CN105288706A - Rapid bleeding-stopping dressing for department of gynaecology and obstetrics and preparation method of rapid bleeding-stopping dressing - Google Patents
Rapid bleeding-stopping dressing for department of gynaecology and obstetrics and preparation method of rapid bleeding-stopping dressing Download PDFInfo
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Abstract
The invention belongs to the field of medical materials for the department of gynaecology and obstetrics, in particular relates to rapid bleeding-stopping dressing for the department of gynaecology and obstetrics, and further discloses a preparation method of the rapid bleeding-stopping dressing. The rapid bleeding-stopping dressing is prepared by taking carboxymethyl chitosan, sodium carboxymethylcellulose, collagen, radix notoginseng and polyving akohol as raw materials, and the form of firstly foaming and then carrying out freeze drying in the gradient form is adopted in the preparation process; compared with the product obtained by the conventional single freeze drying form in the prior art, the prepared bleeding-stopping dressing has the advantages that on the aspects of absorption and bleeding stopping effects, the technical effect of absorbing blood is greatly promoted; the rapid bleeding-stopping dressing has the optimal bleeding stopping effect for the rapid haemorrhagic disease, can realize stopping bleeding within short time, and can be applicable to the emergency treatment for the acute excessive bleeding of the department of gynaecology and obstetrics.
Description
Technical field
The invention belongs to Gynecological medical Material Field, be specifically related to a kind of obstetrics and gynecology department quick hemostatic dressing, and disclose its preparation method further.
Background technology
Clinical medicine data show, and human body does not take effective emergency treatment because of acute hemorrhage, and patient will be dead in 6-20 minute.If human body is lost blood, namely 20% (be grown up about 800cc) exceeding whole body blood volume suffer a shock; Namely 40% (be grown up about 1600cc) exceeding whole body blood volume if lose blood be at death's door.According to statistics, died of wounds number accounts for 10% of total death toll, and the 30%-40% causing death and account for wherein that wherein bleeds profusely, therefore, early stage Bleeding control is the main method reducing mortality rate.
The hemorrhage clinical principal element causing malpractice especially of department of obstetrics and gynecology, also be the main cause causing hemorrhagic shock, because blood capillary groundwater increment sharply declines, effective circulating blood volume falls sharply, cause important vital organ functional disorder, histoorgan anoxia and hypoperfusion, electrolyte disturbance, peripheral circulation exhaustion etc. are the pathological syndrome of feature, the key for the treatment of is timely hemostasis, and supplement effective circulating load enough fast, make blood pressure go up rapidly at short notice, patient just can be made to pull through.
At present, the dressing for the clinical massive hemorrhage of department of obstetrics and gynecology is various in style, and this novel biomaterial of bleeding-stopping dressing many uses chitosan of latest development is hemostasis main body.Described bleeding-stopping dressing not only has biocompatibility and biodegradability, and aboundresources, is applied in bleeding-stopping dressing, has the functions such as antibacterial, antiinflammatory, hemostasis, analgesia, promotion wound healing.Such as, Chinese patent literature CN101450223A discloses a kind of hemostatic material based on chitosan, collagen protein and sodium carboxymethyl cellulose, wherein, sodium carboxymethyl cellulose has the effect alleviating postoperative peritoneal adhesions degree, wound tissue liquid can be controlled ooze out, promote wound surface quickly-healing, good haemostatic effect can be played to generality is hemorrhage, there is good biocompatibility, less to the side effect of human body generation when using during wound healing.
Research display, current most quick hemostatic dressing is all utilize foaming technique to prepare, the bleeding-stopping dressing of loose structure is obtained again by Freeze Drying Technique, the anthemorrhagic speed of the bleeding-stopping dressing prepared by the method and hemostasis amount have been had and have significantly promoted, substantially the situation of general operation acute hemorrhage or operative hemorrhage can be met, but during quick, a large amount of hemostasis demand for obstetrics and gynecology operation acute massive hemorrhage, it still cannot meet the requirement of emergent management.
Summary of the invention
For this reason, technical problem to be solved by this invention is that in prior art, bleeding-stopping dressing cannot meet the problem of obstetrics and gynecology operation hemostasis requirement, and then provides a kind of quick hemostatic dressing being applicable to department of obstetrics and gynecology and using, and discloses its preparation method further.
For solving the problems of the technologies described above, the method preparing obstetrics and gynecology department quick hemostatic dressing of the present invention, comprises the steps:
(1) batch mixing: get the Radix Notoginseng after pulverizing and add water boil extraction, and water extract is concentrated into extractum, obtain Radix Notoginseng extract, for subsequent use;
(2) get carboxymethyl chitosan 40-120 weight portion, sodium carboxymethyl cellulose 10-25 weight portion, collagen protein 20-60 weight portion, Radix Notoginseng extract 30-80 weight portion, polyvinyl alcohol 10-20 weight portion, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 150-250 DEG C is carried out foamable process;
(4) by the raw material after foaming process, carry out lyophilization process under vacuum, control temperature-40 ~-50 DEG C of lyophilization process 1-2h, again control temperature-20 ~-30 DEG C of lyophilization process 1-2h, again control temperature-10 DEG C of lyophilization process 1-2h; Be a circulation with above-mentioned freezing dry process, lyophilization process 2-4 circulation;
(5) the hemostatic material washing will obtained, sterilizing, to obtain final product.
Preferably, described carboxymethyl chitosan is 60-100 weight portion, described sodium carboxymethyl cellulose is 15-20 weight portion, described collagen protein is 30-50 weight portion, described Radix Notoginseng extract is 50-60 weight portion, described polyvinyl alcohol is 12-18 weight portion.
Optimum, described carboxymethyl chitosan is 80 weight portions, described sodium carboxymethyl cellulose is 18 weight portions, described collagen protein is 40 weight portions, described Radix Notoginseng extract is 55 weight portions, described polyvinyl alcohol is 15 weight portions.
In described step (4), described lyophilization treatment step is 3 circulations.
In described step (4), the described lyophilization treatment step of each circulation is specially: control temperature-45 DEG C of lyophilization process 1-2h, again control temperature-25 DEG C of lyophilization process 1-2h, again control temperature-10 DEG C of lyophilization process 1-2h.
In described step (3), the heating-up temperature of described foaming step is 200 DEG C.
In described step (1), described Radix Notoginseng extract is that the Radix Notoginseng after pulverizing adds the water of 2-4 weight times amount, extracts 1-3 gained through boiling.
In described step (2), also comprise the step adding conventional hemostatic compositions, as conventional nutrients such as hyaluronic acids.
In described step (1), described sterilization steps is treatment with irradiation under gamma-rays.
The invention also discloses the obstetrics and gynecology department quick hemostatic dressing prepared by said method.
The invention also discloses the application of above-mentioned bleeding-stopping dressing for the preparation of obstetrics and gynecology operation hemostatic material.
Quick hemostatic dressing of the present invention, although with carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract and the polyvinyl alcohol used conventional in prior art for raw material, each raw material all has the effect promoting hemagglutination, make blood rapid solidification, jointly plays the effect of blood coagulation; The collagen protein added, not only can play Blood clotting, also can wound healing, can realize quick-acting haemostatic powder.The more important thing is, bleeding-stopping dressing of the present invention carries out cryodesiccated mode with gradient profile again owing to have employed first to foam in preparation process, preparation-obtained bleeding-stopping dressing is in absorption and haemostatic effect, relative to the product of the single lyophilization mode adopted conventional in prior art, the technique effect of its absorbing blood significantly promotes.Visible, in the process of the described bleeding-stopping dressing of preparation, the impact of its preparation process difference will much larger than the impact of its raw material components; And adopt quick hemostatic dressing of the present invention best for the haemostatic effect of quick bleeding, hemostasis can be realized within a short period of time, be applicable to the acute emergent management of bleeding profusely of department of obstetrics and gynecology.
Detailed description of the invention
In the following each embodiment of the present invention, described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, polyvinyl alcohol are the conventional product adopted in prior art, effect between the product of commercially available each model zero difference.
Embodiment 1
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 40kg, sodium carboxymethyl cellulose 25kg, collagen protein 20kg, Radix Notoginseng extract 80kg, polyvinyl alcohol 10kg.
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing is prepared by the following method, comprises the steps:
(1) batch mixing: get Radix Notoginseng and pulverize, sieve, the water heated and boiled adding described Radix Notoginseng 2 weight times amount extracts 3 times, and water extract is concentrated into extractum, obtains Radix Notoginseng extract, for subsequent use;
(2) measure described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract, polyvinyl alcohol according to selected, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 150 DEG C carries out foamable process 3h;
(4) by the raw material after foaming process, freezer dryer evacuation 6h is placed in, control temperature-40 DEG C of lyophilization process 2h, again control temperature-20 DEG C of lyophilization process 2h, again control temperature-10 DEG C of lyophilization process 2h; Be a circulation with above-mentioned freezing dry process, repeat above-mentioned lyophilization process 4 circulation;
(5) hemostatic material obtained is added water washing, under gamma-rays, radiation sterilization process, to obtain final product.Embodiment 2
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 120kg, sodium carboxymethyl cellulose 10kg, collagen protein 60kg, Radix Notoginseng extract 30kg, polyvinyl alcohol 20kg.
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing is prepared by the following method, comprises the steps:
(1) batch mixing: get Radix Notoginseng and pulverize, sieve, the water heated and boiled adding described Radix Notoginseng 4 weight times amount extracts 1 time, and water extract is concentrated into extractum, obtains Radix Notoginseng extract, for subsequent use;
(2) measure described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract, polyvinyl alcohol according to selected, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 250 DEG C carries out foamable process 2h;
(4) by the raw material after foaming process, freezer dryer evacuation 6h is placed in, control temperature-50 DEG C of lyophilization process 1h, again control temperature-30 DEG C of lyophilization process 1h, again control temperature-10 DEG C of lyophilization process 1h; Be a circulation with above-mentioned freezing dry process, repeat above-mentioned lyophilization process 2 circulation;
(5) hemostatic material obtained is added water washing, under gamma-rays, radiation sterilization process, to obtain final product.Embodiment 3
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 60kg, sodium carboxymethyl cellulose 20kg, collagen protein 30kg, Radix Notoginseng extract 60kg, polyvinyl alcohol 12kg.
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing is prepared by the following method, comprises the steps:
(1) batch mixing: get Radix Notoginseng and pulverize, sieve, the water heated and boiled adding described Radix Notoginseng 3 weight times amount extracts 2 times, and water extract is concentrated into extractum, obtains Radix Notoginseng extract, for subsequent use;
(2) measure described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract, polyvinyl alcohol according to selected, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 200 DEG C carries out foamable process 3h;
(4) by the raw material after foaming process, freezer dryer evacuation 6h is placed in, control temperature-35 DEG C of lyophilization process 2h, again control temperature-25 DEG C of lyophilization process 1h, again control temperature-10 DEG C of lyophilization process 2h; Be a circulation with above-mentioned freezing dry process, repeat above-mentioned lyophilization process 3 circulation;
(5) hemostatic material obtained is added water washing, under gamma-rays, radiation sterilization process, to obtain final product.Embodiment 4
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 100kg, sodium carboxymethyl cellulose 15kg, collagen protein 50kg, Radix Notoginseng extract 50kg, polyvinyl alcohol 18kg.
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing is prepared by the following method, comprises the steps:
(1) batch mixing: get Radix Notoginseng and pulverize, sieve, the water heated and boiled adding described Radix Notoginseng 3 weight times amount extracts 2 times, and water extract is concentrated into extractum, obtains Radix Notoginseng extract, for subsequent use;
(2) measure described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract, polyvinyl alcohol according to selected, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 200 DEG C carries out foamable process 3h;
(4) by the raw material after foaming process, freezer dryer evacuation 6h is placed in, control temperature-35 DEG C of lyophilization process 2h, again control temperature-25 DEG C of lyophilization process 1h, again control temperature-10 DEG C of lyophilization process 2h; Be a circulation with above-mentioned freezing dry process, repeat above-mentioned lyophilization process 3 circulation;
(5) hemostatic material obtained is added water washing, under gamma-rays, radiation sterilization process, to obtain final product.Embodiment 5
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 80kg, sodium carboxymethyl cellulose 18kg, collagen protein 40kg, Radix Notoginseng extract 55kg, polyvinyl alcohol 15kg.
Described in the present embodiment, obstetrics and gynecology department quick hemostatic dressing is prepared by the following method, comprises the steps:
(1) batch mixing: get Radix Notoginseng and pulverize, sieve, the water heated and boiled adding described Radix Notoginseng 3 weight times amount extracts 2 times, and water extract is concentrated into extractum, obtains Radix Notoginseng extract, for subsequent use;
(2) measure described carboxymethyl chitosan, sodium carboxymethyl cellulose, collagen protein, Radix Notoginseng extract, polyvinyl alcohol according to selected, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 200 DEG C carries out foamable process 3h;
(4) by the raw material after foaming process, freezer dryer evacuation 6h is placed in, control temperature-35 DEG C of lyophilization process 2h, again control temperature-25 DEG C of lyophilization process 1h, again control temperature-10 DEG C of lyophilization process 2h; Be a circulation with above-mentioned freezing dry process, repeat above-mentioned lyophilization process 3 circulation;
(5) hemostatic material obtained is added water washing, under gamma-rays, radiation sterilization process, to obtain final product.
Comparative example 1
Described in this comparative example, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 30kg, sodium carboxymethyl cellulose 35kg, collagen protein 10kg, Radix Notoginseng extract 90kg, polyvinyl alcohol 5kg.The preparation method of described bleeding-stopping dressing is with embodiment 5.
Comparative example 2
Described in this comparative example, obstetrics and gynecology department quick hemostatic dressing comprises the raw material components of following weight portion: carboxymethyl chitosan 130kg, sodium carboxymethyl cellulose 5kg, collagen protein 70kg, Radix Notoginseng extract 20kg, polyvinyl alcohol 30kg.The preparation method of described bleeding-stopping dressing is with embodiment 5.
Comparative example 3
The raw material of bleeding-stopping dressing prepared by this comparative example is identical with embodiment 5, and its difference is only, in the preparation process (4) of described bleeding-stopping dressing, described lyophilization step is under identical vacuum condition, control temperature-35 DEG C of lyophilization process 15h.
Comparative example 4
The raw material of bleeding-stopping dressing prepared by this comparative example is identical with embodiment 5, and its difference is only, in the preparation process (4) of described bleeding-stopping dressing, described lyophilization step is under identical vacuum condition, control temperature-25 DEG C of lyophilization process 15h.
Comparative example 5
The raw material of bleeding-stopping dressing prepared by this comparative example is identical with embodiment 5, and its difference is only, in the preparation process (4) of described bleeding-stopping dressing, described lyophilization step is under identical vacuum condition, control temperature-10 DEG C of lyophilization process 15h.
Comparative example 6
The raw material of bleeding-stopping dressing prepared by this comparative example is identical with embodiment 5, and its difference is only, in the preparation process of described bleeding-stopping dressing, after foamable step, no longer carries out lyophilization process, but direct cooling processing under room temperature.
Experimental example
1, blood flow volume adsorption experiment
The bleeding-stopping dressing prepared in Example 1-5 and comparative example 1-6 respectively, the unified oblong-shaped cutting out length × wide × height=1cm × 1cm × 0.5cm, for subsequent use;
Separately get 50ml blood, be all placed in 200ml beaker, carry out Blood index experimental test at normal temperatures;
Record described bleeding-stopping dressing and adsorb time needed for whole blood, the record that cannot all adsorb no longer absorbs the final time of blood volume, and experimental result sees the following form 1.
Table 1 blood flow volume Adsorption experimental results
| Numbering | Whether all adsorb | (all/maximum) adsorption time |
| Embodiment 1 | Be | 13s |
| Embodiment 2 | Be | 12s |
| Embodiment 3 | Be | 12s |
| Embodiment 4 | Be | 11s |
| Embodiment 5 | Be | 10s |
| Comparative example 1 | Be | 16s |
| Comparative example 2 | Be | 15s |
| Comparative example 3 | No | 20s |
| Comparative example 4 | No | 19s |
| Comparative example 5 | No | 20s |
| Comparative example 6 | No | 25s |
From upper table data, 50mL blood flow volume can realize all absorbing by quick hemostatic dressing of the present invention within the extremely short time, and although the time that comparative example 1-2 group absorbs is slightly long, but still achieve whole absorption of large blood flow volume, comparative example 3-6 group then cannot realize whole absorptions of large blood flow volume.Visible, in the process of the described bleeding-stopping dressing of preparation, the impact of its preparation process difference will much larger than the impact of its raw material components; The bleeding-stopping dressing simultaneously also proving to adopt gradient freezing drying mode of the present invention to obtain is compared to the bleeding-stopping dressing of general normal freeze-drying process, and its technique effect is significantly improved.
2, quick-acting haemostatic powder experiment
Choose the rabbit that 110 body weight are similar, be divided into 11 groups at random, often organize 10, every rabbit cuts off 2/3rds of left ear auricular vein, auris dextra ear edge tremulous pulse and left hind femoral artery, freely use bleeding-stopping dressing pressure dressing wound obtained in experimental example 1-5 level comparative example 1-6 after hemorrhage 10s, 10s respectively.Wherein, the bleeding-stopping dressing that respectively group experiment is used all unification cuts the oblong-shaped of growth × wide × height=2cm × 2cm × 2cm, records each experimental group bleeding stopping period and is recorded in following table 2.
The each experimental group quick-acting haemostatic powder time result of table 2
From upper table data, adopt quick hemostatic dressing of the present invention best for the haemostatic effect of quick bleeding, hemostasis can be realized within a short period of time, be applicable to the acute emergent management of bleeding profusely of department of obstetrics and gynecology.
Obviously, above-described embodiment is only for clearly example being described, and the restriction not to embodiment.For those of ordinary skill in the field, can also make other changes in different forms on the basis of the above description.Here exhaustive without the need to also giving all embodiments.And thus the apparent change of extending out or variation be still among the protection domain of the invention.
Claims (10)
1. prepare a method for obstetrics and gynecology department quick hemostatic dressing, it is characterized in that, comprise the steps:
(1) batch mixing: get the Radix Notoginseng after pulverizing and add water boil extraction, and water extract is concentrated into extractum, obtain Radix Notoginseng extract, for subsequent use;
(2) get carboxymethyl chitosan 40-120 weight portion, sodium carboxymethyl cellulose 10-25 weight portion, collagen protein 20-60 weight portion, Radix Notoginseng extract 30-80 weight portion, polyvinyl alcohol 10-20 weight portion, fully mix;
(3) by above-mentioned raw materials mixture under vacuum, control temperature 150-250 DEG C is carried out foamable process;
(4) by the raw material after foaming process, carry out lyophilization process under vacuum, control temperature-40 ~-50 DEG C of lyophilization process 1-2h, again control temperature-20 ~-30 DEG C of lyophilization process 1-2h, again control temperature-10 DEG C of lyophilization process 1-2h; Be a circulation with above-mentioned freezing dry process, lyophilization process 2-4 circulation;
(5) the hemostatic material washing will obtained, sterilizing, to obtain final product.
2. the method preparing obstetrics and gynecology department quick hemostatic dressing according to claim 1, it is characterized in that, described carboxymethyl chitosan is 60-100 weight portion, described sodium carboxymethyl cellulose is 15-20 weight portion, described collagen protein is 30-50 weight portion, described Radix Notoginseng extract is 50-60 weight portion, described polyvinyl alcohol is 12-18 weight portion.
3. the method preparing obstetrics and gynecology department quick hemostatic dressing according to claim 1 and 2, it is characterized in that, described carboxymethyl chitosan is 80 weight portions, described sodium carboxymethyl cellulose is 18 weight portions, described collagen protein is 40 weight portions, described Radix Notoginseng extract is 55 weight portions, described polyvinyl alcohol is 15 weight portions.
4., according to the arbitrary described method preparing obstetrics and gynecology department quick hemostatic dressing of claim 1-3, it is characterized in that, in described step (4), described lyophilization treatment step is 3 circulations.
5. according to the arbitrary described method preparing obstetrics and gynecology department quick hemostatic dressing of claim 1-4, it is characterized in that, in described step (4), the described lyophilization treatment step of each circulation is specially: control temperature-45 DEG C of lyophilization process 1-2h, again control temperature-25 DEG C of lyophilization process 1-2h, again control temperature-10 DEG C of lyophilization process 1-2h.
6., according to the arbitrary described method preparing obstetrics and gynecology department quick hemostatic dressing of claim 1-5, it is characterized in that, in described step (3), the heating-up temperature of described foaming step is 200 DEG C.
7. according to the arbitrary described method preparing obstetrics and gynecology department quick hemostatic dressing of claim 1-6, it is characterized in that, in described step (1), described Radix Notoginseng extract is the water that Radix Notoginseng after pulverizing adds 2-4 weight times amount, extracts 1-3 gained through boiling.
8., according to the arbitrary described method preparing obstetrics and gynecology department quick hemostatic dressing of claim 1-7, it is characterized in that, in described step (2), also comprise the step adding conventional hemostatic compositions.
9. the obstetrics and gynecology department quick hemostatic dressing prepared by the arbitrary described method of claim 1-8.
10. bleeding-stopping dressing described in claim 9 is for the preparation of the application of obstetrics and gynecology operation hemostatic material.
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| CN108014362A (en) * | 2018-02-07 | 2018-05-11 | 苏州元禾医疗器械有限公司 | A kind of preparation method of the wound dressing of dispeling scar |
| CN108653798A (en) * | 2018-06-29 | 2018-10-16 | 中山大学附属第医院 | Composition and hemostatic material in medical use for hemostasis |
| CN110917384A (en) * | 2019-12-14 | 2020-03-27 | 浙江惠龙医疗科技股份有限公司 | Medical dressing with antibacterial and high absorption functions and preparation method thereof |
| CN111603603A (en) * | 2020-06-03 | 2020-09-01 | 韩皓 | Gynecological rapid hemostatic dressing and preparation method thereof |
| CN113577374A (en) * | 2021-07-26 | 2021-11-02 | 哈尔滨贝科德糖生物科技有限公司 | Composite liquid band-aid and preparation method thereof |
| CN114732940A (en) * | 2022-04-24 | 2022-07-12 | 江苏瀚仁生物科技有限公司 | High-elasticity starch cavity hemostatic material and application and preparation method thereof |
| CN114732940B (en) * | 2022-04-24 | 2022-12-06 | 江苏瀚仁生物科技有限公司 | High-elasticity starch cavity hemostatic material and application and preparation method thereof |
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