Preparation method of drug patch for treating diabetic foot ulcer

Abstract

The invention discloses a preparation method of a drug patch for treating diabetic foot ulcers in the field of medical technology. The method comprises the following steps: step 1, preparing a drug solution according to the composition of the drug solution; and pre-thawing the raw materials PDLA-CPC-PDLA triblock polymer and PLLA-PEG-PLLA respectively; step 2, adding the PDLA-CPC-PDLA triblock polymer to PLLA-PEG-PLLA under room temperature conditions for stirring, and then adding the drug solution to prepare a micelle solution, which is stored at low temperature and sealed; step 3, pouring the micelle solution in step 2 into a hydrogel film model, heating it to 37 degrees to form a hydrogel film, and laminating the hydrogel film on the surface of the patch, wherein an electric heating tube and a control panel for adjusting the electric heating temperature are arranged in the patch; fixing the antibacterial hydrogel on the wound surface by the patch, utilizing the temperature difference between the patient and the patch to make the drug solution easily precipitate from the hydrogel, utilizing the morphological change of the hydrogel film to form a pressing effect, promoting the wound to absorb the drug, and playing the role of sterilization and promoting wound healing.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to a method for preparing a medicine patch for treating diabetic foot ulcers. Background Art

[0002] Diabetic foot ulcer is one of the common late complications of diabetes. The chronic wounds of diabetic foot patients generally stay in the inflammatory stage for a long time, and during this process, there are large amounts of tissue exudate, severe infection, pain, local tissue necrosis, etc. Such wounds often involve infection with pathogenic microorganisms and require long-term medication and dressing changes.

[0003] Traditional dressings such as gauze and cotton pads have poor efficacy, and frequent replacement may cause secondary damage due to adhesion to the wound. And lack of bioactive molecules, the efficacy is limited. As a new type of wound dressing, hydrogel can provide a moist environment, prevent dehydration, and help wound healing; in addition, hydrogel can also prevent microbial infection as a protective barrier. In addition, the composite hydrogel film composed of calcium alginate hydrogel containing nanosilver in the prior art also has a bactericidal effect, but silver ions are continuously released from the hydrogel, forming a certain accumulation on the tissue surface, and the body cannot metabolize it in time. High concentrations of silver ions on the tissue surface will inevitably produce a series of toxic side effects. Among them, the antibacterial hydrogel formed by complexation of PDLA-CPC-PDLA triblock polymer and biodegradable PLLA-PEG-PLLA has greatly improved bactericidal ability against Gram-negative bacteria and Gram-positive bacteria, and the degree of damage to red blood cells by the hydrogel is very low, which is convenient for wound tissue healing. Summary of the invention

[0004] The purpose of the present invention is to provide a method for preparing a drug patch for treating diabetic foot ulcers, which can promote the wound to absorb the drug and play a role in sterilization and promoting wound healing.

[0005] In order to achieve the above object, the technical solution of the present invention is as follows:

[0006] The preparation method of a drug patch for treating diabetic foot ulcers comprises the following steps: step 1, selecting Loropetalum damifolia extract, Angelica sinensis extract, Licorice extract, Angelica dahurica extract and Lithospermum officinale extract according to the weight ratio of the drug solution, removing impurities from each drug extract, dissolving in water and standing to store, to obtain a drug solution;

[0007] Then, the raw materials PDLA-CPC-PDLA triblock polymer and PLLA-PEG-PLLA were pre-thawed respectively;

[0008] Step 2: at room temperature, add PDLA-CPC-PDLA triblock polymer to PLLA-PEG-PLLA and stir to prepare micelle solution, then add each drug solution to the micelle solution, store at low temperature and seal;

[0009] Step three, pour the micro-particle solution of step two into the hydrogel film model, the surface of the hydrogel model is provided with a number of heat-conducting massage blocks, heated to 37 degrees to form a hydrogel film, and the hydrogel film is attached to the surface of the patch. The patch is provided with an electric heating tube and a control panel for adjusting the electric heating temperature. The control panel is electrically connected to a temperature detection head, so that the temperature detection head of the patch is bonded to both sides of the surface of the hydrogel film.

[0010] Furthermore, the weight ratio of the drug solution is 10 parts of Loropetalum dahliae extract, 6 parts of Angelica sinensis extract, 3 parts of Licorice extract, 1 part of Angelica dahurica extract, and 1.2 parts of Lithospermum officinale extract.

[0011] Furthermore, in step three, the massage block is made of medical silicone.

[0012] Further, in step three, the massage block is disc-shaped and embedded on the surface of the hydrogel film.

[0013] Furthermore, in step three, the hydrogel film is formed by complexation with non-covalent bonding as the driving force.

[0014] Furthermore, in step 2 and step 3, the hydrogel film exists in a state of micelle solution at room temperature; at a temperature above 37 degrees, PDLA-CPC-PDLA and PLLA-PEG-PLLA are cross-linked to form a hydrogel film in a gel state.

[0015] Furthermore, in step 2, the ratio of the pharmaceutical solution to the micelle solution is 1:9.

[0016] Furthermore, in step 2, the reaction time of the micelle solution under low temperature storage is 20-23 hours.

[0017] The following beneficial effects are achieved by adopting the above scheme: through the synergistic effect of different medicinal materials such as Loropetalum truncatum, Angelica sinensis, Licorice, Angelica dahurica and Lithospermum officinale, the wound is facilitated to absorb the drug for healing, thereby accelerating the healing process of the wound.

[0018] In the early stage of wound healing, due to the temperature difference between the patient's foot temperature and the hydrogel, the drug in the hydrogel is easily precipitated and gradually accumulates on the wound surface to form a drug layer. Then, through continuous heating of the dressing, a hot compress effect is formed, which promotes blood circulation near the wound and facilitates the wound to absorb the drug.

[0019] At the same time, the hydrogel forms an outer protective layer and the drug forms an inner protective layer to block or kill bacteria and improve the bactericidal effect.

[0020] When the micelle solution changes from liquid to micro-solid, the volume of the hydrogel after absorbing water will increase, pushing the massage block to press on the wound surface, thereby promoting blood circulation and promoting the wound's absorption of drugs, while also playing a role in sterilization and promoting wound healing. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 This is a schematic diagram of the microstructure of the hydrogel film formed in the method for preparing a drug for treating diabetic foot ulcers according to an embodiment of the present invention.

[0022] Figure 2 This is a schematic diagram of the microstructure of the micelle solution of the hydrogel film in the method for preparing a drug for treating diabetic foot ulcers according to an embodiment of the present invention.

[0023] Figure 3 This is a schematic diagram of the application of a method for preparing a medicine for treating diabetic foot ulcers according to an embodiment of the present invention. DETAILED DESCRIPTION

[0024] The following is further described in detail through specific implementation methods:

[0025] The reference numerals in the drawings of the specification include: patch 1 , temperature detection head 11 , hydrogel film 2 , and hydrogel model 3 .

[0026] Example 1

[0027] The embodiment is basically as shown in the attached Figures 1 to 3 As shown: A method for preparing a drug for treating diabetic foot ulcers comprises the following steps:

[0028] Step 1. Select Loropetalum damifolia extract, Angelica sinensis extract, Licorice extract, Angelica dahurica extract and Lithospermum officinale extract according to the weight ratio of the drug solution, remove impurities from each drug extract, dissolve them in water and store them statically to obtain a drug solution; the weight ratio of the drug solution is 10 parts of Loropetalum damifolia extract, 6 parts of Angelica sinensis extract, 3 parts of Licorice extract, 1 part of Angelica dahurica extract and 1.2 parts of Lithospermum officinale extract.

[0029] Then, the raw materials PDLA-CPC-PDLA triblock polymer (made of dextrorotatory polylactic acid (PDLA) and cetylpyridinium chloride (CPC)) triblock polymer and degradable PLLA-PEG-PLLA (made of polylactic acid (PLLA) and polyethylene glycol (PEG) arranged alternately) were pre-thawed respectively;

[0030] Step 2: At room temperature, add the PDLA-CPC-PDLA triblock polymer to PLLA-PEG-PLLA and stir to prepare a micelle solution, then add the drug solution to the micelle solution, react at low temperature for 20-23 hours, store and seal; the ratio of the drug solution to the micelle solution is 1:9.

[0031] Step three, pour the micro-particle solution of step two into the hydrogel film 2 model, the surface of the hydrogel model 3 is provided with a number of heat-conducting massage blocks, heated to 37 degrees to be formed into a hydrogel film 2, and the formation of the hydrogel film 2 is formed by complexation with non-covalent bonds as the driving force; the hydrogel film 2 is attached to the surface of the patch 1, and the patch 1 is provided with an electric heating tube and a control panel for adjusting the electric heating temperature, and the control panel is electrically connected to a temperature detection head 11, so that the temperature detection head 11 of the patch 1 is bonded to both sides of the surface of the hydrogel film 2.

[0032] The hydrogel film 2 exists in the state of micelle solution at room temperature; when the temperature is above 37 degrees, the hydrogel film 2 in gel state is formed by cross-linking PDLA-CPC-PDLA and PLLA-PEG-PLLA.

[0033] The specific implementation process is as follows: According to the records of traditional Chinese medicine, angelica has the effects of nourishing blood, activating blood circulation, regulating menstruation and relieving pain, and detoxifying; licorice has the effects of relieving acute pain and alleviating the medicinal properties; angelica has the effects of reducing swelling and discharging pus; lithospermum has the effects of clearing heat and cooling blood, activating blood circulation and detoxifying, and removing rashes and spots. Through the synergistic effect of different medicinal materials, studies have shown that Loropetalum dahliae has a stronger healing effect. The extracts of each medicinal material are distributed in the hydrogel in the form of solution, which facilitates wound healing and accelerates the wound healing process.

[0034] In the early stage of wound healing, due to the poor blood circulation of diabetic patients, the body temperature of the patient's feet is easily lower than that of normal people. The patch 1 that fits the patient's feet makes it easy for the hydrogel film 2 to exist in the state of micro-particle solution, and the drug solution in the hydrogel film 2 is easy to precipitate. Then, through the continuous heating of the electric heating tube in the patch 1, the drug in the drug solution is gradually accumulated on the wound surface to form a drug layer; it is also easy to form a hot compress effect, promote blood circulation near the wound, and facilitate the wound to absorb the drug.

[0035] After different types of bacteria come into contact with the surface of the hydrogel film 2, the structure of the hydrogel film 2 will destroy the morphology of the bacterial cell membrane / cell wall, thereby killing the bacteria near the wound; at the same time, during the contact between the drug and the wound, the formed drug layer becomes an inner protective layer to block the bacteria and improve the sterilization effect.

[0036] During the continuous heating process of the electric heating tube in the patch 1, the control panel in the patch 1 detects the temperature change of the patient's foot through the temperature detection head 11, and the control panel adjusts the power of the electric heating tube based on the temperature change to facilitate maintaining the shape of the hydrogel film 2.

[0037] When the micelle solution changes from liquid to micro-solid, the volume of the hydrogel will increase after absorbing water, which will promote the fluidity of the drug in the hydrogel, facilitate the contact between the drug and the wound surface, and push the massage block to press the wound surface, so as to promote blood circulation and promote the wound's absorption of drugs, while playing a role in sterilization and promoting wound healing.

[0038] Example 2

[0039] The difference from the above embodiment is that the massage block is made of medical silicone.

[0040] The specific implementation process is as follows: Medical silicone has good biocompatibility, is non-irritating, non-toxic, non-allergic to human tissues, and has very few body rejection reactions; it has good physical and chemical properties, and can maintain its original elasticity and softness during contact with body fluids and tissues, and will not be degraded. It is a fairly stable inert substance. It is also easy to process and shape.

[0041] Example 3

[0042] The difference from the above embodiment is that the massage block is disc-shaped and is embedded on the surface of the hydrogel film.

[0043] The specific implementation process is as follows: the disc-shaped massage block can increase the contact area between the hydrogel films 2. When the hydrogel films 2 undergo morphological changes, it is convenient to drive the massage block to press the patient's feet to promote the patient's blood circulation.

[0044] The above is only an embodiment of the present invention, and the common knowledge such as the known specific structure and / or characteristics in the scheme is not described in detail here. It should be pointed out that for those skilled in the art, several deformations and improvements can be made without departing from the structure of the present invention, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. A method for preparing a drug patch for treating diabetic foot ulcers, characterized in that: The following steps are involved: Step 1: selecting Loropetalum dahliae extract, Angelica sinensis extract, Licorice extract, Angelica dahurica extract and Lithospermum officinale extract according to the weight ratio of the drug solution, removing impurities from each drug extract, dissolving them in water and standing them to obtain a drug solution; Then, the raw materials PDLA-CPC-PDLA triblock polymer and PLLA-PEG-PLLA were pre-thawed respectively; Step 2: at room temperature, add PDLA-CPC-PDLA triblock polymer to PLLA-PEG-PLLA and stir to prepare micelle solution, then add each drug solution to the micelle solution, store at low temperature and seal; Step three, pour the micro-particle solution of step two into the hydrogel film model, the surface of the hydrogel model is provided with a number of heat-conducting massage blocks, which are heated and shaped into a hydrogel film, and the hydrogel film is attached to the surface of the patch. The patch is provided with an electric heating tube and a control panel for adjusting the electric heating temperature, and the control panel is electrically connected to a temperature detection head, so that the temperature detection head of the patch is bonded to both sides of the surface of the hydrogel film.

2. The method for preparing a drug patch for treating diabetic foot ulcers according to claim 1, characterized in that: The weight ratio of the drug solution is: 10 parts of Loropetalum damiana extract, 6 parts of Angelica sinensis extract, 3 parts of Licorice extract, 1 part of Angelica dahurica extract, and 1.2 parts of Lithospermum officinale extract.

3. The method for preparing a drug patch for treating diabetic foot ulcer according to claim 1, characterized in that: In step three, the massage block is made of medical silicone.

4. The method for preparing a drug patch for treating diabetic foot ulcer according to claim 1, characterized in that: In step three, the massage block is disc-shaped and embedded on the surface of the hydrogel film.

5. The method for preparing a drug patch for treating diabetic foot ulcer according to claim 1, characterized in that: In step three, the hydrogel film is formed by complexation with non-covalent bonding as the driving force.

6. The method for preparing a drug patch for treating diabetic foot ulcer according to claim 1, characterized in that: In step 2 and step 3, the hydrogel film exists in the state of micelle solution at room temperature; when the temperature is above 37 degrees, PDLA-CPC-PDLA and PLLA-PEG-PLLA are cross-linked to form a hydrogel film in a gel state.

7. The method for preparing a drug patch for treating diabetic foot ulcer according to claim 1, characterized in that: In step 2, the ratio of the drug solution to the micelle solution is 1:

9.

8. The method for preparing a drug patch for treating diabetic foot ulcers according to claim 1, characterized in that: In step 2, the reaction time of the micelle solution stored at low temperature is 20-23 hours.

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