External composition for diminishing inflammation and swelling and application thereof

Abstract

The invention belongs to the technical field of externally applied anti-inflammation compositions, and particularly relates to an anti-inflammation and detumescence externally applied composition and application thereof.The anti-inflammation and detumescence externally applied composition is prepared from mirabilite particles and borneol powder according to the mass ratio of 1000: (2-6), and 8%-10% of crystal water is removed from the mirabilite particles, and the particle size of the mirabilite particles is 5-30 meshes; the external composition disclosed by the invention has excellent anti-inflammatory and detumescence effects on acute inflammation, and meanwhile, toxins are eliminated and poisoning symptoms are relieved; the external medicine composition is good in medicine effect and high in safety, the external medicine composition can take effect after being used for half an hour, a medicine package becomes wet after being used for 6-8 hours, and symptoms are obviously relieved; the invention provides a method for promoting recovery for local pathological states of acute inflammation, and the effect is remarkable; the invention solves the problem that no medicine or method with good effect and wide anti-inflammatory effect exists in the market at present, and provides an important treatment means and a new way for research on treatment medicines for various acute inflammations such as new coronavirus infection and acute pancreatitis.

Description

Technical Field

[0001] The invention belongs to the technical field of external anti-inflammatory compositions, and in particular relates to an anti-inflammatory and detumescent external composition and an application thereof. Background Art

[0002] The main component of the traditional Chinese medicine Glauber's salt is sodium sulfate decahydrate (Na2SO4·10H2O). It is a crystal that is colorless and transparent with a glassy luster. When the ambient temperature is ≥21°C, it will gradually lose its crystal water until all the water is removed and it becomes anhydrous Glauber's salt (also known as Yuanming powder, the main component of which is sodium sulfate, namely Na2SO4).

[0003] Clinical studies have shown that external use of Na2SO4 cannot absorb moisture from inflamed tissues through human skin. The crystal water of Na2SO4·10H2O is in a saturated state and cannot absorb moisture from inflamed tissues through human skin. In a previous study (Announcement No. CN101112384B), the inventor found that: by air-drying, crushing and sieving the Glauber's salt crystals (Na2SO4·10H2O) in multiple sections, removing part of the moisture in the Glauber's salt and removing the anhydrous sodium sulfate (Na2SO4) powder, strong water-absorbing Glauber's salt particles can be obtained. However, on the one hand, the process time of this technology is long due to natural air drying. On the other hand, high temperature, exposure to the sun, etc. will cause Glauber's salt to melt (Glauber's salt melts when the ambient temperature is ≥34°C), and excessive humidity will cause the Glauber's salt that has been partially dehydrated to absorb moisture and agglomerate. Therefore, it is necessary to accurately control the temperature and humidity of the natural air drying room. If it is not accurately controlled, it will lead to problems such as low yield. Therefore, it is still challenging to improve the water absorption of Glauber's salt and simplify the production process of Glauber's salt with strong water absorption.

[0004] In addition, although there are reports of external use of Glauber's salt in the prior art, and even reports of external use of Glauber's salt mixed with borneol, such as Chinese patent CN202122755820.X discloses an improved portable Glauber's salt external application patch, which mainly protects the improved structure of the Glauber's salt external application patch loaded with a ratio of 450g Glauber's salt: 50g borneol, which has the advantages of easy loading of drugs, uniform distribution of drugs and easy fixation, and high patient compliance. In the application document, it is mentioned that Glauber's salt and borneol are packaged together in a non-woven bag and applied around the navel for the treatment of adhesive intestinal obstruction, but the patent mainly protects the structure of the external application patch, which is to overcome the problem of uneven distribution of drugs and lack of fixation, and the problem of drug aggregation, displacement of the external application bag, and shedding. The mechanism of action of Glauber's salt and borneol has not been studied, and the sodium sulfate decahydrate used is not treated, so it does not have the function of absorbing water from inflammatory tissues through human skin.

[0005] Finally, there are currently no drugs or methods on the market that have good and widespread anti-inflammatory and detumescent effects. The "anti-inflammatory drugs" that people often refer to are antibacterial drugs, which can only play a bactericidal or antibacterial role, and cannot directly reduce inflammation and swelling. As a result, there is a lack of effective anti-inflammatory and detumescent strategies for acute inflammatory diseases such as new coronavirus infection and acute pancreatitis.

[0006] The present invention proposes a product research method to promote recovery based on the local pathological state of acute inflammation, providing a new approach to research therapeutic products for various acute inflammations including new coronavirus infection, acute pancreatitis, etc. Summary of the invention

[0007] In view of the deficiencies of the prior art, the present invention provides an anti-inflammatory and anti-swelling external composition and application thereof.

[0008] This is achieved specifically through the following technical solutions:

[0009] One of the purposes of the present invention is to provide an application of a mirabilite-borneol composition in the preparation of an external anti-inflammatory and detumescent medicine or medicine package for acute inflammation.

[0010] The mirabilite borneol composite is prepared from mirabilite particles and borneol powder in a mass ratio of 1000:(2-6). The mirabilite particles are mirabilite particles with 8%-10% of crystal water removed and a particle size of 5-30 meshes.

[0011] Furthermore, in the application, the acute inflammation is cerebral edema, frontal sinusitis, mumps, gingivitis, cold, pharyngitis, bronchitis, pneumonia, pleural effusion, acute mastitis, acute gastroenteritis, acute attack of chronic cholecystitis, acute pancreatitis, acute appendicitis, periappendiceal abscess, colitis, hemorrhoidal edema, postpartum perineal edema, pelvic inflammatory disease, ascites, acute nephritis, closed soft tissue injury, superficial lymphadenitis, periarthritis of the shoulder, tenosynovitis, synovitis, lumbar muscle strain, acute attack of rheumatoid arthritis, knee joint effusion, bone marrow edema, attack of lumbar disc herniation, attack of gout, duodenal ventricular edema, and liver abscess.

[0012] The pneumonia includes pediatric pneumonia and new coronavirus infection.

[0013] Furthermore, the acute inflammation is novel coronavirus infection or acute pancreatitis.

[0014] Another object of the present invention is to provide an external composition for reducing inflammation and swelling.

[0015] The external composition is prepared from mirabilite particles and borneol powder in a mass ratio of 1000:(2-6); the mirabilite particles are mirabilite particles with 8%-10% crystal water removed and a particle size of 5-30 meshes.

[0016] Furthermore, the anti-inflammatory and detumescent external composition is made of mirabilite particles and borneol powder in a mass ratio of 1000:4.

[0017] Furthermore, the particle size of the mirabilite particles is 5 to 30 meshes, which increases the surface area and specific surface area (m 2 / g), which greatly enhanced the water absorption of 8% to 10% dehydrated sodium sulfate.

[0018] Borneol has the effects of relieving pain and enhancing skin permeability. When used together with Glauber's salt with a particle size of 5 to 30 mesh and 8% to 10% of the crystal water removed, it can enhance the water absorption of the medicine bag.

[0019] However, if the proportion of borneol is too high, the proportion of water-absorbing Glauber's salt particles will decrease, which will lead to a decrease in the water absorption of the composition, while causing waste of borneol and increased costs; if the proportion of borneol is too low, the permeability of the skin will be poor, which is not conducive to the elimination of water, that is, it is not conducive to anti-inflammatory and swelling.

[0020] According to research, the optimal mass ratio of 8% to 10% dehydrated Glauber's salt particles with a particle size of 5 to 30 meshes to borneol is 1000:4.

[0021] In the present invention, mirabilite particles and borneol are made into a medicine bag in a specific ratio. The medicine bag is applied externally to the skin of the acute inflammation site of the human body or the skin closest to the acute inflammation site, and can absorb the moisture in the skin, resulting in a skin dehydrated area. The excess moisture in the acute inflammation tissue (in acute inflammation, the interstitial fluid increases) flows to the skin dehydrated area, and the moisture replenished in the dehydrated area flows out of the body and flows to the medicine bag. In this way, a water channel for the water to flow out of the body is formed, and the excess moisture in the acute inflammation tissue is continuously discharged from the body through the water channel, and the toxins dissolved in the water in the acute inflammation tissue are discharged from the body accordingly (when there is no inflammation at the external application site or the adjacent site, because there is no excess moisture, even if the medicine bag is used, the water channel cannot be established, that is, the medicine bag cannot play the role of draining water through the human skin).

[0022] The third object of the present invention is to provide a method for preparing mirabilite granules:

[0023] Place the Glauber's salt in a low-temperature drying device and dry it at 28-30°C for 4-6 hours. Grind the dried Glauber's salt into particles and powder with a particle size of ≤5 mesh, and remove fine particles and powder with a particle size of ≤30 mesh through a 30-mesh sieve to obtain Glauber's salt particles with a particle size of 5-30 mesh. Take the Glauber's salt particles with a particle size of 5-30 mesh obtained in the above steps and dry them for another hour to remove the free water generated on the surface of the Glauber's salt particles during the crushing and further dehydrate them. Then, pass them through a 30-mesh sieve again to remove fine particles and powder with a particle size of ≤30 mesh newly generated during the re-drying, and obtain Glauber's salt particles with a dehydration rate of 8%-10% and a particle size of 5-30 mesh.

[0024] When the ambient temperature is ≥21℃, then the salt begins to gradually lose water, and when the ambient temperature is ≥34℃, then the salt melts.

[0025] The size of the mirabilite particles is 5 to 30 meshes, and the surface area of ​​the mirabilite particles is increased, and the specific surface area (m 2 / g) increases, greatly enhancing the water absorption of the 8% to 10% dehydrated Glauber's salt. That is, the crystal water content of the Glauber's salt particles is controlled and the specific surface area is greatly increased, so that the Glauber's salt particles of the present invention have the characteristics of strong water absorption.

[0026] The method for preparing the acute inflammation external anti-inflammatory medicine package comprises the following steps:

[0027] (1) Placing the thenardite in a low-temperature drying device and drying it at 28-30° C. for 4-6 hours, crushing the dried thenardite into particles and powder with a particle size of ≤5 mesh, removing fine particles and powder with a particle size of ≤30 mesh through a 30-mesh sieve, taking the thenardite particles of 5-30 mesh obtained in the above step and drying them for another hour to remove free water generated on the surface of the thenardite particles during crushing and further dehydration, and again passing them through a 30-mesh sieve to remove fine particles and powder with a particle size of ≤30 mesh newly generated during re-drying, thereby obtaining thenardite particles with a dehydration rate of 8%-10% and a particle size of 5-30 mesh.

[0028] (2) taking Glauber's salt granules and borneol powder, and mixing the two uniformly in a mass ratio of Glauber's salt granules: borneol powder = 1000: (2-6), thereby obtaining an anti-inflammatory drug for external use in acute inflammation;

[0029] (3) According to the specification requirements, the acute inflammation topical anti-inflammatory drug is divided into absorbent gauze bags using an automatic filling machine, and the bags are sealed in the gauze bags to obtain acute inflammation topical anti-inflammatory drug packages.

[0030] The specification of the absorbent gauze is 50 yarns×70 yarns.

[0031] The acute inflammation external anti-inflammatory medicine package of the present invention has various specifications such as 50 grams, 75 grams, 125 grams, 250 grams and 500 grams.

[0032] The anti-inflammatory medicine package may be a medicine package with a single cavity, or may be a medicine package with 2 to 4 cavities.

[0033] Beneficial effects:

[0034] The topical composition of the present invention has excellent anti-inflammatory and detumescent effects after being packaged with a material having good water permeability and water absorption, especially for acute inflammation. The poisoning symptoms can also be alleviated along with the elimination of toxins. The topical pharmaceutical composition of the present invention has good efficacy and high safety, and can take effect within half an hour of use (water droplets can be seen on the skin). After 6 to 8 hours of use, the medicine bag becomes moist and the symptoms are significantly alleviated.

[0035] The present invention proposes a product research method to promote recovery around the local pathological state of acute inflammation, and the effect is remarkable. The present invention solves the problem that there are no drugs or methods with good and extensive anti-inflammatory and detumescent effects on the market, and provides an important treatment method for various acute inflammations including new coronavirus infection, acute pancreatitis, etc., and provides a new way to reduce inflammation and detumescence.

[0036] Specifically, the present invention mixes the mirabilite particles with a particle size of 5 to 30 meshes and borneol powder with 8% to 10% of crystal water removed in a specific ratio, packs them in a degreased gauze bag, and applies them to the skin of the acute inflammation site of the human body or the skin closest to the acute inflammation site, which can absorb the moisture in the skin and produce a skin water-deficient area. The excess moisture in the acute inflammation tissue (when acute inflammation occurs, the interstitial fluid increases) flows to the skin water-deficient area, and the moisture replenished in the water-deficient area flows out of the body and flows to the medicine bag. In this way, a water channel for the water to flow out of the body is formed, and the excess moisture in the acute inflammation tissue is continuously discharged from the body through the water channel, and the toxins dissolved in the water in the acute inflammation tissue are discharged from the body accordingly (when there is no acute inflammation at the external application site or the adjacent site, because there is no excess moisture, the water channel cannot be established even if the medicine bag is used, that is, the medicine bag cannot play the role of draining water through the human skin).

[0037] At the same time, the water flowing out of the body causes the Glauber's salt to dissolve, forming a hypertonic sodium sulfate liquid (hypertonic salt). Hypertonic sodium sulfate has a dehydrating effect on the skin and promotes the excretion of water.

[0038] This double drainage effect achieves a good anti-inflammatory and detumescence effect. We also unexpectedly discovered that this specific ratio of the composition removes toxic substances while removing water from the inflamed tissue (after the pancreatitis patient applied the drug combination package externally, trypsin was detected in the package), thereby achieving the effect of alleviating the symptoms of poisoning.

[0039] The present invention uses low-temperature drying to treat the mirabilite, so that 8% to 10% of the crystal water of the mirabilite is removed, and then combined with particle size control, a high specific surface area (m 2 / g) of Sodium Sulfate particles greatly improves the water absorption of Sodium Sulfate, and has short processing time, simple control parameters, high product yield, excellent production efficiency and good production stability.

[0040] The present invention uses absorbent cotton gauze to wrap the external medicine composition, achieving good water permeability and water absorption and not easy to be damaged. Then, the external medicine composition is sealed with an aluminum foil bag, which effectively avoids the gradual loss of efficacy due to contact with air, so that the validity period of the external medicine composition is at least 3 years. DETAILED DESCRIPTION

[0041] The specific embodiments of the present invention are further described in detail below, but the present invention is not limited to these embodiments, and any improvement or substitution based on the basic spirit of the present embodiment still falls within the scope of protection required by the claims of the present invention.

[0042] Example 1

[0043] The invention discloses an anti-inflammatory and detumescent external composition, which is composed of mirabilite particles and borneol powder in a mass ratio of 1000:2; the mirabilite particles are mirabilite with 10% of crystal water removed and an average particle size of 20 meshes.

[0044] Example 2

[0045] The invention discloses an anti-inflammatory and detumescent external composition, which is composed of mirabilite particles and borneol powder in a mass ratio of 1000:6; the mirabilite particles are mirabilite with 9% of crystal water removed and an average particle size of 16 meshes.

[0046] Example 3

[0047] A composition for external use for reducing inflammation and swelling is composed of mirabilite particles and borneol powder in a mass ratio of 1000:3; the mirabilite particles are mirabilite with 8% of crystal water removed and an average particle size of 10 meshes.

[0048] Example 4

[0049] A method for preparing an acute inflammation external anti-inflammatory medicine package comprises the following steps:

[0050] (1) Place the Glauber's salt in a low-temperature drying device and dry it at 29°C for 5 hours. Grind the dried Glauber's salt into particles and powder with a particle size of ≤5 mesh, and remove fine particles and powder with a particle size of ≤30 mesh through a 30-mesh sieve to obtain Glauber's salt particles with a size of 5 to 30 mesh. Dry the Glauber's salt particles for another hour to remove free water generated on the surface of the Glauber's salt particles during grinding and further dehydrate them, and again pass through a 30-mesh sieve to remove fine particles and powder with a particle size of ≤30 mesh newly generated during re-drying, to obtain Glauber's salt particles with a particle size of 5 to 30 mesh that are 10% dehydrated;

[0051] (2) taking Glauber's salt granules and borneol powder, and mixing the two evenly in a mass ratio of Glauber's salt granules: borneol powder = 1000:4, thereby obtaining an anti-inflammatory drug for external use in acute inflammation;

[0052] (3) According to the specification requirements, the acute inflammation topical anti-inflammatory drugs are divided into absorbent cotton gauze bags (50 gauze x 70 gauze) of different sizes using an automatic packaging machine, and the bags are sealed in gauze bags to obtain acute inflammation topical anti-inflammatory drug packages.

[0053] Example 5

[0054] A method for preparing an acute inflammation external anti-inflammatory medicine package comprises the following steps:

[0055] (1) Place the Glauber's salt in a low-temperature drying device and dry it at 30°C for 4 hours. Grind the dried Glauber's salt into particles and powder with a particle size of ≤5 mesh, and remove fine particles and powder with a particle size of ≤16 mesh through a 16-mesh sieve to obtain Glauber's salt particles with a size of 5-16 mesh. Dry the obtained Glauber's salt particles with a size of 5-16 mesh for another hour to remove free water generated on the surface of the Glauber's salt particles during grinding and further dehydrate them, and then pass them through a 16-mesh sieve again to remove fine particles and powder with a particle size of ≤16 mesh newly generated during re-drying, to obtain Glauber's salt particles with a dehydration rate of 9% and a particle size of 5-16 mesh;

[0056] (2) taking mirabilite granules and borneol powder, and mixing the two uniformly in a mass ratio of mirabilite granules to borneol powder = 1000:5, thereby obtaining an anti-inflammatory drug for external use in acute inflammation;

[0057] (3) According to the specification requirements, the acute inflammation topical anti-inflammatory drug is divided into absorbent cotton gauze bags of different sizes using an automatic filling machine, and the bags are sealed in the gauze bags to obtain acute inflammation topical anti-inflammatory drug packages.

[0058] Example 6

[0059] A method for preparing an acute inflammation external anti-inflammatory medicine package comprises the following steps:

[0060] (1) Place the medicinal sodium sulfate in a low-temperature drying device and dry it at 28°C for 6 hours. Grind the dried sodium sulfate into particles and powder with a particle size of ≤5 mesh, and remove fine particles and powder with a particle size of ≤12 mesh through a 12-mesh sieve to obtain sodium sulfate particles with a particle size of 5-12 mesh. Take the obtained sodium sulfate particles with a particle size of 5-12 mesh and dry them for another hour to remove the free water generated on the surface of the sodium sulfate particles during grinding and further dehydrate them. Then, pass them through a 12-mesh sieve again to remove fine particles and powder with a particle size of ≤12 mesh generated during re-drying, and obtain sodium sulfate particles with a particle size of 5-12 mesh that are dehydrated by 8%;

[0061] (2) taking Glauber's salt granules and borneol powder, and mixing the two evenly in a mass ratio of Glauber's salt granules: borneol powder = 1000:4, thereby obtaining an anti-inflammatory drug for external use in acute inflammation;

[0062] (3) According to the specification requirements, the acute inflammation topical anti-inflammatory drug is divided into absorbent gauze bags of different sizes using an automatic filling machine, and the bags are sealed in the gauze bags to obtain the acute inflammation topical anti-inflammatory drug packages.

[0063] In the above embodiment, the anti-inflammatory medicine package for external use for acute inflammation can be in various specifications such as 50 grams, 75 grams, 100 grams, 125 grams, 250 grams and 500 grams.

[0064] In the above embodiment, the anti-inflammatory medicine package for external use for acute inflammation can be stored for at least 3 years after being sealed in an aluminum foil bag.

[0065] In the above embodiment, the absorbent cotton gauze can be replaced by materials with pores such as cotton cloth, ordinary gauze, woven cloth, knitted cloth and non-woven cloth.

[0066] In the above embodiment, the method of using the anti-inflammatory medicine bag for external use in acute inflammation is: apply the medicine bag directly to the skin at the site of acute inflammation or the skin closest to the site of acute inflammation, continue to apply it, and replace it every 6 to 8 hours or after the medicine bag is completely moistened; water, alcohol and other substances shall not be added to the medicine bag, and it is forbidden to use it by pregnant women, people with damaged skin, and people with allergies.

[0067] Experimental Example 1 Water absorption test

[0068] After taking the sodium sulfate with different processing techniques (as shown in Table 1) and packaging it in white cotton bags of the same material, the weight of each bag was 500 grams, and applied it to the abdomen of 5 patients with acute pancreatitis (AP) for 10 hours. After clinical observation, the changes of the external application bags are shown in Table 1:

[0069] Table 1

[0070]

[0071] Experimental Example 2 Composition Screening Test

[0072] Using sodium sulfate (not dehydrated and crushed) (Na2SO4·10H2O) alone as the control group, several treatment groups were set up:

[0073] Treatment group 1: Glauber's salt (not dehydrated and crushed) (Na2SO4·10H2O) and borneol at a mass ratio of 1000:4;

[0074] Treatment group 2: Glauber's salt particles with a particle size of 5 to 30 meshes, from which 10% of the crystal water was removed by the method of the present invention;

[0075] Treatment group 3: the mass ratio of the 5-30 mesh size Glauber's salt particles with 10% of crystal water removed by the method of the present invention to borneol is 1000:4;

[0076] Treatment group 4: the mass ratio of the 5-30 mesh size Glauber's salt particles with 9% of crystal water removed by the method of the present invention to borneol was 1000:4;

[0077] Treatment group 5: the mass ratio of the 5-30 mesh size Glauber's salt particles with 8% of crystal water removed by the method of the present invention to borneol was 1000:4;

[0078] Treatment group 6: the mass ratio of the 5-30 mesh size sodium sulfate particles and borneol to which 10% of the crystal water was removed by the method of the present invention was 1000:2;

[0079] Treatment group 7: the mass ratio of the 5-30 mesh size Glauber's salt particles with 10% of crystal water removed by the method of the present invention to borneol was 1000:3;

[0080] Treatment group 8: the mass ratio of the 5-30 mesh size sodium sulfate particles with 10% of crystal water removed by the method of the present invention to the borneol particles was 1000:6;

[0081] After packing the above control group and treatment group in absorbent gauze bags, each bag weighing 250g was applied to the abdomen and bilateral posterior waist of patients with acute pancreatitis (6 bags each time, three times a day, and 8 hours each time). Each bag weighing 125g was applied to the chest of children with pneumonia (1 bag each time, twice a day, and 8 hours each time). After clinical observation, the number of days of hospitalization is shown in Table 2 below:

[0082] Table 2

[0083]

[0084]

[0085] Experimental Example 3: Efficacy Experiment

[0086] Usage method: Place the external application medicine package prepared in Example 4 close to the skin at the site of acute inflammatory lesions or the skin closest to the site of acute inflammatory lesions, and replace it after the external application medicine package is completely moistened or coagulated.

[0087] Criteria for judging efficacy:

[0088] Effective: After use, the contents become moist or coagulate into lumps, and the patient's symptoms and positive signs are alleviated or completely disappear, which is effective.

[0089] Ineffective: If the contents have not changed after 6 to 8 hours of use and remain in dry granular form, or the bag in contact with the skin and a small amount of the contents become slightly moist or clotted, it is invalid.

[0090] Application of topical medicine packs in many inflammatory diseases: From June 2003 to December 2009, the anti-inflammatory results of topical application in some inflammatory diseases are shown in Table 3.

[0091] Table 3

[0092]

[0093]

[0094] As can be seen from Table 3, the external application of this external compress pack only has the effect of reducing inflammation and swelling in the pathological state of acute inflammation, and cannot treat primary diseases. Since acute inflammation is a common pathological state of many inflammatory diseases, this external compress pack is suitable for acute inflammation.

[0095] At the same time, take the unused medicine bag and the medicine bag used by the acute inflammation patient and dilute them with 100ml of normal saline respectively, then take the filtrate and observe, it is found that the dilution of the former is clear, and the dilution of the latter is turbid, indicating that the latter contains substances other than the contents of the external application bag, i.e. toxins and other substances. Pancreatic amylase was detected in the medicine bag used by the acute pancreatitis patient. This shows that the medicine bag excludes water-soluble substances in the inflammatory tissue through the skin. Judging from the fact that the patient's symptoms are significantly alleviated or disappeared at the same time, the medicine bag excludes toxins (including inflammatory mediators) soluble in water while eliminating water in the acute inflammatory tissue through the skin.

[0096] Experimental Example 4 Application Case

[0097] Case 1: Male, 70 years old. On the day of internal fixation of right femoral shaft fracture in a hospital, the patient had swelling in the right lower limb, irritability, shortness of breath, and body temperature of 38.5°C. Only the right lower limb was externally applied with the external application medicine package of Example 4 (250g per package), and 6 packages were used at one time. After 2 hours, the swelling of the patient's right lower limb was significantly reduced, the patient was quiet, breathing was normal, body temperature was normal, and the medicine package became moist.

[0098] Case 2: Female, 50 years old. SAP patient, T41℃, P130-140 times / min, R40 times / min, BP shock at admission. Apply 4 packages of Example 5 external compress kits (500g per package) to the abdomen and waist at one time, and change every 8 hours (the packages become moist after external application). Check 14 hours after admission, shock is corrected, respiratory failure and heart failure are significantly relieved, and body temperature drops to 37-38℃. Check 40 hours after admission, the patient's vital signs have completely returned to normal. Reduce the amount of external compress kits until recovery.

[0099] Case 3: A 7-year-old male patient had incision pain, irritability, shortness of breath, body temperature of 38.5°C, and slightly red and swollen incision in the range of 10mmx5mm. Two packs of the external application medicine pack (50g package) of Example 6 were applied only to the red and swollen foreskin. After 2 hours, the child's incision pain was relieved, he was quiet, his body temperature was normal, his breathing was normal, and the medicine pack was moist.

[0100] Case 4: Male patient, 61 years old, fever, weakness, throat discomfort, body temperature measured at 38.5°C, positive for COVID-19 nucleic acid test. Apply one pack of the external application medicine pack (125g package) prepared in Example 4 from the submandibular area to the front of the neck. After 8 hours of external application, the body temperature returned to normal and the medicine pack became moist.

[0101] In addition, the inventors have conducted pancreatic amylase assay on the external compress packs of the present invention used by 10 AP (acute pancreatitis) patients and found that all of them contained pancreatic amylase.

[0102] The contents of the external application package of some AP application cases were taken and diluted with normal saline for amylase determination. The results are shown in Table 4:

[0103] Table 4

[0104]

[0105]

[0106] Experimental Example 5: Product Microbiological Detection

[0107] The acute inflammation external anti-inflammatory medicine package obtained in Example 4 (which has been radioactively sterilized) was subjected to microbial detection, and the results are shown in Table 5:

[0108] Table 5

[0109]

[0110]

[0111] Experimental Example 6 Acute oral toxicity test

[0112] The acute inflammation external anti-inflammatory medicine package obtained in Example 4 (which had been radioactively sterilized) was subjected to an acute oral toxicity experiment.

[0113] 1. Materials and Methods

[0114] 1.1 Experimental animals and environment: Kunming mice were provided by Guizhou Medical Experimental Animal Center: SCXK(Guizhou)2023-0002, animal quality certificate number: 2306111. Mouse feed was provided by Beijing Keao Xieli Feed Co., Ltd.: SCXK(Beijing)2019-0003. Experimental animal use license: SYXK(Guizhou)2020-0001, temperature: 20-26℃, relative humidity: 40-70%.

[0115] 1.2 Sample treatment: Grind the sample, pass it through an 80-mesh sieve, weigh 5 g, mix it with distilled water to make up to 30 mL, and set aside.

[0116] 2. Test methods:

[0117] 2.1 Testing basis: National Drug Administration "Technical Specifications for Safety of Cosmetics" (2015 edition), acute oral toxicity test.

[0118] 2.2 Test dose: 5000 mg / kg BW.

[0119] 2.3 Observation test: 14 days.

[0120] 2.4 Experimental process: 10 experimental animals were selected, weighing 18-20 grams, half male and half female. They were fasted overnight before the experiment, and drinking water was not restricted. The one-time limit method was used for the experiment. The animals were weighed during the experiment and exposed once by gavage with an intragastric dose of 0.03mL / gBW. They continued to fast for 3 hours after the exposure. The experimental animals were regularly observed for poisoning symptoms and deaths on the first day of exposure, and then carefully examined at least once a day. During the 14 days of observation, the general condition and clinical manifestations of the experimental animals were observed and recorded every day. The experimental animals were weighed on the 7th and 14th days, and the weight changes of the animals were observed. The results are shown in Table 6;

[0121] Table 6

[0122]

[0123] As shown in Table 6, no poisoning symptoms or death were observed in the experimental mice during and at the end of the experiment. At the end of the experiment, the experimental animals were killed by cervical dislocation and no abnormalities were found in the gross autopsy. LD 50 >5000mg / kgBW.

[0124] Experimental Example 7 Heavy Metal Detection

[0125] The acute inflammation external anti-inflammatory medicine package obtained in Example 4 (which has been radioactively sterilized) was tested for heavy metals, and the results are shown in Table 7;

[0126] Table 7

[0127]

[0128] Experimental Example 8 Multiple Skin Irritation Test

[0129] The acute inflammation external anti-inflammatory medicine package obtained in Example 4 (which had been radioactively sterilized) was subjected to multiple skin irritation tests.

[0130] 1. Experimental animals and environment: White rabbits, weighing 2.0-3.0 kg. Provided by Guizhou Medical Experimental Animal Center: SCXK (Guizhou) 2023-0002, Animal Quality Certificate No.: 2306110. Animal feed was provided by Beijing Keao Xieli Feed Co., Ltd.: SCXK (Beijing) 2019-0003. Experimental Animal Use License: SYXK (Guizhou) 2020-0001. Temperature: 18-24℃, relative humidity: 40-70%, single cage feeding.

[0131] 2. Sample processing: Moisten the sample with distilled water to make a paste and apply it to the animal skin.

[0132] 3. Methods:

[0133] 3.1 Testing basis: National Drug Administration "Technical Specifications for Safety of Cosmetics" (2015 edition), multiple skin irritation tests.

[0134] 3.2 Test method: Select 4 healthy, adult rabbits with intact skin and acclimate them to the experimental animal room environment for 3 days. Shave the hair on both sides of the spine of the experimental animals on the back 24 hours before the test without damaging the epidermis. The hair removal range is 3cm×3cm each, and the application area is 2.5cm×2.5cm. Take 0.5g of the test substance prepared for treatment and apply it directly to the hairless skin on one side. The other side is used as a control. Apply once a day for 14 consecutive days. Starting from the second day, remove the hair before each application, and use warm water to clean the residual test substance. Observe the results after one hour, and observe other toxic effects besides irritation, as shown in Table 8;

[0135] Table 8

[0136]

[0137]

[0138] It can be seen from Table 8 that no toxic effects other than skin irritation were observed during the test.

Claims

1. Use of a mirabilite-borneol composition in the preparation of an external anti-inflammatory drug or medicine pack for acute inflammation, characterized in that: The mirabilite borneol composite is prepared from mirabilite particles and borneol powder in a mass ratio of 1000:(2-6). The mirabilite particles are mirabilite particles with 8%-10% of crystal water removed and a particle size of 5-30 meshes.

2. The use according to claim 1, characterized in that The acute inflammation is cerebral edema, frontal sinusitis, mumps, gingivitis, cold, pharyngitis, bronchitis, pneumonia, pleural effusion, acute mastitis, acute gastroenteritis, acute attack of chronic cholecystitis, acute pancreatitis, acute appendicitis, periappendiceal abscess, colitis, hemorrhoidal edema, postpartum perineal edema, pelvic inflammatory disease, ascites, acute nephritis, closed soft tissue injury, superficial lymphadenitis, periarthritis of the shoulder, tenosynovitis, synovitis, lumbar muscle strain, acute attack of rheumatoid arthritis, knee joint effusion, bone marrow edema, attack of lumbar disc herniation, attack of gout, duodenal ventricular ulcer, and liver abscess.

3. The use according to claim 1, characterized in that The acute inflammation includes novel coronavirus infection and acute pancreatitis.

4. The use according to claim 2, characterized in that The pneumonia includes pediatric pneumonia and new coronavirus infection.

5. An anti-inflammatory and detumescent composition for external use, characterized in that: The external composition is prepared from mirabilite particles and borneol powder in a mass ratio of 1000:(2-6); the mirabilite particles are mirabilite particles with 8%-10% crystal water removed and a particle size of 5-30 meshes.

6. The anti-inflammatory and detumescent external composition according to claim 5, characterized in that: The anti-inflammatory and detumescent external composition is prepared from mirabilite particles and borneol powder in a mass ratio of 1000:

4.

7. The anti-inflammatory and detumescent external composition according to claim 5, characterized in that: The particle size of the mirabilite granules is 5 to 30 meshes, and the external composition is used for preparing an external anti-inflammatory drug or medicine package for acute inflammation.

8. The anti-inflammatory and detumescent composition for external use according to any one of claims 5 to 7, characterized in that: The preparation method of the Glauber's salt granules is as follows: placing Glauber's salt in a low-temperature drying device, drying it at 28-30°C for 4-6 hours, crushing the dried Glauber's salt into particles and powder with a particle size of ≤5 mesh, and removing fine particles and powder with a particle size of ≤30 mesh through a 30-mesh sieve. Taking the 5-30 mesh Glauber's salt granules obtained in the above steps, drying them for another hour to remove free water generated on the surface of the Glauber's salt granules during crushing and further dehydrating them, and passing them through a 30-mesh sieve again to remove fine particles and powder with a particle size of ≤30 mesh newly generated during re-drying, and obtaining Glauber's salt granules with a dehydration rate of 8%-10% and a particle size of 5-30 mesh.

9. The use of the mirabilite-borneol composition according to claims 1 to 4 or the anti-inflammatory and detumescent external composition according to claim 5, characterized in that: The preparation method of the acute inflammation external anti-inflammatory medicine package comprises the following steps: (1) placing the thenardite in a low-temperature drying device and drying it at 28-30° C. for 4-6 hours, crushing the dried thenardite into particles and powder with a particle size of ≤5 mesh, and removing fine particles and powder with a particle size of ≤30 mesh through a 30-mesh sieve; taking the thenardite particles with a particle size of 5-30 mesh obtained in the above step and drying them for another hour, and again passing them through a 30-mesh sieve to remove fine particles and powder with a particle size of ≤30 mesh generated during the further drying, to obtain thenardite particles with a particle size of 5-30 mesh and a dehydration level of 8%-10%; (2 Take mirabilite granules and borneol powder, and mix them evenly according to the mass ratio of mirabilite granules: borneol powder = 1000: (2-6), so as to obtain an anti-inflammatory drug for external use for acute inflammation; (3) According to the specification requirements, the acute inflammation topical anti-inflammatory drug is divided into absorbent gauze bags using an automatic filling machine, and the bags are sealed in the gauze bags to obtain acute inflammation topical anti-inflammatory drug packages.

10. The use of the mirabilite-borneol composition according to claims 1 to 4, characterized in that: The anti-inflammatory medicine package may be a medicine package with a single cavity, or may be a medicine package with 2 to 4 cavities.

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