CN104841007B - A kind of suture and its preparation method - Google Patents
A kind of suture and its preparation method Download PDFInfo
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- CN104841007B CN104841007B CN201510315358.8A CN201510315358A CN104841007B CN 104841007 B CN104841007 B CN 104841007B CN 201510315358 A CN201510315358 A CN 201510315358A CN 104841007 B CN104841007 B CN 104841007B
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Abstract
The present invention provides the preparation method of a kind of suture, comprises the following steps: step one: freshly extd animal tendon contacts with treatment solution 1 1-2h at 30-40 DEG C and obtains tendon raw material 1; Step 2: at 30-40 DEG C, described tendon raw material 1 is contacted with treatment solution 2 1-2h and obtains tendon raw material 2; Step 3: at 15-30 DEG C, described tendon raw material 2 is contacted with treatment solution 3 0.5-1h and obtains tendon raw material 3; Step 4: by described tendon raw material 3 and O at 15-30 DEG C3Contact 0.5-1h obtains tendon raw material 4; Step 5: at 15-30 DEG C, described tendon raw material 4 is contacted with medical alcohol 20-30h and is cured acquisition tendon raw material 5; Wherein, the moiety of described treatment solution 1 is stomach en-and/or acetic acid; The moiety of described treatment solution 2 is trypsinase and/or NaCO3; The moiety of described treatment solution 3 is NaClO and/or NaOH. The suture utilizing the method to prepare has intensity height, assimilation effect height, mortality is low, security is high advantage.
Description
Technical field
The present invention relates to medical material manufacture field, it is specifically related to a kind of suture and its preparation method.
Background technology
Suture is a kind of thread like material sewed up for body operation, develops its development history from material and experienced by: silk thread, catgut, chemosynthesis line, pure natural collagen protein suture line; From absorptivity, experienced by: non-absorbing suture line and absorbable suture; Natural suture line and artificial suture line two kinds it is divided into according to raw-material source.
The animal tendon suture utilizing animal tendon material to prepare is the absorbable suture of a kind of pure natural, take from animal tendon tissue, there is many characteristics of collagen protein material, compare with other suture lines have good absorbing effect, pulling force strong, promote the exclusive functions such as wound healing, be thus widely used in medical sutures process.
Due to the singularity of Application Areas, suture needs to meet following characteristic and requires: 1. can keep enough intensity in wound healing process, also should extend to adapt to wound oedema, and be retracted into original length with wound retraction; 2. after wound healing its again can degraded and absorbed voluntarily, no longer leave foreign matter; 3. do not produce inflammation; 4. nonirritant and carinogenicity; 5. it is easy to the process such as dyeing, sterilizing, sterilization; 6. can form knot securely; 7. easy to make, cheap, can produce in a large number.
Existing medical animal tendon suture line is eliminated after the reasons such as not good and inactivation of virus effect is good usually can cause the inflammatory reaction of patient, relative disease and final wound healing due to immunogenicity and is produced scar and subcutaneous lump. It is therefore desirable to provide the preparation method of a kind of new suture, thus obtain the animal tendon suture line that intensity is good, security is high.
Summary of the invention
It is an object of the invention to overcome in prior art the defect existed, it is provided that the preparation method of the suture that a kind of intensity is good, security is high and the suture prepared by the method.
The present invention provides the preparation method of a kind of suture, comprises the following steps:
Step one: at 30-40 DEG C, freshly extd animal tendon is contacted with treatment solution 1 1-2h and obtains tendon raw material 1; Step 2: at 30-40 DEG C, described tendon raw material 1 is contacted with treatment solution 2 1-2h and obtains tendon raw material 2; Step 3: at 15-30 DEG C, described tendon raw material 2 is contacted with treatment solution 3 0.5-1h and obtains tendon raw material 3; Step 4: by described tendon raw material 3 and O at 15-30 DEG C3Contact 0.5-1h obtains tendon raw material 4; Step 5: at 15-30 DEG C, described tendon raw material 4 is contacted with medical alcohol 20-30h and is cured acquisition tendon raw material 5;
Wherein, the moiety of described treatment solution 1 is stomach en-and/or acetic acid; The moiety of described treatment solution 2 is trypsinase and/or NaCO3; The moiety of described treatment solution 3 is NaClO and/or NaOH.
Wherein, the object of step one and step 2 is that the animal tendon in order to make and its hetero-organization depart from, and obtains the animal tendon of high purity. The object of step 3 and step 4 is the immunogenicity in order to remove animal tendon and deactivation and the removal carrying out virus. The object of step 5 is to be cured by animal tendon.
In preferred situation, containing stomach en-and acetic acid in described treatment solution 1; Containing trypsinase and NaCO in described treatment solution 23; Containing NaClO and NaOH in described treatment solution 3.
Optionally, in described treatment solution 1, the concentration of stomach en-is 0.3-2.5 weight %; The concentration of acetic acid is 0.1-0.6mol/L.
Preferably, when in described treatment solution 1 containing stomach en-and acetic acid, the concentration of stomach en-is 0.6-1.8%; The concentration of acetic acid is 0.45-0.55mol/L; PH is 2-3.
Optionally, in described treatment solution 2, the concentration of trypsinase is 0.3-2.0 weight %; NaCO3Concentration be 0.15-0.65mol/L.
Preferably, when described treatment solution 2 contains trypsinase and NaCO3Time, the concentration of trypsinase is 0.5-1.5%; NaCO3Concentration be 0.45-0.55mol/L; PH is 9-10.
Optionally, in described treatment solution 3, the concentration of NaClO is 0.01-10 weight %; The concentration of NaOH is 0.05-0.15mol/L.
Preferably, when in described treatment solution 3 containing NaClO and NaOH, the concentration of NaClO is 0.01-8 weight %; The concentration of NaOH is 0.08-0.12mol/L; PH is 12-14.
Optionally, when described method is also included in 100,000 grades of purification workshops, temperature is 18-28 DEG C, humidity is 45-65%, air-dry for described tendon raw material 5 and polishing are obtained suture.
Optionally, described method is also included in and adopts the Co60 of 20-25KGy dosage that described suture is carried out irradiation sterilization. Wherein, described method utilizes pure water that tendon raw material is carried out rinsing 3-5 time after being also included in step one, two, three, four and five, removes treatment solution and the O of residual3Composition;
Optionally, described animal tendon is the long-tail Mammalss such as coypu ail tendo, ox ail tendo, horse ail tendo. Preferably, described animal tendon is coypu ail tendo.
Wherein, in method provided by the present invention, the mode of the contact of animal tendon and treatment solution 1-3 is for be soaked in treatment solution 1-3 by described animal tendon, and the present invention has no particular limits for the amount soaking the treatment solution 1-3 used, as long as guaranteeing submergence tendon raw material.
Wherein, in step 3, tendon raw material 3 and O3During contact, O3Concentration be 0.3-0.6mg/L, air pressure during process is 0.3-0.6MPa.
Present invention also offers the suture utilizing method of the present invention to prepare.
Method operating process provided by the present invention is easy, and the suture utilizing the method to prepare has that intensity height, good absorbing effect, mortality are low, security height, advantage without cicatrization.
Accompanying drawing explanation
Fig. 1 is experimentation on animals tissue resorption slice map group. Wherein, A is that animal tendon suture group absorbs situation, and B is that chemosynthesis line is combined into situation, and a is the 4th day, and b is the 10th day, and c is the 18th day.
Fig. 2 is experimentation on animals tissue collagen fibroplasia figure group. Wherein, A is animal tendon suture group, and B is chemosynthesis line group, and a is the 8th day, and b is the 10th day.
Fig. 3 is experimentation on animals tissue inflammation reaction figure group. Wherein, A is animal tendon suture group, and B is chemosynthesis line group.
Fig. 4 is experimentation on animals tissue resorption slice map group. Wherein, A is that animal tendon suture group absorbs situation, and B is that chemosynthesis line is combined into situation, and a is the 10th day, and b is the 12nd day
Embodiment
Below will the present invention is described in detail by embodiment. It will be appreciated that providing of following examples is only object in order to play explanation, it is not used to the scope to the present invention and limits. The technician of this area is not when deviating from objective and the spirit of the present invention, it is possible to the present invention carries out various amendment and replacement.
Embodiment 1-5
Moiety according to the treatment solution 1-3 provided in table 1 prepares suture 1-5.
First extracting coypu ail tendo also cleans totally; At 35 DEG C, it is soaked in treatment solution 1 by freshly extd tendon 1.5h obtains tendon raw material 1; At 35 DEG C, it is soaked in treatment solution 2 by tendon raw material 1 1.5h obtains tendon raw material 2; At 25 DEG C, it is soaked in treatment solution 3 by tendon raw material 2 45min obtains tendon raw material 3; By tendon raw material 3 (content 0.45mg/L, air pressure is 0.1MPa) O at 25 DEG C3Contact 45min obtains tendon raw material 4; At 25 DEG C, it is soaked in medical alcohol by tendon raw material 4 24h is cured and obtain tendon raw material 5; 100,000 grades purify in workshop, temperature be 18-28 DEG C, humidity be 45-65% when, tendon raw material 5 is carried out air-dry, polishing somatotype, band medical sutures pin and packaging; Finally when the Co60 radiation that dosage is 20-25KGy, sterilizing obtains suture 1-5.
Table 1
Embodiment 6
Adopting the method identical with embodiment 1 to prepare suture, difference is only, in treatment solution 1, does not add acetate component, obtains suture 6.
Embodiment 7
Adopting the method identical with embodiment 1 to prepare suture, difference is only, in treatment solution 2, does not add NaCO3Composition, obtains suture 7.
Embodiment 8
Adopting the method identical with embodiment 1 to prepare suture, difference is only, in treatment solution 3, does not add NaOH composition, obtains suture 8.
Test case 1
Test case 1 is for illustration of the tensile strength of the suture line 1-8 obtained in embodiment 1-8: the tensile strength adopting suture line tension tester detection suture 1-8, test intensity results is as shown in table 2 below, following data are all the tensile strength of 3-0, and test quantity is 300.
Table 2
| Sequence number | Suture line | Tensile strength |
| 1 | Suture line 1 | 21.3��0.7 |
| 2 | Suture line 2 | 22.1��0.8 |
| 3 | Suture line 3 | 23.7��1.3 |
| 4 | Suture line 4 | 20.2��2.4 |
| 5 | Suture line 5 | 19.7��1.8 |
| 6 | Suture line 6 | 22.6��2.7 |
| 7 | Suture line 7 | 23.1��1.2 |
| 8 | Suture line 8 | 22.4��1.3 |
Can being learnt by above Data Data, the tensile strength of suture line 3 is maximum, and above data all meet the industry standard of suture 3-0. Resisting from anti-intensity, suture line 1-8 all can be used for making suture line.
Test case 2
Test case 2 is for illustration of the absorption situation of the suture line 3 obtained in embodiment 3: experimental group suture line 3 is to big white rabbit myometrial suture, control group adopts suture line (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of big white rabbit is sewed up, then getting suture line otch sample when the 4th, 10,18 day in animal body and do HE stained and the absorption situation of basis of microscopic observation suture line at x10, assimilation effect is shown in Fig. 1. It may be seen that suture line 3 (animal tendon suture group) absorbed completely at the 18th day from assimilation effect figure, and control group (chemosynthesis line group) to absorb situation undesirable.
Test case 3
Test case 3 is for illustration of the collegen filament proliferative conditions of the suture line 3 obtained in embodiment 3: experimental group suture line 3 is to the big white rabbit back that implants, control group adopts suture line (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) implant big white rabbit back equally, then get suture line otch sample when 8,10 days in animal body do VG stained and at the basis of microscopic observation collegen filament proliferative conditions of x10. Collagen proliferative conditions is shown in Fig. 2. : experimental group (animal tendon suture group) has collegen filament hyperplasia on the 8th day and invades suture inside, within the 10th day, do not observe collegen filament proliferative conditions is owing to suture line has been degraded and absorbed, as can be seen from Figure 2 in-vivo tissue cell cannot continue to produce collegen filament hyperplasia around suture; Control group (chemosynthesis line group) all can observe obvious collegen filament proliferative conditions at the 8th, 10 day, it is owing to the suture line of chemosynthesis is not obviously absorbed so just can continue to produce collegen filament hyperplasia around suture line, along with the prolongation of soak time, excessive collegen filament hyperplasia will cause scar and the generation of subcutaneous lump.
Test case 4
Test case 4 is for illustration of the inflammatory reaction situation of the suture line 3 obtained in embodiment 3: experimental group suture line 3 is to big white rabbit myometrial suture, control group adopts suture line (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of big white rabbit is sewed up, then getting suture line otch sample when the 10th day in animal body and do HE stained and the inflammatory reaction situation of basis of microscopic observation suture line at x10, inflammatory reaction effect is shown in Fig. 3. As can be seen from the figure, experimental group (animal tendon suture group) can not observe suture line and without obvious inflammatory cell infiltration, namely without inflammatory reaction; And control group (chemosynthesis group) partially absorbs and inflammatory cell infiltration obvious, namely there is obvious inflammatory reaction.
Test case 5
Test case 5 is for illustration of the TNF-�� level change of the suture line 3 obtained in embodiment 3: experimental group suture line 3 is to white rabbit myometrial suture greatly, control group adopts suture line (the PGA suture of chemosynthesis, purchased from Nantong Hua Likang Medical Devices Co., Ltd.) equally the otch of big white rabbit is sewed up, then suture line is got in animal body the 10th, otch sample when 12 days, adopt immunohistochemical methods SABC method cut into slices and at the basis of microscopic observation suture line staining conditions of x40, Bresalier sxemiquantitative formula is adopted to judge coloration result thus judge TNF-�� level, TNF-�� time variations sees the following form:
Table 3
| Group | 10th day | 12nd day |
| Animal tendon suture group | ��* | ��* |
| PGA line group | 1.12��0.34 | 1.18��0.31 |
* representing and compare P < 0.05 with PGA suture group, result is not observed in " " expression
Statistical study: there were significant differences for both TNF-�� of Post operation the 10th day, the 12nd day: animal tendon suture line group does not observe TNF-�� and PGA line group has TNF-��, this may with completely whether absorption be relevant, namely PGA line does not absorb the infiltration causing inflammatory cell and makes the existence of TNF-�� and have the trend of increase, and sections observation design sketch is shown in Fig. 4.
Although, above the present invention is described in detail with a general description of the specific embodiments, but on basis of the present invention, it is possible to it being made some modifications or improvements, this will be apparent to those skilled in the art. Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (9)
1. the preparation method of a suture, it is characterised in that, comprise the following steps:
Step one: at 30-40 DEG C, freshly extd animal tendon is contacted with treatment solution 1 1-2h and obtains tendon raw material 1;
Step 2: at 30-40 DEG C, described tendon raw material 1 is contacted with treatment solution 2 1-2h and obtains tendon raw material 2;
Step 3: at 15-30 DEG C, described tendon raw material 2 is contacted with treatment solution 3 0.5-1h and obtains tendon raw material 3;
Step 4: by described tendon raw material 3 and O at 15-30 DEG C3Contact 0.5-1h obtains tendon raw material 4;
Step 5: at 15-30 DEG C, described tendon raw material 4 is contacted with medical alcohol 20-30h and is cured acquisition tendon raw material 5;
Described method is also included in 100,000 grades of purification workshops, temperature 18-28 DEG C, humidity 45-65% when, air-dry for described tendon raw material 5 and polishing is obtained suture;
Wherein, the moiety of described treatment solution 1 is stomach en-and/or acetic acid; The moiety of described treatment solution 2 is trypsinase and/or NaCO3; The moiety of described treatment solution 3 is NaClO and/or NaOH.
2. preparation method according to claim 1, it is characterised in that, in described treatment solution 1, the concentration of stomach en-is 0.3-2.5 weight %; The concentration of acetic acid is 0.1-0.6mol/L.
3. preparation method according to claim 1 and 2, it is characterised in that, in described treatment solution 2, the concentration of trypsinase is 0.3-2.0 weight %; NaCO3Concentration be 0.15-0.65mol/L.
4. preparation method according to claim 3, it is characterised in that, in described treatment solution 3, the concentration of NaClO is 0.01-10 weight %; The concentration of NaOH is 0.05-0.15mol/L.
5. according to preparation method described in any one in claim 1,2 and 4, it is characterised in that, described animal tendon is coypu ail tendo, ox ail tendo or horse ail tendo.
6. preparation method according to claim 5, it is characterised in that, described animal tendon is coypu ail tendo.
7. preparation method according to claim 6, it is characterised in that, O3Air pressure during process is 0.1MPa, and concentration is 0.3-0.6mg/L.
8. preparation method according to claim 7, it is characterised in that, described method also comprises the Co adopting 20-25KGy dosage60Described suture is carried out irradiation sterilization.
9. utilize in claim 1-8 the suture that the method described in any one prepares.
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4488911A (en) * | 1975-10-22 | 1984-12-18 | Luck Edward E | Non-antigenic collagen and articles of manufacture |
| CN1262959A (en) * | 2000-03-01 | 2000-08-16 | 郑思华 | Preparation method of coypu collagen operating suture |
| CN1879898A (en) * | 2006-04-29 | 2006-12-20 | 双城市北龙生物技术开发有限公司 | Production method of absorbable suture of mammal nerve fiber |
| CN101085373A (en) * | 2006-06-09 | 2007-12-12 | 湖南然原医用高科技蛋白线有限公司 | Method for producing nutria tendon tissue medical suture and straining device for the same |
-
2015
- 2015-06-10 CN CN201510315358.8A patent/CN104841007B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4488911A (en) * | 1975-10-22 | 1984-12-18 | Luck Edward E | Non-antigenic collagen and articles of manufacture |
| CN1262959A (en) * | 2000-03-01 | 2000-08-16 | 郑思华 | Preparation method of coypu collagen operating suture |
| CN1879898A (en) * | 2006-04-29 | 2006-12-20 | 双城市北龙生物技术开发有限公司 | Production method of absorbable suture of mammal nerve fiber |
| CN101085373A (en) * | 2006-06-09 | 2007-12-12 | 湖南然原医用高科技蛋白线有限公司 | Method for producing nutria tendon tissue medical suture and straining device for the same |
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| CN104841007A (en) | 2015-08-19 |
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