CN105617447A

CN105617447A - Degradable medical suture line and preparation method thereof

Info

Publication number: CN105617447A
Application number: CN201510943364.8A
Authority: CN
Inventors: 不公告发明人
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-12-17
Filing date: 2015-12-17
Publication date: 2016-06-01

Abstract

The invention discloses a degradable medical suture line which is prepared by the following main raw materials in parts by weight: 7-10 parts of red-spotted stonecrop, 10-13 parts of veronicastrum herb, 9-11 parts of black medic herb, 6-9 parts of digua fig root, 4-7 parts of passiflora edulis, 3-7 parts of semen litchi, 12-15 parts of drynaria rhizome, 6-9 parts of bauhinia purpurea, 10-13 parts of thunbergia fragrans, 28-40 parts of polylactic acid and 14-17 parts of silk fibroin. The degradable medical suture line disclosed by the invention has the benefits that all the raw materials can be biologically degraded and completely absorbed in a human body and are free from stimulation on tissues and toxic and side effects; the suture line can effectively promote wound healing, has no apparent stitch trace after wound healing and can satisfy the clinical demands.

Description

Degradable medical stitching thread and preparation method

Technical field

The present invention relates to field of medical materials, particularly relate to a kind of degradable medical stitching thread and preparation method.

Background technology

Operation suture thread is a kind of for wound suture, tissue ligation and fixing aseptic line. Non-biodegradation stitching thread can not be absorbed by organisms, and has tissue reaction in various degree, sews up epidermis especially skin of face meeting scar; And after biodegradable suture degrades in bodily tissue, easily absorbed or drain, it is to avoid secondary operates on the misery caused to patient, decreases the infection chance of wound, and cicatrix is little. Therefore, biodegradable medical suture increasingly causes the attention of people.

In general, desirable degradable stitching thread should possess following basic demand: can carry out disinfection thoroughly; There is certain mechanical performance (such as suitable mechanical strength and ductility, flexibility and elastic recovery, moistening intensity and coefficient of friction etc.); Stitching, knotting operation conveniently, hold knot functional; The intensity of certain time can be kept in vivo, absorbed after wound healing; Bio-compatible, NIP reacts; Stable and reliable product quality, cheap and easy to get, preservation convenience.

The raw material of polylactic acid is the dimer (lactide) of lactic acid or lactic acid, has a chiral carbon in its molecule, has optical activity. The catabolite D-lactic acid of Pfansteihl can be reacted by the complete metabolism of human body, inorganization. PLA forms oligomer by C-O key hydrolysis unstable on main chain, is then degraded to water and carbon dioxide under the effect of enzyme further, by regulating relative molecular mass and its degradation speed of structure-controllable system of PLA. PLA stitching thread biocompatibility is better, soft, easily dye dark color, and hot strength is high, sews up and ties a knot more convenient; Intermediate product lactic acid is also the product of internal normal sugar metabolism, to human non-toxic, without accumulation, is a comparatively ideal medical absorbable suture of analogy.

Application publication number CN104940989A(application number 201510352531.1) Chinese invention patent document disclose a kind of absorbable suture and preparation method thereof, be made up by mass fraction proportioning of following raw material: collagen protein 24-55 part, fibroin 23-56 part, fibroin 12-27 part, sericin 13-23 part, glycolic 12-30 part, lactic acid 11-28 part, PGA 2-14 part, polylactide 6-20 part, poly (glycolide-co-lactide) 4-16 part, sodium carbonate 1-7 part, deionized water 40-65 part. Application publication number CN104940986A(application number 201510308466.2) Chinese invention patent document disclose a kind of stitching thread suitable in Intradermal and preparation method thereof, it is made up of each component of following mass parts: polypropylene 45-63 part, butanediol 17-29 part, glycerol 9-18 part, maleic anhydride 5-21 part, ammonium dihydrogen phosphate 2-11 part, polylactic acid 13-27 part, PGA 2-10 part, 2,6-tri-grades of butyl-4-methylphenol 4-18 parts. Application publication number CN105079868A(application number 201510492433.8) Chinese invention patent document disclose a kind of good absorbable medical suture of the compatibility and preparation method thereof, it is made up of each component of following mass parts: PGA 20-40 part, polydactyl acid 10-20 part, polylactic acid 50-70 part, hyaluronic acid 10-20 part, methyl methacrylate 5-7 part, epoxy soybean oil 4-6 part, tea tree oil 2-4 part, polycaprolactone 1-5 part, calcium stearate 0.1-0.3 part.

In existing absorbable medical suture, degradation time is longer, and degradation rate is low, and model of action is single, limited use in preventing and treating wound infection and promotion wound healing, still can not meet the needs of people, needs to be improved further.

Summary of the invention

In order to make up above-mentioned deficiency, it is an object of the invention to provide a kind of degradable medical stitching thread and preparation method thereof, there is good biocompatibility, degradable can absorb in vivo, body tissue is had no side effect.

The technical scheme is that

Degradable medical stitching thread, it is prepared from by following main materials medicine, it is weight portion: Herba hylotelephii erythrosticti 7-10, Herba veronicastri villosuli 10-13, Herba Medicaginis Lupulinae 9-11, Radix Fici tikouae 6-9, Herba Passiflorae Caeruleae 4-7, Semen Litchi 3-7, Rhizoma Drynariae 12-15, Bauhinia purpurea 6-9, Thunbergia fragrans Roxb. 10-13, polylactic acid 28-40; Fibroin albumen 14-17.

In preferred scheme: Herba hylotelephii erythrosticti 8-9, Herba veronicastri villosuli 11-12, Herba Medicaginis Lupulinae 9.5-10.5, Radix Fici tikouae 7-8, Herba Passiflorae Caeruleae 5-6, Semen Litchi 4-6, Rhizoma Drynariae 13-14, Bauhinia purpurea 7-8, Thunbergia fragrans Roxb. 11-12, polylactic acid 32-36; Fibroin albumen 15-16.

More preferably: Herba hylotelephii erythrosticti 8.5, Herba veronicastri villosuli 11.5, Herba Medicaginis Lupulinae 10, Radix Fici tikouae 7.5, Herba Passiflorae Caeruleae 5.5, Semen Litchi 5, Rhizoma Drynariae 13.5, Bauhinia purpurea 7.5, Thunbergia fragrans Roxb. 11.5, polylactic acid 34; Fibroin albumen 15.5.

The preparation method of degradable medical stitching thread, it is characterised in that step is as follows:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add shao-hsing rice wine, slow fire boiling 20-44 minute (preferred slow fire boiling 24-40 minute), filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 10-20 minute (preferred vexed 13-17 minute), put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) crude drug after step (2) process and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier in 60-75 DEG C fully dry (being preferable over 65-70 DEG C fully to dry), are ground into fine powder, sieve, obtain fine powder, standby;

(4) dripping dichloromethane in polylactic acid to just dissolving, step (3) gained fine powder mixes, and adds fibroin albumen, stabilizer and Biological cross-linker, after mixing, is placed in reactor and is warming up to 100 DEG C dries, blended, makes granule, standby;

(5) it is placed on spinning-drawing machine by step (4) gained granule melt spinning, makes the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection, encapsulation, to obtain final product.

The preparation method of above-mentioned degradable medical stitching thread, preferred scheme is, in step (1), the amount of shao-hsing rice wine is described raw material dose 1.0-1.6 times (amount of preferred shao-hsing rice wine is 1.2-1.4 times of described raw material dose, it is more preferable to measuring of shao-hsing rice wine be 1.3 times of described raw material dose).

The preparation method of above-mentioned degradable medical stitching thread, it is preferred that scheme is, step (3) is crossed 45-75 mesh sieve (preferred cross 55-65 mesh sieve, it is more preferable to mistake 60 mesh sieve).

The preparation method of above-mentioned degradable medical stitching thread, preferred scheme is, stabilizer described in step (4) is mass fraction be 0.18%-0.24% lignin (preferred described stabilizer is mass fraction is the lignin of 0.20%-0.22%, it is more preferable to described stabilizer be mass fraction be the lignin of 0.21%).

The preparation method of above-mentioned degradable medical stitching thread, preferred scheme is, Biological cross-linker described in step (1) is mass fraction be 0.2%-0.4% genipin (preferred described Biological cross-linker is mass fraction is the genipin of 0.25%-0.35%, it is more preferable to described Biological cross-linker be mass fraction be the genipin of 0.3%).

The preparation method of above-mentioned degradable medical stitching thread, it is preferred that scheme is, the time dry in (4) in step (1) be 2-5 hour (the preferred dry time is 3-4 hour, it is more preferable to the dry time be 3.5 hours).

The preparation method of above-mentioned degradable medical stitching thread, it is preferred that scheme is, in step (1) temperature of melt spinning be 170-200 DEG C (temperature of preferred melt spinning is 180-190 DEG C, it is more preferable to the temperature of melt spinning be 185 DEG C).

Effect and the physicochemical property of each raw material components are respectively as follows:

Herba hylotelephii erythrosticti: base: for the herb of Herba hylotelephii erythrosticti kind of plant Herba hylotelephii erythrosticti. Chemical analysis: get sedoheptose in leaf. Nature and flavor: picric acid, cold. Gui Jing: 1. " book on Chinese herbal medicine must be joined ": " enter meridian of Hand-SHAO YIN. " 2. " book on Chinese herbal medicine is new again ": " enter Liver Channel. " function cures mainly: heat clearing away, removing toxic substances, hemostasis. Control erysipelas, urticaria, dysphoria with smothery sensation mania and irritation, spitting of blood, haematemesis, treat skin ulcer, toxic swelling, rubella, dermatitis rhus, the puckery pain of conjunctival congestion, traumatic hemorrhage.

Herba veronicastri villosuli: base: for stem and leaf or the root of the raw Herba veronicastri villosuli of goatweed axil or Herba veronicastri villosuli. Chemical analysis: containing sterol, mannitol, tannin, resin, saccharide, inorganic salt etc. Pharmacological action: the 1. effect to Schistosoma japonicum: Herba veronicastri villosuli (kind is not identified) experiment in vitro, can make polypide all dead through more than 40 minutes. But to experimental white mice, rabbit, dog schistosomicide, continuously treatment 2 months, not can prove that it has bilharzial effect in animal body of killing. 2. the impact on gastrointestinal tract and urinary system amount: normal person is administered orally Herba veronicastri villosuli 5��10 grams, and in 1��4 hour, urine volume slightly increases, the significant minimizing of urine volume after 4 hours, oxide excretion situation is similar to urine volume; Namely feel dizzy after taking medicine, Nausea and vomiting after about 1 hour, 4 hours postabdomen angor, diarrhoea, recovered gradually after 8 hours, dog is oral and vomiting all occurs in intramuscular injection, and illustrating that Herba veronicastri villosuli causes vomiting is central action after absorption. Therefore Herba veronicastri villosuli disappears the effect of Xu's ascites, is reach to get rid of internal liquid by fierce telling, rush down, not diuresis. Nature and flavor: 1. " detailed outline is picked up any lost article from the road ": " cold in nature. " 2. " east, Fujian book on Chinese herbal medicine ": " acrid in the mouth is bitter, cold nature. " return through " east, Fujian book on Chinese herbal medicine ": " enter liver, lung, kidney three warp. " function cures mainly: row water, dissipating blood stasis, detumescence, removing toxic substances. Harness the river swollen, dysuria, hepatitis, menoxenia, treat carbuncle sore and swell, traumatic injury, burn.

Herba Medicaginis Lupulinae: base: for the herb of leguminous plant shamrock. Chemical analysis: herb is containing estrogen-like composition. Seed is containing Saponin, galactose. Root and in spending containing multiple Saponin, as the hydrolysis of medicagenic acid glycoside obtains medicagenic acid, hederagenin and people bean soap alcohol B, C, D, E, F etc. 4 kinds of triterpenoid saponin, i.e. soyasaponinss, hederagenin-3-O-��-D-glucopyanoside, medicagenic acid-3-O-��-D-glucopyanoside and medicagenic acid-3 are got again subsequently, the double; two glucopyanoside of 28-from root. Hua Zhongshang contains flavone compound: larix sibirica flavone and its 5 '-O-��-D-Glucose glycoside, 3,5 '-O-��-D-diglucosides, 3,7,5 '-O-��-D-tri-glucose glycosides, the glycoside of nimbecetin, Quercetin and myricetin-3-O-glucoside. Aerial parts is containing carotene, vitamin C, vitamin B1, vitamin B2, pyridoxol, pantothenic acid and nicotinic acid. Nature and flavor: sweet; Bitter; Micro-puckery; Cool in nature; Mild toxicity. Gui Jing: lung; Liver; Gallbladder; Kidney channel. Function cures mainly: clearing away heat-damp and promoting diuresis; Relaxing muscles and tendons and activating QI and blood in the collateral; Relieving cough and asthma; Removing pathogenic heat from blood and toxic substance from the body. Main jaundice due to damp-heat; Pyretic stranguria; Stone jaundice due to damp-heat; Pyretic stranguria; Stranguria caused by urinary stone; Rheumatic arthralgia; Cough with asthma; Hemorrhoidal bleeding; Finger furuncle; Venom.

Radix Fici tikouae: base: for the root of moraceae plants Radix Pachyrhizi Erosi banyan. Nature and flavor: bitter; Puckery; Cool in nature. Gui Jing: spleen; Kidney channel. Function cures mainly: clearing away heat-damp and promoting diuresis; Reducing swelling and alleviating pain. Master has loose bowels; Dysentery; General edema with yellowish skin; Rheumatic arthralgia; Seminal emission; Carry; Scrofula; Hemorrhoid; Toothache; Traumatic pain.

Herba Passiflorae Caeruleae: base: for the herb of Passifloraceae plant Herba Passiflorae Caeruleae. Chemical analysis: containing chrysin, benzodiazepine compounds, New Zealand's Passiflora edulis sims cyanogen glycoside B-4-sulfuric ester, leaf is containing flavonoid glycoside, diphenol Huang cave pigment, the one common ketone glycoside of phenol, the herb C-glucosan derivative containing apigenin and luteolin, wherein there is vitexin, lead orientin, the double; two glycoside of apigenin-8-C-. Also containing lipoid, containing Jiao's property catechol, gallic acid, Palmic acid, myristic acid sitosterol, glucose etc. in flower and fruit ear. Nature and flavor: bitter in the mouth; Warm in nature. Function cures mainly: except wind; Dehumidifying; Invigorate blood circulation; Pain relieving. Main headache due to common cold; Nasal obstruction watery nasal discharge; Rheumatic arthritis; Dysmenorrhea; Neuralgia; Lose eye; Dysentery; Fracture.

Semen Litchi: base: for the seed of sapindaceous plant Fructus Litchi. Chemical analysis: seed is containing Saponin 1.12%, tannin 3.43%. Again containing ��-(methylene cyclopropyl) glycine. As given hunger the mouse subcutaneous injection (60-400 mg/kg) of 22 hours this thing, blood glucose can being made to decline, liver glycogen content is significant reduction also. Nature and flavor: sweet puckery, temperature. Gui Jing: enter liver, kidney channel. Function cures mainly: warming middle-JIAO, regulates the flow of vital energy, pain relieving. Control gastric abscess, colicky, women's pricking caused by the stagnation of QI and blood.

Rhizoma Drynariae: base: for the rhizome of Plants of Polypodiaceae Mongolian oak Herba pteridii latiusculi, drynaria baronii Diels, Drynaria propinqua, precipice Rhizoma Zingiberis Recens, bright close net Herba pteridii latiusculi and Davalliaceae plant great Ye Rhizoma Drynariae, Rhizoma Drynariae etc. Chemical analysis: Drynaria fortunei(Kunze) J.Smith rhizome starch-containing 16. 4%, glucose 5. 37%, also containing naringin. Nature and flavor: bitter, temperature. Gui Jing: enter liver, kidney channel. Function cures mainly: the kidney invigorating, invigorates blood circulation, hemostasis. Control suffer from a deficiency of the kidney chronic diarrhea and lumbago, rheumatic arthralgia, toothache, tinnitus, traumatic injury sprain and contusion, bone injury, appendicitis, alopecia areata, clavus.

Bauhinia purpurea: base: pulse family bauhinia Bauhinia purpurea, is used as medicine with root. Nature and flavor: micro-puckery are micro-cool. Function cures mainly: hemostasis, spleen invigorating. For spitting blood, dyspepsia.

Thunbergia fragrans Roxb.: base: for the stem and leaf of acanthaceous plant Thunbergia fragrans Roxb.. Nature and flavor: acrid in the mouth; Micro-acid; Property is put down. Function cures mainly: invigorating the stomach and promoting digestion; Removing toxic substances and promoting subsidence of swelling. Main dyspepsia; Abdominal distention; Diarrhoea; Carbuncle furuncle.

Polylactic acid: being be polymerized, with lactic acid, the polymer obtained for primary raw material, raw material sources fully and can regenerate. The production process of polylactic acid is pollution-free, and product can biodegradation, it is achieved the circulation in nature, is therefore desirable Green Polymer Material. Polylactic acid (H-[OCHCH₃CO] n-OH) Heat stability is good, processing temperature 170-230 DEG C, the solvent resistance having had, available various ways is processed, such as extruding, spinning, biaxial stretch-formed, injection-blow molding. Outside the product decapacitation biodegradation being made up of polylactic acid, biocompatibility, glossiness, the transparency, feel and heat-resist, also there is certain antibiotic property, anti-flammability and ultraviolet-resistent property, therefore purposes is very extensive, can be used as packaging material, fiber and non-woven fabric etc., be mainly used in the fields such as clothing (underwear, coat), industry (building, agricultural, forestry, papermaking) and health care.

Fibroin albumen: be the natural polymer fibrin extracted from silkworm silk, content accounts for the 70%��80% of silkworm silk, containing 18 seed amino acids, wherein glycine (Gly), alanine (Ala) and serine (Ser) account for more than the 80% of total composition. Fibroin itself has good mechanical performance and physicochemical property, such as good pliability and tensile strength, breathable moisture permeability, slow-releasing etc., and can obtain different forms through different disposal, such as fiber, solution, powder, film and gel etc. Fibroin albumen has good biocompatibility, the material of the variforms such as film forming, gel, microcapsule can be prepared, physicochemical property due to its uniqueness, fibroin material is studied widely in field of biomedical materials, such as immobilized enzyme material, cell culture substrate, medicinal slow release agent, artificial organ etc.

Degradable medical stitching thread scientific formula provided by the invention, preparation method is simple, easy to use. In addition, the excellent results of the present invention is also manifested by:

1, polylactic acid is combined by the present invention with other Chinese medicine raw material, scientific formulation, and gained stitching thread intensity is high, pliability is good, has good tensile strength and knot strength;

2, all raw materials of the present invention all can biodegradation in vivo, can fully absorb in vivo, to tissue non-stimulated, have no side effect;

3, inventive suture can be effectively facilitated the healing of wound, and without obvious stitch vestige after wound healing, it is possible to meet clinical needs.

Detailed description of the invention

Describe technical scheme in detail below in conjunction with embodiment and experimental example, but protection domain is not by this restriction.

Embodiment 1 degradable medical stitching thread, is prepared from by following main materials medicine, is weight portion (35g/ part): Herba hylotelephii erythrosticti 7 parts; Herba veronicastri villosuli 10 parts; Herba Medicaginis Lupulinae 9 parts; Radix Fici tikouae 6 parts; Herba Passiflorae Caeruleae 4 parts; Semen Litchi 3 parts; Rhizoma Drynariae 12 parts; Bauhinia purpurea 6 parts; Thunbergia fragrans Roxb. 10 parts; Polylactic acid 28 parts; Fibroin albumen 14 parts.

The preparation method of degradable medical stitching thread is:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add the shao-hsing rice wine of 1.0 times of described raw material doses, slow fire boiling 20 minutes, filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 10 minutes, put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) it is fully dry in 60 DEG C that the crude drug after step (2) being processed and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier, is ground into fine powder, crosses 45 mesh sieves, obtains fine powder, standby;

(4) in polylactic acid, dichloromethane is dripped to just dissolving, step (3) gained fine powder mixes, add fibroin albumen, stabilizer (described stabilizer is mass fraction is the lignin of 0.18%) and Biological cross-linker (described Biological cross-linker is mass fraction is the genipin of 0.2%), after mixing, it is placed in reactor and is warming up to 100 DEG C dry 2 hours, blended, make granule, standby;

(5) step (4) gained granule is placed on spinning-drawing machine in 170 DEG C of melt spinnings, makes the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection, encapsulation, to obtain final product.

The using method of gained suture of the present invention is: be suitable for the various surgery stitching operations of humans and animals, after having sewed up, it is not necessary to take out, can degradable, absorption in vivo.

Embodiment 2 degradable medical stitching thread, is prepared from by following main materials medicine, is weight portion (15g/ part): Herba hylotelephii erythrosticti 10 parts; Herba veronicastri villosuli 13 parts; Herba Medicaginis Lupulinae 11 parts; Radix Fici tikouae 9 parts; Herba Passiflorae Caeruleae 7 parts; Semen Litchi 7 parts; Rhizoma Drynariae 15 parts; Bauhinia purpurea 9 parts; Thunbergia fragrans Roxb. 13 parts; Polylactic acid 40 parts; Fibroin albumen 17 parts.

The preparation method of degradable medical stitching thread is:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add the shao-hsing rice wine of 1.6 times of described raw material doses, slow fire boiling 44 minutes, filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 20 minutes, put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) it is fully dry in 75 DEG C that the crude drug after step (2) being processed and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier, is ground into fine powder, crosses 75 mesh sieves, obtains fine powder, standby;

(4) in polylactic acid, dichloromethane is dripped to just dissolving, step (3) gained fine powder mixes, add fibroin albumen, stabilizer (described stabilizer is mass fraction is the lignin of 0.24%) and Biological cross-linker (described Biological cross-linker is mass fraction is the genipin of 0.4%), after mixing, it is placed in reactor and is warming up to 100 DEG C dry 5 hours, blended, make granule, standby;

(5) step (4) gained granule is placed on spinning-drawing machine in 200 DEG C of melt spinnings, makes the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection, encapsulation, to obtain final product.

Typical case one: grandson XX, female, 22 years old, student. There is epigastrium paroxysmal dull pain without obvious inducement when upper self-study at night on November 16th, 2012 in patient, companion's Nausea and vomiting symptom, check to school infirmary, give anti-inflammation drugs treatment, after taking medicine two hours, patients symptomatic has no and alleviates, and right lower abdomen is planted in stomachache transfer, abdominal distention is obvious, is sent to me by teacher on duty and classmate and institute treats. Checking: patient has heating paresthesia that hypogastric region pressing pain is attached most importance to Right Lower Abdomen, abdominal paracentesis has a small amount of suppurative liquid, and the visible midriff of X-ray examination has two little air fluid levels. Diagnosis is acute appendicitis. Carry out excision vermiform appendix. During stitching, agree to use the present embodiment gained degradable medical stitching thread to sew up through the patient head of a family, after having sewed up, notify that family long band patient regularly arrives examination in hospital. After one week, observing suture wound without obvious redness, infect sign, wound is without obvious pain, recovering good, after two weeks, observe wound and substantially recover, suture is without pruritis, after one month, wound recovers completely, and stitching thread basic absorption in vivo is complete, and patient is without any discomfort.

Embodiment 3 degradable medical stitching thread, is prepared from by following main materials medicine, is weight portion (30g/ part): Herba hylotelephii erythrosticti 8 parts; Herba veronicastri villosuli 11 parts; Herba Medicaginis Lupulinae 9.5 parts; Radix Fici tikouae 7 parts; Herba Passiflorae Caeruleae 5 parts; Semen Litchi 4 parts; Rhizoma Drynariae 13 parts; Bauhinia purpurea 7 parts; Thunbergia fragrans Roxb. 11 parts; Polylactic acid 32 parts; Fibroin albumen 15 parts.

The preparation method of degradable medical stitching thread is:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add the shao-hsing rice wine of 1.2 times of described raw material doses, slow fire boiling 24 minutes, filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 13 minutes, put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) it is fully dry in 65 DEG C that the crude drug after step (2) being processed and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier, is ground into fine powder, crosses 55 mesh sieves, obtains fine powder, standby;

(4) in polylactic acid, dichloromethane is dripped to just dissolving, step (3) gained fine powder mixes, add fibroin albumen, stabilizer (described stabilizer is mass fraction is the lignin of 0.20%) and Biological cross-linker (described Biological cross-linker is mass fraction is the genipin of 0.25%), after mixing, it is placed in reactor and is warming up to 100 DEG C dry 3 hours, blended, make granule, standby;

(5) step (4) gained granule is placed on spinning-drawing machine in 180 DEG C of melt spinnings, makes the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection, encapsulation, to obtain final product.

Embodiment 4 degradable medical stitching thread, is prepared from by following main materials medicine, is weight portion (20g/ part): Herba hylotelephii erythrosticti 9 parts; Herba veronicastri villosuli 12 parts; Herba Medicaginis Lupulinae 10.5 parts; Radix Fici tikouae 8 parts; Herba Passiflorae Caeruleae 6 parts; Semen Litchi 6 parts; Rhizoma Drynariae 14 parts; Bauhinia purpurea 8 parts; Thunbergia fragrans Roxb. 12 parts; Polylactic acid 36 parts; Fibroin albumen 16 parts.

The preparation method of degradable medical stitching thread is:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add the shao-hsing rice wine of 1.4 times of described raw material doses, slow fire boiling 40 minutes, filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 17 minutes, put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) it is fully dry in 70 DEG C that the crude drug after step (2) being processed and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier, is ground into fine powder, crosses 65 mesh sieves, obtains fine powder, standby;

(4) in polylactic acid, dichloromethane is dripped to just dissolving, step (3) gained fine powder mixes, add fibroin albumen, stabilizer (described stabilizer is mass fraction is the lignin of 0.22%) and Biological cross-linker (described Biological cross-linker is mass fraction is the genipin of 0.35%), after mixing, it is placed in reactor and is warming up to 100 DEG C dry 4 hours, blended, make granule, standby;

(5) step (4) gained granule is placed on spinning-drawing machine in 190 DEG C of melt spinnings, makes the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection, encapsulation, to obtain final product.

Typical case two: Song XX, female, 27 years old, professional. Patient's readme: repeatedly occur lump and pain without obvious inducement at axillary fossa at the beginning of 2014 3 months, sometimes also with heating paresthesia, after using antibiotic therapy, symptom substantially alleviates. But soon, above-mentioned symptom recurs, and increases rapidly due to Diagnosis and the persistent symptom of hyperpyrexia occurs, come my institute on May 3rd, 2014 and check treatment. Check that diagnosis is scorching for bilateral subtropics vortex. After anti-inflammatory treatment, symptom is improved, and for preventing disease relapse and thoroughly eliminating symptom, agrees to carry out subtropics vortex excision through patient. Operation process make good progress, and uses the present embodiment gained degradable medical stitching thread to sew up during stitching, after patient discharge, exhorts that regularly my institute checks. After 7 days, patient wound, without obvious redness, infects sign, and wound is without obvious pain, recovering good, after two weeks, observe wound and substantially recover, suture is without pruritis, after one month, wound recovers completely, and stitching thread basic absorption in vivo is complete, and patient is without any discomfort.

Embodiment 5 degradable medical stitching thread, is prepared from by following main materials medicine, is weight portion (25g/ part): Herba hylotelephii erythrosticti 8.5 parts; Herba veronicastri villosuli 11.5 parts; Herba Medicaginis Lupulinae 10 parts; Radix Fici tikouae 7.5 parts; Herba Passiflorae Caeruleae 5.5 parts; Semen Litchi 5 parts; Rhizoma Drynariae 13.5 parts; Bauhinia purpurea 7.5 parts; Thunbergia fragrans Roxb. 11.5 parts; Polylactic acid 34 parts; Fibroin albumen 15.5 parts.

The preparation method of degradable medical stitching thread is:

(1) Herba hylotelephii erythrosticti and Herba veronicastri villosuli mixing, add the shao-hsing rice wine of 1.3 times of described raw material doses, slow fire boiling 32 minutes, filter, and filtrate is standby;

(2) adding Semen Litchi, Radix Fici tikouae, Bauhinia purpurea and Rhizoma Drynariae in above-mentioned filtrate, mix thoroughly, vexed 15 minutes, put in steamer, water proof boils and is sucked to filtrate, takes out, standby;

(3) it is fully dry in 68 DEG C that the crude drug after step (2) being processed and Herba Medicaginis Lupulinae, Herba Passiflorae Caeruleae and Thunbergia fragrans Roxb. are together placed in air drier, is ground into fine powder, crosses 60 mesh sieves, obtains fine powder, standby;

(4) in polylactic acid, dichloromethane is dripped to just dissolving, step (3) gained fine powder mixes, add fibroin albumen, stabilizer (described stabilizer is mass fraction is the lignin of 0.21%) and Biological cross-linker (described Biological cross-linker is mass fraction is the genipin of 0.3%), after mixing, it is placed in reactor and is warming up to 100 DEG C dry 3.5 hours, blended, make granule, standby;

(5) step (4) gained granule is placed in spinning-drawing machine (model: LHFJ030 type FDY spinning-drawing machine; purchase in without Textile Machinery Co., Ltd of China of Ceylon) in 185 DEG C of melt spinnings, make the stitching thread of various model, ethylene oxide sterilizing under nitrogen protection; encapsulation, to obtain final product.

The experimental study of experimental example gained degradable medical stitching thread (embodiment 5) of the present invention:

1, the Study on biocompatibility of suture of the present invention

The pretreatment of 1.1 samples

The preparation of gained suture solution of the present invention: aseptically, suture shredded, make homogenate, takes Partial filtration and is dissolved in normal saline, and mass concentration is 5mg/mL.

1.2 test methods

Selecting 10 skins without the White Rabbit of any disease and damage, body weight, at about 2.5kg, is divided into two groups, back shaving, respectively shaving district intradermal injection suture solution of the present invention on the left of 10 White Rabbits, and every injection 1g, as experimental group. Selecting shaving district injecting normal saline on the right side of 5 White Rabbits, every injection 1g, as negative control group. The ethanol normal saline of shaving district injection 15% on the right side of other 5 White Rabbits, every injection 1g, as positive controls. After injection 1h, 1d, 2d, 3d, observe whether injection site has redness, hydrops etc. to stimulate phenomenon.

1.3 result of the tests

Skin Irritation Test result is as shown in table 1.

Table 1 Skin Irritation Test result (only)

As shown in Table 1, negative control group White Rabbit skin of back is without bad phenomenon such as congested, red and swollen and hydrops; Positive controls White Rabbit skin of back has 3 redness occur after injection 1h, and 5 hydrops phenomenon occur, and to 3d, above-mentioned bad phenomenon disappears. And use the experimental group of suture solution of the present invention, at day part all without untoward reaction such as redness, hydrops, it was shown that degradable medical stitching thread of the present invention has good histocompatibility.

2, Degrading experiment

2.1 subjects and pretreatment

Taking 40 healthy White Rabbits, body weight, at more than 2kg, is equally divided into two groups, experimental group and matched group. White Rabbit is fixed on operating-table, scrapes off abdominal part fine hair, according to a conventional method White Rabbit is anaesthetized, and operative region is carried out routine disinfection.

2.2 test methods

White Rabbit skin of abdomen, peritoneum, muscle layer is successively cut by surgical operation, stomach, small intestinal are taken out from abdominal cavity, it is about the otch of 5cm, sews up by a kind of suture (experimental group) promoting wound healing of gained of the present invention and medical catgut (purchasing in Shanghai Dinghua Medical Instruments Co., Ltd) respectively. Skin incision suture gauze applies, fixing, sub-cage rearing. White Rabbit, eye split zygonema implant site, the tension force degraded of stitching thread and absorbing state is slaughtered when 10d, 20d, 30d, 50d, 70d and 90d.

2.3 result of the tests

Result of study shows, when 10d, medical sutures line tension of the present invention is degraded to about the 55% of raw material; Suture deliquescing of the present invention, rough coat during 20d, tarnishing, tension force continues to reduce; When the 30th day, suture of the present invention lost tension force gradually, met organization healing physiological requirement. Matched group tension force when the 30th day is degraded to original about 70%, also corresponds to organization healing physiological requirement. And compared with matched group, the vivo degradation performance of suture of the present invention is substantially better than matched group.

Finally it should be noted that, embodiment is the detailed description of the invention that the present invention is optimum, it is not limited to the present invention, although the present invention being described in detail with reference to previous embodiment, for a person skilled in the art, technical scheme described in foregoing embodiments still can be modified by it, or wherein portion of techniques feature carries out equivalent replacement. All within the spirit and principles in the present invention, any amendment of making, equivalent replacement, improvement etc., should be included within protection scope of the present invention.

Claims

1. degradable medical stitching thread, it is characterised in that be prepared from by following main materials medicine, be weight portion: Herba hylotelephii erythrosticti 7-10; Herba veronicastri villosuli 10-13; Herba Medicaginis Lupulinae 9-11; Radix Fici tikouae 6-9; Herba Passiflorae Caeruleae 4-7; Semen Litchi 3-7; Rhizoma Drynariae 12-15; Bauhinia purpurea 6-9; Thunbergia fragrans Roxb. 10-13; Polylactic acid 28-40; Fibroin albumen 14-17.

2. degradable medical stitching thread as claimed in claim 1, it is characterised in that be prepared from by following main materials medicine, be weight portion: Herba hylotelephii erythrosticti 8-9; Herba veronicastri villosuli 11-12; Herba Medicaginis Lupulinae 9.5-10.5; Radix Fici tikouae 7-8; Herba Passiflorae Caeruleae 5-6; Semen Litchi 4-6; Rhizoma Drynariae 13-14; Bauhinia purpurea 7-8; Thunbergia fragrans Roxb. 11-12; Polylactic acid 32-36; Fibroin albumen 15-16.

3. degradable medical stitching thread as claimed in claim 1, it is characterised in that be prepared from by following main materials medicine, be weight portion: Herba hylotelephii erythrosticti 8.5; Herba veronicastri villosuli 11.5; Herba Medicaginis Lupulinae 10; Radix Fici tikouae 7.5; Herba Passiflorae Caeruleae 5.5; Semen Litchi 5; Rhizoma Drynariae 13.5; Bauhinia purpurea 7.5; Thunbergia fragrans Roxb. 11.5; Polylactic acid 34; Fibroin albumen 15.5.

4. the preparation method of the degradable medical stitching thread as described in as arbitrary in claim 1-3, it is characterised in that step is as follows:

5. the preparation method of degradable medical stitching thread according to claim 4, it is characterized in that, in step (1), the amount of shao-hsing rice wine is described raw material dose 1.0-1.6 times (amount of preferred shao-hsing rice wine is 1.2-1.4 times of described raw material dose, it is more preferable to measuring of shao-hsing rice wine be 1.3 times of described raw material dose).

6. the preparation method of degradable medical stitching thread according to claim 4, it is characterised in that step (3) is crossed 45-75 mesh sieve (preferred cross 55-65 mesh sieve, it is more preferable to mistake 60 mesh sieve).

7. the preparation method of degradable medical stitching thread according to claim 4, it is characterized in that, stabilizer described in step (4) is mass fraction be 0.18%-0.24% lignin (preferred described stabilizer is mass fraction is the lignin of 0.20%-0.22%, it is more preferable to described stabilizer be mass fraction be the lignin of 0.21%).

8. the preparation method of degradable medical stitching thread according to claim 4, it is characterized in that, Biological cross-linker described in step (1) is mass fraction be 0.2%-0.4% genipin (preferred described Biological cross-linker is mass fraction is the genipin of 0.25%-0.35%, it is more preferable to described Biological cross-linker be mass fraction be the genipin of 0.3%).

9. the preparation method of degradable medical stitching thread according to claim 4, it is characterised in that the time dry in (4) in step (1) be 2-5 hour (the preferred dry time is 3-4 hour, it is more preferable to the dry time be 3.5 hours).

10. the preparation method of degradable medical stitching thread according to claim 4, it is characterized in that, in step (1) temperature of melt spinning be 170-200 DEG C (temperature of preferred melt spinning is 180-190 DEG C, it is more preferable to the temperature of melt spinning be 185 DEG C).