Medicine bag for local edema after tumor operation and radiotherapy and preparation method of medicine bag

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicine bag for treating local edema after tumor operation and radiotherapy and a preparation method thereof.The medicine bag is prepared from, by weight, 20-30 parts of radix astragali, 20-30 parts of radix paeoniae rubra, 20-30 parts of mirabilite, 15-20 parts of poria cocos, 15-20 parts of rhizoma curcumae longae, 10-15 parts of borneol, 10-15 parts of pollen typhae, 20-40 parts of self-heating matrix, 30-70 parts of hyaluronic acid and 50-80 parts of glycerinum. The used traditional Chinese medicines have the effects of inducing diuresis to alleviate edema, promoting blood circulation to remove blood stasis, resisting inflammation, easing pain and the like, and the prepared self-heating matrix has the characteristics of continuous and controllable moisture absorption and heat release, can promote a medicine bag to form a gel state during use, provides a warm environment for transdermal penetration of the active ingredients of the traditional Chinese medicines, effectively improves local edema symptoms after tumor surgery and radiotherapy, and has a good application prospect. The clinical application value is relatively high.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a medicine package for local edema after tumor surgery and radiotherapy and a preparation method thereof. Background Art

[0002] After tumor surgery and radiotherapy, patients often experience local edema, pain, and slow wound healing. The occurrence of this local edema will not only affect the patient's recovery speed, but may also lead to complications such as poor blood circulation, tissue hypoxia, and persistent inflammation. In addition, tumor radiotherapy can cause increased sensitivity of local skin, and the wound surface is more susceptible to infection and irritation, which further increases the difficulty of treatment. Although traditional physical cooling, pressure bandaging, and conventional topical ointments can relieve edema and pain to a certain extent, they have many limitations. For example, ordinary topical drugs require additional heating or cold compress equipment when applied, which is inconvenient to use. At the same time, their moisturizing and antibacterial effects are weak, and it is difficult to meet the needs of long-term use. Some topical drugs may cause skin sensitivity or allergic reactions due to their strong irritating ingredients, especially when the skin is fragile after tumor surgery or radiotherapy, the patient's resistance is reduced and they are more susceptible to attack by pathogenic microorganisms.

[0003] Currently, the external products on the market for patients after tumor surgery and radiotherapy have single functions. There is an urgent need for an easy-to-use, multifunctional anti-edema medicine package to provide cancer patients with a more efficient solution for treating local edema problems. Summary of the invention

[0004] In view of the above situation, the present invention provides a medicine package for local edema after tumor surgery and radiotherapy and a preparation method thereof, which uses active Chinese medicine substances as the main detumescent, antibacterial and analgesic ingredients, has the characteristics of safety and mildness, and utilizes a hygroscopic gel composite matrix to wrap magnesium sulfate and calcium chloride, which absorbs moisture and releases heat when in contact with air, thereby providing suitable transdermal conditions for the Chinese medicine ingredients and alleviating edema after tumor surgery or radiotherapy.

[0005] To achieve the above purpose, the technical solution adopted by the present invention is as follows: The invention provides a medicine package for local edema after tumor surgery and radiotherapy. The medicine package comprises the following raw materials in parts by weight: 20-30 parts of astragalus, 20-30 parts of red peony root, 20-30 parts of mirabilite, 15-20 parts of tuckahoe, 15-20 parts of turmeric, 10-15 parts of borneol, 10-15 parts of pollen cattail, 20-40 parts of self-heating matrix, 30-70 parts of hyaluronic acid and 50-80 parts of glycerol.

[0006] Furthermore, the self-heating matrix comprises the following raw materials in parts by weight: 50-80 parts of magnesium sulfate, 30-50 parts of calcium chloride and 20-50 parts of chitosan.

[0007] Furthermore, the chitosan has a deacetylation degree of 85-95% and a molecular weight of 100-150 kDa.

[0008] The preparation method of the self-heating matrix comprises the following steps: S1: Weigh 20-50 parts of chitosan and dissolve them in pH 5.0 acetate buffer at a mass volume ratio of 1 g:6 mL to obtain a chitosan solution; S2: Weigh 50-80 parts of magnesium sulfate and 30-50 parts of calcium chloride, mix them to obtain a mixture, and dissolve the mixture in purified water in an ice bath at a mass volume ratio of 1 g:4 mL to obtain a mixture solution; S3: adding the mixture solution obtained in step S2 to the chitosan solution obtained in step S1, stirring for 20 min under magnetic stirring at 100 rpm to obtain a self-heating matrix solution; S4: spray drying the self-heating matrix solution obtained in step S3, with the spray dryer inlet temperature of 150-200°C, outlet temperature of 60-100°C, atomizer speed of 21500 rpm, and electric heating power of 60 kW to obtain a self-heating matrix.

[0009] The present invention also provides a method for preparing a medicine package for treating local edema after tumor surgery and radiotherapy, which specifically comprises the following steps: Step 1: Weigh 20-30 parts of Astragalus, 20-30 parts of Red Peony Root, 20-30 parts of Sodium Sulfate, 15-20 parts of Poria, 15-20 parts of Curcuma Longa, 10-15 parts of Borneolum Syntheticum and 10-15 parts of Pollen Typhae, mix and finely grind, and pass through a 120-mesh sieve to obtain Chinese medicine fine powder; Step 2: Weigh 30-70 parts of hyaluronic acid and 50-80 parts of glycerol, add them to the Chinese medicine powder obtained in step 1, and stir at 200 rpm for 30 min to obtain a viscous Chinese medicine matrix; Step 3: drying the traditional Chinese medicine matrix obtained in step 2 in an oven at 60° C. for 12 h to obtain traditional Chinese medicine matrix powder; Step 4: Weigh 20-40 portions of the self-heating matrix, mix them evenly with the traditional Chinese medicine matrix powder obtained in step 3, and vacuum-pack them to obtain a medicine package for local edema after tumor surgery and radiotherapy.

[0010] The beneficial effects achieved by the present invention are as follows: The local edema medicine package after tumor surgery and radiotherapy prepared by the present invention uses traditional Chinese medicine as the main active ingredient to exert its effect through transdermal transmission. The ingredients such as paeoniflorin, saponin, curcumin and the like in red peony root, mirabilite, turmeric and borneol have the effects of promoting blood circulation and removing blood stasis, and anti-inflammatory and analgesic. The polysaccharides and volatile oils in astragalus, tuckahoe and pollen cattail have the effects of promoting diuresis and reducing swelling, and strengthening the spleen and dredge menstruation. The magnesium sulfate in the self-heating matrix is ​​exposed to the air when used, has strong hygroscopicity, can promote chitosan, hyaluronic acid and glycerol to form a gel state, and the moisture absorption process of magnesium sulfate generates heat , and it releases heat by oxidizing reaction with polyphenol ingredients in traditional Chinese medicine. Without the help of additional heaters, it can provide a warm environment for the transdermal penetration of traditional Chinese medicine ingredients. Calcium chloride and chitosan can control the exothermic temperature and duration of magnesium sulfate, and effectively wrap magnesium sulfate in the formed gel without contacting the skin to cause irritation, and has a long-lasting heat-generating effect; in addition, hyaluronic acid and glycerol also have a moisturizing effect, avoiding dry and dehydrated skin caused by long-term dressings. Chitosan and traditional Chinese medicine ingredients such as curcumin and saponins also have antibacterial activity, which can effectively prevent local infection after tumor surgery and radiotherapy.

[0011] The medicine package for local edema after tumor surgery and radiotherapy provided by the present invention adopts a moisture absorption and self-heating mechanism and utilizes active ingredients of traditional Chinese medicine for treatment. It has the characteristics of simple operation, safety, durability, swelling reduction and pain relief, and has high clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 This is a flow chart of the preparation of the drug package for edema after tumor surgery and radiotherapy of the present invention; Figure 2 The self-heating temperature of the edema medicine package after tumor surgery and radiotherapy prepared in Comparative Example 1 and Examples 1-3 varies with time; Figure 3 The results are the granuloma net weight and inflammation inhibition rate of rats after using the edema medicine packs after tumor surgery and radiotherapy prepared by Examples 1-3 and Comparative Examples 1-3.

[0013] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention. DETAILED DESCRIPTION

[0014] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only 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 ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0015] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein may be applied to the present invention. The preferred implementation methods and materials described herein are for demonstration purposes only and are not intended to limit the content of this application.

[0016] In the following embodiments, the preparation process of the local edema drug package after tumor surgery and radiotherapy is as follows: Figure 1 As shown, unless otherwise specified, all methods are conventional; the materials used in the following embodiments, unless otherwise specified, are new materials purchased from the market.

[0017] Example 1: This example provides a medicine pack for local edema after tumor surgery and radiotherapy, which includes the following raw materials in parts by weight: 20 parts of astragalus, 20 parts of red peony root, 20 parts of mirabilite, 15 parts of poria, 15 parts of turmeric, 10 parts of borneol, 10 parts of pollen, 20 parts of self-heating matrix, 30 parts of hyaluronic acid and 50 parts of glycerol.

[0018] The self-heating matrix comprises the following raw materials in parts by weight: 50 parts of magnesium sulfate, 50 parts of calcium chloride and 30 parts of chitosan. The specific preparation method is as follows: S1: Weigh 30 parts of chitosan and dissolve it in pH 5.0 acetate buffer at a mass volume ratio of 1 g:6 mL to obtain a chitosan solution; S2: Weigh 50 parts of magnesium sulfate and 50 parts of calcium chloride, mix them to obtain a mixture, and dissolve the mixture in purified water in an ice bath at a mass volume ratio of 1 g:4 mL to obtain a mixture solution; S3: adding the mixture solution obtained in step S2 to the chitosan solution obtained in step S1, stirring for 20 min under magnetic stirring at 100 rpm to obtain a self-heating matrix solution; S4: spray drying the self-heating matrix solution obtained in step S3, with the spray dryer inlet temperature of 150° C., outlet temperature of 60° C., atomizer speed of 21500 rpm, and electric heating power of 60 kW to obtain a self-heating matrix.

[0019] This embodiment also provides a method for preparing a drug package for local edema after tumor surgery and radiotherapy, which specifically includes the following steps: Step 1: Weigh 20 parts of Astragalus, 20 parts of Red Peony Root, 20 parts of Sodium Sulfate, 15 parts of Poria, 15 parts of Curcuma Longa, 10 parts of Borneolum Syntheticum and 10 parts of Pollen Typhae, mix and finely grind, and pass through a 120-mesh sieve to obtain Chinese medicine micro powder; Step 2: Weigh 30 parts of hyaluronic acid and 50 parts of glycerol, add them to the Chinese medicine powder obtained in step 1, and stir at 200 rpm for 30 min to obtain a viscous Chinese medicine matrix; Step 3: drying the traditional Chinese medicine matrix obtained in step 2 in an oven at 60° C. for 12 h to obtain traditional Chinese medicine matrix powder; Step 4: Weigh 20 portions of the self-heating matrix, mix them evenly with the traditional Chinese medicine matrix powder obtained in step 3, and vacuum-pack them to obtain a medicine package for local edema after tumor surgery and radiotherapy.

[0020] Example 2: This example provides a medicine pack for local edema after tumor surgery and radiotherapy, which includes the following raw materials in parts by weight: 25 parts of astragalus, 25 parts of red peony root, 25 parts of mirabilite, 20 parts of poria, 20 parts of turmeric, 15 parts of borneol, 15 parts of pollen, 40 parts of self-heating matrix, 70 parts of hyaluronic acid and 80 parts of glycerol.

[0021] The self-heating matrix comprises the following raw materials in parts by weight: 70 parts of magnesium sulfate, 40 parts of calcium chloride and 50 parts of chitosan. The specific preparation method is as follows: S1: Weigh 50 parts of chitosan and dissolve it in pH 5.0 acetate buffer at a mass volume ratio of 1 g:6 mL to obtain a chitosan solution; S2: Weigh 70 parts of magnesium sulfate and 40 parts of calcium chloride, mix them to obtain a mixture, and dissolve the mixture in purified water in an ice bath at a mass volume ratio of 1 g:4 mL to obtain a mixture solution; S3: adding the mixture solution obtained in step S2 to the chitosan solution obtained in step S1, stirring for 20 min under magnetic stirring at 100 rpm to obtain a self-heating matrix solution; S4: spray drying the self-heating matrix solution obtained in step S3, with the spray dryer inlet temperature of 150° C., outlet temperature of 60° C., atomizer speed of 21500 rpm, and electric heating power of 60 kW to obtain a self-heating matrix.

[0022] This embodiment also provides a method for preparing a drug package for local edema after tumor surgery and radiotherapy, which specifically comprises the following steps: Step 1: Weigh 25 parts of Astragalus, 25 parts of Red Peony Root, 25 parts of Sodium Sulfate, 20 parts of Poria, 20 parts of Curcuma Longa, 15 parts of Borneolum Syntheticum and 15 parts of Pollen Typhae, mix and finely grind, and pass through a 120-mesh sieve to obtain Chinese medicine fine powder; Step 2: Weigh 70 parts of hyaluronic acid and 80 parts of glycerol, add them to the Chinese medicine powder obtained in step 1, and stir at 200 rpm for 30 min to obtain a viscous Chinese medicine matrix; Step 3: drying the traditional Chinese medicine matrix obtained in step 2 in an oven at 60° C. for 12 h to obtain traditional Chinese medicine matrix powder; Step 4: Weigh 40 portions of the self-heating matrix, mix them evenly with the traditional Chinese medicine matrix powder obtained in step 3, and vacuum-pack them to obtain a medicine package for local edema after tumor surgery and radiotherapy.

[0023] Example 3: This example provides a medicine pack for local edema after tumor surgery and radiotherapy, which includes the following raw materials in parts by weight: 30 parts of astragalus, 30 parts of red peony root, 30 parts of mirabilite, 18 parts of poria, 18 parts of turmeric, 12 parts of borneol, 12 parts of pollen, 30 parts of self-heating matrix, 50 parts of hyaluronic acid and 60 parts of glycerol.

[0024] The self-heating matrix comprises the following raw materials in parts by weight: 80 parts of magnesium sulfate, 30 parts of calcium chloride and 20 parts of chitosan. The specific preparation method is as follows: S1: Weigh 20 parts of chitosan and dissolve it in pH 5.0 acetate buffer at a mass volume ratio of 1 g:6 mL to obtain a chitosan solution; S2: Weigh 80 parts of magnesium sulfate and 30 parts of calcium chloride, mix them to obtain a mixture, and dissolve the mixture in purified water in an ice bath at a mass volume ratio of 1 g:4 mL to obtain a mixture solution; S3: adding the mixture solution obtained in step S2 to the chitosan solution obtained in step S1, stirring for 20 min under magnetic stirring at 100 rpm to obtain a self-heating matrix solution; S4: spray drying the self-heating matrix solution obtained in step S3, with the spray dryer inlet temperature of 150° C., outlet temperature of 60° C., atomizer speed of 21500 rpm, and electric heating power of 60 kW to obtain a self-heating matrix.

[0025] This embodiment also provides a method for preparing a drug package for local edema after tumor surgery and radiotherapy, which specifically includes the following steps: Step 1: Weigh 30 parts of Astragalus, 30 parts of Red Peony Root, 30 parts of Sodium Sulfate, 18 parts of Poria, 18 parts of Curcuma Longa, 12 parts of Borneolum Syntheticum and 12 parts of Pollen Typhae, mix and finely grind, and pass through a 120-mesh sieve to obtain Chinese medicine fine powder; Step 2: Weigh 50 parts of hyaluronic acid and 60 parts of glycerol, add them to the Chinese medicine powder obtained in step 1, and stir at 200 rpm for 30 min to obtain a viscous Chinese medicine matrix; Step 3: drying the traditional Chinese medicine matrix obtained in step 2 in an oven at 60° C. for 12 h to obtain traditional Chinese medicine matrix powder; Step 4: Weigh 30 portions of the self-heating matrix, mix them evenly with the traditional Chinese medicine matrix powder obtained in step 3, and vacuum-pack them to obtain a medicine package for local edema after tumor surgery and radiotherapy.

[0026] The difference between Comparative Example 1 and Example 1 is that magnesium sulfate and calcium chloride are not added, and the rest is the same as Example 1; The difference between Comparative Example 2 and Example 1 is that chitosan is not added, and the rest is the same as Example 1; The difference between Comparative Example 3 and Example 1 is that no glycerol is added, and the rest is the same as Example 1.

[0027] Study on the change of self-heating temperature with time Take the medicine packages prepared in Comparative Example 1 and Examples 1-3, open the packages, and use a temperature measuring gun to measure the temperature of the medicine packages at 10 s, 1 min, 20 min, 1 h, 2 h and 4 h. The results are shown in Figure 2 .

[0028] Investigation of inflammation inhibition rate SPF SD rats weighing 200-220 g were selected, and the bilateral groin and abdominal hair were removed. The rats were anesthetized with isoflurane. In a sterile environment, 20 mg of sterile dry cotton balls were implanted subcutaneously in the bilateral groins, and the incisions were sutured. The rats that were only opened and sutured were used as sham operation groups. The rats that were not given the drug and used the drug packs prepared in Examples 1-3 and Comparative Examples 1-3 were used as control groups, Example 1 groups, Example 2 groups, Example 3 groups, Comparative Example 1 groups, Comparative Example 2 groups, and Comparative Example 3 groups, with 3 rats in each group being investigated. Each application lasted for 2 hours, 2 times / day, with an interval of 6 hours each time, and the drug administration lasted for 7 consecutive days. After the last administration, the rats were anesthetized and killed, the granulomas in the groin of the rats were weighed and recorded in wet weight, and then dried at 60°C for 24 hours, and the dry weight of the granulomas was weighed and recorded. The net weight of the granulomas and the inflammation inhibition rate were calculated. The results are shown in Figure 3 Granuloma net weight = granuloma weight of dried cotton ball - original cotton ball weight, inflammation inhibition rate % = (average granuloma net weight of control group - average granuloma net weight of drug group) / average granuloma net weight of control group × 100%.

[0029] Treatment Effects 104 patients with edema after tumor surgery or radiotherapy were randomly divided into a control group and an observation group, 52 cases in each group. The average age of the control group was 42.25±8.23 years old, and the average course of disease was 5.02±1.12 months; the average age of the observation group was 44.12±8.10 years old, and the average course of disease was 5.18±1.08 months. The patients in the control group were given conventional oral diosmin tablets, 0.9 g / time, 2 times / day, and lymphatic drainage treatment; the patients in the observation group were given the medicine package prepared in Example 1, 2 h / time, 2 times / day, with an interval of 6 h, lymphatic drainage treatment; each group was treated for 3 weeks. The efficacy criteria are as follows: cured: symptoms such as upper limb edema and pain did not recur, and the circumference difference between the affected and healthy sides of the upper limb decreased by ≥75%; markedly effective: symptoms of upper limb edema and pain were significantly improved, 75%> the circumference difference between the affected and healthy sides of the upper limb decreased by ≥50%; effective: symptoms of upper limb edema and pain were relieved, 50%> the circumference difference between the affected and healthy sides of the upper limb decreased by ≥25%; ineffective: the above symptoms were not relieved or even aggravated, and the circumference difference between the affected and healthy sides of the upper limb decreased by <25%. The efficacy results are shown in Table 1. The occurrence of adverse reactions in the two groups of patients was also recorded, and the results are shown in Table 2.

[0030] Table 1 Comparison of clinical efficacy between the two groups

[0031] Table 2 Comparison of adverse reactions between the two groups

[0032] Figure 2 The results showed that the prepared self-heating matrix had good self-heating properties and could maintain a temperature of around 40°C for 3 hours, which could greatly improve the efficiency of clinical hot compresses.

[0033] Figure 3 The results show that Examples 1-3 and Comparative Examples 1-3 all have good inflammation inhibition rates, and the Chinese medicine used has good anti-inflammatory effects.

[0034] The clinical treatment results in Table 1 and Table 2 show that the drug package prepared in Example 1 is effective in alleviating edema after tumor surgery or radiotherapy, and is safe to use, has low adverse reactions, and has high patient compliance.

[0035] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

[0036] The present invention and its implementation methods are described above, which is not restrictive. The drawings are only one of the implementation methods of the present invention, and the actual application is not limited thereto. In short, if ordinary technicians in the field are inspired by it and design methods and embodiments similar to the technical solution without creativity without departing from the purpose of the invention, they should all fall within the protection scope of the present invention.

Claims

1. A medicine package for local edema after tumor surgery and radiotherapy, characterized in that: The medicine package comprises the following raw materials in parts by weight: 20-30 parts of astragalus, 20-30 parts of red peony root, 20-30 parts of mirabilite, 15-20 parts of tuckahoe, 15-20 parts of turmeric, 10-15 parts of borneol, 10-15 parts of pollen cattail, 20-40 parts of self-heating matrix, 30-70 parts of hyaluronic acid and 50-80 parts of glycerol; The self-heating matrix comprises the following raw materials: magnesium sulfate, calcium chloride and chitosan, and the specific preparation method is as follows: S1: weigh chitosan and dissolve it in acetate buffer to obtain a chitosan solution; S2: Weigh magnesium sulfate and calcium chloride, mix them and dissolve them in purified water to obtain a mixture solution; S3: adding the mixture solution obtained in step S2 to the chitosan solution obtained in step S1, stirring, to obtain a self-heating matrix solution; S4: spray-drying the self-heating matrix solution obtained in step S3 to obtain a self-heating matrix.

2. A medicine package for local edema after tumor surgery and radiotherapy according to claim 1, characterized in that: The weight proportions of the magnesium sulfate, calcium chloride and chitosan are 50-80 parts, 30-50 parts and 20-50 parts respectively; In step S1, the mass volume ratio of chitosan to acetate buffer is 1 g:6 mL, and the pH of the acetate buffer is 5.0; In step S2, the mixture is obtained after the mixing, the mass volume ratio of the mixture to purified water is 1 g:4 mL, and the dissolution process is carried out in an ice bath; In step S4, the spray drying conditions are as follows: inlet temperature 150-200°C, outlet temperature 60-100°C, atomizer speed 21500rpm, and electric heating power 60 kW.

3. A medicine package for local edema after tumor surgery and radiotherapy according to claim 1, characterized in that: The chitosan has a deacetylation degree of 85-95% and a molecular weight of 100-150 kDa.

4. A method for preparing a drug package for treating local edema after tumor surgery and radiotherapy according to any one of claims 1 to 3, characterized in that: The specific preparation method is as follows: Step 1: Weigh astragalus, red peony root, mirabilite, tuckahoe, turmeric, borneol and pollen cattail, mix, finely grind and sieve to obtain Chinese medicine micro powder; Step 2: Weigh hyaluronic acid and glycerin, add them to the Chinese medicine powder obtained in step 1, and stir to obtain a viscous Chinese medicine matrix; Step 3: drying the traditional Chinese medicine matrix obtained in step 2 to obtain traditional Chinese medicine matrix powder; Step 4: Weigh the self-heating matrix and mix it with the traditional Chinese medicine matrix powder obtained in step 3, and encapsulate it to obtain a medicine package for local edema after tumor surgery and radiotherapy.

5. The method for preparing a drug package for treating local edema after tumor surgery and radiotherapy according to claim 4, characterized in that: In step 1, the mesh size of the sieve is 120 meshes; In step 3, the drying process is carried out in an oven at a temperature of 60°C; In step 4, the packaging is vacuum packaging.

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