CN105288719A - Medical stitching material and preparation technology thereof - Google Patents

Abstract

The invention discloses a medical stitching material. The medical stitching material is prepared from 30-45 parts by mass of fibroin, 55-70 parts by mass of collagen, 2-6 parts by mass of castor oil, 10-20 parts by mass of polyvinyl pyrrolidine, 2-8 parts by mass of an antiseptic, 3-6 parts by mass of root and rhizome of tartary buckwheat, 5-7 parts by mass of brittle falsepimpernel herb, 4-9 parts by mass of tangerine leaf, 6-9 parts by mass of peruvian groundcherry herb, 3-5 parts by mass of fortunearia sinensis, 4-10 parts by mass of divaricate carpesium, 6-9 parts by mass of lotus leaf, 5-8 parts by mass of root, stem and leaf of Lindera angustifolia Cheng, 3-6 parts by mass of hairyvein agrimony and 7-10 parts by mass of Chinese starjasmine stem. The medical stitching material has good flexibility, can form a knot easily, has good consistence and a certain extensibility, can adapt wound oedema, has good biocompatibility, can promote wound heal and can reduce scar.

Description

Medical sutures material and preparation technology thereof

Technical field

The present invention relates to medical devices field, particularly relate to a kind of medical sutures material and preparation technology thereof.

Background technology

Stitching thread is widely used in all kinds of surgical operation, and in order to sew up wound, conjunctive tissue is epochmaking medical material.Operation suture thread sews up human body and tissue, organ and blood and keeps long-term or lasting contacting, and by its behavior in living tissue, biological nondegradable and biodegradable can be divided into absorb.Wherein biodegradable absorb to tissue and the repair and reconstruction important in inhibiting of organ.Disappearing by being degraded into the absorbable material of human body, avoiding some harmful effects such as the rejection in body, non-infectious inflammation.

Publication No. CN104548192A(application number 201310499974.4) Chinese patent literature disclose a kind of preparation method of collagen sutures, this kind of sutural preparation method of collagen protein is the tail of the collagen protein one by one muscle be stripped out from the tail of castor,, screening straight, air-dry through defat, inactivation of virus, rinsing, dehydration, reason, carries out oil tanning, cleaning, vacuum packaging and sterilization to satisfactory collagen protein tail muscle.Publication No. CN104474586A(application number 201410684015.4) Chinese patent literature disclose a kind of polyglycolic acid class Surgical Absorbable Suture and preparation method thereof, component: polyglycolic acid, polylactic acid, salmon collagen, fibroin albumen, chitosan, cross-linking agent, stabilizing agent and antibacterial.Publication No. CN104940989A(application number 201510352531.1) Chinese patent literature disclose a kind of absorbable suture and preparation method thereof, raw material has collagen protein 24 ~ 55 parts, fibroin 23 ~ 56 parts, fibroin 12 ~ 27 parts, sericin 13 ~ 23 parts, glycolic 12 ~ 30 parts, lactic acid 11 ~ 28 parts, PGA 2 ~ 14 parts, polylactide 6 ~ 20 parts, poly (glycolide-co-lactide) 4 ~ 16 parts, sodium carbonate 1 ~ 7 part, deionized water 40 ~ 65 parts.

The collagen cell compatibility is good, and the healing with wound can be absorbed gradually, and without the need to taking out stitches, meet environmental protection theory, this series products is subject to the favor of people day by day.

Summary of the invention

For the deficiencies in the prior art, the object of this invention is to provide that a kind of preparation technology is simple, the medical sutures material of good biocompatibility and preparation method thereof.

Technical scheme of the present invention is:

Medical sutures material, is prepared from primarily of following raw materials according, is mass parts: fibroin 30-45, collagen protein 55-70, Oleum Ricini 2-6, polyvinylpyrrolidine 10-20, antibacterial 2-8, Radix Et Rhizoma Fagopyri Tatarici 3-6, Herba Linderniae Crustaceae 5-7, Folium Citri tangerinae 4-9, Fructus Seu Herba Pubescentis 6-9, Folium seu Radix Fortuneariae Sinensis 3-5, Herba Carpesii Divaricati 4-10, Folium Nelumbinis 6-9, Lindera angustifolia Cheng 5-8, Herba Agrimoniae 3-6, Caulis Trachelospermi 7-10.

In preferred scheme, fibroin 35-40, collagen protein 60-65, Oleum Ricini 3-5, polyvinylpyrrolidine 13-17, antibacterial 4-6, Radix Et Rhizoma Fagopyri Tatarici 4-5, Herba Linderniae Crustaceae 5.5-6.5, Folium Citri tangerinae 5-8, Fructus Seu Herba Pubescentis 7-8, Folium seu Radix Fortuneariae Sinensis 3.5-4.5, Herba Carpesii Divaricati 5-9, Folium Nelumbinis 7-8, Lindera angustifolia Cheng 6-7, Herba Agrimoniae 4-5, Caulis Trachelospermi 8-9.

Be more preferably, fibroin 37.5, collagen protein 62.5, Oleum Ricini 4, polyvinylpyrrolidine 15, antibacterial 5, Radix Et Rhizoma Fagopyri Tatarici 4.5, Herba Linderniae Crustaceae 6, Folium Citri tangerinae 6.5, Fructus Seu Herba Pubescentis 7.5, Folium seu Radix Fortuneariae Sinensis 4, Herba Carpesii Divaricati 7, Folium Nelumbinis 7.5, Lindera angustifolia Cheng 6.5, Herba Agrimoniae 4.5, Caulis Trachelospermi 8.5.

Described medical sutures material, antibacterial is a kind of in nanometer silver, poly hexamethylene biguanide and propyl p-hydroxybenzoate or any two kinds mixture.

The preparation method of described medical sutures material, step is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 20-28 minute, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 900-1300 mesh sieve, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and antibacterial are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, water-bath stretches, and dries, sterilizing, obtains suture material.

The preparation method of described medical sutures material, step (1) is added a cover and (preferably, is added a cover stewing 7-11 minute in stewing 5-13 minute; Be more preferably, add a cover stewing 9 minutes).

The preparation method of described medical sutures material, step (2) is placed in steamer to steam (preferably, steams 17-23 minute in 15-25 minute; Be more preferably, steam 20 minutes).

The preparation method of described medical sutures material, step (4) big fire is boiled 22-26 minute (preferred, big fire boils 24 minutes).

The preparation method of described medical sutures material, step (4) pulverized 1000-1200 mesh sieve (preferred, to pulverize 1100 mesh sieves).

The preparation method of described medical sutures material, step (5) water-bath draft temperature is 20-40 DEG C, and (preferred, water-bath draft temperature is 25-35 DEG C; Be more preferably, water-bath draft temperature is 30 DEG C).

Medical sutures material preparation science provided by the invention, technique is simple.In addition, excellent results of the present invention also shows:

1, products made thereby of the present invention has good soft and moist property, easily ties a knot, and hold knot property good;

2, the present invention has certain extensibility, can adapt to the edema of wound;

3, good biocompatibility of the present invention, and can wound healing be promoted, reduce the formation of cicatrix.

Detailed description of the invention

Describe technical scheme of the present invention in detail below in conjunction with embodiment and experimental example, but protection domain is not limited thereto.

embodiment 1medical sutures material, is prepared from (every part of 10g) primarily of following raw materials according: fibroin 30 parts, collagen protein 55 parts, Oleum Ricini 2 parts, polyvinylpyrrolidine 10 parts, antibacterial 2 parts, Radix Et Rhizoma Fagopyri Tatarici 3 parts, Herba Linderniae Crustaceae 5 parts, Folium Citri tangerinae 4 parts, Fructus Seu Herba Pubescentis 6 parts, Folium seu Radix Fortuneariae Sinensis 3 parts, Herba Carpesii Divaricati 4 parts, 6 parts, Folium Nelumbinis, Lindera angustifolia Cheng 5 parts, Herba Agrimoniae 3 parts, Caulis Trachelospermi 7 parts.

The preparation method of above-mentioned medical sutures material is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing 5 minutes, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam 15 minutes, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 20 minutes, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 900 mesh sieves, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and nanometer silver are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, at 20 DEG C, water-bath stretches, and dries, sterilizing, obtains suture material.

embodiment 2medical sutures material, is prepared from (every part of 10g) primarily of following raw materials according: fibroin 45 parts, collagen protein 70 parts, Oleum Ricini 6 parts, polyvinylpyrrolidine 20 parts, antibacterial 8 parts, Radix Et Rhizoma Fagopyri Tatarici 6 parts, Herba Linderniae Crustaceae 7 parts, Folium Citri tangerinae 9 parts, Fructus Seu Herba Pubescentis 9 parts, Folium seu Radix Fortuneariae Sinensis 5 parts, Herba Carpesii Divaricati 10 parts, 9 parts, Folium Nelumbinis, Lindera angustifolia Cheng 8 parts, Herba Agrimoniae 6 parts, Caulis Trachelospermi 10 parts.

The preparation method of medical sutures material is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing 13 minutes, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam 25 minutes, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 28 minutes, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 1300 mesh sieves, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and poly hexamethylene biguanide are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, at 40 DEG C, water-bath stretches, and dries, sterilizing, obtains suture material.

embodiment 3medical sutures material, is prepared from (every part of 10g) primarily of following raw materials according: fibroin 35 parts, collagen protein 60 parts, Oleum Ricini 3 parts, polyvinylpyrrolidine 13 parts, antibacterial 4 parts, Radix Et Rhizoma Fagopyri Tatarici 4 parts, Herba Linderniae Crustaceae 5.5 parts, Folium Citri tangerinae 5 parts, Fructus Seu Herba Pubescentis 7 parts, Folium seu Radix Fortuneariae Sinensis 3.5 parts, Herba Carpesii Divaricati 5 parts, 7 parts, Folium Nelumbinis, Lindera angustifolia Cheng 6 parts, Herba Agrimoniae 4 parts, Caulis Trachelospermi 8 parts.

The preparation method of medical sutures material is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing 7 minutes, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam 17 minutes, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 22 minutes, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 1000 mesh sieves, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and propyl p-hydroxybenzoate are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, at 25 DEG C, water-bath stretches, and dries, sterilizing, obtains suture material.

Typical case: xxx, man, 16 years old.Main suit: recently more because eating cold drink, has a dull ache around self-induction umbilicus, after be transferred to Right Lower Abdomen, persistence distending pain, be difficult to restrain oneself, examination in hospital, low grade fever 37.4 DEG C, mcBurney point tenderness, Roche levies the positive, ultrasonic examination, is diagnosed as acute appendicitis, patient accepts operation for appendicitis, Advances of operative technique is smooth, uses the present embodiment gained medical sutures material when sewing up the incision, and after patient wakes up, wound pain is not obvious, within postoperative two days, wound is without obvious redness, pain, after one week, wound healing is good, there is not rejection phenomenon, patient discharge.

embodiment 4medical sutures material, is prepared from (every part of 10g) primarily of following raw materials according: fibroin 40 parts, collagen protein 65 parts, Oleum Ricini 5 parts, polyvinylpyrrolidine 17 parts, antibacterial 6 parts, Radix Et Rhizoma Fagopyri Tatarici 5 parts, Herba Linderniae Crustaceae 6.5 parts, Folium Citri tangerinae 8 parts, Fructus Seu Herba Pubescentis 8 parts, Folium seu Radix Fortuneariae Sinensis 4.5 parts, Herba Carpesii Divaricati 9 parts, 8 parts, Folium Nelumbinis, Lindera angustifolia Cheng 7 parts, Herba Agrimoniae 5 parts, Caulis Trachelospermi 9 parts.

The preparation method of medical sutures material is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing 11 minutes, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam 23 minutes, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 26 minutes, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 1200 mesh sieves, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and antibacterial (mixture of nanometer silver and poly hexamethylene biguanide) are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, at 35 DEG C, water-bath stretches, and dries, sterilizing, obtains suture material.

Typical case: xxx, female, 42 years old.Main suit: accidentally fall down when having a bath, cause right arm red and swollen, pain is obvious, limitation of activity, hospital's x-ray inspection is diagnosed as closed fracture, and patient accepts internal fixation operation, this the present embodiment gained medical sutures material is used when sewing up the incision, within postoperative 2 days, patient wound has slight redness, and pain is not obvious, without infecting, postoperative 8 days, wound healing is good, becomes the healing of line sample, patient discharge.

embodiment 5medical sutures material, is prepared from (every part of 10g) primarily of following raw materials according: fibroin 37.5 parts, collagen protein 62.5 parts, Oleum Ricini 4 parts, polyvinylpyrrolidine 15 parts, antibacterial 5 parts, Radix Et Rhizoma Fagopyri Tatarici 4.5 parts, Herba Linderniae Crustaceae 6 parts, Folium Citri tangerinae 6.5 parts, Fructus Seu Herba Pubescentis 7.5 parts, Folium seu Radix Fortuneariae Sinensis 4 parts, Herba Carpesii Divaricati 7 parts, 7.5 parts, Folium Nelumbinis, Lindera angustifolia Cheng 6.5 parts, Herba Agrimoniae 4.5 parts, Caulis Trachelospermi 8.5 parts.

The preparation method of medical sutures material is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing 9 minutes, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam 20 minutes, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 24 minutes, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 1100 mesh sieves, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and antibacterial (mixture of nanometer silver and propyl p-hydroxybenzoate) are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, at 30 DEG C, water-bath stretches, and dries, sterilizing, obtains suture material.

Pharmacology and the application of the present invention's primary raw material used are as follows:

Fibroin: have another name called: fibroin albumen.Fibroin albumen, it is the natural polymer fibrin extracted from silkworm silk, content accounts for 70% ~ 80% of silkworm silk, and containing 18 seed amino acids, wherein glycine (gly), alanine (ala) and serine (ser) account for more than 80% of total composition.Fibroin itself has good mechanical performance and physicochemical property, as good pliability and tensile strength, breathable moisture permeability, slow-releasing etc., and can obtain different forms through different disposal.Fibroin albumen has good biocompatibility, can prepare the material of the variforms such as film forming, gel, microcapsule.

Collagen protein: be a kind of biopolymer is white, transparent powder.Main component in animal connective tissue, be also the functional protein that mammal in-vivo content is maximum, distribution is the widest, account for 25% ~ 30% of total protein, some organism is even up to more than 80%.Collagen protein, because having good biocompatibility, biodegradable and biological activity, therefore obtains in fields such as food, medicine, organizational project, cosmetics and applies widely.

Oleum Ricini: Oleum Ricini is the triglyceride of fatty acid, is present in castor seeds.Character is almost colourless or micro-yellowy clarification thick liquid, Oleum Ricini has good intermiscibility to celluloid, ethyl cellulose, cellulose acetate-butyrate, polyamide, fourth tripolycyanamide (or carbamide) formaldehyde resin, Colophonium, Lac etc., and can be used as plasticizer to use, Oleum Ricini has good stability, colour retention, pliability, pigment-dispersing, wettability, lubricity, low-temperature characteristics, electrical characteristic and biological nature.

Polyvinylpyrrolidine: there is hydrophilic and easily to flow the powder of white or substantial white, have micro-smelly.As thickening agent, dispersion stabilizer and bonding regulator etc. in high molecular polymerization process.There is excellent physiological inertia, do not participate in human metabolism, there is again excellent biocompatibility, any stimulation is not formed to skin, mucosa, eye etc.

Nanometer silver: particle diameter accomplishes nano level argent simple substance.Nanometer silver particle diameter, mostly at 25 ran, has strong suppression and killing action to tens of kinds of pathogenic microorganism such as escherichia coli, gonococcus, chlamydia trachomatiss, and can not produce drug resistance.Have broad-spectrum antiseptic, strong bactericidal, permeability is strong, and reparative regeneration is lastingly antibacterial, the advantages such as safety non-toxic.

Poly hexamethylene biguanide: be a kind of high molecular polymer, there is the ability of extremely strong kill bacteria and virus, the bacteriostasis time is long, to the corrosion-free effect of various metal material, degradable, does not pollute environment, and toxicity is low, the features such as use safety, are widely used in fields such as medicine, culture fishery, leather processing, work domestics use of water.Can be used for the aspects such as textile industry, paper-making industry, wood-processing industry, rubber industry, agricultural, also can as the flocculating agent of sewage disposal.

Propyl p-hydroxybenzoate: have another name called propylparaben, to Para Hydroxy Benzoic Acid propyl ester.Colourless little crystallization or white powder.The main antiseptic being used as food, cosmetics, feedstuff etc.

Radix Et Rhizoma Fagopyri Tatarici: base is former: for polygonaceae plant hardship supports the root and rhizome of wheat.Nature and flavor: sweetness and bitterness are flat.Function cures mainly: treat for stomachache, dyspepsia, dysentery, impairment caused by overstrain, lumbago and skelalgia.

Herba Linderniae Crustaceae: base is former: be the herb of goatweed Herba Linderniae Crustaceae.Nature and flavor: mildly bitter flavor are light, cool in nature.Function cures mainly: clearing away heat-damp and promoting diuresis, promoting blood circulation and stopping pain.Main anemopyretic cold, damp-heat dysentery, oedema due to nephritis, leucorrhea, menoxenia, carbuncle furuncle and phyma poison, venom, traumatic injury.

Folium Citri tangerinae: base is former: be the leaf of the multiple Fructus Citri tangerinae classes such as rutaceae tangerine produced in fujian province or Zhu's Fructus Citri tangerinae.Nature and flavor: toil are flat.Function cures mainly: soothing the liver, and circulation of qi promoting is reduced phlegm, detumescence poison.Control hypochondriac pain, acute mastitis, lung abscess, cough, chest and diaphragm feeling of fullness, hernia.

Fructus Seu Herba Pubescentis: base is former: be the Herb of eggplant kind of plant Fructus Seu Herba Pubescentis.Nature and flavor: bitter, cool.Function cures mainly: heat-clearing and toxic substances removing, antiinflammatory diuretic.Cure mainly cold, fever, parotitis, bronchitis, acute pyelonephritis, orchitis, bubble rash, furuncle, colicky.

Folium seu Radix Fortuneariae Sinensis: base is former: be branch and leaf or the root of Hamamelidaceae Plants Folium seu Radix Fortuneariae Sinensis.Nature and flavor: bitter, puckery are flat.Function cures mainly: QI invigorating, hemostasis.Cure mainly the deficiency of vital energy, knife injury is hemorrhage.

Herba Carpesii Divaricati: base is former: be the herb of feverfew Herba Carpesii Divaricati.Nature and flavor: toil are cool.Function cures mainly: heat-clearing and toxic substances removing.Cure cold, wind syndrome of head, has loose bowels, laryngopharynx swelling and pain, acute conjunctivitis, carbuncle sore tumefacting virus, and blood stasis is hemorrhage.

Folium Nelumbinis: base is former: be the leaf of nymphaeaceae plant lotus.Nature and flavor: bitter are flat.Gui Jing: return liver, spleen, stomach warp.Function cures mainly: clearing away summer-heat, sending up the lucid YANG, cooling blood for hemostasis.For summer-heat excessive thirst, diarrhea due to summer heat and dampness, diarrhea due to hypofunction of the spleen, heat in blood tells nosebleed, metrorrhagia of having blood in stool.Burnt FOLIUM NELUMBINIS astringent therapy removing stasis to stop bleeding.For multiple hemorrhage and puerperal blood faints.

Lindera angustifolia Cheng: base is former: be root or the branch and leaf of canella Ramulus et Folium Linderae Angustifoliae.Nature and flavor: pungent, micro-puckery, temperature.Function cures mainly: expelling wind and removing dampness, relaxing muscles and tendons and activating QI and blood in the collateral, removing toxic substances and promoting subsidence of swelling.For flu, headache, dyspepsia, gastroenteritis, dysentery, rheumatic arthritis, numb, traumatic injury, carbuncle sore tumefacting virus, urticaria, lymphoid tuberculosis.

Herba Agrimoniae: base is former: be the herb of rosaceous plant Agrimony.Nature and flavor: bitter, puckery are flat.Gui Jing: GUIXIN, Liver Channel.Function cures mainly: astringing to arrest bleeding, preventing the attack (or recurrence) of malaria, dysentery relieving, removing toxic substances.For hemoptysis, spit blood, metrostaxis, malaria, dysentery, de-power impairment caused by overstrain, carbuncle sore tumefacting virus, pudendal pruritus leukorrhagia.

Caulis Trachelospermi: base is former: be stem, the leaf of apocynaceae plant trachelospermum jasminoide.Nature and flavor: bitter, are slightly cold.Gui Jing: GUIXIN, liver, kidney channel.Function cures mainly: dispelling wind and removing obstruction in the collateral, and removing heat from blood is subsided a swelling.For beriberoid pyretic arthralgia, the contracture of muscle arteries and veins, soreness of waist and knee joint, sore throat, carbuncle, injury from falling down.

test example 1the basic parameter of gained medical sutures material (embodiment 5) of the present invention and biocompatibility:

1, basic parameter: embodiment 5 products made thereby is 2-0 type I class stitching thread in pharmaceuticals industry standard YY1116-2010 " absorbability surgical sutures ", and its wire range should be 0.350-0.429mm.According to the test method in industry standard, the diameter recording the medical sutures material that the present embodiment obtains is 0.410mm, and single suture tensile strength is 10.5N.

2, biocompatibility test

Subjects: the Wistar rat of healthy adult 40, body weight 220-250g, male and female half and half, and the new zealand white rabbit of healthy adult, about body weight 2.5kg, 10.

Test method: (1) acute systemic toxicity random choose 20 rats, are divided into experimental group and matched group, often organizes 10, record original body mass.To the made suture material of experimental group rats by intraperitoneal injection the present invention homogenate (aseptically, made for the present invention suture material shears is shredded, homogenate becomes suspension, and concentration is 10mg/mL, filters, use physiological saline solution again, concentration is 3mg/mL), matched group injecting normal saline, every rat injection 5ml, respectively at 24h, 48h and weigh for 72 hours after injection, observe and record the state of rat, toxic manifestations and death time and quantity.

Toxic degree classification and corresponding symptom as follows: nontoxic: to have no signs of toxicity; Light: mild, but without hypokinesia, dyspnea or abdominal part stimulate disease; In: abdominal part irritation, dyspnea, hypokinesia, blepharoptosis, diarrhoea, body weight drops to 180-200g usually; Heavy: exhaustion, cyanosis, to tremble, severe abdominal irritation, blepharoptosis, dyspnea, loses weight to below 180g; Dead: namely dead after injection.

In 72h, experimental group reaction is less than matched group and is Pass Test requirement, as experimental group rat have more than two or two to occur in, then this material is defective for severe signs of toxicity or death.

(2) hemolytic test to be taken a blood sample 20ml from new zealand white rabbit, adds heparin sodium and makes anticoagulant Sanguis Leporis seu oryctolagi.Get the made anticoagulant Sanguis Leporis seu oryctolagi of 8ml to add normal saline 10ml and dilute.Test is divided into three groups, experimental group, negative control group and positive controls, often organizes 3 test tubes, respectively to adding the made suture material solution of the present invention in three groups of test tubes, normal saline and adding distil water, each 10ml.Three groups of test tubes are put into the water-bath inside holding of 37 DEG C after 30 minutes, add the Sanguis Leporis seu oryctolagi 0.2ml of dilution, jog mixes the water-bath being placed in 37 DEG C again and is incubated one hour.Pour out each pipe centrifugal 5 minutes, Aspirate supernatant, in cuvette, measures absorbance with spectrophotometer (under 545nm wavelength).Result gets each cell mean, calculates hemolysis rate.

Hemolysis rate=(experimental group absorbance-negative control group absorbance)/(positive controls absorbance-negative control group absorbance) × 100%

(3) wound suture effect gets 20 rats, be divided into experimental group and matched group at random, often organize 10, shave off rat left lumbar before experiment by hair, and the penthiobarbital solution of intravenous injection 2.5% is anaesthetized, fur skin is shaved in sterilization, aseptically cut right side skin and reach abdominal cavity, the made suture material of experimental group rat otch the present invention is sewed up, and control rats otch chromicized catgut is sewed up, and observes wound healing situation every day and record.

Result of the test: 1,24h, 48h and 72h after Acute systemic toxicity injection, rats in test groups body weight slightly increases, there is not death and toxic reaction, with matched group zero difference, illustrate that the made suture material solution of the present invention is negative reaction in acute systemic toxicity, the made suture material safety non-toxic of surperficial the present invention.

2, hemolytic test records experimental group hemolysis rate is 0.84%, meets the hemolysis rate that in pharmaceuticals industry standard YY1116-2010 " absorbability surgical sutures ", 4.7.3 specifies and is not more than 5%.

3, postoperative 1 day of wound suture effect, experimental group rat otch, has no obvious redness, control rats otch, obviously red and swollen, experimental group rat healing in postoperative 3 days is good, do not occur infecting, control rats has 2 routine otch to occur low-grade infection, 15 days after operation, the equal primary healing of experimental group rat, have no sutures breaks phenomenon, control rats 8 primary healings, 2 secondary healing, the made suture material of illustrative experiment group the present invention used can meet the needs that wound surface is sewed up.

The present invention selects the plurality of Chinese plants such as Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Folium Citri tangerinae, Fructus Seu Herba Pubescentis, Folium seu Radix Fortuneariae Sinensis, Herba Carpesii Divaricati, Folium Nelumbinis, Lindera angustifolia Cheng, Herba Agrimoniae, Caulis Trachelospermi, extract wherein effective ingredient, play anti-inflammatory analgetic, removing toxic substances and promoting subsidence of swelling isoreactivity, in conjunction with fibroin and collagen protein, be cross-linked and prepare medical sutures material, make it have good biocompatibility, and fusion has therapeutic Chinese medicine ingredients, non-stimulated to organism safe.

It should be pointed out that detailed description of the invention is the more representational example of the present invention, obvious technical scheme of the present invention is not limited to above-described embodiment, can also have a lot of distortion.Those of ordinary skill in the art, with the present invention clear and definite disclosed or according to undoubted the obtaining of the written description of file, the claimed scope of this patent all should be thought.

Claims (10)

1. medical sutures material, is characterized in that, is prepared from primarily of following raw materials according, be mass parts: fibroin 30-45, collagen protein 55-70, Oleum Ricini 2-6, polyvinylpyrrolidine 10-20, antibacterial 2-8, Radix Et Rhizoma Fagopyri Tatarici 3-6, Herba Linderniae Crustaceae 5-7, Folium Citri tangerinae 4-9, Fructus Seu Herba Pubescentis 6-9, Folium seu Radix Fortuneariae Sinensis 3-5, Herba Carpesii Divaricati 4-10, Folium Nelumbinis 6-9, Lindera angustifolia Cheng 5-8, Herba Agrimoniae 3-6, Caulis Trachelospermi 7-10.

2. medical sutures material as claimed in claim 1, is characterized in that, fibroin 35-40, collagen protein 60-65, Oleum Ricini 3-5, polyvinylpyrrolidine 13-17, antibacterial 4-6, Radix Et Rhizoma Fagopyri Tatarici 4-5, Herba Linderniae Crustaceae 5.5-6.5, Folium Citri tangerinae 5-8, Fructus Seu Herba Pubescentis 7-8, Folium seu Radix Fortuneariae Sinensis 3.5-4.5, Herba Carpesii Divaricati 5-9, Folium Nelumbinis 7-8, Lindera angustifolia Cheng 6-7, Herba Agrimoniae 4-5, Caulis Trachelospermi 8-9.

3. medical sutures material as claimed in claim 1, is characterized in that, fibroin 37.5, collagen protein 62.5, Oleum Ricini 4, polyvinylpyrrolidine 15, antibacterial 5, Radix Et Rhizoma Fagopyri Tatarici 4.5, Herba Linderniae Crustaceae 6, Folium Citri tangerinae 6.5, Fructus Seu Herba Pubescentis 7.5, Folium seu Radix Fortuneariae Sinensis 4, Herba Carpesii Divaricati 7, Folium Nelumbinis 7.5, Lindera angustifolia Cheng 6.5, Herba Agrimoniae 4.5, Caulis Trachelospermi 8.5.

4. medical sutures material as claimed in claim 1, it is characterized in that, described antibacterial is a kind of in nanometer silver, poly hexamethylene biguanide and propyl p-hydroxybenzoate or any two kinds mixture.

5. the preparation method of the medical sutures material as described in as arbitrary in claim 1-3, it is characterized in that, step is:

(1) by Folium Citri tangerinae and Herba Carpesii Divaricati remove impurity, be placed in frying pan and add refined honey water and mix thoroughly, moistening 20 minutes, heating stir-fries, and when frying to dry tack free, spray Chinese liquor, adds a cover stewing, takes out, dries in the air cool;

(2) get Folium seu Radix Fortuneariae Sinensis to clean, be placed in steamer and steam, take out, dry, together pulverize with Folium Nelumbinis and Herba Agrimoniae, make medicated powder, then be placed in frying pan, when slow fire is fried to medicated powder coke yellow, take out, dry in the air cool;

(3) get Lindera angustifolia Cheng roguing, flood taking-up in 4 hours with clear water, clean, evengranular coarse sand is placed in frying pan and is heated to 80 DEG C, add Lindera angustifolia Cheng and stir-fry to have to surface and heave, take out, dry in the air cool, section;

(4) Radix Et Rhizoma Fagopyri Tatarici, Herba Linderniae Crustaceae, Fructus Seu Herba Pubescentis and Caulis Trachelospermi are cleaned, together be placed in penetrating bag with step (1) (2) (3) made raw material, add decocting in water again, big fire takes out penetrating bag after boiling 20-28 minute, obtains medicinal liquid, and penetrating bag adds water and boils, merge twice and decoct gained medicinal liquid, concentrate drying, pulverized 900-1300 mesh sieve, made medicated powder;

(5) fibroin and collagen protein deionized water dissolving are mixed with mixed liquor, again step (4) made medicated powder, Oleum Ricini, polyvinylpyrrolidone and antibacterial are added in mixed liquor, be 100-120 DEG C in temperature, rotating speed is the mastic being stirred to thickness in the reactor of 900-1300 rev/min, by made mastic deaeration, be placed in spray webbing machine, spray webbing, water-bath stretches, and dries, sterilizing, obtains suture material.

6. the preparation method of medical sutures material as claimed in claim 5, is characterized in that, step (1) is added a cover and (preferably, added a cover stewing 7-11 minute in stewing 5-13 minute; Be more preferably, add a cover stewing 9 minutes).

7. the preparation method of medical sutures material as claimed in claim 5, is characterized in that, step (2) is placed in steamer to steam (preferably, steams 17-23 minute in 15-25 minute; Be more preferably, steam 20 minutes).

8. the preparation method of medical sutures material as claimed in claim 5, is characterized in that, step (4) big fire is boiled 22-26 minute (preferred, big fire boils 24 minutes).

9. the preparation method of medical sutures material as claimed in claim 5, is characterized in that, step (4) pulverized 1000-1200 mesh sieve (preferred, to pulverize 1100 mesh sieves).

10. the preparation method of medical sutures material as claimed in claim 5, is characterized in that, step (5) water-bath draft temperature is 20-40 DEG C, and (preferred, water-bath draft temperature is 25-35 DEG C; Be more preferably, water-bath draft temperature is 30 DEG C).