CN106693034A - Preparation method of pollution-free surgical dressing for sterilizing and stopping bleeding - Google Patents

Abstract

The invention relates to a method for preparing a non-polluting bactericidal and hemostatic medical dressing. The amniotic membrane is processed by staged vacuum freeze-drying technology and soaked in traditional Chinese medicine extracts to prepare an effective bactericidal and hemostatic medical dressing, which can be widely used in various Compared with the prior art, the medical dressing prepared by the invention stops bleeding, relieves pain, promotes healing, has no side effects on human body, and is safe to use for the treatment of wounds in different degrees. The preparation method of the invention is simple, easy to implement, low in cost and pollution-free.

Description

A kind of preparation method of pollution-free bactericidal hemostatic medical dressing

The present invention is a divisional application of application number: 2015104682485, application date: 2015-08-03, and invention name: a preparation method of a bactericidal and hemostatic medical dressing.

technical field

The invention belongs to the field of medical materials, in particular to a method for preparing a non-polluting bactericidal and hemostatic medical dressing.

Background technique

In people's daily life, burns and scalds often occur, causing wounds with different depths, and are very easy to cause infection and various complications. Therefore, the development of effective medical dressings for this field is an urgent problem to be solved. Due to its unique characteristics, the amniotic membrane has attracted the attention of scholars at home and abroad. The amniotic membrane is derived from the cytotrophoblast, which is the inner layer of the double membrane of the embryo. It is composed of epithelial cell layer, basement membrane and avascular matrix. The amniotic membrane contains a variety of collagens protein and laminin, fibronectin, glycosaminoglycan, hyaluronic acid, etc. It is the presence of these active substances that can promote the adhesion and migration of epithelial cells, induce epithelial differentiation, and prevent epithelial apoptosis, making the amnion a "transplantable basement membrane" to promote epithelialization. In addition, amnion stroma also contains many growth factors, such as nerve growth factor (NGF), hepatocyte growth factor (HGF), keratinocyte growth factor (KGF), transforming growth factor-α (TGF-α), transforming growth factor -β1 (TGF-β1), epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), etc., can promote ocular surface epithelialization, reduce inflammatory response, inhibit fibrous tissue proliferation and angiogenesis. Therefore, the application of amniotic membrane in ocular surface reconstruction has attracted much attention in recent years.

Contents of the invention

The purpose of the present invention is to combine amniotic membrane and specific Chinese herbal medicine to prepare an effective bactericidal and hemostatic medical dressing, so as to solve the above-mentioned problems in the prior art.

The present invention adopts the following technical scheme: a preparation method of a pollution-free bactericidal and hemostatic medical dressing, comprising the following steps:

(1) Disinfection and sterilization: After washing the amniotic membrane with normal saline, soak it in aqueous hydrogen peroxide solution for 2-3 hours, and then clean it with water; soak the sterilized amniotic membrane in an aqueous solution containing antibiotics for 2-3 hours;

(2) Vacuum freeze-drying in stages: place the amniotic membrane obtained in step (1) in a solution of 5-10 g/L sodium alginate and 1-5 g/L hyaluronic acid, let it stand for 10-15 hours, and then carry out vacuum freeze-drying , first pre-freeze at 2-5°C for 2-3 hours, then cool down to -10-15°C, freeze for 3-5 hours, continue to cool down to -20-25°C, freeze for 3-5 hours, and continue to cool down to - 40～-50℃, freeze for 7～10 hours, control the water content of the amniotic membrane at 5～10%;

(3) Soaking Chinese medicine: soak the amniotic membrane obtained in step (2) in the Chinese medicine extract, heat to make the soaking temperature 30-50°C, and the soaking time is 10-15h; wherein the Chinese medicine extract is prepared by the following method : Take Chinese medicinal materials according to the following parts by mass, 8-10 parts of Daqingye, 3-5 parts of Fructus Cnidii, 3-5 parts of Panax notoginseng, 1-5 parts of Scutellaria baicalensis, 1-3 parts of dandelion, 2-3 parts of wild chrysanthemum, Honeysuckle 1-3 parts, Gudan 3-5 parts, Qili Dan 6-8 parts, frankincense 2-3 parts, myrrh 5-10 parts, cloves 2-5 parts, safflower 1-3 parts, rhubarb 3-5 parts 3-5 parts of licorice, 1-2 parts of atractylodes rhizome, add water and decoct for 1-2 hours, the obtained decoction is subjected to ultrafiltration and nanofiltration to obtain the refined liquid of traditional Chinese medicine, and then add medical alcohol and water to mix to adjust the solution The alcohol concentration is 65-70%, and heated to 60-70°C to obtain the Chinese medicine extract;

(4) Vacuum drying: the amniotic membrane treated in step (3) is vacuum-dried at a temperature of 60-70° C., and the drying time is 2-4 hours;

(5) Encapsulation and sterilization: the amniotic membrane after vacuum drying is packaged and sterilized to be stored at room temperature.

In a preferred embodiment of the present invention, the concentration of the aqueous hydrogen peroxide solution is 2-4 g/L.

In a preferred embodiment of the present invention, the antibiotics are selected from one or both of penicillin, streptomycin, and gentamicin, and the dosages are 50 μg/mL, 30 μg/mL, and 10 μg/mL, respectively. ;

In a preferred embodiment of the present invention, the degree of vacuum in step (4) is 0.01-0.05 MPa.

The medical dressing prepared by the present invention can be widely used in the treatment of various degrees of wounds. Compared with the prior art, the present invention has the following beneficial effects:

(1) After long-term experimental research, it was found that the use of staged vacuum freeze-drying technology, the amniotic membrane is freeze-dried at a gradually lowered temperature, and the stepwise cooling can retain its collagen and active factor components to the greatest extent, making the amniotic membrane more stable. The composition is not damaged. After testing, the prepared medical dressing contains 290.1±1.0 μg/mg of type I collagen, 356.8±2.0 μg/mg of type III collagen, 47.1±1.0 μg/mg of type IV collagen, and 71.2 μg/mg of hepatocyte growth factor ±1.0μg/mg, basic fibroblast growth factor 56.1±1.0μg/mg; and fresh amniotic membrane contains type Ⅰ collagen 303.5±5.3 μg/mg, type Ⅲ collagen 384.2±4.5 μg/mg, type Ⅳ collagen 53.6± 1.7μg/mg, hepatocyte growth factor 89.9±3.2μg/mg, basic fibroblast growth factor 71.1±1.0μg/mg.

(2) By impregnating the specific traditional Chinese medicine formula of the present invention, the obtained amniotic membrane dressing can more effectively stop bleeding, relieve pain, and promote healing, and has no side effects on the human body, and is safe to use.

(3) The preparation method of the present invention is simple, easy to implement, low in cost and non-polluting.

detailed description

The technical solutions of the present invention and their effects are further described below in conjunction with examples.

Example 1

(1) Disinfection and sterilization: After cleaning the amniotic membrane with physiological saline, soak it in 2g/L hydrogen peroxide aqueous solution for 2 hours, and then wash it with water; soak the sterilized amniotic membrane in an aqueous solution containing 50 μg/mL penicillin for 3 hours;

(2) Vacuum freeze-drying in stages: put the amniotic membrane obtained in step (1) in a solution of 8g/L sodium alginate and 5g/L hyaluronic acid for 10 hours, then carry out vacuum freeze-drying, first at 3°C Pre-freeze for 3 hours, then cool down to -10°C, freeze for 5 hours, continue to cool down to -20°C, freeze for 5 hours, continue to cool down to -50°C, freeze for 8 hours, and control the moisture content of the amniotic membrane at 7%;

(3) Soaking Chinese medicine: soak the amniotic membrane obtained in step (2) in the Chinese medicine extract, heat to make the soaking temperature 30°C, and the soaking time is 15h; wherein the Chinese medicine extract is prepared by the following method: according to the following mass Take Chinese medicinal materials, 10 parts of Daqingye, 3 parts of Cnidium, 4 parts of Panax notoginseng, 2 parts of Scutellaria baicalensis, 2 parts of Dandelion, 2 parts of wild chrysanthemum, 2 parts of honeysuckle, 3 parts of Gu Dan, 6 parts of Qili Dan, 2 parts of frankincense 6 parts of myrrh, 3 parts of cloves, 2 parts of safflower, 3 parts of rhubarb, 3 parts of licorice, 1 part of atractylodes, add water and decoct for 2 hours, and the obtained decoction is subjected to ultrafiltration and nanofiltration to obtain refined Chinese medicine solution, then add medical alcohol and water to mix, adjust the alcohol concentration in the solution to 70%, and heat to 60°C to obtain the Chinese medicine extract;

(4) Vacuum drying: the amniotic membrane treated in step (3) is subjected to vacuum drying treatment, the vacuum degree is 0.02MPa, the temperature is 70°C, and the drying time is 2 hours;

(5) Encapsulation and sterilization: the amniotic membrane after vacuum drying is packaged and sterilized to be stored at room temperature.

After testing, the prepared medical dressing contained 290.1 μg/mg type I collagen, 356.8 μg/mg type III collagen, 47.1 μg/mg type IV collagen, 71.2 μg/mg hepatocyte growth factor, and 71.2 μg/mg basic fibroblast growth factor 56.1 μg/mg, which is relatively close to the composition of fresh amniotic membrane, indicating that the above preparation method basically does not damage the composition of amniotic membrane, and maintains its original appearance to a great extent.

The prepared medical dressing was used on the wound surface to test its effect on wound healing (rate, time). The animal model of deep second-degree skin burn was selected as the animal model to evaluate the effect of dressing on wound healing.

Male Wistar rats were randomly divided into groups, including the natural healing group, the commercially available conventional medical dressing group, and the medical dressing group of the present invention. only animals. After the rats were successfully anesthetized, scald them in an 80° C. water bath for 15 seconds to cause 10% deep second-degree skin burns on the back of the rats (confirmed by pathological examination sections), and give 5 ml of normal saline through the abdominal cavity after the injury. Except for the natural healing group, each group covered the wound with corresponding dressings. The wound healing rate was measured at each time point after the injury. Firstly, the wound surface was traced on translucent paper, and then as a template, the cardboard with uniform texture was cut into the same size, and then weighed with a balance. The weight indirectly indicates the size of the wound area. The wound healing rate was calculated according to the formula: wound healing rate (%)=(original wound area−unhealed wound area)/original wound area. Pathological examination, to understand the quality of wound healing, and determine the healing time according to the wound healing. The test results show that the medical dressing group of the present invention is superior to the natural healing group and the commercially available conventional medical dressing group in terms of wound recovery time and wound healing rate.

The present invention is not limited to the specific embodiments and descriptions, and without departing from the gist of the present invention claimed in the scope of the claims, various modifications can be made by those with ordinary knowledge in the technical field to which the present invention belongs, and the The above-mentioned deformation belongs to the protection scope of the present invention.

Claims (1)

1. a kind of preparation method of free of contamination bactericidal haemostatic medical dressing, it is characterised in that comprise the following steps：

(1) disinfection：After cleaning amnion with physiological saline, 2-3h in aqueous hydrogen peroxide solution is soaked in, is then cleaned with water Totally；Amnion after sterilization is soaked in the 2~3h of the aqueous solution containing antibiotic；

(2) vacuum freeze drying stage by stage：The amnion that step (1) is obtained is placed in the sodium alginate and 1~5g/L of 5~10g/L After standing 10~15h in hyaluronic acid solution, vacuum freeze drying is carried out, first 2~3h of pre-freeze at 2~5 DEG C, then lowers the temperature To -10~-15 DEG C, 3~5h is freezed, continuing to cool to -20~-25 DEG C, freeze 3~5h, continuing to cool to -40~-50 DEG C, 7~10h is freezed, the moisture of amnion is controlled 5~10%；

(3) Chinese medicine is impregnated：The amnion that step (2) is obtained is immersed in Chinese medical extract, heating makes soaking temperature 30~50 DEG C, soak time is 10~15h；Wherein described Chinese medical extract is prepared by the following method and obtains：Taken by following mass parts Chinese medicinal material, folium isatidis 8-10 parts, frutus cnidii 3-5 parts, pseudo-ginseng 3-5 parts, root of large-flowered skullcap 1-5 parts, dandelion 1-3 parts, chrysanthemum indicum 2-3 Part, honeysuckle 1-3 parts, 3-5 parts of bone pellet, Fructus Tribuli 6-8 parts, frankincense 2-3 parts, myrrh 5-10 parts, cloves 2-5 parts, safflower 1-3 Part, rheum officinale 3-5 parts, Radix Glycyrrhizae 3-5 parts, rhizoma atractylodis 1-2 parts, add water to cook 1-2 hours, after the decoction liquor for obtaining is through ultrafiltration and nanofiltration, Purification of tcm liquid is obtained, medicinal alcohol and water mixing is subsequently adding, alcohol concentration is 65-70% in regulation solution, and is heated to 60-70 DEG C obtains described Chinese medical extract；

(4) it is vacuum dried：Amnion after step (3) treatment is carried out into vacuum drying treatment, temperature is 60~70 DEG C, drying time 2-4 hours；

(5) encapsulation sterilizing：Preserved at normal temperatures by the amnion after vacuum drying is packed, sterilized；

The concentration of the aqueous hydrogen peroxide solution is 2~4g/L；

The vacuum of the step (4) is 0.01-0.05MPa.