicinal gelatin in a vacuum emulsifying machine to fully swell for 2h, heat up to 65°C until completely melted, stir uniformly at a speed of 60rpm, and vacuum defoaming.

3. Weigh 200g of glycerol, 90g of ethylene glycol, and 0.1g of PHMB, add them to the above solution under vacuum, keep the constant temperature at 65°C, and continue to stir at 100rpm under vacuum until uniform.

4. Weigh 1 g of transglutaminase and dissolve it in 50 g of purified water. After the dissolution is complete, add it to the above solution in a vacuum state, keep the temperature at 65 °C, and continue to stir at 50 rpm for 30 minutes in a vacuum state;

5. The above product is poured into the mold shown in Figure 1B, covered with polyethylene film, and left for 24 hours after demoulding and boxing.

Example 2 Preparation of Equivalent Tissue Compensation B (equivalent B)

1. Weigh 1g of carboxymethylcellulose, 1g of PVA, 8g of sodium chloride and 397.5g of purified water into a vacuum emulsifier, and stir at 100rpm until the dissolution is uniform.

2. Weigh 120g of medicinal gelatin in a vacuum emulsifier to fully swell for 2h, heat up to 65°C until completely melted, stir uniformly at a speed of 60rpm, and vacuum defoaming.

3. Weigh 320 g of glycerol, 100 g of ethylene glycol, and 0.2 g of PHMB, add them to the above solution under vacuum, keep the constant temperature at 65°C, and continue to stir at 50 rpm under vacuum until uniform.

4. Weigh 2.5g of transglutaminase and dissolve it in 50g of purified water. After the dissolution is complete, add it to the above solution in a vacuum state, keep the temperature at 65°C, and continue to stir at 100rpm for 10-40min in a vacuum state;

5. The above product is poured into the mold shown in Figure 1B, covered with polyethylene film, and left to stand for 12-36 hours after demoulding and boxing.

Example 3 Preparation of Equivalent Tissue Compensation (equivalent C)

1. Weigh 5g of carboxymethyl cellulose, 5g of PVA, 10g of sodium chloride and 299g of purified water into a vacuum emulsifier, and stir at 200rpm until the dissolution is uniform.

2. Weigh 150g of medicinal gelatin in a vacuum emulsifier to fully swell for 2h, heat up to 65°C until completely melted, stir uniformly at a speed of 60rpm, and vacuum defoaming.

3. Weigh 400g of glycerol, 100g of ethylene glycol, and 1g of PHMB, add them to the above solution under vacuum, keep the constant temperature at 65°C, and continue to stir at 20-200rpm under vacuum until uniform.

4. Weigh 5g of transglutaminase and dissolve it in 25g of purified water. After the dissolution is complete, add it to the above solution in a vacuum state, keep the temperature at 65°C, and continue to stir at 60rpm in a vacuum state for 10-40min;

5. The above product is poured into the mold shown in Figure 1B, covered with polyethylene film, and left to stand for 12-36 hours after demoulding and boxing.

Example 4 Determination of performance parameters of breast cancer equivalent tissue compensator

The following parameters were tested with the equivalent tissue compensator in Examples 1-3 as the test group, and the tissue compensator with commercially available silica gel and polystyrene as the main components as the control group.

1. Density and homogeneity determination

The equivalent tissue compensators of the experimental group and the control group were randomly cut into small pieces of different sizes, and the measurement was carried out according to the balance method in the density measurement standard GB4472-84, and the variance was calculated. The results are shown in Table 1 below

2. Measurement of thickness and uniformity

The equivalent tissue compensators of the test group and the control group were laid flat on the stainless steel table, and the thicknesses H ₁ , H ₂ , and H ₃ were measured at any three positions (and marked) using the calibrated vernier calipers, and the average value was calculated as H _{0 ,} and calculate its variance. The results are shown in Table 1.

3. Antibacterial properties

The equivalent tissue compensators of the experimental group and the control group were cut into small pieces with a diameter of 1 cm under sterile conditions, and were applied to the coated Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans respectively. Incubate at 37°C for 36h in a 9cm petri dish, and measure the diameter (mm) of the inhibition zone. The results are shown in Table 1.

Table 1 Determination of performance parameters of equivalent tissue compensators

The anterior surface tumor radiotherapy represented by the breast cancer radiotherapy regimen needs to add a 5mm tissue compensation to improve the uniformity of the dose in the superficial target area. In the design of tissue compensator, the anatomical structure and component elements of the tissue in the irradiation field should be met; at the same time, the density, thickness and uniformity of the tissue compensator will directly affect the dose of the radiation target area. The original elements of the products of Examples 1, 2, and 3 are C, H, O, N, Na, and Cl, which meet the design requirements for the constituent elements of equivalent tissue compensators in ICRU (International Commission on Radiation Units and Measurements) No. 44 report. The tissue compensator in the embodiment is prepared by the inter-transmission network gel technology, without adding additional curing agent, and at the same time using negative pressure hot infusion and low-temperature molding technology, the density and thickness of the product meet the requirements for use, and its uniformity is better. Improve the dose distribution of superficial radiotherapy. Silicone products in the control products contain a large amount of Si, a non-human constituent element; polystyrene products have lower density, which affects the accuracy of the TPS plan. And the uniformity of density and thickness is limited due to the need to add additional curing agent in the preparation process, and the uniformity is poor, which affects the uniformity of the dose of the irradiation field in actual use.

During radiotherapy, while the radiation kills tumor cells, it inevitably causes tissue damage in the radiation field. Especially in the mid-term of the patients receiving radiotherapy, the skin stratum corneum, sebum membrane and epidermis of the patients were damaged. This requires that the equivalent tissue compensator for superficial radiotherapy needs to have a certain antibacterial self-purification effect to avoid further aggravation of radioactive damage caused by secondary infection caused by radioactive damage caused by the pathogenic microorganisms adsorbed by the product itself. From the results in Table 1, it can be seen that the products in the examples have strong antibacterial effects on clinically representative pathogenic microorganisms, which further meets the needs of clinical use.

Example 5 Biocompatibility Test

The equivalent tissue compensator designed in the present invention is mainly used in superficial tissue radiotherapy, and needs to be closely attached to human skin when used as an external medical consumable. The products in the product were tested for biocompatibility (cytotoxicity, irritation, sensitization) according to GB/T16886.10-2017, and the results are shown in Table 2.

1. Cytotoxicity

The tissue compensators A, B, and C in the examples were arbitrarily cut, and then extracted with 1640 cell culture medium or fetal bovine serum cell culture medium at a ratio of 0.2 g/ml for 24 hours. The MTT method specified in ISO10993-5:2009 was tested, and three groups of experiments were performed in parallel.

2. Stimulating

The tissue compensators A, B, and C in the examples were arbitrarily cut, and then leached and filtered with normal saline and castor oil at a ratio of 0.2 g/ml. According to GB/T16886.10-2017 "Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test", the test system uses New Zealand rabbits to detect the skin irritation caused by the direct contact between the sample extract and the test system, and evaluate the samples. Potential skin irritation. In the test, the skin reaction of the experimental group does not exceed the skin reaction of the control group, which is 0 points, which is a very slight irritation.

3. Allergy

The tissue compensators A, B, and C in the examples were arbitrarily cut, and then leached and filtered with normal saline and castor oil at a ratio of 0.2 g/ml. According to GB/T16886.10-2017 "Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Test", the guinea pig maximum dose test was used to evaluate the potential skin sensitization of the samples.

Table 2 Biocompatibility of equivalent tissue compensators

It can be seen from Table 2 that:

1) The cell proliferation rates of the extracts of the equivalents A, B, and C in the embodiment are all greater than 95%, and have no cytotoxicity;

2) During the irritation test, the skin reaction on the test side of the equivalents A, B, and C is not higher than the skin reaction on the control side, showing very slight skin irritation;

3) In the sensitization test, no skin sensitization was found in the physiological saline extracts of equivalents A, B, and C, and the sensitization of the positive control was 100%, confirming the validity of the test.

In conclusion, the equivalents A, B, and C in the above examples have good biocompatibility, and all meet the biocompatibility requirements of GB/T16886.10-2017 medical devices.

Example 6

50 patients who needed radiotherapy after benign radical mastectomy were selected and randomly divided into control group and experimental group. Before CT simulation, the existing 30cm*30cm*0.5cm tissue equivalent compensator (silica gel) on the market was used respectively. , polystyrene material) and the tissue compensator of the same specification prepared by the present invention covers the local chest wall skin surface irradiated by the patient, performs CT scanning after fixation, and transmits the image to the treatment planning system to delineate the target area and the organ at risk. At the same time, outline the space between the compensator and the skin. The average number of cavities and the average maximum cavity volume (unit: ml) were determined, and the patients were consulted about their comfort in using the compensator. The pigmentation of the skin on the chest wall and the skin reaction of the radiotherapy plan were observed and graded according to the ROTG standard. The results are shown in Table 3.

Table 3 Clinical Use of Equivalent Tissue Compensation

According to the relevant data in Table 3, it can be found that the equivalent tissue compensator manufactured by the present invention has better application performance and basically no cavity effect; the patient feels comfortable during use, and the skin is not easily caused by tearing during the picking and placing process. Sexual damage, thereby aggravating radiation skin damage.

The above are only the embodiments of the present invention, and are not intended to limit the scope of the present invention. Any equivalent transformation made by using the contents of the description of the present invention, or directly or indirectly applied in other related technical fields, are similarly included in the scope of the present invention. within the scope of patent protection.

Claims (10)

1. an equivalent tissue compensator based on ergonomics, is characterized in that, is mainly made of the raw material of following weight portion: 8-20 servings of natural polymer materials Water-soluble cellulose 0.01-1 serving Water-soluble polymer 0.01-1 part Polyol 25-65 parts Inorganic salt 0.1-1 part Antibacterial agent 0.01-1 serving Cross-linking agent 0.1-2 parts Purified water was supplemented to make up to 100 parts by weight. 2. The ergonomic equivalent tissue compensator according to claim 1, wherein the natural polymer material is selected from the group consisting of type I collagen, type II collagen, III collagen, gelatin, carrageenan One or more of gum, xanthan gum, agar, and sodium alginate. 3. The ergonomic equivalent tissue compensator according to claim 1, wherein the water-soluble cellulose is selected from the group consisting of microcrystalline cellulose, carboxymethyl cellulose, hydroxymethyl cellulose, One or more of hydroxypropyl methylcellulose, hydroxyethyl cellulose and chitosan. 4. The ergonomic equivalent tissue compensator according to claim 1, wherein the water-soluble polymer is selected from the group consisting of polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, and polyacrylate one or more of them. 5. The ergonomic equivalent tissue compensation according to claim 1, wherein the polyhydric alcohol is selected from the group consisting of propylene glycol, ethylene glycol, glycerol, polyethylene glycol, and sorbitol. one or more. 6. The ergonomic equivalent tissue compensation according to claim 1, wherein the inorganic salt is selected from one or more of hydrochloride, sulfate, phosphate, and carbonate kind. 7. The ergonomic equivalent tissue compensation according to claim 1, wherein the antibacterial agent is selected from quaternary ammonium salts, PHMB, PHMG, octenidine, potassium sorbate, benzene One or more of oxyethanol, sodium benzoate and paraben. 8. The ergonomic equivalent tissue compensator according to claim 1, wherein the cross-linking agent is pentanediol, genipin, transglutaminase, alanine transaminase, aspartate One or more combinations of aminotransferases and the like. 9. The ergonomic equivalent tissue compensator of claim 1, wherein Described natural macromolecular material is A-type medicinal gelatin, and the parts by weight are 9-15 parts; The water-soluble cellulose is carboxymethyl cellulose, and the parts by weight are 0.05-0.5 parts by weight; The water-soluble macromolecular polymer is polyvinyl alcohol, and the parts by weight are 0.05-0.5 parts; Described polyhydric alcohol is ethylene glycol and glycerol, wherein the weight fraction of ethylene glycol in the equivalent tissue compensator raw material is 5-15 parts, and the weight fraction of glycerol in the equivalent tissue compensator raw material 20-50 servings; Described inorganic salt is sodium chloride, and the parts by weight are 0.5 part-1 part; The antibacterial agent is PHMB, and the parts by weight are 0.01 part-0.1 part; The cross-linking agent is glutamine transaminase, and the parts by weight are 0.1-0.5 parts. 10. The preparation process of the ergonomic-based equivalent tissue compensator according to any one of claims 1-9, characterized in that, comprising the steps of: 1) Weigh water-soluble cellulose, water-soluble polymers, inorganic salts and an appropriate amount of purified water The empty emulsifier is fully dissolved; 2) Weigh the natural polymer material to fully swell in a vacuum emulsifier, and heat it up to 65°C until it is completely melted. , and uniformly stirred at 20-200 rpm, this is solution A; 3) Add polyol and antibacterial agent under vacuum; stir uniformly at 20-100rpm, this is the solution B; 4) Weigh the cross-linking agent and dissolve it in an appropriate amount of purified water for later use, this is solution C; 5) Transfer the completely dissolved solution C into the upper solution B, keep the constant temperature at 65°C, and keep the vacuum state to Stir at 50-200rpm for 10-40min; 6) The fully reacted product is poured into different shapes of molds according to different uses, covering Polyethylene film, let stand for 12-36h to release the mold, and then pack it in a box.

Images