Duiyiweizhengshu hemostatic bandage and preparation method thereof

Abstract

The present application belongs to the technical field of medical hemostatic dressings and bandages, and particularly relates to a Duyuwei emergency hemostatic bandage, which comprises a bandage main body, the bandage main body is composed of a tight band and a dressing pad, the dressing pad is fixed to the front end of the tight band, the dressing pad is composed of an absorption area, a tablet area and a pad base layer, the absorption area and the tablet area are fixed on the pad base layer by traditional Chinese medicine glue, the absorption area is composed of Duyuwei gelatin sponge, the tablet area is composed of Duyuwei external-use tablets, and the pad base layer is composed of a medical degreasing cotton pad. A preparation method of the Duyuwei emergency hemostatic bandage comprises the following steps: Duyuwei medicinal material decoction piece component extraction, Duyuwei external-use tablet preparation, traditional Chinese medicine glue preparation, Duyuwei gelatin sponge preparation and Duyuwei hemostatic bandage preparation. The present application has the advantages of rapid hemostasis and remarkable efficacy: the Duyuwei extract, the gelatin sponge and the traditional Chinese medicine glue synergistically act to significantly shorten the hemostasis time. Animal experiments show that the average hemostasis time is short.

Description

Technical Field

[0001] This invention belongs to the field of medical hemostatic dressings and bandages, and particularly relates to a unique emergency hemostatic bandage and its preparation method. Background Technology

[0002] Lamiophoros rotata is a Tibetan medicine unique to the Qinghai-Tibet Plateau, possessing pharmacological effects such as promoting blood circulation and stopping bleeding, removing blood stasis and relieving pain, and antibacterial and anti-inflammatory properties. Currently, oral preparations of Lamiophoros rotata are available for gynecological bleeding and traumatic bleeding, but research on its external preparations and composite hemostatic bandages is still limited.

[0003] Most existing hemostatic bandages are made of ordinary gauze or non-woven fabric, relying solely on physical pressure to stop bleeding. They lack the synergistic effect of active pharmaceutical ingredients, resulting in limited hemostatic efficacy. Some medicated bandages use a single dosage form (such as ointment or powder), leading to uneven drug release, easy detachment, and the adhesive materials are often chemically synthesized glues, which may cause skin irritation or allergic reactions.

[0004] Therefore, developing an emergency hemostatic bandage with good hemostatic effect, uniform drug release, good biocompatibility, and convenient use has important clinical significance and market value. Summary of the Invention

[0005] In response to the problems mentioned in the prior art, the present invention provides a unique first aid hemostatic bandage and its preparation method.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A unique first-aid hemostatic bandage, comprising a bandage body 1, characterized in that: the bandage body 1 is composed of a tight band 2 and a padding 3; The pad 3 is fixed to the front end of the clamp 2; The pad 3 is composed of an absorbent area 4, a tablet area 5, and a base layer 6; The absorption zone 4 and the tablet zone 5 are bonded and fixed to the base layer 6 with traditional Chinese medicine adhesive; the absorption zone 4 is made of Duyiwei gelatin sponge; the tablet zone 5 is made of Duyiwei external tablets; and the base layer 6 is made of medical degreased cotton pads.

[0007] Preferably, the absorption zone 4 and the tablet zone 5 are arranged alternately and fixed on the base layer 6, and are bonded and fixed by traditional Chinese medicine adhesive.

[0008] Preferably, the tight band 2 is an elastic bandage, a non-woven bandage, or a high-elastic gauze bandage.

[0009] Preferably, the pad 3 and the bandage 2 are fixed by sewing or medical adhesive.

[0010] A method for preparing a unique first-aid hemostatic bandage, characterized by comprising the following steps: Step 1. Extract the components of the Lamiophlomis rotata medicinal material slices; specifically, it includes the following steps: Step 1. Select complete Lamiophlomis rotata slices, weigh them, and place them in a round-bottom flask; Step 2. Decoct with water twice: For the first time, add 10 - 16 times the amount of water, soak for 30 minutes, heat to a gentle boil and maintain for 20 - 60 minutes, filter while it is hot through a 350-mesh sieve, and cool the filtrate; for the second time, add 8 - 14 times the amount of water, heat to a gentle boil and maintain for 10 - 40 minutes, filter while it is hot through a 350-mesh sieve; Step 3. Combine the two filtrates, and concentrate them under reduced pressure into a fluid extract with a relative density of 1.02 - 1.05 g / mL; Step 4. After vacuum freeze-drying, seal it with a rubber stopper and crimp an aluminum cap to obtain the dried powder of the Lamiophlomis rotata extract; Step 2. Prepare the Lamiophlomis rotata external tablets; specifically, it includes the following steps: Step 1. Mix the dried powder of the Lamiophlomis rotata extract, pharmaceutical excipients (such as starch, microcrystalline cellulose), and dispersants (such as polyethylene glycol) evenly according to the mass ratio of 1 - 5:1 - 5:0.01 - 1; Step 2. Add it to the hopper of a tableting machine and press it into tablets; Step 3. Prepare the traditional Chinese medicine glue; specifically, it includes the following steps: Step 1. Select traditional Chinese medicine materials with hemostatic effects (such as Bletilla striata, Panax notoginseng, etc.), and crush them; Step 2. Add distilled water 6 - 8 times the amount of the medicinal materials, soak for 10 - 12 hours, stir constantly, filter, and reserve the filtrate; Step 3. Soak the medicinal residues 2 more times, with the water consumption each time being 4 times the amount of the medicinal materials, soak for 1 - 4 hours each time, and filter; Step 4. Combine the three filtrates and concentrate them into a thick paste; Step 5. After cooling, add 95% ethanol to make the alcohol content reach more than 70%, stir, a large amount of flocculent precipitate will form, and let it stand for 1 hour; Step 6. Vacuum filter until dry, add an appropriate amount of 95% ethanol to the precipitate again, stir, let it stand, and filter until dry, repeat three times; Step 7. Evaporate the ethanol, place it in an oven and dry it at a low temperature, slightly grind it finely to obtain the traditional Chinese medicine glue powder; Step 8. When in use, mix the traditional Chinese medicine glue powder and distilled water evenly according to the mass ratio of 1 - 10:2 - 8 to obtain a viscous colloid, and prepare it for use immediately; Step 4. Prepare the Lamiophlomis rotata gelatin sponge; specifically, it includes the following steps: Step 1. Weigh double-distilled water, gelatin, traditional Chinese medicine glue, and the dried powder of the Lamiophlomis rotata extract according to the mass ratio of 50 - 200:1 - 10:1 - 5:1 - 5 respectively; Step 2. Stir the above materials充分搅拌至均匀 until they are completely dissolved in a water bath at 55°C; Step 3: Pour into a glass freeze-drying dish and let cool at room temperature; Step 4: Seal the freeze-dried disc with plastic wrap and pre-freeze it in a -80℃ freezer for 24 to 48 hours; Step 5: After it solidifies into a block, place it in a vacuum freeze dryer for freeze drying. Step 6: After freeze-drying, a sponge-like porous material is obtained. Cut it into the same size and package it for later use. Step 5: Preparation of the Unique Herbal Hemostatic Bandage; specifically including the following steps: Step 1: Arrange the absorbent 4 (Duyiwei gelatin sponge) and the tablet area 5 (Duyiwei external tablets) alternately on the padding layer 6 (degreased cotton pad); Step 2: Use traditional Chinese medicine adhesive to bond and fix the parts together; Step 3: Secure the pad 3 to the front end of the bandage 2 (by sewing or gluing). Step 4: After completing the production of the main body of the bandage 1, perform radiation sterilization; Step 5: Roll it up and put it into an aluminum packaging bag, then vacuum seal it.

[0011] Working principle: When there is bleeding from a wound, open the vacuum packaging, take out the main bandage, place the dressing pad on the wound, and tighten the bandage. The absorbent area inside the dressing can quickly absorb large amounts of bleeding. The unique herbal ingredient in the absorbent area and the unique herbal extract in the tablet area can exert hemostatic, analgesic, and antibacterial effects. The herbal adhesive also has a hemostatic effect and enhances the binding force between the layers, preventing drug migration.

[0012] The present invention has the following beneficial effects: 1. Rapid hemostasis and significant efficacy: The synergistic effect of *Duyiwei* extract, gelatin sponge, and traditional Chinese medicine adhesive significantly shortens the hemostasis time. Animal experiments show a short average hemostasis time.

[0013] 2. Uniform drug release: The tablet area and absorption area are arranged alternately, and the porous structure of the gelatin sponge promotes rapid drug release, resulting in a high drug release rate.

[0014] 3. Good biocompatibility and non-irritating: Made with natural materials such as gelatin, absorbent cotton, and traditional Chinese medicine adhesive, the skin irritation index is 0, there is no allergic reaction, and it is not easy to adhere to the wound.

[0015] 4. Reasonable structure and easy to use: The main body of the bandage is composed of a tight band, an absorbent area, a tablet area, and a padding base. It is vacuum-packed and radiation-sterilized, and can be used immediately after opening. It is suitable for emergency rescue, field, battlefield and other scenarios.

[0016] 6. Controllable process, suitable for industrial production: The process parameters for extraction, tableting, freeze drying, assembly, etc. are clear, the quality is stable, and mass production is possible. Attached Figure Description

[0017] Figure 1 Schematic structural diagram of the hemostatic bandage in the present invention; Figure 2 In the present invention Figure 1 Front view; Figure 3 In the present invention Figure 1 Top view; Figure 4 In the present invention Figure 1 Left view; Figure 5 Physical picture of the Lamiophlomis rotata external tablet in the present invention; Figure 6 Test product picture of the Lamiophlomis rotata first aid hemostatic bandage in the present invention. Detailed implementation manners

[0018] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention.

[0019] Embodiment 1 A Lamiophlomis rotata first aid hemostatic bandage, as Figures 1-4 shown, includes a bandage main body 1, and the bandage main body 1 is composed of a tightening band 2 and a dressing pad 3; the dressing pad 3 is fixed to the front end of the tightening band 2; the dressing pad 3 is composed of an absorption area 4, a tablet area 5 and a pad base layer 6; the absorption area 4 and the tablet area 5 are adhesively fixed to the pad base layer 6 by traditional Chinese medicine glue; the absorption area 4 is composed of Lamiophlomis rotata gelatin sponge; the tablet area 5 is composed of Lamiophlomis rotata external tablets; the pad base layer 6 is composed of a medical absorbent cotton pad. The absorption area 4 and the tablet area 5 are arranged alternately and fixed to the pad base layer 6, and are adhesively fixed by traditional Chinese medicine glue. The tightening band 2 is an elastic rubber bandage, a non-woven fabric bandage or a gauze high-elastic bandage. The dressing pad 3 and the tightening band 2 are fixed by sewing or medical adhesives.

[0020] A preparation method of a Lamiophlomis rotata first aid hemostatic bandage includes the following steps: Step 1: Extract the components of Lamiophlomis rotata medicinal herb slices; specifically include the following steps: Step 1: Select complete Lamiophlomis rotata slices, weigh them, and place them in a round-bottom flask; Step 2: Decoct with water twice: Add 10 - 16 times the amount of water for the first time, soak for 30 minutes, heat to slightly boiling and maintain for 20 - 60 minutes, filter while it is hot through a 350-mesh sieve, and cool the filtrate; Add 8 - 14 times the amount of water for the second time, heat to slightly boiling and maintain for 10 - 40 minutes, and filter while it is hot through a 350-mesh sieve; Step 3: Combine the two filtrates and concentrate under reduced pressure to obtain a fluid extract with a relative density of 1.02–1.05 g / mL; Step 4: After vacuum freeze-drying, seal with rubber stoppers and roll aluminum caps to obtain the dried powder of the *Duyiwei* extract. Step 2: Preparation of Duyiwei external application tablets; specifically including the following steps: Step 1: Mix the dried powder of Du Yi Wei extract, pharmaceutical excipients (such as starch, microcrystalline cellulose), and dispersant (such as polyethylene glycol) in a mass ratio of 1-5:1-5:0.01-1 until homogeneous; Step 2: Add to the tablet press hopper and compress into tablets, such as... Figure 5 As shown; Step 3: Conduct quality inspections by batch, including: Appearance: Smooth and round, with uniform color; Weight variation: The limit is ±7.5% when the average tablet weight is <0.3g; and ±5% when the average tablet weight is ≥0.3g. Disintegration time limit: Take 6 tablets, they should all disintegrate within 3 minutes; Hardness: 3 samples were tested, and the average value was between 40 and 150 N; Friability: Take 6 pieces, loss rate <1%; Microbial limits: Meets the requirements of the Chinese Pharmacopoeia.

[0021] Step 3: Preparation of Traditional Chinese Medicine Adhesive; specifically including the following steps: Step 1: Select Chinese medicinal herbs with hemostatic properties (such as Bletilla striata, Panax notoginseng, etc.) and pulverize them; Step 2: Add 6 to 8 times the amount of distilled water to the medicinal materials and soak for 10 to 12 hours, stirring constantly. Filter and keep the filtrate for later use. Step 3: Soak the dregs twice more, each time using 4 times the amount of water as the medicinal material, for 1 to 4 hours each time, then filter. Step 4: Combine the three filtrates and concentrate them into a thick paste; Step 5: After cooling, add 95% ethanol to make the alcohol content reach more than 70%, stir, and a large amount of flocculent precipitate will be precipitated. Let it stand for 1 hour. Step 6: Vacuum filter to dryness, add an appropriate amount of 95% ethanol to the precipitate, stir, let stand, filter to dryness, and repeat three times. Step 7: Evaporate the ethanol, place in an oven to dry at low temperature, grind slightly to obtain Chinese herbal glue powder; Step 8: When using, mix the Chinese herbal adhesive powder with distilled water at a mass ratio of 1-10:2-8 to obtain a viscous colloid. Prepare and use immediately. Step 4: Preparation of Unique Gelatin Sponge; specifically including the following steps: Step 1: Weigh out the double-distilled water, gelatin, traditional Chinese medicine glue, and dried powder of Du Yi Wei extract according to the mass ratio of 50-200:1-10:1-5:1-5 respectively. Step 2: Stir the above materials thoroughly until uniform, and place them in a 55℃ water bath to dissolve them completely; Step 3: Pour into a glass freeze-drying dish and let cool at room temperature; Step 4: Seal the freeze-dried disc with plastic wrap and pre-freeze it in a -80℃ freezer for 24 to 48 hours; Step 5: After it solidifies into a block, place it in a vacuum freeze dryer for freeze drying. Step 6: After freeze-drying, a sponge-like porous material is obtained. Cut it into the same size and package it for later use. Step 5: Preparation of the Unique Herbal Hemostatic Bandage; such as Figure 6 As shown, the specific steps include the following: Step 1: Arrange the absorbent 4 (Duyiwei gelatin sponge) and the tablet area 5 (Duyiwei external tablets) alternately on the padding layer 6 (degreased cotton pad); Step 2: Use traditional Chinese medicine adhesive to bond and fix the parts together; Step 3: Secure the pad 3 to the front end of the bandage 2 (by sewing or gluing). Step 4: After completing the production of the main body of the bandage 1, perform radiation sterilization; Step 5: Roll it up and put it into an aluminum packaging bag, then vacuum seal it.

[0022] Example 2 1. Preparation of *Lysimachia christinae* extract Take 200g of *Duyiwei* slices, add 3200mL of water for the first time, soak for 30 minutes, simmer for 60 minutes, and filter; add 2800mL of water for the second time, simmer for 40 minutes, and filter; combine the filtrates, concentrate to 1.05g / mL, and freeze-dry to obtain powder.

[0023] 2. Preparation of external application tablets Take 60g of the above powder, 60g of excipient (starch), and 2g of dispersant (polyethylene glycol), mix well, compress into tablets, with a tablet weight of 0.3g, a hardness of 90N, and a disintegration time of 2 minutes.

[0024] 3. Preparation of Traditional Chinese Medicine Adhesive Take 100g of Bletilla striata, soak it in 800mL of water for 12 hours, and filter it. Soak the residue in 400mL of water twice, 2 hours each time. Combine the filtrates, concentrate them, add ethanol to make the alcohol content 75%, precipitate, filter, dry, and obtain powder. When using, add distilled water at a ratio of 1:5 to make a colloid.

[0025] 4. Preparation of Gelatin Sponge 200g of double-distilled water, 10g of gelatin, 5g of traditional Chinese medicine glue, and 5g of Du Yi Wei powder were mixed, dissolved, and freeze-dried to obtain a sponge.

[0026] 5. Bandage assembly Arrange the sponge sheet (2cm×2cm) and the external application sheet (1cm in diameter) alternately on the degreased cotton pad, glue them together with Chinese medicine adhesive, fix them to the elastic non-woven fabric band, and then sterilize and package them.

[0027] Hemostatic efficacy test: Using a New Zealand rabbit femoral artery bleeding model, the bandage of this invention (n=6) achieved an average hemostasis time of 1.5 minutes, which is superior to commercially available ordinary bandages (4.2 minutes). Skin irritation test showed no erythema or edema, uniform drug release, and no obvious inflammatory reaction observed in tissue sections.

[0028] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A unique first-aid hemostatic bandage, comprising a bandage body, characterized in that: The main body of the bandage (1) is composed of a tight band (2) and a pad (3); The pad (3) is fixed to the front end of the tight band (2); The pad (3) consists of an absorbent area (4), a tablet area (5), and a base layer (6); The absorption area (4) and the tablet area (5) are bonded and fixed to the base layer (6) with traditional Chinese medicine adhesive; the absorption area (4) is made of Duyiwei gelatin sponge; the tablet area (5) is made of Duyiwei external tablets; the base layer (6) is made of medical degreased cotton pads.

2. The unique first-aid hemostatic bandage according to claim 1, characterized in that, The absorption zone (4) and the tablet zone (5) are arranged alternately and fixed on the base layer (6) and are bonded and fixed by traditional Chinese medicine adhesive.

3. The unique first-aid hemostatic bandage according to claim 1, characterized in that, The tight band (2) is an elastic bandage, a non-woven bandage, or a high-elastic gauze bandage.

4. The unique first-aid hemostatic bandage according to claim 1, characterized in that, The pad (3) and the bandage (2) are secured by sewing or medical adhesive.

5. A method for preparing a unique first-aid hemostatic bandage, characterized in that, Includes the following steps: Step 1: Extraction of components from the medicinal herb slices; Step 2: Preparation of Duyiwei external application tablets; Step 3: Preparation of Traditional Chinese Medicine Adhesive; Step 4: Preparation of Unique Gelatin Sponge; Step 5: Preparation of the Duyiwei hemostatic bandage.

6. The method for preparing a unique first-aid hemostatic bandage according to claim 5, characterized in that, In step one, the specific steps for extracting the components of the unique herbal medicine slices are as follows: Step 1: Select whole, unique medicinal slices, weigh them, and place them in a round-bottom flask; Step 2: Boil twice with water: For the first boil, add 10 to 16 times the amount of water, soak for 30 minutes, heat to a simmer and maintain for 20 to 60 minutes, filter while hot through a 350-mesh sieve, and cool the filtrate; for the second boil, add 8 to 14 times the amount of water, heat to a simmer and maintain for 10 to 40 minutes, and filter while hot through a 350-mesh sieve. Step 3: Combine the two filtrates and concentrate under reduced pressure to obtain a fluid extract with a relative density of 1.02–1.05 g / mL; Step 4: After vacuum freeze-drying, seal with rubber stoppers and roll aluminum caps to obtain the dried powder of the *Duyiwei* extract.

7. The method for preparing a unique first-aid hemostatic bandage according to claim 5, characterized in that, In step two, the specific steps for preparing the Duyiwei external application tablets are as follows: Step 1: Mix the dried powder of Du Yi Wei extract, pharmaceutical excipients, and dispersant at a mass ratio of 1-5:1-5:0.01-1 until homogeneous; Step 2: Add the contents to the tablet press hopper and press into tablets.

8. The method for preparing a unique first-aid hemostatic bandage according to claim 5, characterized in that, In step three, the specific steps for preparing the traditional Chinese medicine adhesive are as follows: Step 1: Select Chinese medicinal herbs with hemostatic properties and pulverize them; Step 2: Add 6 to 8 times the amount of distilled water to the medicinal materials and soak for 10 to 12 hours, stirring constantly. Filter and keep the filtrate for later use. Step 3: Soak the dregs twice more, each time using 4 times the amount of water as the medicinal material, for 1 to 4 hours each time, then filter. Step 4: Combine the three filtrates and concentrate them into a thick paste; Step 5: After cooling, add 95% ethanol to make the alcohol content reach more than 70%, stir, and a large amount of flocculent precipitate will be precipitated. Let it stand for 1 hour. Step 6: Vacuum filter to dryness, add an appropriate amount of 95% ethanol to the precipitate, stir, let stand, filter to dryness, and repeat three times. Step 7: Evaporate the ethanol, place in an oven to dry at low temperature, grind slightly to obtain Chinese herbal glue powder; Step 8: When using, mix the Chinese herbal medicine powder with distilled water at a mass ratio of 1-10:2-8 to obtain a viscous colloid. Prepare and use immediately.

9. The method for preparing a unique first-aid hemostatic bandage according to claim 5, characterized in that, In step four, the specific steps for preparing the unique gelatin sponge are as follows: Step 1: Weigh out the double-distilled water, gelatin, traditional Chinese medicine glue, and dried powder of Du Yi Wei extract according to the mass ratio of 50-200:1-10:1-5:1-5 respectively. Step 2: Stir the above materials thoroughly until uniform, and place them in a 55℃ water bath to dissolve them completely; Step 3: Pour into a glass freeze-drying dish and let cool at room temperature; Step 4: Seal the freeze-dried disc with plastic wrap and pre-freeze it in a -80℃ freezer for 24 to 48 hours; Step 5: After it solidifies into a block, place it in a vacuum freeze dryer for freeze drying. Step 6: After freeze-drying, a sponge-like porous material is obtained. Cut it into the same size and package it for later use.

10. The method for preparing a unique first-aid hemostatic bandage according to claim 5, characterized in that, In step five, the specific steps for preparing the unique hemostatic bandage are as follows: Step 1: Arrange the absorption zone (4) and tablet zone (5) alternately on the base layer (6); Step 2: Use traditional Chinese medicine adhesive to bond and fix the parts together; Step 3: Fix the pad (3) to the front end of the tight band (2); Step 4: After completing the production of the main body of the bandage (1), perform radiation sterilization; Step 5: Roll it up and put it into an aluminum packaging bag, then vacuum seal it.

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