阅读说明：本技术 中药黄精多糖手术缝线及其制备方法 (Traditional Chinese medicine polygonatum polysaccharide surgical suture and preparation method thereof ) 是由 姜程曦 罗莎 鲍康德 任仙樱 赵祺 范欣荣 费璇 余佳兴 周丹 周玉娟 于 2021-05-24 设计创作，主要内容包括：本发明属于医疗器械领域,具体涉及一种中药黄精多糖手术缝线。本发明创新性地在手术缝线中加入黄精多糖,使该手术缝线不仅具有传统缝线的性能,还具有抗菌抗炎作用。(The invention belongs to the field of medical instruments, and particularly relates to a traditional Chinese medicine polygonatum polysaccharide surgical suture. The invention adds rhizoma polygonati polysaccharide in the operation suture innovatively, so that the operation suture not only has the performance of the traditional suture, but also has the antibacterial and anti-inflammatory effects.)

1. The traditional Chinese medicine polygonatum polysaccharide surgical suture is characterized in that: it comprises polygonatum polysaccharide.

2. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 1, which is characterized in that: the polysaccharide is prepared by electrostatic spinning of an electrostatic spinning solution containing polygonatum polysaccharide.

3. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 2, which is characterized in that: the electrostatic spinning solution containing the polygonatum sibiricum polysaccharide is obtained by mixing a PCL solution and a polygonatum sibiricum polysaccharide aqueous solution.

4. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 3, which is characterized in that: the concentration of the polygonatum polysaccharide in the electrostatic spinning solution containing the polygonatum polysaccharide is 11.88-19.8 mg/ml.

5. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 4, which is characterized in that: the concentration of the polygonatum polysaccharide in the electrostatic spinning solution containing the polygonatum polysaccharide is 15.84-16.84 mg/ml.

6. The method for preparing a traditional Chinese medicine polygonatum polysaccharide surgical suture according to any one of claims 2 to 5, which is characterized by comprising the following steps:

(1) preparing an electrostatic spinning solution containing polygonatum polysaccharide;

(2) putting the electrostatic spinning solution containing the polygonatum polysaccharide into an electrostatic spinning machine, starting the electrostatic spinning machine, and collecting the traditional Chinese medicine polygonatum polysaccharide surgical suture on a receiver.

7. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 6, which is characterized in that: in the step (2), the solution flow rate is 0.8 mu m/s-3.2 mu m/s.

8. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 7, which is characterized in that: in the step (2), the solution flow rate is 1.6 μm/s.

9. The traditional Chinese medicine polygonatum polysaccharide surgical suture according to claim 6, which is characterized in that: in the step (2), the voltage is 11 kV-15 kV.

10. The traditional Chinese medicine polygonatum polysaccharide surgical suture of claim 9, which is characterized in that: in the step (2), the voltage is 13 kV.

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a traditional Chinese medicine polygonatum polysaccharide surgical suture.

Background

Polygonatum sibiricumPolygonatum sibiricum Red.Is prepared from (A) of LiliaceaeLiliaceae) Sealwort belongs toPolygonatum Mill.) Dried rhizomes of perennial grasses. Modern pharmacological studies prove that polygonatum polysaccharide (PSP) has important functions of resisting tumors, resisting oxidation, inhibiting bacteria, resisting inflammation and the like, and has great potential in the aspects of biomedical application such as chemical sensitization, radiation sensitization, wound healing and the like.

With the development of biomedical technology, compound drug carriers become a hotspot of research in the field of wound repair. The electrospun nanofiber is the most effective and practical wound dressing, and can be prepared into a composite carrier together with silk fibroin, chitosan or collagen and the like, so that the medicament can be regulated and continuously released, and the wound healing is promoted. The suture is one of the most important medical instruments in wound dressing materials, and the operation sutures such as nylon thread, animal tendon thread and the like on the market have the defects of being not beneficial to suture operation, needing secondary operation for removing the suture, being easily infected by the suture and the like^[10-14]. The natural polysaccharide has good biocompatibility and water solubility, is biodegradable, has wide sources, has wide application in drug controlled release carriers, and is a promising suture material drug. However, no traditional Chinese medicine polysaccharide surgical suture is currently used for wound healing research.

Disclosure of Invention

The invention aims to overcome the defects of the existing suture preparation technology and provides a traditional Chinese medicine polygonatum polysaccharide surgical suture.

The technical scheme adopted by the invention is as follows: a traditional Chinese medicine rhizoma Polygonati polysaccharide surgical suture comprises rhizoma Polygonati polysaccharide.

Preferably, the polysaccharide is prepared from an electrostatic spinning solution containing polygonatum polysaccharide through electrostatic spinning.

Preferably, the electrospinning solution containing polygonatum polysaccharide is obtained by mixing a Polycaprolactone (PCL) solution with a polygonatum polysaccharide (PSP) aqueous solution.

Preferably, the concentration of the polygonatum polysaccharide in the electrostatic spinning solution containing the polygonatum polysaccharide is 11.88-19.8 mg/ml.

Preferably, the concentration of the polygonatum polysaccharide in the electrostatic spinning solution containing the polygonatum polysaccharide is 15.84-16.84 mg/ml.

The preparation method of the traditional Chinese medicine polygonatum polysaccharide surgical suture is characterized by comprising the following steps:

(1) preparing an electrostatic spinning solution containing polygonatum polysaccharide;

(2) putting the electrostatic spinning solution containing the polygonatum polysaccharide into an electrostatic spinning machine, starting the electrostatic spinning machine, and collecting the traditional Chinese medicine polygonatum polysaccharide surgical suture on a receiver.

Preferably, in the step (2), the solution flow rate is 0.8 mu m/s-3.2 mu m/s.

Preferably, in the step (2), the solution flow rate is 1.6 μm/s.

Preferably, in the step (2), the voltage is 11 kV to 15 kV.

Preferably, in step (2), the voltage is 13 kV.

The invention has the following beneficial effects: the invention adds the polygonatum polysaccharide in the operation suture creatively, so that the operation suture has the antibacterial and anti-inflammatory effects.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is within the scope of the present invention for those skilled in the art to obtain other drawings based on the drawings without inventive exercise.

FIG. 1 is SEM images of rhizoma Polygonati polysaccharide nanofibers at different concentrations, and (a) - (f) are SEM images of P1-P6 respectively;

FIG. 2 is an infrared spectrum of PCL granules, PCL suture, Polygonatum sibiricum polysaccharide and PCL suture;

FIG. 3 is an XRD pattern of polygonatum polysaccharide powder, PCL suture, polygonatum polysaccharide and PCL suture;

in fig. 4, (a) the contact angles of PCL containing different polygonatum polysaccharide contents and polygonatum polysaccharide surgical sutures were measured; (b) a contact angle statistical chart of PCL and polygonatum polysaccharide surgical suture lines with different polygonatum polysaccharide contents;

in fig. 5, (a) mechanical property test of PCL and polygonatum polysaccharide surgical sutures with different polygonatum polysaccharide contents; (b) a mechanical property test statistical chart of PCL of different polygonatum polysaccharides and polygonatum polysaccharide surgical sutures;

in FIG. 6, (a) photographs of the experimental course of suture release in different solution systems with different PSP content; (b) release profiles of the flavedo polysaccharide in PBS solution with pH7 for sutures with different PSP contents; (c) suture of varying PSP content at pH 7H₂O₂The release curve of the solution rhizoma polygonati polysaccharide; (d) degradation profiles of sutures with different PSP contents in PBS solution at pH 6; (e) degradation profiles of sutures with different PSP contents in PBS solution at pH 7; (f) suture of varying PSP content at pH 6H₂O₂Degradation profile in solution; (g) suture of varying PSP content at pH 7H₂O₂Degradation profile in solution;

in fig. 7, (a) and (b) are respectively the antibacterial experimental test and statistical chart of the polygonatum polysaccharide surgical suture with different concentrations.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in detail with reference to the accompanying drawings.

The sources of reagents used in the following examples are as follows: rhizoma Polygonati polysaccharide (purity of 95 wt%) was purchased from Shanghai Hu's laboratory Equipment, Inc.; hexafluoroisopropanol (1, 1,1,3,3,3-Hexafluoro-2-propanol, HFIP, 99.5%) was purchased from shanghai alatin; polycaprolactone (PCL) was purchased from Sigma-Aldrich, USA; mouse fibroblasts (NIH 3T 3) were purchased from American Type Culture Collection (ATCC).

Example 1:

(1) preparing 10% PCL solution and 13.6% rhizoma polygonati polysaccharide aqueous solution, mixing 6.4 ml PCL solution and 0.6 ml rhizoma polygonati polysaccharide aqueous solution to obtain 7 ml mixed solution, wherein the concentration of the rhizoma polygonati polysaccharide in the mixed solution is 11.88 mg/ml;

(2) about 10 ml of mixed solution is taken by an injector and is placed into an electrostatic spinning machine, the metal needle head of the injector is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During electrospinning, the solvent evaporates, leaving only the nanofibers attached to the receiver to form a nanofiber yarn.

The flow rate of the solution through the spinneret is an important factor because it affects the amount of material transported and the jet velocity. As shown in Table 1, the solution flow rates of 0.8 μm/s, 1.6 μm/s and 3.2 μm/s were tested in this example, and it was found that the flow rate of 1.6 μm/s can stabilize the polymer solution passing through the spinneret to obtain sewing threads with the best uniformity. In addition to the solution flow rate, the voltage also affects the jet velocity of the material. By comparing the voltages of 11 kV, 13 kV and 15 kV, the spinning voltage of 13 kV is found that the jet flow is stable, the mechanical property of the obtained suture is good, the fiber sewing thread with good shape and uniformity can be spun, and the obtained fiber thread is marked as P4.

Example 2:

(1) preparing 10% PCL solution and 13.87% polygonatum polysaccharide aqueous solution, mixing 6.2 ml PCL solution and 0.8 ml polygonatum polysaccharide aqueous solution to obtain 7 ml mixed solution, wherein the concentration of the polygonatum polysaccharide in the mixed solution is 15.84 mg/ml;

(2) about 10 ml of mixed solution is taken by an injector and is placed into an electrostatic spinning machine, the metal needle head of the injector is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During the electrospinning process, the solvent evaporates leaving only the nanofibers attached to the receiver to form a nanofiber yarn, labeled P5.

Example 3:

(1) preparing 10% PCL solution and 13.87% polygonatum polysaccharide aqueous solution, mixing 6.0 ml PCL solution and 1.0 ml polygonatum polysaccharide aqueous solution to obtain 7 ml mixed solution, wherein the concentration of the polygonatum polysaccharide in the mixed solution is 19.81 mg/ml;

(2) about 10 ml of mixed solution is taken by an injector and is placed into an electrostatic spinning machine, the metal needle head of the injector is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During the electrospinning process, the solvent evaporates leaving only the nanofibers attached to the receiver to form a nanofiber yarn, labeled P6.

Comparative example 1:

(1) preparing 10% PCL solution and 13.87% polygonatum polysaccharide aqueous solution, mixing 6.8 ml PCL solution and 0.2 ml polygonatum polysaccharide aqueous solution to obtain 7 ml mixed solution, wherein the concentration of the polygonatum polysaccharide in the mixed solution is 3.96 mg/ml;

(2) about 10 ml of mixed solution is taken by an injector and is placed into an electrostatic spinning machine, the metal needle head of the injector is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During the electrospinning process, the solvent evaporates leaving only the nanofibers attached to the receiver to form a nanofiber yarn, labeled P2.

Comparative example 2:

(1) preparing 10% PCL solution and 13.87% polygonatum polysaccharide aqueous solution, mixing 6.6 ml PCL solution and 0.4ml polygonatum polysaccharide aqueous solution to obtain 7 ml mixed solution, wherein the concentration of the polygonatum polysaccharide in the mixed solution is 7.92 mg/ml;

(2) about 10 ml of mixed solution is taken by an injector and is placed into an electrostatic spinning machine, the metal needle head of the injector is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During the electrospinning process, the solvent evaporates leaving only the nanofibers attached to the receiver to form a nanofiber yarn, labeled P3.

Comparative example 3:

about 10 ml of 10% PCL solution is taken by a syringe and put into an electrostatic spinning machine, the metal needle head of the syringe is 20G, the distance between the needle point and the collector is 15 cm, the flow rate of the solution is 1.6 mu m/s, and the voltage is 13 kV. During the electrospinning process, the solvent evaporates leaving only the nanofibers attached to the receiver to form a nanofiber yarn, labeled P1.

Test example 1: observing the microstructure of the surface of the suture by a scanning electron microscope, finding that the PCL polymer solution and the PCL-PSP solution can generate smooth and uniform nanofiber bundles which are combined into a linear shape and have regularly arranged, dense and uniform surfaces, and comparing with pure PCL spinning, the addition of the polygonatum polysaccharide has no influence on the surface structure of the suture, and the figure is 1.

Test example 2: the change of the mechanical properties of the sewing thread after drug loading was examined by tensile testing. Statistically, the mechanical properties of the sutures of the PCL group and the PCL-PSP group have no significant difference (P is more than 0.05) within the allowable error range. The experiment proves that the polygonatum polysaccharide can change the mechanical property strength and the maximum tensile stress of the thread, and is related to the concentration of the added polygonatum polysaccharide, as shown in fig. 5a-b, the mechanical strength of the example 2 (adding 15.84 mg/ml of polygonatum polysaccharide operation suture) is the maximum, so that the polygonatum polysaccharide has drug-carrying slow-release performance and certain toughness.

Test example 3: the performance of sewing thread under different parameters can be evaluated by measuring the contact angle of the film material. The smaller the contact angle, the more hydrophilic; conversely, the larger the contact angle, the more hydrophobic. As a result, the hydrophilicity of the polygonatum polysaccharide is enhanced with the increase of the content of the polygonatum polysaccharide, as shown in figure 4 a.

Test example 4: the drug release degradation performance of the PCL-PSP suture under different acidity and medium is discussed by detecting the concentration of PSP. Media of the same acidity (PBS and H)₂O₂) Experiments show that the PSP is in H₂O₂The release rate and degradation rate in the medium are significantly better than those of PBS medium, which is probably compatible with H₂O₂The hydrophilicity is strongly concerned. Experiments with different acidity (pH 6 and pH 7) of the same medium showed (fig. 6b to 6 g) that there was no significant difference in the degradation of PSP at acidity pH6 and pH7, which may be the case with suturesThe line stability is relevant. The surgical suture experiments with different PSP concentrations show that the PSP release rate and the degradation rate are enhanced as the concentration of polygonatum polysaccharide is increased, wherein the suture with the PSP concentration of 19.80 mg/ml has the best release degradation performance, and the PCL-PSP suture with the concentration of 15.84 mg/ml is used as the second step.

Test example 5: the antibacterial property of the surgical suture is evaluated by PCL-PSP group sutures with different concentrations, and the suture containing the PCL-PSP group sutures with different concentrations is found to have an unobvious antibacterial effect, and the suture added with 0-0.4ml of polygonatum polysaccharide (0-7.92 mg/ml) is judged to have an unobvious antibacterial effect, the colony count is higher than 400, and the antibacterial effects of the sutures of examples 1-3 (the polygonatum polysaccharide concentration is 11.88-19.8 mg/ml) have significant differences, as shown in FIGS. 7a and 7 b. Therefore, when the added polygonatum polysaccharide is not less than 11.88 mg/ml, the suture composite material has certain antibacterial property.

In conclusion, the PCL-PSP surgical suture composite material is successfully prepared, and the PCL-PSP surgical suture composite material with the PSP concentration of 15.84-19.8 mg/ml is preferably added through comprehensive comparison of a stretching experiment, an antibacterial property experiment and the like. The chemical bond between PSPs and the chemical bond formed by PSP and PCL increase the permeability of the suture, have antibacterial effect, reduce secondary damage to tissues and effectively promote the adhesion of cells and the nano-scaffold, thereby improving the growth capacity of the cells and inhibiting the generation of inflammation. Therefore, the PCL-PSP surgical suture composite material has certain innovativeness and advancement and has great potential in the fields of clinical application and the like.

The above disclosure is only for the purpose of illustrating the preferred embodiments of the present invention, and it is therefore to be understood that the invention is not limited by the scope of the appended claims.