A sore-removing, muscle-generating and antibacterial Chinese medicine composition, preparation method and application thereof

Abstract

The invention discloses a Chinese medicine composition for healing sores, promoting tissue regeneration and inhibiting bacteria, a preparation method and application thereof, comprising the Chinese medicine composition consisting of the following raw materials in parts by weight: 60 parts of fig leaf powder, 50 parts of fig fruit, 50 parts of calcined pearls, 40 parts of rhubarb, 30 parts of Panax notoginseng, 30 parts of ganoderma lucidum and 30 parts of borneol. The calcined pearls are placed in a preheated iron pot, heated until they burst, and ground into fine powders that all pass through a 100-mesh sieve; rhubarb, fig leaves, Panax notoginseng and ganoderma lucidum are ground into fine powders that pass through a 600-mesh sieve and mixed; the borneol is crushed into powders with a wall-breaking machine so that all of them pass through a 100-mesh sieve; 500 ml of water is added to 50 g of fig fruit, and the mixture is simmered over a slow fire for about 1 hour, and cooled to 75°C; the above-mentioned subdivided mixture is added into a powder, and then simmered for 10 minutes, and the mixture is cooled and then cooled to obtain the composition. The Chinese medicine composition is applied to hemorrhoids, pressure sores and bedsores, and has the advantages of healing sores, promoting tissue regeneration and inhibiting bacteria, and having low irritation.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical manufacturing and traditional Chinese medicine technology, and in particular to a sore-removing, muscle-promoting and antibacterial traditional Chinese medicine composition, a preparation method and application thereof. Background Art

[0002] At present, hemorrhoids are soft venous masses formed by the expansion and bending of the venous plexus under the mucosa of the terminal rectum and the skin of the anal canal. They can be clinically divided into three types: external hemorrhoids, internal hemorrhoids and mixed hemorrhoids. Among them, the most common clinically is internal hemorrhoids, which are mainly manifested by bleeding and hemorrhoid prolapse, and are divided into grades I-IV. Grade I: there is blood in the stool but no hemorrhoid prolapse; Grade II: there is blood in the stool and hemorrhoid prolapse often accompanied by self-reduction; Grade III: there is occasional blood in the stool, and hemorrhoids often need to be reduced by force after prolapse; Grade IV: there is occasional blood in the stool, and hemorrhoids often prolapse again after reduction. External hemorrhoids are mainly manifested by the tumor outside the anal margin, and severe pain occurs when thrombosis occurs. Mixed hemorrhoids are symptoms of internal and external hemorrhoids coexisting, and hemorrhoids can be prolapsed in a ring shape. Hemorrhoids are a common clinical disease in my country, with a popular saying that "nine out of ten people suffer from hemorrhoids". The disease is related to the Chinese people's physical constitution, eating habits, excessive fatigue, bad bowel habits, pregnancy, genetic factors, etc. It is reported that the incidence of anorectal diseases is 59.1%, and hemorrhoids account for 87.25% of anorectal diseases. People of all ages may suffer from this disease, and the incidence rate gradually increases with age. Severe cases affect people's life and health, and mild cases affect people's quality of life.

[0003] In the prior art, the treatment of hemorrhoids is mainly through two means, one is drug treatment, the other is surgical treatment, wherein surgical treatment requires hospitalization of the patient, the cost is high, due to the particularity of the location of the hemorrhoids, the recovery is slow, and it is very easy to be infected by bacteria, and a series of complications such as anal bleeding, urinary retention, edema, etc. occur, which are painful for the patient and difficult to accept. Therefore, the treatment principle of hemorrhoids is to use simple treatment without complicated methods, and to use drug treatment without using instruments or surgical treatment, so the patient should first use drug treatment after suffering from hemorrhoids, and drug treatment includes three types of oral administration, external treatment and injection therapy, wherein the oral administration refers to treatment by oral medication, mainly based on Chinese medicine decoction and Chinese patent medicine, and the patient delays pain by adjusting the internal microenvironment after taking the medicine, and eliminates the phenomena such as edema and bleeding. External treatment mainly includes: compressing method, plugging method and fumigation method. Injection therapy has colonoscopic sclerosant therapy and lauromacrogol sclerosant injection therapy. Relatively speaking, patients are more accepting of external treatments with fewer side effects, and the application of medicine is the most acceptable. On the one hand, hemorrhoids are private diseases, and the application of medicine is easier for patients to accept. On the other hand, external compresses are convenient to carry and easy to use, and can immediately relieve symptoms such as pain through targeted drug delivery. However, existing external medicines, especially in airtight areas or in hot summer when the human body is prone to sweating and breeding bacteria, are needed for Chinese medicine compositions that have antibacterial properties, sore-healing and muscle-growing properties, and low irritation.

[0004] In summary, there is at least one of the following technical problems:

[0005] How to provide a Chinese medicine composition with antibacterial, sore-healing and tissue-regenerating properties and low irritation for the auxiliary treatment of hemorrhoids, pressure sores and bedsores. Summary of the invention

[0006] The main purpose of the present invention is to provide a Chinese herbal composition with antibacterial properties, so as to solve the technical problem of providing a Chinese herbal composition with antibacterial properties, sore-healing and muscle-regenerating properties, and low irritation, for the auxiliary treatment of hemorrhoids, pressure sores, and bedsores.

[0007] In order to achieve the above object, according to one aspect of the present invention, a Chinese medicine composition for sore abscess, muscle growth and antibacterial effect is provided, comprising:

[0008] The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 60 parts of fig leaf powder, 50 parts of fig fruit, 50 parts of calcined pearls, 40 parts of rhubarb, 30 parts of Panax notoginseng, 30 parts of ganoderma lucidum and 30 parts of borneol.

[0009] According to another aspect of the present invention, a method for preparing a Chinese medicine composition for sore abscess, muscle growth and antibacterial function is provided, comprising:

[0010] Step 1: Place the calcined pearls in a preheated iron pot, heat until they burst, and grind them into fine powder that can pass through a 100-mesh sieve;

[0011] Step 2: Grind rhubarb, fig leaves, Panax notoginseng and Ganoderma lucidum into 600-mesh fine powder and mix;

[0012] Step 3: Crush the borneol into powder using a wall breaker and make it all pass through a 100-mesh sieve;

[0013] Step 4: Add 50g of figs to 500ml of water, simmer for about 1 hour, and cool to 75°C;

[0014] Step 5: Mix the ingredients in steps 1-3 into powder and add it into the mixture. Boil for 10 minutes and cool it down before serving.

[0015] Preferably, the finished product is a paste.

[0016] According to another aspect of the present invention, there is provided an application of a Chinese medicine composition for healing sores, promoting tissue regeneration and inhibiting bacteria, including application in hemorrhoids.

[0017] Preferably, it also includes application to pressure sores.

[0018] Preferably, the method also includes application to bedsores.

[0019] The application of the technical solution of the present invention has the following technical effects:

[0020] The invention adopts the principle of combining "elimination method" with "clearing method", and its usage is as follows: the ointment is applied to the lesion site, and various Chinese medicinal ingredients contained in the ointment are fully utilized, pearl and ganoderma lucidum are used to astringe and regenerate muscles, detoxify the skin, relieve pain and stop bleeding, Panax notoginseng is used to promote blood circulation and remove blood stasis, reduce swelling and relieve pain, borneol is used to disperse fire and detoxify, and rhubarb is used to clear away heat and cool blood, so as to repair wounds and ulcer surfaces formed due to long-term hemorrhoids and the breeding of bacteria, block the growth of harmful bacteria and have anti-infection effects, promote capillary formation, increase the proliferation of fibroblasts, and thus promote rapid wound healing. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

[0022] Figure 1 The process flow chart of the preparation of the Chinese medicinal composition for sore-removing, muscle-promoting and antibacterial function according to the present invention is shown;

[0023] Figure 2 The diagrams before, during and after treatment of a typical case 5 of the Chinese medicinal composition for sore-removing, muscle-regenerating and antibacterial treatment are shown, wherein a is a diagram for the early stage of treatment, b is a diagram for the middle stage of treatment, and c is a diagram for the late stage of treatment;

[0024] Figure 3 A diagram showing the treatment process of a typical case 19 of the Chinese medicinal composition for sore astringence, muscle growth and antibacterial effect;

[0025] Figure 4 The treatment process diagram of typical case 20 of the Chinese medicinal composition for healing sores, promoting tissue regeneration and inhibiting bacteria is shown. DETAILED DESCRIPTION

[0026] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0027] like Figures 1 to 4 As shown, an embodiment of the present invention provides a traditional Chinese medicine composition for healing sores, promoting tissue regeneration and inhibiting bacteria. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 60 parts of fig leaf powder, 50 parts of fig fruit, 50 parts of calcined pearls, 40 parts of rhubarb, 30 parts of Panax notoginseng, 30 parts of Ganoderma lucidum, and 30 parts of borneol.

[0028] Pharmacological analysis of the raw materials of the ointment of the present invention:

[0029] Regarding the raw material medicine fig, its efficacy is detoxification and swelling, clearing away heat and moistening the intestines. Pharmacological analysis shows that the diameter of the antibacterial ring of fig extract against 8 bacteria such as Staphylococcus aureus, Escherichia coli, and Bacillus cereus is greater than 7mm, and it has obvious antibacterial effect on Staphylococcus aureus and Bacillus subtilis, thus playing the antibacterial role in this patent.

[0030] Regarding the raw material drug calcined pearl, its effect is astringent, regenerating skin, detoxifying and protecting skin. Pharmacological analysis: Enhance immunity, antibacterial and antiviral. That is, it has obvious inhibitory effects on Staphylococcus aureus, hemolytic streptococci, dysentery, typhoid, meningococcus, pneumococcus, pus aeruginosa and influenza virus.

[0031] Regarding the raw material rhubarb, its effects are clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and dredge menstruation. Pharmacological analysis: Rhubarb has strong anti-infection effects, can regulate immunity, anti-inflammatory, antipyretic, anti-pathogenic microorganisms, hemostatic effects, and has inhibitory effects on a variety of Gram-positive and negative bacteria, among which the most sensitive are Staphylococcus and Streptococcus, followed by diphtheria Corynebacterium, Typhoid and Paratyphoid Corynebacterium, Pneumococcus, Shigella.

[0032] Regarding the raw material drug Panax notoginseng, its efficacy is good at stopping bleeding, removing blood stasis and promoting new blood. Pharmacological analysis: Panax notoginseng has good hemostatic effect and can significantly shorten bleeding and coagulation time. It has a significant inhibitory effect on the increase in capillary permeability, inflammatory exudation, tissue edema, leukocyte migration and late granulation tissue hyperplasia caused by inflammation. The anti-inflammatory mechanism is both direct anti-inflammatory effect.

[0033] Regarding the raw material drug Ganoderma lucidum, its effects are: anti-inflammatory, analgesic, detoxification and hemostasis. Pharmacological analysis: Ganoderma lucidum whole powder water extract and alcohol extract have good inhibitory effects on Escherichia coli, Staphylococcus aureus, Micrococcus luteus, Proteus and Bacillus subtilis.

[0034] Regarding the raw material drug borneol, the effect: heat dissipation and pain relief, mostly used for the treatment of sores, scabies and tinea. Pharmacological analysis: It has a strong inhibitory effect on Escherichia coli K88, hemolytic Escherichia coli, Erysipelothrix rhizogenes and Pasteurella suis.

[0035] This patent achieves the comprehensive effect achieved by mixing and boiling the above raw materials to exert their comprehensive efficacy.

[0036] The test results and test data of the present invention are as follows:

[0037] Test 1: Ointment microbial contamination test:

[0038] The materials and equipment used for the ointment microbial contamination test include: the ointment of the present invention, an electric constant temperature incubator and a mold incubator. Test method: Test basis: "Disinfection Technical Specifications".

[0039] The results of the ointment microbial contamination test are as follows:

[0040] Table 1 Results of ointment microbial contamination test

[0041] Detection indicators Standard value Measured value Total bacterial colony count (cfu / g) ≤200 ＜10 Total fungal colony count (cfu / g) ≤100 ＜10 Coliform bacteria Not to be detected Not detected Pseudomonas aeruginosa Not to be detected Not detected Hemolytic Streptococcus Not to be detected Not detected Staphylococcus aureus Not to be detected Not detected

[0042] The test results show that the total bacterial colony count, total fungal colony count, coliform group, Pseudomonas aeruginosa, hemolytic streptococcus and Staphylococcus aureus indicators of the ointment of the present invention are all in line with the standard value range specified in the "Technical Specifications for Disinfection".

[0043] Test 2: Antibacterial test:

[0044] The materials required for the antibacterial test include: test strains: Staphylococcus aureus (ATCC6538) cultured to the 6th generation, Escherichia coli (8099) cultured to the 6th generation, both provided by Shandong Provincial Center for Disease Control and Prevention. Test sample: ointment of the present invention. Test carrier: filter paper. Culture medium: nutrient agar culture medium, sterilized by pressure steam for standby use.

[0045] Antibacterial test method: The test basis is: "Technical Specifications for Disinfection". Operation steps: Wash the 24-hour slant culture of the test bacteria, prepare a bacterial suspension of appropriate concentration, and make bacterial slices for use. Take 5g of the paste, add the bacterial slices, start timing, and act for 2min, 5min, 10min, and 20min respectively, take it out, add it to a 5ml PBS test tube, mix it thoroughly, and dilute it appropriately as the test group. Take 1 bacterial slice and add it directly to a 5ML PBS test tube, mix it thoroughly, and dilute it appropriately as the control group. Take 1.0mL respectively, place it in two plates, pour 15mL of nutrient agar medium cooled to 40℃-45℃, turn the plate to make it fully uniform, turn the plate over after the agar solidifies, and culture it at 35C±2℃ for 48h, and count the viable colonies. And calculate the antibacterial rate. Repeat 3 times under the test temperature of 19-21℃.

[0046] X=(NC-NS) / Ncx 100%

[0047] X: inhibition rate, %; Nc: average colony count of control samples; Ns: average colony count of tested samples.

[0048] Antibacterial test results:

[0049] Under the condition of 19-21℃, the average inhibition rates of the tested ointment on Escherichia coli on the contaminated carriers for 2min, 5min, 10min and 20min were 65.89%, 71.54%6, 74.19%6 and 76.62% respectively; the average inhibition rates of the tested ointment on Staphylococcus aureus on the contaminated carriers for 2min, 5min, 10min and 20min were 62.00%, 67.85%, 71.23%6 and 75.04% respectively.

[0050] The specific results are shown in Tables 2 and 3 below:

[0051] Table 2 Antibacterial test results (test strain Escherichia coli)

[0052]

[0053] Table 3 Antibacterial test results (test strain Staphylococcus aureus)

[0054]

[0055] Conclusion of the antibacterial test: Under the conditions of 19℃-21℃, the average antibacterial rates of the tested ointment of the present invention on Escherichia coli on the contaminated carrier for 2min, 5min, 10min and 20min were 65.89%, 71.54%, 74.19% and 76.62% respectively; the average antibacterial rates on Staphylococcus aureus on the contaminated carrier for 2min, 5min, 10min and 20min were 62.00%, 67.85%, 71.23% and 75.04% respectively, both of which are in line with the requirements of the Technical Specifications for Disinfection.

[0056] Test 3: Ointment stability test (microbiological method):

[0057] Materials required for the ointment stability test: Test strain: Staphylococcus aureus (ATCC6538) cultured to the 6th generation, provided by Shandong Provincial Center for Disease Control and Prevention. Test sample: ointment of the present invention. Test carrier: filter paper. Culture medium: nutrient agar culture medium, sterilized with pressure steam for standby use.

[0058] Ointment stability test method: Test basis: "Disinfection Technical Specifications".

[0059] Sample treatment: The tested ointment of the present invention was placed in a 37°C constant temperature incubator for 3 months and then tested. Operation steps: Wash the 24h slant culture of the tested bacteria, prepare a bacterial suspension of appropriate concentration, and make bacterial slices for use. Take 5g of sample, add the bacterial slice, start timing, act for 2min, 5min, 10min, and 20min respectively, take it out, add it to a 5ML PBS test tube, mix it thoroughly, and dilute it appropriately as the test group. Take 1 bacterial slice and add it directly to a 5ML PBS test tube, mix it thoroughly, and dilute it appropriately as the control group. Take 1.0mL respectively, place it in two plates, pour it with 15mL of nutrient agar medium cooled to 40℃-45℃, rotate the plate to make it fully uniform, turn the plate 35° after the agar solidifies, culture it for 48h, and count the viable colonies. And calculate the antibacterial rate. Repeat 3 times under the test temperature of 19℃-21℃.

[0060] X-(NC-NS) / Ncx100%

[0061] Ⅹ: Inhibition rate, %; Nc: Average colony count of control samples; Ns: Average colony count of tested samples

[0062] Results: Under the condition of 19℃-21℃, the tested ointment of the present invention was placed in a 37℃ constant temperature incubator for three months, and the average antibacterial rates of Staphylococcus aureus on the contaminated carrier for 2min, 5min, 10min, and 20min were 53.82%, 58.82%, 62.17%, and 65.59%, respectively. The specific results are shown in the table below.

[0063] Table 4 Ointment stability test results

[0064]

[0065] Conclusion of the ointment stability test: Under the conditions of 19°C-21°C, the tested ointment of the present invention, after being placed in a constant temperature incubator at 37°C for three months, had an average inhibition rate of 53.82%, 58.82%, 62.17% and 65.59% against Staphylococcus aureus on the contaminated carrier for 2min, 5min, 10min and 20min, respectively, which is in line with the requirements of the Technical Specifications for Disinfection.

[0066] Test 4: Multiple complete skin irritation test

[0067] Materials and animals required for multiple complete skin irritation tests: Test sample: the ointment of the present invention.

[0068] Animals: 3 ordinary New Zealand rabbits, provided by Jinan Xilingjiao Breeding and Propagation Center, production license number: SCXK (Lu) 20150001. Environmental conditions: barrier environment animal room of Shandong Experimental Animal Center, use license number: SYXK (Lu) 20140010, temperature 20-25℃, relative humidity 50-70%. Rabbit feed was provided by Beijing Huafukang Biotechnology Co., Ltd., production license number: SCXK (Beijing) 20140008.

[0069] Multiple complete skin irritation test method: Test basis: "Technical Specifications for Disinfection". Ointment: Use the ointment of the present invention for the test. Test steps: The day before the test, cut off the hair on both sides of the spine of the experimental rabbit's back, and the hair removal range is about 3cm×3cm on the left and right. The test was carried out using the self-control method, taking 0.5mL of the test sample and applying it on the exposed skin on the right side, and the exposed skin on the left side was used as a control. After 4 hours of application for each experimental rabbit, wash the skin of the application site with warm water to remove the residue, apply it times a day, and apply it continuously for 14 days. Observe and record the skin reaction of the application site 24 hours after each application, and evaluate the skin reaction score and irritation intensity according to the skin irritation reaction scoring standard of the "Technical Specifications for Disinfection".

[0070] The results of multiple complete skin irritation tests showed that after the test substances were removed, no abnormal changes such as erythema and edema occurred in the experimental sites of the animals, and the average score of each animal of this sample was 0 every day.

[0071] Table 5 Scoring table for multiple complete skin irritation tests

[0072]

[0073]

[0074] Conclusion of multiple complete skin irritation tests: According to the skin irritation reaction scoring and irritation intensity grading standards of the "Disinfection Technical Specifications", the ointment stock solution of the present invention was subjected to multiple complete skin irritation tests using experimental rabbits and was found to be non-irritating to the skin.

[0075] Test 5: Acute eye irritation test

[0076] Acute eye irritation test materials and animals: Test sample: ointment of the present invention. Animals: 3 ordinary New Zealand rabbits, provided by Jinan Xilingjiao Breeding and Breeding Center, production license number: SCXK (Lu) 201500013. Environmental conditions: barrier environment animal room of Shandong Provincial Experimental Animal Center, use license number: SYXK (Lu) 20140010, temperature 20-25°C, relative humidity 50-70%. Rabbit feed was provided by Beijing Huafukang Biotechnology Co., Ltd., production license number: SCXK (Beijing) 20140008

[0077] Acute eye irritation test method: Test basis: "Disinfection Technical Specifications"

[0078] Acute eye irritation test ointment: Test steps of using the ointment of the present invention: 0.1 mL of the test substance is sucked and dripped into the conjunctival sac of one eye of the experimental rabbit, and the other eye is treated with physiological saline as a normal control. After dripping the test substance, the eye is passively closed for 4 seconds, and rinsed with physiological saline after 30 seconds. The damage and recovery of the conjunctiva, iris and cornea of ​​the experimental rabbit are observed with the naked eye at 1 hour, 24 hours, 48 ​​hours and 72 hours after eye dripping, and the irritation reaction is scored, and the average scores of corneal damage, iris damage, conjunctival congestion and conjunctival edema of each animal at 24 hours, 48 ​​hours and 72 hours are calculated respectively, and the irritation intensity of the test substance to the eye is determined according to the eye irritation grading standard.

[0079] Results of the acute eye irritation test: The average scores of the three experimental rabbits in corneal damage, iris damage, conjunctival congestion and conjunctival edema were: corneal damage: 0 points; iris damage: 0 points; conjunctival congestion: 1.0 points; conjunctival edema: 0 points, and the eye irritation reactions of all animals were completely recovered within 72 hours.

[0080] Table 6 Acute eye irritation test scoring table

[0081]

[0082]

[0083] Conclusion of acute eye irritation test According to the acute eye irritation reaction score and eye irritation reaction grading standards in the "Technical Specifications for Disinfection", this ointment is non-irritating.

[0084] Test 6: pH value and sensory perception

[0085] Materials: Test sample: the ointment of the present invention. Instruments: UB-7 pH meter (No. 225) 3 Calibration buffer: phosphate buffer (pH 6.86, 25°C), sodium tetraborate buffer (pH 9.18, 25°C, purchased from Shanghai Leici Chuangyi Instrument Co., Ltd.

[0086] Test method: Test basis: Determination of pH value of disinfectant in the Technical Specifications for Disinfection. Test environment: temperature 22°C; relative humidity 55%. Operation steps: Take the ointment of the present invention and visually observe the sensory index, weigh 5.0g of the sample, add 45.0ml of water, mix well, and measure the pH value.

[0087] Test results: pH value measurement results of the ointment aqueous solution (10 times dilution) of the present invention Sample batch number Sample serial number Average pH value.

[0088] Table 7 pH test data

[0089] Ointment Ointment serial number pH average value Ointment 1-1 7.61 7.61 Ointment 1-2 7.61 7.61

[0090] Test conclusion: The tested ointment of the present invention is a dark green ointment, and the pH value of the tested ointment aqueous solution of the present invention (10-fold dilution) is 7.61, which is close to neutral and has little irritation.

[0091] Test 1-6 Test conclusion

[0092] The pH value of the aqueous solution of the paste sample (10-fold dilution) was 7.61.

[0093] The total bacterial colony count (cfug), the total fungal colony count (cfug), the coliform group, Pseudomonas aeruginosa, the hemolytic streptococcus and the Staphylococcus aureus indicators of the ointment of the present invention are all in line with the provisions of the "Technical Specifications for Disinfection".

[0094] Under the condition of 19-21 ℃, the average antibacterial rates of the tested ointment of the present invention on Escherichia coli on the contaminated carrier for 2min, 5min, 10min and 20min were 65.89%, 71.54%, 74.19% and 76.62% respectively; the average antibacterial rates of the tested ointment of the present invention on Staphylococcus aureus on the contaminated carrier for 2min, 5min, 10min and 20min were 62.00%, 67.85%, 71.23% and 75.04% respectively, both of which are in line with the requirements of the Technical Specifications for Disinfection.

[0095] Under the condition of 19-21°C, after being placed in a constant temperature incubator at 37°C for three months, the average antibacterial rates of the ointment of the present invention on Staphylococcus aureus on the contaminated carrier for 2min, 5min, 10min and 20min were 53.82%, 58.82%, 62.17% and 65.59%, respectively, which met the requirements of the Technical Specifications for Disinfection.

[0096] According to the skin irritation reaction scoring and irritation intensity grading standards of the "Disinfection Technical Specifications", the ointment stock solution of the present invention is non-irritating to the skin after multiple complete skin irritation tests using experimental rabbits.

[0097] According to the acute eye irritation reaction scoring and eye irritation reaction grading standards of the "Disinfection Technical Specifications", the ointment stock solution of the present invention is non-irritating in an acute eye irritation test using experimental rabbits.

[0098] Clinical trial data:

[0099] Typical case 1: Zhang XX, male, 39 years old, computer repairman.

[0100] The patient had a swelling around the anus six years ago. After drinking or taking spicy food, the anus itched and foreign body sensation worsened. He had used Huaijiao Pills and other hemorrhoid creams for treatment, but the symptoms were not relieved significantly. The swelling worsened during defecation and slightly relieved after defecation. In the past month, he felt anal swelling and pain, so he came to see a doctor. Examination showed that there was a swelling protruding from the anus, and the surface mucosa was obviously swollen. Finger examination touched the soft hemorrhoid mucosa in the anus, but no hard swelling or foreign body was touched. He was diagnosed with varicose external hemorrhoids.

[0101] Treatment: For patients diagnosed with varicose external hemorrhoids, the Chinese medicine composition of the present invention is placed in a 5 ml syringe and applied to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each application. After application, the remaining medicine is injected into the anus at one time, with an injection depth of 3-5 cm. The hemorrhoids retracted after 15 days of treatment.

[0102] Typical case 2: Meng Moumou, male, 35 years old, self-employed.

[0103] The patient developed anal itching and dampness five years ago. In the past three years, there has been an obvious foreign body sensation, which has become increasingly severe. It worsens after eating spicy food or defecating, and there is often a feeling of heaviness and other discomfort. Recently, he came to see a doctor because he felt heaviness at the anus. Examination showed a fibrotic mass at the anus, connective hyperplasia of the surface mucosa, and no bleeding. The diagnosis was "connective tissue external hemorrhoids." Six tubes of wound care ointment were given, and applied to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each application. After applying the remaining medicine, all of it was injected into the anus at one time, with an injection depth of 3-5 cm. The hemorrhoids retracted after 10 days of treatment.

[0104] Typical case 3: Ma Moumou, male, 44 years old.

[0105] The patient reported that there was anal prolapse without obvious cause for 3 months, which could not be reduced by hand, with a little damage to the mucosa, occasional blood in the stool, bright red, small amount, and blood on the tissue, but no systematic diagnosis and treatment. The stool was once a day and formed. Hemorrhoids were visible around the anal margin, and no space-occupying mass was felt during the rectal examination, and the finger cot was not stained with blood.

[0106] Treatment: The Chinese medicine composition of the present invention is placed in a syringe and applied to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After application, the remaining medicine is injected into the anus at one time, with an injection depth of 3-5 cm. The hemorrhoids shrink after 7 days of treatment.

[0107] Typical case 4: Patient: Zhang XX, male, 61 years old.

[0108] Medical history: Ten years ago, the patient had blood in his stool without any obvious cause, accompanied by prolapse of the anus. He did not receive treatment and gradually recovered. Over the past ten years, the above symptoms recurred every time he ate spicy food or overworked. Three years ago, he had bleeding and prolapse of the mass after drinking. After prolapse, the mass could not return to the anus on its own, and there was no pain or other discomfort. He came to the clinic for treatment because he felt a swelling at the anus in the past week. Examination showed that there was a prolapse of the mass at the anus, with connective hyperplasia of the surface mucosa, and no bleeding. Digital examination touched soft hemorrhoidal mucosa in the anus, but no hard mass or foreign body was touched. The diagnosis was "mixed hemorrhoids",

[0109] Treatment: Give the ointment of the present invention, evenly distribute it into three 5ml syringes, apply it to the hemorrhoids three times a day, three times each time, and three to five minutes apart each time. After applying, inject all the remaining medicine into the anus at one time, with an injection depth of 3-5cm. After 15 days of treatment, the hemorrhoids completely retracted.

[0110] Typical case 5: Patient: Dong Moumou, male, 53 years old.

[0111] Medical history: The patient suffered from "high cervical cord injury and paraplegia" due to trauma 15 years ago. Three years ago, the skin on the right sole of the foot became necrotic and formed a pressure sore. He was treated in the hospital for debridement and dressing change, but the condition recurred and could not be cured. Examination showed an ulcer wound of about 9×5cm on the outside of the arch of the right sole, and the plantar fascia was visible. The edge of the wound was pale and regular, and the granulation tissue in the wound was dark purple, soft to the touch, and no bleeding. The diagnosis was "pressure sore stage 4".

[0112] Treatment: Apply the ointment of the present invention to the wound surface, the standard is that the liquid is completely applied to the ulcer surface and flush with the normal skin. Apply gauze elastic bandage on the outside, change the dressing once a day, and rinse the wound surface with physiological saline when changing the dressing.

[0113] Typical case 6: Liu Moumou, female, 47 years old, from Suqian, Jiangsu.

[0114] The patient had suffered from hemorrhoids for 15 years, with occasional attacks. During this treatment, the doctor's examination showed that the patient had external hemorrhoids, and the hemorrhoid attacks caused skin tags and mild pain.

[0115] Treatment: The Chinese medicine composition of the present invention is placed in a syringe and applied to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After application, the remaining medicine is injected into the anus at one time, with an injection depth of 3-5 cm. After one day of using the ointment of the present invention, the pain is basically gone. After eight days of use, the skin tags caused by the previous hemorrhoid attack have returned to normal skin thickness.

[0116] Typical case 7: Zhang XX, female, 39 years old, from Meishan, Sichuan.

[0117] I have suffered from hemorrhoids for 20 years and they often break out. I have tried many methods to treat hemorrhoids before, but the number of external hemorrhoids has increased. The doctor's examination showed that the patient had multiple external hemorrhoids with secretions, itching, and occasional pain. After applying the ointment on the outside for three days, all the hemorrhoids basically disappeared, leaving only a small part of the skin tag.

[0118] Treatment: Put the Chinese medicine composition of the present invention into a syringe and apply it to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After applying, inject all the remaining medicine into the anus at one time, with an injection depth of 3-5 cm.

[0119] Typical case 8: Li Moumou, female, 42 years old.

[0120] Suffering from hemorrhoid disease for 18 years, often attack, used a variety of methods for treating hemorrhoids before, there has been no obvious therapeutic effect. According to the results of the examination by Dr. Liu, the patient has complex external hemorrhoids and mixed hemorrhoids, and hemorrhoids have repeatedly attacked and formed skin tags. Several external hemorrhoids are obviously congested, causing obvious tenderness. Mixed hemorrhoids repeatedly attack and form complex skin tags, which are not easy to clean, easy to breed bacteria, and cause itching. Treatment: The Chinese medicine composition of the present invention is placed in a syringe, and the hemorrhoids are applied three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at a time, and the injection depth is 3-5 cm. After applying with one ointment, the pain disappears and the external hemorrhoids are significantly reduced. After using three sticks, the external hemorrhoids basically disappear, and the mixed hemorrhoids are also significantly reduced.

[0121] Typical case 9: Tang Moumou, female, 25 years old.

[0122] Suffering from hemorrhoids for 7 years. This treatment was due to severe pain in the anus. Doctors examined him and found that there were anal fissures between the skin tags formed by the previous hemorrhoid attack. Apply ointment to the anal fissures, and the pain was significantly relieved on the same day. Treatment: Place the Chinese medicine composition of the present invention in a syringe and apply it to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is injected into the anus at one time, with an injection depth of 3-5 cm. After using two, the pain completely disappeared.

[0123] Typical case 10: Tan Moumou, male, 48 years old.

[0124] Suffering from hemorrhoids for 12 years. The main symptom of the patient is annular prolapse in the anus, with obvious tenderness. The doctor examined and found that it was moderate mixed hemorrhoids. The ointment was used for administration in the anus and application on the outside. The pain basically disappeared after one day of use. Treatment: The Chinese medicine composition of the present invention is placed in a syringe and applied to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After application, the remaining medicine is all injected into the anus at one time, with an injection depth of 3-5 cm. After three days of use, the affected area basically returned to normal.

[0125] Typical case 11: Song Moumou, female, 70 years old.

[0126] Suffering from hemorrhoid disease for more than 30 years. The main symptom of the patient is that the hemorrhoids need to be put back by hand after they fall out. The doctor's examination results show that the external hemorrhoids and internal hemorrhoids are in the third stage. Use ointment for rectal administration and external application. Treatment: Place the Chinese medicine composition of the present invention in a syringe and apply it to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at one time, with an injection depth of 3-5 cm. After one day of use, the volume of the external hemorrhoids is significantly reduced, and the internal hemorrhoids can be retracted by themselves after defecation.

[0127] Typical case 12: Xie Moumou, female, 58 years old.

[0128] Suffering from hemorrhoid disease for more than 20 years. Occasionally, the main symptom of the patient is slight pain in the anus. The doctor's examination results showed that the patient had mixed hemorrhoids and external hemorrhoids. One thrombosed external hemorrhoid was obviously congested. Use ointment for anal administration and external application. After one day of use, the painful and congested external hemorrhoids disappeared. Treatment: Place the Chinese medicine composition of the present invention in a syringe and apply it to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at one time, with an injection depth of 3-5 cm. After three days of use, all hemorrhoids in the affected area are significantly reduced.

[0129] Typical case 13: Sun Moumou, female, 56 years old.

[0130] Suffering from hemorrhoid disease for more than 30 years. Occasionally, the main symptoms of the patient are mild pain in the anus and obvious foreign body sensation. The doctor's examination result is old external hemorrhoids. Use ointment to apply to the hemorrhoids. Treatment: Place the Chinese medicine composition of the present invention in a syringe and apply it to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at one time, with an injection depth of 3-5 cm. After one day of use, the pain completely disappeared and the foreign body sensation gradually eased. After three days of use, the foreign body sensation completely disappeared. The anus area basically returned to the state before the attack.

[0131] Typical case 14: Song Moumou, female, 40 years old.

[0132] Suffering from hemorrhoid disease for 12 years. The patient's symptoms are severe pain in external hemorrhoids in the anus, and he has been bedridden for treatment. Doctors examined and found that it was thrombosed external hemorrhoids. Use ointment to apply on the outside. After one day of use, the pain was significantly relieved and the hemorrhoids were significantly reduced. After three days of use, the pain disappeared completely, and the congestion of external hemorrhoids disappeared completely, leaving only the surface skin of the hemorrhoids. Treatment: The Chinese medicine composition of the present invention is placed in a syringe, and the hemorrhoids are applied three times a day, three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at a time, and the injection depth is 3-5 cm.

[0133] Typical case 15: Tian, ​​male, 43 years old.

[0134] Medical history: The patient first had blood in his stool seven years ago after drinking alcohol. He did not receive treatment. In the following two years, the condition became more serious and the tumor began to prolapse. A year later, the tumor could not be retracted into the anus by itself after prolapse. There was no pain but a foreign body sensation. He did not drink alcohol or eat spicy food for the past two months, but the symptoms did not improve, so he came to see a doctor. Examination showed that there was a tumor prolapsed at the anus, and the surface mucosa was partially damaged with a small amount of bleeding. Digital examination touched the soft hemorrhoid mucosa in the anus, but no foreign body was touched. Diagnosed as "internal hemorrhoids stage 4"

[0135] Treatment: Apply the composition of the present invention to the hemorrhoids three times a day, three times each time, with an interval of three to five minutes between each application. After application, inject all the remaining medicine into the anus at once, with an injection depth of 3-5 cm. The hemorrhoids will shrink after a total of 13 days of treatment.

[0136] Typical case 16: Mr. Li, male, 40 years old.

[0137] Three years ago, the patient had blood in the stool after eating spicy food, accompanied by a lump protruding from the anus. He did not receive treatment and gradually recovered after stopping eating spicy food. Over the past three years, the above symptoms recurred every time he ate spicy food or was overworked. One year ago, he had bleeding and a lump protruding after drinking alcohol. After protruding, the lump could not be retracted into the anus by itself, and he usually felt like a foreign body. In the past ten days, he felt a swelling and pain at the anus, so he came to see a doctor. Examination showed that a lump protruded from the anus, and he was diagnosed with "third-stage internal hemorrhoids". Apply the composition of the present invention three times each time, with an interval of three to five minutes between each time. After applying, the remaining medicine is all injected into the anus at one time, with an injection depth of 3-5 cm. The hemorrhoids retracted after 10 days of treatment.

[0138] Typical case 17: Zhong Moumou, male, 36 years old.

[0139] Medical history: The patient had internal hemorrhoids with bloody stools three years ago, but recovered soon after without treatment. Later, he had repeated bloody stools accompanied by mild pain. One year ago, after eating spicy hot pot, he had persistent pain during defecation accompanied by a foreign body sensation and swelling, which did not subside for a long time, so he came to see a doctor.

[0140] Treatment: Apply the composition of the present invention three times each time, with an interval of three to five minutes between each application. After applying, inject the remaining drug into the anus at once, with an injection depth of 3-5 cm. The hemorrhoids will shrink after 5 days of treatment.

[0141] Typical case 18: Zhao Moumou, female, 25 years old.

[0142] Medical history: The patient began to have anal swelling protruding during defecation without obvious cause more than half a year ago. The swelling can be reduced by itself after rest, accompanied by blood in the stool. The bleeding is bright red and drips to the surface of the stool. The amount is not much. There is no pain in the stool, tenesmus, fever, fatigue, abdominal pain, bloating, nausea, vomiting and other discomforts. In the past month, the patient's symptoms have worsened, and the patient's symptoms have recurred. Yesterday, he had a lot of bleeding and came to the doctor. Examination showed that there was a swelling protruding from the anus, and the surface mucosa was not damaged. The soft hemorrhoidal mucosa was touched in the anus by digital examination, and no foreign body was touched. There was no blood on the finger cot, and the diagnosis was "mixed hemorrhoids".

[0143] Treatment: Apply the composition of the present invention three times each time, with an interval of three to five minutes between each time. After applying, inject the remaining medicine into the anus at once, with an injection depth of 3-5 cm. The treatment lasts for 4 days, and it takes two weeks to be completely cured.

[0144] Typical case 19: Wang Moumou, female, 78 years old.

[0145] The patient suffered from "cerebral infarction and diabetes" five years ago, which led to paralysis of the right limbs. Two years ago, the skin on the right hip was damaged and bedsores formed. After multiple treatments, the patient came to the clinic with poor results. Examination: A skin lesion of about 6×7cm in size was found on the outside of the right hip. The skin on the edge was reddish brown, with a clear boundary with the surrounding skin. The skin epidermis inside the lesion was missing, and the white base was exposed. The surface was covered with necrotic tissue, and the necrotic tissue reached deep into the skin. The diagnosis was "stage three bedsores".

[0146] For treatment, apply the composition of the present invention to the ulcer surface of bedsore, with the middle thick and the edges slightly thin, and the central ointment is about one coin thicker than the normal skin. Bandage with gauze and sterile dressing, change the dressing once a day, and rinse the wound with normal saline during the dressing change. Keep blood sugar stable below 8mmol / L during treatment, turn over every 2-3 hours during treatment to avoid new skin lesions, and use an anti-bedsore air cushion on the affected hip when lying on the right side. The wound healed completely after 19 days of treatment.

[0147] Typical case 20: Zheng Moumou, male, 64 years old.

[0148] The patient had right hand debridement, suture and Kirschner wire fixation under brachial plexus anesthesia due to "pain and bleeding in the right hand caused by the noodle press for more than 5 hours". Five days after the operation, the skin of the patient's right hand was black and necrotic, with yellow-white purulent exudation. The dorsal surface of the palm was covered with necrotic tissue, and the necrotic tissue reached the deep layer of the skin. The diagnosis was "skin necrosis after right hand compression injury". After debridement, wound care ointment type B was injected under the necrotic skin on the palm side of the right hand, and the remaining necrotic skin on the dorsal side of the palm was evenly applied to the wound. The standard was that the ointment was applied to the necrotic wound, about the thickness of a coin. Gauze and sterile dressings were used for bandaging, and the dressing was changed once a day. When changing the dressing, the wound was repeatedly rinsed with hydrogen peroxide + saline (more than 3 times). During the treatment, the affected limb was suspended in front of the chest, and the patient was instructed to do appropriate functional exercises. After 10 days of treatment, the infected wound healed completely.

[0149] Another embodiment of the present invention provides a method for preparing a Chinese medicine composition for sore abscess, muscle growth and antibacterial properties, comprising:

[0150] Step 1: Place the calcined pearls in a preheated iron pot, heat until they burst, and grind them into fine powder that can pass through a 100-mesh sieve;

[0151] Step 2: Grind rhubarb, fig leaves, Panax notoginseng and Ganoderma lucidum into 600-mesh fine powder and mix;

[0152] Step 3: Crush the borneol into powder using a wall breaker and make it all pass through a 100-mesh sieve;

[0153] Step 4: Add 50g of figs to 500ml of water, simmer for about 1 hour, and cool to 75°C;

[0154] Step 5: Mix the ingredients in steps 1-3 into powder and add it into the mixture. Boil for 10 minutes and cool it down before serving.

[0155] Another embodiment of the present invention provides an application of a Chinese medicine composition for healing sores, promoting tissue regeneration and inhibiting bacteria, including application in hemorrhoids, pressure sores and bedsores.

[0156] Usage for the treatment of hemorrhoids:

[0157] Use 3 times a day, 3 times each time. For internal hemorrhoids of stage I and II, the drug should be injected 3-5cm into the anus to cover the affected area; for internal hemorrhoids of stage III and IV: it can be applied on the surface of the prolapsed hemorrhoids and then inserted back, or it can be injected into the anus after the hemorrhoids are located so that the drug can cover them. External hemorrhoids: Apply directly. For mixed hemorrhoids, the above two methods can be combined. Anal fissures and perianal abscesses: Apply directly. Mild anal fistulas: Inject the drug into the anus and apply a small amount outside the anus.

[0158] Stage I hemorrhoids: Bleeding in the stool will stop on the day of medication, and should be taken for three consecutive days.

[0159] Stage II hemorrhoids: The bleeding in the stool will stop on the day of medication. If the medication is used more than 3 times within 24 hours, the symptoms will be significantly alleviated. Use the medication continuously for 6 to 7 days.

[0160] Stage III hemorrhoids: If the medication is used properly, the bleeding in the stool will stop on the same day. If the medication is used more than 8 times continuously in 48 hours, the symptoms will be significantly alleviated. The medication should be used continuously for 7 to 9 days.

[0161] Stage IV hemorrhoids: Take the medicine properly, take it 3 times within 12 hours, use it continuously, the symptoms will gradually ease after 12 days of medication.

[0162] Anal fissure and anal fistula: For patients with early anal fissure, use the medicine for 1 to 2 days, and for patients with chronic anal fissure, use the medicine for 3 to 4 days. It has a curative effect on early anal fistula.

[0163] From the above description, it can be seen that the above embodiments of the present invention achieve the following technical effects:

[0164] The invention adopts the treatment principle of traditional Chinese medicine for different hemorrhoids, the principle of combining "elimination method" with "clearing method", and its usage is: apply the ointment to the lesion site, and make full use of various Chinese medicinal ingredients contained in the ointment, such as pearl and ganoderma lucidum, astringent and regeneration, detoxification and skin care, analgesia and hemostasis, Panax notoginseng blood circulation and stasis, swelling and pain relief, borneol heat dissipation and detoxification, rhubarb heat clearing and cooling blood, etc., to repair the wound and ulcer surface formed by long-term hemorrhoids, and can quickly block the growth of harmful bacteria and anti-infection. Promote capillary formation and increase the proliferation of fibroblasts, thereby promoting rapid wound healing.

[0165] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicinal composition for healing sores, promoting tissue regeneration and inhibiting bacteria, Features: The raw materials and weight portions of the Chinese medicine composition are: 60 parts of fig leaf powder, 50 parts of fig fruit, 50 parts of calcined pearls, 40 parts of rhubarb, 30 parts of Panax notoginseng, 30 parts of Ganoderma lucidum, and 30 parts of borneol.

2. A method for preparing the Chinese medicine composition for sore-removing, myogenic and antibacterial properties as claimed in claim 1, It is characterized in that The method comprises: step 1: placing calcined pearls in a preheated iron pot, heating until the pearls burst, and grinding the pearls into fine powder that passes through a 100-mesh sieve; Step 2: Grind rhubarb, fig leaves, Panax notoginseng and Ganoderma lucidum into 600 mesh fine powder and mix; Step 3: Crush the borneol into powder using a wall breaker and make it all pass through a 100-mesh sieve; Step 4: Add 50g of figs to 500ml of water, simmer for about 1 hour, and cool to 75°C; Step 5: Mix the fine powders from steps 1-3 into medicinal powder and add it into the mixture. Boil for 10 minutes and cool it down before serving.

3. The method for preparing the sore-removing, myogenic and antibacterial Chinese medicine composition according to claim 2, It is characterized in that The finished product is a paste.

4. Use of the sore-removing, myogenic and antibacterial Chinese medicine composition as claimed in claim 1 in the preparation of medicines, It is characterized in that The medicine is used for hemorrhoids.

5. Use of the sore-removing, myogenic and antibacterial Chinese medicine composition according to claim 4 in the preparation of medicines, It is characterized in that The medicament is also used for pressure sores.

6. Use of the sore-removing, myogenic and antibacterial Chinese medicine composition according to claim 4 in the preparation of medicines, It is characterized in that The drug is also used for bedsores.

Images