Disinfecting and hemostatic composition and preparation method thereof

Abstract

The invention relates to the field of disinfection and hemostasis, and provides a disinfection and hemostasis composition and a preparation method thereof.The disinfection and hemostasis composition is prepared from, by weight, 30-50 parts of a composite antibacterial disinfectant, 1-5 parts of hydrogenated castor oil, 1-3 parts of codonopsis pilosula and 2-8 parts of hemostasis traditional Chinese medicine ingredients. The disinfection and hemostasis composition provided by the invention has the characteristics of good sterilization, disinfection and hemostasis effects.

Description

Technical Field

[0001] The present invention relates to the field of disinfection and hemostasis, and particularly to a disinfection and hemostasis composition and a preparation method thereof. Background Art

[0002] In recent years, with the gradual improvement of people's living and medical standards, people's attention to health and safety has gradually increased, and people have also gradually paid more attention to daily disinfection. Some products such as hand sanitizers have emerged. Then, the development of the components that play a role in disinfection and sterilization in these products has become increasingly important. In daily life, traumatic bleeding is very common. These disinfectants should not only have basic disinfection and sterilization functions but also have good hemostatic effects.

[0003] Most of the products on the market at present cannot have both disinfection and hemostasis effects, and there are also problems such as poor biocompatibility or environmental friendliness. Chitosan has good biocompatibility, antibacterial properties, and the ability to promote wound healing, and has great potential when applied in a disinfection and hemostasis composition. However, chitosan itself has problems such as poor water solubility and poor thermal stability, which affect its application prospects.

[0004] Patent CN 115414446B discloses a traditional Chinese medicine composition for traumatic hemostasis and a preparation method thereof. The traditional Chinese medicine composition includes Clinopodium polycephalum (Vant.) C. Y. Wu et Hsuan, Sedum aizoon L., Portulaca oleracea L., chitosan, and wheat bran. The present invention can achieve rapid hemostasis, and at the same time can prevent bacterial infection and the occurrence of inflammation, and also has a good effect on the repair of wound skin. However, this application still has certain limitations. For example, the traditional Chinese medicine composition contains chitosan, and the water solubility of chitosan is poor. If this traditional Chinese medicine composition is applied to water-based products, there will be certain application limitations.

[0005] Therefore, there is an urgent need in the market for a disinfection and hemostasis composition with good bactericidal, disinfectant, and hemostatic effects. Summary of the Invention

[0006] Aiming at the problems existing in the prior art, the present invention synthesizes a disinfection and hemostasis composition from a composite antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and a hemostatic traditional Chinese medicine component. The composite antibacterial disinfectant contains triclosan and modified chitosan, so that the disinfection and hemostasis composition has the characteristics of good bactericidal, disinfectant, and hemostatic effects.

[0007] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0008] On the one hand, the present invention provides a disinfection and hemostasis composition, and the disinfection and hemostasis composition includes the following raw materials: 30-50 parts of a composite antibacterial disinfectant, 1-5 parts of hydrogenated castor oil, 1-3 parts of Codonopsis pilosula, and 2-8 parts of a hemostatic traditional Chinese medicine component.

[0009] In some embodiments of the present invention, the composite antibacterial disinfectant is a mixture of triclosan and modified chitosan.

[0010] In some embodiments of the present invention, the mass ratio of triclosan to modified chitosan is 1:(1.5 - 2.5).

[0011] Preferably, the mass ratio of triclosan to modified chitosan is 1:2.

[0012] In some embodiments of the present invention, the preparation method of the modified chitosan comprises the following steps:

[0013] (1) Add chitosan to an aqueous hydrochloric acid solution, stir, add absolute ethanol for precipitation, perform vacuum filtration on the precipitate, wash, and dry to obtain chitosan hydrochloride for later use;

[0014] (2) Add the chitosan hydrochloride obtained in step (1) to deionized water, stir and then add it to liquid paraffin, stir at 50 - 60 °C for 20 - 40 min, add glutaraldehyde, stir, wash, centrifuge, and dry to obtain chitosan hydrochloride microspheres for later use;

[0015] (3) Add the chitosan hydrochloride microspheres obtained in step (2) to deionized water, stir, add dicyandiamide, heat to 120 - 140 °C, stir, cool, perform vacuum distillation, precipitate the filtrate with absolute ethanol, wash, filter, purify, dry, and grind the precipitate to obtain the product for later use;

[0016] (4) Mix soy protein isolate powder and the product obtained in step (3), and perform ball milling to obtain the modified chitosan.

[0017] In some embodiments of the present invention, in step (2), the mass ratio of chitosan hydrochloride to glutaraldehyde is 1:(0.2 - 0.5).

[0018] Preferably, in step (2), the mass ratio of chitosan hydrochloride to glutaraldehyde is 1:0.3.

[0019] In some embodiments of the present invention, in step (3), the mass ratio of chitosan hydrochloride microspheres to dicyandiamide is 1:(0.3 - 0.7).

[0020] Preferably, in step (3), the mass ratio of chitosan hydrochloride microspheres to dicyandiamide is 1:0.4.

[0021] In some embodiments of the present invention, in step (4), the mass ratio of the product to soy protein isolate powder is 1:(0.4 - 0.7).

[0022] Preferably, in the step (4), the mass ratio of the product to soy protein isolate is 1:0.5.

[0023] Chitosan has the effects of antibacterial, antioxidant, promoting wound healing, etc., and has good biocompatibility. Adding it to the disinfection and hemostasis composition can effectively improve the product performance. However, both the water solubility and alcohol solubility of chitosan have certain limitations, and the heat resistance of chitosan also needs to be improved, which leads to certain limitations in the application of the disinfection and hemostasis composition.

[0024] On the one hand, the applicant first modifies chitosan to prepare a derivative, chitosan hydrochloride. Chitosan hydrochloride combines a hydrochloride structure on the amino group of chitosan, thereby improving the water solubility of chitosan. Further, the applicant uses chitosan hydrochloride as the raw material and glutaraldehyde as the cross-linking agent to prepare chitosan hydrochloride microspheres. The cross-linked structure inside the chitosan hydrochloride microspheres improves the thermal stability of chitosan. Furthermore, the applicant grafts biguanide active groups onto the chitosan hydrochloride microspheres (to obtain the product), increasing the number of amino groups on the chitosan hydrochloride microspheres, retaining both the high stability and strong physiological activity of the guanidine structure and improving the antibacterial ability of chitosan. On the other hand, the applicant composites soy protein isolate with the above product to obtain modified chitosan, thereby improving the biocompatibility, wound healing promotion ability, hemostasis effect, and antibacterial activity of chitosan. In addition, there is a synergistic antibacterial effect between the modified chitosan and triclosan, enhancing the inhibitory and killing effects on bacteria.

[0025] In some embodiments of the present invention, the hemostatic traditional Chinese medicine component is a composition of Clausena lansium leaves and carbonized human hair.

[0026] In some embodiments of the present invention, the mass ratio of Clausena lansium leaves to carbonized human hair is 1:(0.3 - 0.7).

[0027] Preferably, the mass ratio of Clausena lansium leaves to carbonized human hair is 1:0.5.

[0028] Clausena lansium leaves have the effects of hemostasis, promoting granulation, clearing heat and detoxifying, and can effectively promote the healing of wounds. Carbonized human hair has the functions of astringing hemostasis, removing stasis, shortening the bleeding time, and accelerating blood coagulation, and also has a strong inhibitory effect on Staphylococcus aureus, Salmonella typhi, Salmonella paratyphi A, and Bacillus dysenteriae. The applicant unexpectedly discovers that the two have excellent synergistic hemostatic and antibacterial effects by controlling the ratio of Clausena lansium leaves to carbonized human hair.

[0029] On the other hand, the present invention also provides a preparation method of the disinfection and hemostasis composition described in the above technical solution, including the following steps:

[0030] Mix the composite antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and traditional Chinese medicine components for hemostasis, stir for 10 - 20 minutes, and grind for 5 - 10 minutes to obtain the disinfection and hemostasis composition.

[0031] Compared with the prior art, the present invention has the following beneficial effects:

[0032] (1) The present invention synthesizes a disinfection and hemostasis composition using a composite antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and traditional Chinese medicine components for hemostasis. The composite antibacterial disinfectant contains triclosan and modified chitosan. Through the synergistic effect among the components, the disinfection and hemostasis composition has the characteristics of good bactericidal, disinfection, and hemostasis effects.

[0033] (2) Using chitosan as the raw material, the present invention first modifies chitosan to prepare derivative chitosan hydrochloride. Further, the applicant uses chitosan hydrochloride as the raw material and glutaraldehyde as the crosslinking agent to prepare chitosan hydrochloride microspheres. Furthermore, the applicant grafts biguanide active groups onto the chitosan hydrochloride microspheres and finally mixes them with soy protein isolate by ball milling to obtain modified chitosan, which improves the water solubility, antibacterial property, and thermal stability of chitosan. There is also a synergistic antibacterial effect between modified chitosan and triclosan, enhancing the inhibitory and killing effects on bacteria.

[0034] (3) The present invention controls the proportion of Clausena lansium leaves and human hair carbon to form the traditional Chinese medicine components for hemostasis, which has a good synergistic hemostasis effect and promotes wound healing, and also has a certain antibacterial and disinfection effect.

[0035] (4) The disinfection and hemostasis composition prepared by the present invention has the characteristics of good bactericidal, disinfection, and hemostasis effects, can be widely applied to the field of disinfectants, and has good commercial application value. Specific Embodiments

[0036] The following will illustrate the present invention in combination with specific implementation examples. It should be noted that the following examples are examples of the present invention, only used to illustrate the present invention, and not to limit the present invention. Without departing from the gist or scope of the present invention, other combinations and various improvements within the concept of the present invention can be made.

[0037] In the following examples and comparative examples, except for modified chitosan, the compound monomers and related reagents used can all be purchased from the market. Among them, chitosan is purchased from Shaanxi Ran Kang Biotechnology Co., Ltd.; soy protein isolate is purchased from Shanghai Zhongfeng Biotechnology Co., Ltd.; hydrogenated castor oil is purchased from Jinan Runbenxiang Chemical Co., Ltd.

[0038] Preparation Example 1

[0039] The synthesis method of modified chitosan A includes the following steps:

[0040] (1) Add 10 g of chitosan to 50 ml of 30 wt% hydrochloric acid aqueous solution, stir for 1 h, add 40 ml of absolute ethanol for precipitation, perform vacuum filtration on the precipitate under reduced pressure, wash it 3 times with deionized water, and dry it at 60 °C for 12 h to obtain chitosan hydrochloride for standby.

[0041] (2) Add 10 g of the chitosan hydrochloride obtained in step (1) to 40 ml of deionized water, stir for 30 min, then add it to 50 g of liquid paraffin, stir at 55 °C for 30 min, add 3 g of glutaraldehyde, stir for 3 h, wash it 3 times successively with petroleum ether and isopropanol, centrifuge, and dry it under vacuum at 60 °C for 12 h to obtain chitosan hydrochloride microspheres for standby.

[0042] (3) Add 10 g of the chitosan hydrochloride microspheres obtained in step (2) to 50 ml of deionized water, stir for 30 min, add 4 g of dicyandiamide, heat to 130 °C, stir for 4 h, cool to room temperature, perform vacuum distillation, precipitate the filtrate with 40 ml of absolute ethanol, wash the precipitate with deionized water, filter it, purify it by Soxhlet extraction with acetone, dry it at 60 °C for 12 h, and grind it to obtain the product for standby.

[0043] (4) Mix 5 g of soy protein isolate powder and 10 g of the product obtained in step (3), and perform ball milling to obtain modified chitosan A.

[0044] Preparation Example 2

[0045] Modified chitosan B, the specific implementation method is the same as that of modified chitosan A, the difference is that: in step (2), the mass of glutaraldehyde is replaced with 1.5 g.

[0046] Preparation Example 3

[0047] Modified chitosan C, the specific implementation method is the same as that of modified chitosan A, the difference is that: in step (3), the mass of dicyandiamide is replaced with 2.5 g.

[0048] Preparation Example 4

[0049] Modified chitosan D, the specific implementation method is the same as that of modified chitosan A, the difference is that: in step (4), the mass of soy protein isolate powder is replaced with 3.5 g.

[0050] Example 1

[0051] A disinfection and hemostasis composition, by weight, comprises the following raw materials: 40 parts of a composite antibacterial disinfectant, 3 parts of hydrogenated castor oil, 2 parts of Codonopsis pilosula, and 5 parts of a hemostatic traditional Chinese medicine component.

[0052] The compound antibacterial disinfectant is a mixture of triclosan and modified chitosan A, and the mass ratio is 1:2.

[0053] The hemostatic traditional Chinese medicine component is a composition of Clausena lansium leaves and human hair carbon, and the mass ratio is 1:0.5.

[0054] The preparation method of the disinfection and hemostasis composition in this embodiment includes the following steps:

[0055] Mix the compound antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and the hemostatic traditional Chinese medicine component, stir for 15 minutes, and grind for 7 minutes to obtain the disinfection and hemostasis composition.

[0056] Example 2

[0057] A disinfection and hemostasis composition, by weight, includes the following raw materials: 30 parts of the compound antibacterial disinfectant, 1 part of hydrogenated castor oil, 1 part of Codonopsis pilosula, and 2 parts of the hemostatic traditional Chinese medicine component.

[0058] The compound antibacterial disinfectant is a mixture of triclosan and modified chitosan A, and the mass ratio is 1:1.5.

[0059] The hemostatic traditional Chinese medicine component is a composition of Clausena lansium leaves and human hair carbon, and the mass ratio is 1:0.3.

[0060] The preparation method of the disinfection and hemostasis composition in this embodiment includes the following steps:

[0061] Mix the compound antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and the hemostatic traditional Chinese medicine component, stir for 10 minutes, and grind for 5 minutes to obtain the disinfection and hemostasis composition.

[0062] Example 3

[0063] A disinfection and hemostasis composition, by weight, includes the following raw materials: 50 parts of the compound antibacterial disinfectant, 5 parts of hydrogenated castor oil, 3 parts of Codonopsis pilosula, and 8 parts of the hemostatic traditional Chinese medicine component.

[0064] The compound antibacterial disinfectant is a mixture of triclosan and modified chitosan A, and the mass ratio is 1:2.5.

[0065] The hemostatic traditional Chinese medicine component is a composition of Clausena lansium leaves and human hair carbon, and the mass ratio is 1:0.7.

[0066] The preparation method of the disinfection and hemostasis composition in this embodiment includes the following steps:

[0067] Mix the compound antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula, and the hemostatic traditional Chinese medicine component, stir for 20 minutes, and grind for 10 minutes to obtain the disinfection and hemostasis composition.

[0068] Example 4

[0069] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that the mass ratio of Clausena lansium leaves and human hair carbon in the hemostatic traditional Chinese medicine components is 1:0.15.

[0070] Example 5

[0071] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that the mass ratio of Clausena lansium leaves and human hair carbon in the hemostatic traditional Chinese medicine components is 1:0.9.

[0072] Example 6

[0073] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that modified chitosan B replaces modified chitosan A in equal amount.

[0074] Example 7

[0075] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that modified chitosan C replaces modified chitosan A in equal amount.

[0076] Example 8

[0077] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that modified chitosan D replaces modified chitosan A in equal amount.

[0078] Example 9

[0079] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that Clausena lansium leaves replace the hemostatic traditional Chinese medicine components in equal amount.

[0080] Example 10

[0081] This example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that human hair carbon replaces the hemostatic traditional Chinese medicine components in equal amount.

[0082] Example 11

[0083] This comparative example provides a disinfection and hemostasis composition and a preparation method thereof. The specific implementation manner is the same as that of Example 1, except that chitosan replaces modified chitosan A in equal amount.

[0084] Performance test

[0085] The sterilization and hemostatic properties of the disinfection and hemostasis compositions described in the above Examples 1-11 were tested, and the test results are shown in Table 1.

[0086] Take 5 g of the disinfection and hemostasis composition and add it to 50 ml of 75 wt% aqueous ethanol solution, stir evenly to prepare a disinfection and hemostasis preparation, and test the disinfection and hemostasis preparation.

[0087] (1) Sterilization performance

[0088] Taking Escherichia coli as an example, the antibacterial rate of the disinfection and hemostasis preparation was tested. Take a loop of the slant culture of Escherichia coli and inoculate it into the broth medium. After culturing at 37 °C for 24 hours, take 0.2 ml each and inoculate it into 3 plate media. Respectively take 1 ml of the disinfection and hemostasis preparation prepared in the above examples in equal amounts and drop them onto the 3 plate media; after acting for 3 min, detect the average antibacterial rate, and the rest of the operations comply with the "Disinfection Technical Specification".

[0089] (2) Hemostatic performance

[0090] Take 12 healthy clean-grade New Zealand rabbits, half male and half female, with a body weight of 220 ± 20 g, and divide them into 4 groups evenly. After anesthetizing them by injecting 35 mg / kg of 2 wt% sodium pentobarbital into the marginal ear vein and disinfecting them with 75 wt% medical alcohol, perform a scratch treatment on each group. The depth and length of the wound are the same (depth 1 mm, length 1 cm). After allowing it to bleed freely for 5 s, disinfect the wound with 75 wt% medical alcohol, and then take 2 g of the disinfection and hemostasis preparation prepared in the example in the same amount and apply it to the scratched part. Observe the wound hemostasis time of each group, that is, the time from the moment the disinfection and hemostasis preparation is applied until the bleeding stops.

[0091] Table 1

[0092] Group Antibacterial Rate (%) Hemostasis Time (s) Example 1 99.95 40 Example 2 99.93 45 Example 3 99.90 42 Example 4 99.50 80 Example 5 99.45 75 Example 6 97.70 62 Example 7 96.65 64 Example 8 97.60 70 Example 9 99.23 95 Example 10 99.15 90 Example 11 95.63 65

[0093] As can be seen from the data in Table 1, the disinfection and hemostasis compositions in Examples 1-3 of the present invention as a whole have good disinfection and hemostasis properties. Among them, in Examples 4-5, the proportions of Clausena lansium leaves and human hair carbon in the hemostatic traditional Chinese medicine components were changed, so that the two could not exert good hemostatic synergistic effects, resulting in a longer hemostasis time, but had little impact on the antibacterial rate; in Examples 6-8, the addition proportions of glutaraldehyde, dicyandiamide and soy protein isolate in the synthesis process of modified chitosan were changed, which affected the solubility, antibacterial property and stability of modified chitosan, resulting in a significant decrease in the antibacterial property of the disinfection and hemostasis composition, but had little impact on the hemostasis property; in Examples 9-10 and Example 11, human hair carbon and Clausena lansium leaves were not added to the hemostatic traditional Chinese medicine components and chitosan was used to replace modified chitosan A in equal amounts. Tests found that the hemostasis properties of the disinfection and hemostasis compositions in Examples 9-10 showed poor results and had little impact on the disinfection and sterilization properties, and the disinfection and sterilization properties of the disinfection and hemostasis composition in Example 11 showed poor results and had little impact on the hemostasis property.

[0094] The above embodiments are only for illustrating the technical concept and characteristics of the present invention, and the purpose is to enable those who are familiar with this technology to understand the content of the present invention and implement it. It cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit and essence of the present invention should be covered within the protection scope of the present invention.

Claims

1. A disinfecting hemostatic composition, characterized in that: The disinfection and hemostasis composition comprises the following raw materials by weight: 30-50 parts of composite antibacterial disinfectant, 1-5 parts of hydrogenated castor oil, 1-3 parts of Codonopsis pilosula, and 2-8 parts of hemostatic traditional Chinese medicine ingredients.

2. The disinfecting hemostatic composition according to claim 1, characterized in that The composite antibacterial disinfectant is a mixture of trichlorohydroxydiphenyl ether and modified chitosan.

3. The disinfecting hemostatic composition according to claim 2, characterized in that: The mass ratio of trichlorohydroxydiphenyl ether to modified chitosan is 1:(1.5-2.5).

4. The disinfecting hemostatic composition according to claim 2, characterized in that: The preparation method of the modified chitosan comprises the following steps: (1) adding chitosan to a hydrochloric acid aqueous solution, stirring, adding anhydrous ethanol to precipitate, filtering the precipitate under reduced pressure, washing, and drying to obtain chitosan hydrochloride for later use; (2) adding the chitosan hydrochloride of step (1) into deionized water, stirring, then adding into liquid paraffin, stirring at 50-60° C. for 20-40 min, adding glutaraldehyde, stirring, washing, centrifuging, and drying to obtain chitosan hydrochloride microspheres for use; (3) adding the chitosan hydrochloride microspheres of step (2) into deionized water, stirring, adding dicyandiamide, heating to 120-140° C., stirring, cooling, and distilling under reduced pressure, precipitating the filtrate with anhydrous ethanol, washing, filtering, purifying, drying, and grinding the precipitate to obtain a product for later use; (4) Mixing the isolated soy protein powder and the product of step (3), and ball milling to obtain modified chitosan.

5. The disinfecting hemostatic composition according to claim 4, characterized in that: In the step (2), the mass ratio of chitosan hydrochloride to glutaraldehyde is 1:(0.2-0.5).

6. The disinfecting hemostatic composition according to claim 4, characterized in that: In the step (3), the mass ratio of chitosan hydrochloride microspheres to dicyandiamide is 1:(0.3-0.7).

7. The disinfecting hemostatic composition according to claim 4, characterized in that: In the step (4), the mass ratio of the product to the isolated soy protein powder is 1:(0.4-0.7).

8. The disinfecting hemostatic composition according to claim 1, characterized in that: The hemostatic Chinese medicinal ingredient is a composition of Phellodendron chinense leaves and Xueyu charcoal.

9. The disinfecting hemostatic composition according to claim 8, characterized in that: The mass ratio of the yellow-peeled leaves to the blood charcoal is 1:(0.3-0.7).

10. A method for preparing the disinfecting hemostatic composition according to any one of claims 1 to 9, characterized in that: The following steps are involved: The composite antibacterial disinfectant, hydrogenated castor oil, Codonopsis pilosula and hemostatic Chinese medicinal ingredients are mixed, stirred for 10-20 minutes, and ground for 5-10 minutes to obtain a disinfectant hemostatic composition.