Application of pharmaceutical composition in preparation of antibacterial agent

Abstract

The invention provides application of a traditional Chinese medicine compound prepared from 70-100 parts of rheum officinale, 70-100 parts of mirabilite and 70-100 parts of gallnut in preparation of an antibacterial agent. The traditional Chinese medicine compound disclosed by the invention is simple in medicine flavor, good in antibacterial property on bacteria (such as staphylococcus aureus and escherichia coli) and fungi (such as candida albicans), low in cost, good in effect, capable of reaching the word size eliminating product standard, small in toxic and side effects, and good in stability and effectiveness shown by accelerated storage experiments, and the raw materials are pure traditional Chinese medicine raw materials. The preservation time is long, and the application prospect is very good.

Description

[0001] This application is a divisional application for the invention patent with application number 2023107633184, invention name "Use of a pharmaceutical composition in the preparation of antibacterial agents", and application date June 27, 2023. Technical Field

[0002] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to use of a pharmaceutical composition in preparing an antibacterial agent. Background Art

[0003] Bacteria and fungi are the two most common pathogens. After infecting organisms, they can cause many diseases such as pneumonia and gastroenteritis. Therefore, inhibiting and killing the growth of bacteria and fungi is the key to preventing and treating related diseases.

[0004] Since the advent of penicillin, antibiotics have become the most widely used antimicrobial agents, achieving remarkable clinical success in treating diseases and saving countless lives. However, the overuse of antibiotics has led to the emergence of bacterial resistance, and long-term antibiotic use can easily cause adverse reactions. Therefore, further exploration of antimicrobial agents with improved antimicrobial efficacy, a low resistance to resistance, and minimal side effects is urgently needed.

[0005] Compared to Western antibiotics, traditional Chinese medicine (TCM) possesses unique mechanisms of action, exhibits minimal toxicity and side effects, and is less susceptible to drug resistance. Consequently, with the advancement of evidence-based medicine, research on the antibacterial and anti-inflammatory properties of TCM has become a hot topic. Chinese scholars began studying the antibacterial effects and antibacterial components of TCM as early as the 1950s. As this research continues, antibacterial activity has been discovered in a variety of TCM herbs. For example, Zhang Xiaoli et al. compared the in vitro antibacterial effects of gallnuts and Chinese gallnuts and found that they had inhibitory effects on Grapevine, Pseudomonas aeruginosa, Candida albicans, Bacillus subtilis, and Escherichia coli (Zhang Xiaoli, Li Xue, Gao Suni, Li Kangshe. Comparative study on the in vitro antibacterial effects of gallnuts and Chinese gallnuts [J]. China Pharmaceuticals, 2018, 27(23): 29-31.). Sheng Jiejing et al. compared the antibacterial activity of rhubarb and its processed products and confirmed that rhubarb and its processed products had different degrees of bactericidal effects on Escherichia coli, Staphylococcus aureus, Staphylococcus albicans, Bacillus subtilis, and Candida albicans.

[0006] There are also numerous reports on the antibacterial effects of traditional Chinese medicine (TCM) compound formulas. For example, Chinese patent CN113633685B discloses a formula composed of seven herbs: scutellaria baicalensis, honeysuckle, isatis root, forsythia suspensa, hawthorn, mint, and gallnut. Its antibacterial effects against Escherichia coli and Staphylococcus aureus have been demonstrated. Another example is patent application CN114432387A, which discloses an antibacterial formula with demonstrated antibacterial effects against Escherichia coli, Staphylococcus aureus, and beta-hemolytic streptococci, suggesting its potential value in treating gynecological inflammation.

[0007] However, the antibacterial compounds reported so far have many different flavors, are relatively expensive, and their antibacterial effects still need to be further improved. Summary of the Invention

[0008] The object of the present invention is to provide a composition with a simplified formula and excellent antibacterial effect for use in an antibacterial agent.

[0009] The present invention provides a use of a pharmaceutical composition in the preparation of an antibacterial agent, wherein the pharmaceutical composition comprises the following raw materials in parts by weight:

[0010] 70-100 parts of rhubarb, 70-100 parts of Glauber's salt, and 70-100 parts of gallnut.

[0011] Furthermore, the pharmaceutical composition is prepared from the following raw materials in parts by weight:

[0012] 80-90 parts of rhubarb, 80-90 parts of sodium sulfate, and 80-90 parts of gallnut.

[0013] Furthermore, the pharmaceutical composition is prepared from the following raw materials in parts by weight:

[0014] 90 parts of rhubarb, 90 parts of sodium sulfate, and 90 parts of gallnuts.

[0015] Furthermore, the antimicrobial agent is a preparation for killing bacteria and / or fungi, or a preparation for inhibiting the growth of bacteria and / or fungi; and / or, the preparation is a preparation for external use.

[0016] Furthermore, the external preparation is a lotion.

[0017] Furthermore, the bacteria are Gram-positive bacteria or Gram-negative bacteria;

[0018] The Gram-positive bacteria include: Staphylococcus, Streptococcus, Pneumococcus, Bacillus anthracis, Corynebacterium diphtheriae, and Corynebacterium tetani; the Staphylococcus includes Staphylococcus aureus;

[0019] The Gram-negative bacteria include: Escherichia coli, Proteus, Klebsiella pneumoniae, Brucella, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Acinetobacter, Bordetella parapertussis, Bordetella cholerae, and Bacillus parahaemolyticus;

[0020] The fungi include: Candida, Geotrichum, Trichosporon, Malassezia; the Candida include Candida albicans;

[0021] And / or, the antibacterial agent is a preparation against drug-resistant bacteria; the drug-resistant bacteria include methicillin-resistant Staphylococcus aureus, multidrug-resistant Mycobacterium tuberculosis, extended-spectrum β-lactamase bacteria, vancomycin-resistant enterococci, carbapenem-resistant Enterobacteriaceae, multidrug-resistant Pseudomonas aeruginosa, and multidrug-resistant Acinetobacter baumannii.

[0022] Furthermore, the antibacterial agent is a drug for preventing and treating diseases caused by bacterial and / or fungal infections.

[0023] Furthermore, the disease caused by the bacterial and / or fungal infection is a gynecological disease, andrological disease, gastroenteritis, pneumonia, fasciitis, mastitis or cow mastitis.

[0024] Furthermore, the gynecological disease is Bartholin's gland cyst, pelvic inflammatory disease and / or vaginitis; the andrological disease is the prevention and treatment of prostatitis.

[0025] Furthermore, the drug is a drug for preventing postoperative infection and / or promoting wound healing.

[0026] The "Sodium Sulfate" described in the present invention is a sulfate mineral, Sodium Sulfate Family Sodium Sulfate, which is a processed and refined crystal mainly containing sodium sulfate decahydrate and is a traditional Chinese medicine.

[0027] The beneficial effects of the present invention are as follows: the present invention provides a use of a traditional Chinese medicine compound prepared from rhubarb, sodium sulfate and gallnut in an antibacterial agent. The compound has simple medicinal flavors, has excellent antibacterial properties against bacteria (such as Staphylococcus aureus and Escherichia coli) and fungi (such as Candida albicans), is low in cost and effective, and can meet the standards for antibacterial products. The present invention uses pure traditional Chinese medicine raw materials, has low toxic and side effects, and shows excellent stability and effectiveness in accelerated storage experiments. The compound can be stored for up to 2 years, and has good application prospects.

[0028] Obviously, based on the above contents of the present invention, according to common technical knowledge and customary means in this field, without departing from the above basic technical ideas of the present invention, other various forms of modifications, replacements or changes can be made.

[0029] The following further describes the above content of the present invention in detail through specific embodiments in the form of examples. However, this should not be construed as limiting the scope of the above subject matter of the present invention to the following examples. All technologies implemented based on the above content of the present invention fall within the scope of the present invention. DETAILED DESCRIPTION

[0030] The raw materials and equipment used in the present invention are all known products, which are obtained by purchasing commercial products. The preparation process of the lotion made from the composition of the present invention is mature and can be made by referring to conventional methods in the prior art.

[0031] Example 1. Preparation of the compound antibacterial lotion of the present invention

[0032] Recipe: 90g rhubarb, 90g Glauber's salt, and 90g gallnut.

[0033] Preparation method: Weigh the above medicinal ingredients according to the ratio, add 1800 mL of water and soak for 40 minutes, boil and keep boiling for 30 minutes, filter, concentrate the filtrate to 30 g of the original medicine per 100 mL, divide and package to obtain the lotion.

[0034] Example 2: Preparation of the compound antibacterial lotion of the present invention

[0035] Recipe: 70g rhubarb, 100g Glauber's salt, and 100g gallnut.

[0036] Preparation method: Same as Example 1

[0037] Example 3: Preparation of the compound antibacterial lotion of the present invention

[0038] Recipe: 100g rhubarb, 70g Glauber's salt, and 70g gallnut.

[0039] Preparation method: same as Example 2

[0040] Example 4: Preparation of the compound antibacterial lotion of the present invention

[0041] Recipe: 70g rhubarb, 70g Glauber's salt, 100g gallnut.

[0042] Preparation method: Same as Example 1

[0043] Example 5: Preparation of the compound antibacterial lotion of the present invention

[0044] Recipe: 80g rhubarb, 90g Glauber's salt, and 90g gallnut.

[0045] Preparation method: same as Example 1.

[0046] Example 6: Preparation of the compound antibacterial lotion of the present invention

[0047] Recipe: 90g rhubarb, 80g Glauber's salt, 90g gallnut.

[0048] Preparation method: same as Example 1.

[0049] Example 7: Preparation of the compound antibacterial lotion of the present invention

[0050] Recipe: 70g rhubarb, 100g Glauber's salt, 70g gallnut.

[0051] Preparation method: same as Example 1.

[0052] Example 8: Preparation of the compound antibacterial lotion of the present invention

[0053] Recipe: 100g rhubarb, 70g Glauber's salt, and 100g gallnut.

[0054] Preparation method: same as Example 1.

[0055] The beneficial effects of the present invention are demonstrated by experimental examples below.

[0056] Experimental Example 1: Experimental study on the compound antibacterial lotion of the present invention

[0057] 1. Equipment

[0058] 1. Test samples

[0059] 1# Rhubarb water extract: Add 30g of rhubarb to 200mL of water, soak for 40 minutes, boil and keep boiling for 30 minutes, filter, and concentrate the filtrate to 30g of the original medicine per 100mL.

[0060] 2# Gallnut water extract: Add 30g of Gallnut to 200mL of water, soak for 40 minutes, boil and keep boiling for 30 minutes, filter, and concentrate the filtrate to 30g of the original medicine per 100mL.

[0061] 3# 30% Sodium Sulfate Solution: Dissolve 30g Sodium Sulfate in 100mL hot water.

[0062] 4# Rhubarb and gallnut water extract: Add 30g each of rhubarb and gallnut to 400mL of water, soak for 40 minutes, boil and keep boiling for 30 minutes, filter, and concentrate the filtrate to 30g of the original medicine per 100mL.

[0063] 5# Rhubarb and Sodium Sulfate Water Extract: Add 30g each of rhubarb and Sodium Sulfate to 400mL of water, soak for 40 minutes, boil and keep boiling for 30 minutes, filter, and concentrate the filtrate to 30g of the original medicine per 100mL.

[0064] 6# Gallnut and Sodium Sulfate Water Extract: Add 30g each of Gallnut and Sodium Sulfate to 400mL of water, soak for 40 minutes, boil and keep boiling for 30 minutes, filter, and concentrate the filtrate to 30g of the original medicine per 100mL.

[0065] 7# Manghuang Lotion 1 (prepared according to Example 1)

[0066] 8# Manghuang Lotion 2 (the medicinal material ratio is 70g of rhubarb, 100g of sodium sulfate, and 70g of gallnut, prepared according to the method of Example 1)

[0067] 9# Manghuang Lotion 3 (the medicinal material ratio is 100g of rhubarb, 70g of sodium sulfate, and 100g of gallnut, prepared according to the method of Example 1)

[0068] 10# Manghuang Lotion 4 (the medicinal material ratio is 100g of rhubarb, 70g of sodium sulfate, and 70g of gallnut, prepared according to the method of Example 1)

[0069] 2. Test strains: Escherichia coli (8099) was tested using fresh slant cultures of passages 5 and 6; Staphylococcus aureus (ATCC 6538) was tested using fresh slant cultures of passages 5 and 6; Candida albicans (ATCC 10231) was tested using fresh slant cultures of passage 6. All strains were provided by the Guangdong Provincial Food Microbiology Safety Engineering Technology Research and Development Center.

[0070] 3. Instruments and equipment: KC-SP-YQ-179 electric constant temperature incubator (DHP-9272), KC-SP-YQ-586 biological safety cabinet (HR50-IIA2).

[0071] 2. Experimental Methods

[0072] 1. Inspection basis: Appendix C4 of GB 15979-2002 Hygiene Standard for Disposable Sanitary Products.

[0073] 2. Test conditions: temperature 20-23°C, relative humidity 50-54%.

[0074] 3. Sample preparation: original

[0075] 3. Experimental Results

[0076] Table 1 Antibacterial effects of different compound antibacterial lotions

[0077]

[0078]

[0079] As can be seen from the above results: for Escherichia coli, the rhubarb water extract containing 30g of the original drug per 100mL and the 30% sodium sulfate solution had no antibacterial effect. The gallnut water extract containing 30g of the original drug per 100mL had an antibacterial rate of more than 50% in the 2-minute action time, i.e., it had an antibacterial effect. The action time exceeded 5min and the antibacterial rate exceeded 90%, i.e., it produced a relatively strong antibacterial effect. However, when rhubarb, sodium sulfate, and gallnut were compounded in pairs to form the original drug containing the same dose, the antibacterial effect was significantly reduced relative to the gallnut water extract, or even had no antibacterial effect. When rhubarb, sodium sulfate, and gallnut were combined to form the original drug containing the same dose, the antibacterial effect was significantly enhanced, and the antibacterial rate exceeded 90% in the 2-minute action time compared to the gallnut water extract, reaching a relatively strong antibacterial effect. In particular, the antibacterial lotion of Example 1, prepared with the three in a 1:1:1 ratio, could achieve a 100% antibacterial rate in 2 minutes.

[0080] For Staphylococcus aureus and Candida albicans, the antibacterial rates of rhubarb water extract, Glauber's salt solution, and gallnut water extract were less than 50%, and the antibacterial effect was poor. When rhubarb, Glauber's salt, and gallnut were compounded in pairs to prepare a solution containing the same dose of native medicine, the antibacterial effect was not improved. However, when rhubarb, Glauber's salt, and gallnut were compounded to prepare a solution containing 30g of native medicine per 100mL, the antibacterial effect was greatly improved, with an inhibition rate exceeding 50%. In particular, the antibacterial lotion of Example 1 obtained by compounding in a ratio of 1:1:1 reached an inhibition rate of 100% against Staphylococcus aureus after 10 minutes of action, and an inhibition rate of 100% against Candida albicans after 2 minutes of action, producing a strong antibacterial effect.

[0081] From the perspective of the antibacterial effect on bacteria and fungi, the compound antibacterial lotion of the present invention achieves a synergistic effect by compounding rhubarb, sodium sulfate and gallnut in a specific ratio.

[0082] Experimental Example 2: Physical Property Test of the Compound Antibacterial Lotion of the Present Invention

[0083] 1. pH value

[0084] 1. Equipment

[0085] 1.1 Test sample: the lotion stock solution of Example 1.

[0086] 1.2. Instrument: KC-SPYQ-054 pH meter (PHS-3C).

[0087] 1.3. Calibration buffer solutions: potassium hydrogen phthalate buffer solution (pH = 4.00, 25°C); mixed phosphate solution (pH = 6.86, 25°C); borax buffer solution (pH = 9.18, 25°C).

[0088] 2. Methods

[0089] 2.1. Inspection basis: Technical Specifications for Disinfection (2002 edition) 2.2.1.4.

[0090] 2.2. Test conditions: Temperature 20-22°C, relative humidity 46-61%. Repeat the test twice.

[0091] 2.3. Sample treatment: as is.

[0092] 3. Results

[0093] The pH values of the two batches of detergent stock solutions were measured twice, and the pH values of the detergents were 4.00 and 3.76 respectively. The results are shown in Table 2.

[0094] Table 2 pH value measurement results

[0095]

[0096] Combined with the test results in Table 2, the pH value range of the compound antibacterial lotion was determined to be 3.8-4.2 through multiple tests.

[0097] 2. Osmotic pressure

[0098] 1.1 Test sample: the lotion stock solution of Example 1.

[0099] 1.2. Instrument: Osmometer SMC 30.

[0100] 2. Methods

[0101] 2.1.Test basis: Chinese Pharmacopoeia 2020 Edition Part IV General Chapter 0632 Osmolality Determination Method.

[0102] 2.2. Test conditions: Temperature 20-22°C, relative humidity 46-61%.

[0103] 2.3. Sample treatment: as is.

[0104] 3. Results

[0105] The osmotic pressure of the compound antibacterial lotion was determined to be 550-580 mmol / L through multiple measurements of multiple batches of lotion stock solutions.

[0106] Experimental Example 3: Safety Performance Test of the Compound Antibacterial Lotion of the Present Invention

[0107] 1. Materials and Animals

[0108] 1.1 Test sample: the lotion stock solution of Example 1.

[0109] 1.2 Experimental animals

[0110] Species / Strain: Rabbit / New Zealand Rabbit; Grade: General Grade; Number and Gender: 12, including 6 males and 6 females; Weight: 2.0-2.5 kg;

[0111] Breeding Unit ①: Jinan Xilingjiao Breeding and Breeding Center; Laboratory Animal Production License No.: SCXK(Lu)20200004; Laboratory Animal Quality Certificate No.: No.370822211100065962, No.370822211100062245;

[0112] Breeding unit ②: Shandong Ailek Biotechnology Co., Ltd.; Laboratory Animal Production License No.: SCXK(Lu)20190006; Laboratory Animal Quality Certificate No.: No.370839221100042373.

[0113] 2. Skin irritation test

[0114] 1. Method

[0115] 1.1. Test basis: "Technical Specifications for Disinfection" (2002 Edition) 2.3.3 Skin Irritation Test

[0116] 1.2. Sample preparation: Use the original sample without preparation.

[0117] 1.3. Test methods

[0118] 1.3.1 Animal Preparation: 24 hours before the experiment, remove the hair on both sides of the spine of a New Zealand rabbit using a depilatory agent, avoiding any damage to the skin. The hair removal area should be approximately 3 cm x 3 cm on each side.

[0119] 1.3.2 Exposure Method: The next day, apply 0.5 g of the test substance to the left side of the skin. The right side of the skin serves as a blank control. 4 hours after application, rinse with water to remove any residue. Apply once daily for 14 consecutive days.

[0120] 1.3.3 Symptom observation: Observe the results 24 hours after each application according to the Disinfection Technical Specifications.

[0121] Table 2-11 in 2.3.3 (2002 edition) scores the irritation reaction of animal skin erythema and edema. In order to facilitate the application of the test substance and the observation of the results, the hair should be clipped if necessary. The treatment method of the control area is the same as that of the test area.

[0122] 1.3.4 Evaluation regulations: Calculate the average score (irritation index) for each animal per day according to the following formula, and evaluate the level of irritation intensity of the test substance on animal skin according to Table 2-12 in 2.3.3 of the "Technical Specifications for Disinfection" (2002 Edition).

[0123]

[0124] 2. Results

[0125] Within 14 days after exposure, no skin erythema or edema was observed in either the control or test areas of the New Zealand rabbits. The mean skin irritation score was 0. This indicates that the compound antibacterial lotion of the present invention exhibited no irritation in multiple intact skin irritation tests on New Zealand rabbits, meeting the requirements of the Technical Specifications for Disinfection (2002 edition).

[0126] 3. Acute eye irritation test

[0127] 1. Method

[0128] 1.1. Test basis: Technical Specifications for Disinfection (2002 edition), 2.3.4 Acute eye irritation test.

[0129] 1.2. Sample preparation: Use the original sample without preparation.

[0130] 1.3 Test method:

[0131] 1.3.1 Animal preparation: Before the experiment, examine both eyes of each New Zealand rabbit. If no abnormality is found, the rabbit can be used for the experiment.

[0132] 1.3.2 Exposure Method: 0.1 g of the test substance was instilled into the conjunctival sac of the left eye of the animal. The eye was passively closed for 4 seconds. After 30 seconds, the eye was flushed with normal saline. The right eye was treated with normal saline as a normal control.

[0133] 1.3.3 Symptom Observation: Observe the conjunctiva, iris, and cornea of the New Zealand rabbits for damage and recovery 1 hour, 24 hours, 48 hours, and 72 hours after eye instillation. If no irritation occurs within 72 hours, terminate the study.

[0134] 1.3.4 Evaluation Rules: Score the acute irritation reactions of the cornea, iris, and conjunctiva of New Zealand rabbits according to Table 2-13 in 2.3.4 of the Technical Specifications for Disinfection (2002 Edition). Calculate the average score for each animal at three different observation times (24 hours, 48 hours, and 72 hours) for corneal damage, iris damage, conjunctival hyperemia, and conjunctival edema (i.e., the sum of the 24-hour, 48-hour, and 72-hour scores for each animal divided by the number of observations, 3). Determine the irritation intensity of the test substance to the eyes of New Zealand rabbits based on the average score and recovery time for corneal, iris, and conjunctival hyperemia and edema, respectively, according to the eye irritation grading standards in Tables 2-14 and 2-15 in 2.3.4 of the Technical Specifications for Disinfection (2002 Edition).

[0135] 2. Results

[0136] No corneal damage, iris damage, conjunctival congestion, or chemosis was observed 24, 48, or 72 hours after eye instillation. The mean eye irritation score was 0. This indicates that the compound antibacterial lotion of the present invention was non-irritating to the eyes of New Zealand rabbits. This meets the requirements of the Technical Specification for Disinfection (2002 edition).

[0137] IV. Vaginal mucosal irritation test

[0138] 1. Method

[0139] 1.1. Test basis: Technical Specifications for Disinfection (2002) 2.3.5 Vaginal mucosal irritation test.

[0140] 1.2. Preparation of test substance: Use stock solution and prepare without any reagent.

[0141] 1.3 Test method:

[0142] 1.3.1 Animal Preparation: Before the experiment, examine the vaginal opening of the animals. If there is no discharge, congestion, edema, or other damage, the animals can be used for the experiment. Divide the animals into a poison-treated group and a control group, with 3 animals in each group.

[0143] 1.3.2 Operating procedures

[0144] (1) Connect a blunt-ended flexible tube about 8 cm long to a 2 mL syringe. Fill the syringe and catheter with the test solution and set aside. Prepare one set for each animal. Fix the animal on its back, exposing the perineum and vaginal opening. Moisten the catheter with the test solution and gently insert it into the vagina (4 cm to 5 cm). Slowly inject 2 mL of the test solution with a syringe, remove the catheter, and the infection is complete. Repeat the infection every 24 hours for 5 consecutive days. The control group animals are treated with normal saline in the same way.

[0145] (2) 24 hours after the last exposure, the animals were killed by gas embolism. The intact vagina was removed by dissection and longitudinally incised. No congestion or edema was observed by naked eye. The vagina was then fixed in 10% neutral buffered formalin solution for at least 24 hours. Tissue sections were prepared from the two ends and three central areas of the vagina and stained with HE for histopathological examination.

[0146] 1.3.3 Evaluation Regulations

[0147] (1) Histopathological examination results The irritation response of the vaginal mucosa was scored according to Table 3.

[0148] (2) The mean score of vaginal mucosal irritation response of the three animals in the experimental group was calculated by adding the scores of the three sites and then dividing by the total number of observations (number of animals * 3). The scoring method for the control group was the same as above.

[0149] (3) After subtracting the mean score of the control group from the mean score of the experimental group to obtain the stimulation index, the stimulation intensity was graded according to Table 4.

[0150] Table 3 Vaginal mucosal irritation response scoring criteria

[0151]

[0152]

[0153] Stimulus response integral = A + B + C + D

[0154] Table 4 Vaginal mucosal irritation intensity classification

[0155]

[0156] 2. Results

[0157] The compound antibacterial lotion of the present invention has a vaginal mucosal irritation index of 0.89 on New Zealand rabbits. The reaction intensity of multiple vaginal mucosal irritation tests on New Zealand rabbits is extremely mild, which meets the requirements of the "Disinfection Technical Specifications" (2002 edition).

[0158] Experimental Example 4: Effect of the stability of the compound antibacterial lotion of the present invention

[0159] 1. Equipment

[0160] 1. Test sample: the lotion stock solution of Example 1.

[0161] 2. Test strain: Candida albicans (ATCC 10231) fresh slant cultures of passages 4 and 6 were used for testing. All strains were provided by the Guangdong Food Microbiology Safety Engineering Technology Research and Development Center.

[0162] 3. Instruments and equipment: KC-SP-YQ-179 electric constant temperature incubator (DHP-9272), KC-SP-YQ-S86 biological safety cabinet (HR50-IIA2), KC-SP-YQ-125 constant temperature and humidity chamber (LHS-100CL).

[0163] 2. Experimental Methods

[0164] 1. Inspection basis: Appendices C4 and C6 of GB 15979-2002 Hygiene Standard for Disposable Sanitary Products.

[0165] 2. Test conditions: temperature 19-23°C, relative humidity 50-54%.

[0166] 3. Sample preparation: original

[0167] 3. Experimental Results

[0168] 1. Inhibitory effect on Candida albicans

[0169] 1.1 The antibacterial rate data of the antibacterial lotion of Example 1 of the present invention on Candida albicans (ATCC 10231) after being treated for 2 minutes, 5 minutes, 10 minutes, and 20 minutes are shown in Table 5.

[0170] Table 5 Antibacterial effect of Example 1 antibacterial lotion stock solution on Candida albicans

[0171]

[0172] Note: The negative control showed no sterile growth.

[0173] 1.2 The antibacterial wash solution of Example 1 of the present invention was prepared and stored at 54°C for 14 days. The antibacterial rate data for Candida albicans (ATCC 10231) at 2 min, 5 min, 10 min, and 20 min are shown in Table 6.

[0174] Table 6 Antibacterial effect of Example 1 antibacterial lotion stock solution on Candida albicans

[0175]

[0176] Note: The negative control showed no sterile growth.

[0177] 1.3 The antibacterial wash solution of Example 1 of the present invention was prepared and stored at 37°C for 90 days. The antibacterial rate data for Candida albicans (ATCC 10231) at 2 min, 5 min, 10 min, and 20 min are shown in Table 7.

[0178] Table 7 Antibacterial effect of Example 1 antibacterial lotion stock solution on Candida albicans

[0179]

[0180] Note: The negative control showed no sterile growth.

[0181] As shown, according to GB 15979-2002, "Hygienic Standard for Disposable Sanitary Products," under experimental conditions, the antibacterial wash of the present invention exhibited an average inhibition rate of >99.96% against Candida albicans after exposure to water for 2, 5, 10, and 20 minutes. Furthermore, the wash maintained a strong antibacterial effect against Candida albicans after storage at 54°C and 37°C for 14 and 90 days, respectively. This product demonstrates a two-year stability, meeting the requirements of GB 15979-2002, "Hygienic Standard for Disposable Sanitary Products."

[0182] In summary, the traditional Chinese medicine compound lotion composed of three herbs, rhubarb, sodium sulfate and gallnut, has excellent antibacterial properties against bacteria (such as Staphylococcus aureus and Escherichia coli) and fungi (such as Candida albicans), is low in cost and effective, and can meet the standards of a disinfectant product. The present invention uses pure traditional Chinese medicine raw materials, has low toxic and side effects, and shows excellent stability and effectiveness in accelerated storage experiments. The storage time can be up to 2 years, and the invention has good application prospects.

Claims

1. Use of a pharmaceutical composition in the preparation of an antibacterial agent, characterized in that: The pharmaceutical composition is made of the following raw materials in parts by weight: 90 parts of rhubarb, 90 parts of sodium sulfate, 90 parts of gallnut; The antibacterial agent is an external preparation for killing Gram-negative bacteria, or an external preparation for inhibiting the growth of Gram-negative bacteria.

2. The use according to claim 1, characterized in that The external preparation is a lotion.

3. The use according to claim 1, characterized in that The Gram-negative bacteria include: Escherichia coli, Proteus, Klebsiella pneumoniae, Brucella, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Acinetobacter, Bordetella parapertussis, Bordetella cholerae, and Bacillus parahaemolyticus.

4. The use according to any one of claims 1 to 3, characterized in that The antibacterial agent is a drug for preventing and treating diseases caused by Gram-negative bacteria infection.

5. The use according to claim 4, characterized in that The diseases caused by Gram-negative bacteria infection are gynecological diseases, men's diseases, gastroenteritis, pneumonia, fasciitis, mastitis or cow mastitis.

6. The use according to claim 7, characterized in that The gynecological disease is Bartholin's gland cyst, pelvic inflammatory disease and / or vaginitis; the andrological disease is the prevention and treatment of prostatitis.

7. The use according to any one of claims 1 to 3, characterized in that The medicine is a medicine for preventing postoperative infection and / or promoting wound healing.

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