CN112826849A

CN112826849A - Compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects and preparation method thereof

Info

Publication number: CN112826849A
Application number: CN202110046747.0A
Authority: CN
Inventors: 任力
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-01-15
Filing date: 2021-01-15
Publication date: 2021-05-25

Abstract

The invention discloses a compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects and a preparation method thereof, relates to the technical field of natural plant traditional Chinese medicines, and aims to solve the technical problems of clinical treatment of bacterial infection and antibacterial medicines mainly relying on antibiotics and chemical synthesis. The ratio of radix et rhizoma Rhei to flos Caryophylli is 3-2: 1-2. Experiments prove that the Chinese medicinal preparation can be prepared into liquid preparations or solid preparations, can treat burns, scalds, toothache, skin itch, prevent and treat influenza and the like, is used for inhibiting bacteria and resisting viruses, has the advantages of no toxic or side effect, no irritation, easy acceptance by patients and wide antibacterial spectrum, and is suitable for popularization and application.

Description

Compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects and preparation method thereof

Technical Field

The invention relates to natural plant traditional Chinese medicines, in particular to a compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects and a preparation method thereof, which are used for inhibiting bacteria and resisting viruses.

Background

Currently, clinical treatment of bacterial infections still relies on the use of antibiotics. The discovery and application of antibiotics to human beings is a great revolution of human beings. However, with the wide clinical use of antibiotics, inevitable harm also appears, so that not only the use of antibiotics is in danger, but also the health of human beings is seriously threatened again due to the appearance of 'super drug-resistant bacteria'.

Medical researchers have indicated that approximately 50% of the antibiotics are abused worldwide each year, and that this ratio is even close to 80% in china. Antibiotics are generally available without prescription in china, india and pakistan, which in part has led the general public to abuse, misuse antibiotics. Local doctors have to use more potent antibiotics to treat patients, again resulting in more drug resistance of the pathogens. Due to abuse of drugs, germs adapt to the antibiotic environment quickly, and various 'super germs' emerge successively.

Furthermore, DNA contamination due to antibiotic abuse is also another major factor contributing to "superbacteria". The rapid increase in the types and numbers of bacterial resistance genes cannot be explained by random mutation of organisms. Bacteria can not only exchange genes within the same species, but also between different species, and can even obtain genes from DNA scattered from the same species that have died. Therefore, the drug-resistant gene is rapidly transmitted among bacteria, and the generation of 'super pathogen' is further promoted.

The antibiotic can kill pathogenic bacteria and cause damage to human body. The medicine enters the stomach through the oral cavity and is absorbed into the blood through the intestinal tract and is conveyed to each cell of a human body, the medicine reaching the focus part can perform the sterilization function on pathogenic bacteria, the medicine in other tissues does not perform the sterilization function, but metabolic products are discharged out of the body through the liver and the kidney, and the medicine has certain damage effect on viscera such as the liver and the kidney, such as chloramphenicol, lincomycin, tetracycline, erythromycin and the like, and needs to be metabolized in the liver.

In addition, many antibiotics such as penicillin, streptomycin, etc. can cause allergic reactions, such as anaphylactic shock, mild rashes, fever, hematopoietic system suppression, etc., and even damage to the nervous system, such as central nervous system, hearing, vision, peripheral nervous system lesions, neuromuscular block, etc.

In summary, the invention and application of antibiotics and synthetic antibacterial drugs is one of the greatest achievements in the medical field of the 20 th century. The application of antibiotics and synthetic antibacterial drugs to human beings effectively cures various serious bacterial infectious diseases, effectively reduces the death rate of various serious bacterial infectious diseases, and further raises the climax of research and development and wide application of antibacterial drugs. In the middle of the 20 th century, over 500 kinds of antibiotic raw material medicines are on the market, and the clinical common varieties of the antibiotic raw material medicines are over hundreds. Before the enormous achievements of development and application of antibacterial drugs by human beings, the danger of infectious diseases starts to be overcome, and the application of antibiotics and synthetic antibacterial drugs also becomes desirable. However, it has been found that some bacterial infectious diseases, which are originally easy to treat, are now subject to new changes, and the antibiotics or synthetic antibacterial drugs, which are originally effective, are no longer effective in controlling the infection. The fact that pathogenic bacteria develop resistance to antibiotics is quickly documented, and the potential for fire resistance to develop and spread of some pathogenic bacteria is very alarming. According to statistics, the drug resistance rate of staphylococcus aureus to common antibiotic penicillin G is only 1% in the early 40 th century and is over 90% in the hurdle at the end of the last century; methicillin-resistant staphylococcus aureus (MRSA) with extremely high drug resistance and extremely high pathogenicity has the separation rate of 2% in 1974 and rapidly increases to 39.7% by the end of the last century, and becomes a main pathogenic bacterium causing serious bacterial infection in hospitals. At the same time, penicillin-resistant streptococcus pneumoniae (PRSP), another drug-resistant strain that causes severe community infections, has also developed rapidly. At the end of the last century, the separation rate of hospitals in major cities in China reaches 22.5 percent through sampling investigation, the separation rate of hospitals in the United states reaches 33.5 percent, and cases killed by drug-resistant bacteria infection are increased year by year. The gonorrhoeae caused by gonococcal infection is expected to be cured quickly by penicillin G treatment, but 60% of the existing gonococcal have drug resistance, and penicillin G has difficulty in controlling the development and delay. In the 80 s of the 20 th century, when quinolone antibacterial drugs are synthesized to be on the market, clinical pathogenic bacteria are very sensitive to the novel antibacterial drugs, the drug-resistant strains are almost zero, but after the quinolone antibacterial drugs are widely used for 20 years, the drug resistance rate of the clinical pathogenic bacteria to the synthetic antibacterial drugs rapidly rises. It is proved that the clinically used effective antibacterial drugs are possible to have resistant strains, and a plurality of pathogenic bacteria can also have resistance to a plurality of antibacterial drugs, namely multiple drug resistance. The development and spread of pathogenic bacterial resistance has posed a serious threat to human health. The WHO issues a warning for this: "the new superbacteria, which are resistant to all drugs, will bring the human back to the past years of infectious disease.

Still another serious problem is the very intractable multi-drug resistant infection of gram-positive cocci, which are resistant to almost all antibacterial drugs except individual antibiotics, and pose a great threat to clinical use, and have attracted global shock and attention. They include methicillin-resistant staphylococcus aureus (MRSA), methicillin-resistant staphylococcus epidermidis (MRSE) and methicillin-resistant hemolytic staphylococcus, the latter two staph being coagulase-negative, also known as methicillin-resistant coagulase-negative staphylococcus (MRCNS); penicillin-resistant streptococcus pneumoniae.

Streptococcus pneumoniae is originally highly sensitive to both penicillin and ampicillin. The streptococcus pneumoniae has drug-resistant strains to penicillins since the beginning of the 80 s, penicillin-resistant streptococcus pneumoniae is separated from various places in the future, and the drug resistance rate of the streptococcus pneumoniae to penicillins in some countries and regions is up to more than 40%. Multiple drug resistance caused by methicillin-resistant staphylococcus aureus (MRSA) has been a serious clinical problem, and the MRSA infection rate has been significantly higher than in the past, such as 2.4% MRSA incidence in 1975 and 35% rise in 1996 in the united states. In particular, the nosocomial infection MRSA accounts for a high proportion caused by Staphylococcus aureus, and the nosocomial infection MRSA accounts for 60-80% of the Japanese 1999 report. The reported MRSA incidence rate difference among various regions is large, and JAC reports that the MRSA incidence rate among different countries in Europe is less than 1% in 1999 and can reach 80% in the highest; the MRSA incidence rate reported in various places of China also fluctuates between 20% and 80%, China journal of medicine in 2001 published the results of Chinese bacterial drug resistance monitoring research, 9 regions monitored in 1998-1999 have the incidence rates of 27.55% and 15.67% for hospitalized infected patients MRSA and 81.82% for hospital-infected patients MRSA, 15.57% and 41.67% for community infection and hospital-infected patients MRSE, respectively, and the incidence rates of MRSA and MRSE in hospital-infected patients are obviously higher than the incidence rate of community infection.

Penicillin resistance of streptococcus pneumoniae to penicillin was first discovered in the mid 60 s, but it was noted that the outbreak of pneumonia caused by penicillin-resistant streptococcus pneumoniae (PRSP) was first developed in south africa in 1977. PRSP has been isolated worldwide and has become one of the most striking focuses on drug-resistant positive coccal infections. Penicillin G resistant streptococcus pneumoniae (PRSP) separation rates have increased significantly worldwide in recent years, particularly in some european countries, some regions of the united states, and some regions of south east asia where PRSP has been as high as 40% to 70%.

Disclosure of Invention

The invention aims to: in order to overcome the situation that antibiotics and chemically synthesized antibacterial drugs are still mainly relied on in clinical treatment of bacterial infection in the market at present, the invention provides a compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects and a preparation method thereof.

The invention relates to a Chinese medicinal compound prescription from plants for resisting bacteria, inflammation and virus and a preparation method of a preparation thereof. The method extracts effective components from medicinal plants by a simple, environment-friendly and convenient production method to prepare various external preparations: liquid preparation, nose drop, ointment, plastics, liniment, suppository, oral preparation, etc.

The invention provides a compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects, which adopts two traditional Chinese medicines, namely rhubarb and clove, and comprises the following raw materials in percentage by weight: rhubarb, clove and rhubarb, wherein the ratio of rhubarb to clove is 3: 1; radix et rhizoma Rhei, flos Caryophylli, and radix et rhizoma Rhei, flos Caryophylli, 2: 2

In recent years, the rheum officinale has a large number of cases reported in the anti-infection aspect: the compound preparation has obvious curative effect on acute abdominal diseases such as acute biliary tract infection, acute pancreatitis, acute appendicitis and the like. Rhubarb is also commonly used to treat common infections and inflammations, such as carbuncle and furuncle, cellulitis, purulent pharyngolaryngitis, mouth and lip ulcer, acute conjunctivitis, and gingival abscess. The two cooked rhubarb tablets prepared by different processes are used for treating and observing suppurative tonsillitis of children, and the contrast observation is carried out on 30 patients treated by other medicines, so that the two groups taking the cooked rhubarb tablets have good effects and show better antipyretic and anti-inflammatory effects; in the control group, 11 of 30 patients are treated by erythromycin and TMP, and 19 patients are treated by artificial bezoar, and the curative effect of the control group is not obviously different from that of the new and old mature rhubarb products.

The modern clinic can be used for treating epidemic meningitis, lobar pneumonia, acute biliary tract infection, acute parotitis, acute appendicitis, acute infectious icterohepatitis, acute enteritis, bacillary dysentery, digestive tract hemorrhage, pharyngolaryngitis, gingival abscess, dermatitis, eczema, gonorrhea, herpes zoster, etc.

According to the reports of the literature, rhubarb has the inhibition effect on bacteria, fungi, viruses and the like, has a wide antibacterial spectrum, and has the inhibition effect on staphylococcus, hemolytic streptococcus, diphtheria bacillus, gonococcus, mycobacterium phlei, brucellosis bacillus, plague bacillus, typhoid fever, paratyphoid bacillus, dysentery bacillus, cerumen bacillus, gonococcus and the like in different degrees. Modern pharmacological research considers that emodin, aloe-emodin and rhein have antibacterial and anti-inflammatory effects, and the lowest in vitro inhibitory concentrations of emodin (I) and aloe-emodin (II) to staphylococcus aureus, 209P escherichia coli and Shigella flexneri are respectively 15mg/L, 480mg/L, 120mg/L, 7.5mg/L, 600mg/L and 60mg/L in the bearing forest. The minimum inhibitory concentration of the clinically isolated 119 strains of staphylococcus aureus is 20-160 mg/L in I and 10-80 mg/L in II. After the induction resistance test, II generates the drug resistance, while I does not generate the drug resistance. The results of the reports of the Wangwang, Chen Smart and Minghua show that rhein, emodin and aloe-emodin which are anthraquinone derivatives have strong bacteriostatic action on 100 clinically common anaerobic bacteria, and 8 mug/ml can inhibit the growth of 76-91% of the anaerobic bacteria, wherein the rhein-anthraquinone derivatives can inhibit the growth of 90-100% of strains of the most common fragile bacillus, and compared with common anti-anaerobic bacteria medicaments, the MIC of the rhein-anthraquinone derivatives is slightly higher than that of metronidazole, but compared with other anti-anaerobic bacteria medicaments, such as cephalothin and the like, the MIC of the rhein-anthraquinone derivatives is approximately similar to or better than that of the rhein-anthraquinone derivatives. Experiments also show that the rhubarb anthraquinone derivative is mainly used for inhibiting bacteria but not killing bacteria, and the action part of the rhubarb anthraquinone derivative can interfere the formation of cell walls of anaerobic bacteria and the permeability of cell membranes.

Chen Zhi Ben and Chen Qin Hua reported that in the 30 s, Fujian folk secret recipe used rhubarb to treat venereal diseases including acute gonorrhea, early syphilis and chancroid, but had definite curative effect but had the side effect of discharging the lower-jiao. Experiments are carried out on the MIC of the gonococci by using rhein, rhein analogues (chrysophanol oxidation products), emodin, aloe-emodin and the like with stronger activity, and the results are as follows: the 4 anthraquinone derivatives have strong antibacterial effect on clinically separated gonococcus by rhein. The penicillin positive control is sensitive to three strains, but has poor effect on the other two strains, the latter two strains are possibly drug-resistant strains, and the inhibition effect of 5 clinically isolated strains is parallel to that of penicillins although the MIC of rhein is greater than that of penicillin. In order to determine whether several clinically isolated gonococcal strains are resistant to rhein, experiments are carried out by taking standard strains stored in the biological product verification of the Ministry of health as reference, and the results show that the MIC of the emodin is greater than 32, and the rhein and analogues thereof are all 8, which are much higher than the bacteriostatic value of the clinically isolated strains and are equivalent to the bacteriostatic value M IC4-8 mu g/ml of rhein extracted from leguminous plants to the gonococcal strains in 1949, and further show that the bacteriostatic action of the rhein to the gonococcal strains is positive. The anti-inflammatory effect of the keemun on the emodin is used as an experiment, and the result shows that the emodin can obviously inhibit the plantar swelling caused by the carrageenan and the increase of the permeability of the capillary vessels in the abdominal cavity caused by acetic acid, has obvious inhibiting effect on the acute pleurisy caused by the carrageenan and has anti-inflammatory effect. Thereby providing basis for the anti-inflammatory effect of the traditional Chinese medicine rhubarb. The experimental result also shows that the emodin has quick response, has better antagonistic action on early-stage exudation of inflammation, increased capillary permeability, leukocyte migration and the like, and has obvious antagonistic action on acute inflammation.

Besides the antibacterial action, rhubarb has the antiviral action: the rhubarb decoction has strong inhibition effect on influenza virus, and also has the effects of orphan virus, hepatitis B virus, poliovirus and the like. The minimum effective dose of rhubarb is 5mg per embryo by an in vitro method and an in vivo method of chicken embryos. The therapeutic index of the emodin for Wangquan et Georgi to resist HSV-2333 strain is 4.0, 2.4 and 3.9 times that of acyclovir serving as a reference product, and the therapeutic index of the emodin for Wangquan et Georgi to resist coxsackie virus B group virus is 4.7, 1.0 and 2.9 times that of ribavirin serving as a reference product. The drug effect is better than that of two positive controls. To date, a number of chemical agents have been found to have anti-herpes virus effects, but often have been too toxic or drug resistant which limits their clinical use. The reports of Wangzhiyu and Wangzusingting show that the rhubarb ethanol extract has obvious antiviral effect on cell culture, has the effective inhibition rate of 100 mu g/ml on Herpes Simplex Virus (HSV), has the prevention effect on HSV infection and has the direct killing effect on virus particles. The rhubarb ethanol extract has extremely low cytotoxicity, does not have cytotoxicity at 20000 mug/ml, even is beneficial to cell growth, and suggests that the rhubarb ethanol extract can be taken orally for treating systemic infection, such as encephalitis, visceral infection and the like, which is incomparable with any medicine for treating HSV infection.

The effective parts of clove have the inhibiting effect on bacteria, staphylococcus and tubercle bacillus. Clove oil and eugenol have strong inhibition effect on brucella and avian tuberculosis in test tubes, and have obvious inhibition effect on common disease-curing dermatophytes. Because clove oil and eugenol have no irritation to skin and are well absorbed. Octopm and the like have antibacterial and anti-inflammatory effects, and comparison of in vitro antibacterial activities of 15 crude drug alcohol extracts and effective components thereof shows that eugenol is highly sensitive to acne pathogenic bacteria, and observation under an oil microscope shows that the number of bacteria in unit area after inhibiting staphylococcus aureus, staphylococcus epidermidis and acne short-stick bacteria is obviously reduced compared with that before inhibiting, most of the bacteria are dissolved and dead, and lose normal forms, thus prompting that the pathogenicity of the bacteria is possibly correspondingly reduced. The Minimum Inhibitory Concentrations (MIC) of eugenol for inhibiting Brevibacterium acnes and Staphylococcus aureus are 17,106 μ g/ml respectively. Experiments also find that the eugenol and the erythromycin have a synergistic bacteriostatic action. The research of Xiaining and the like shows that eugenol has strong inhibiting effect on staphylococcus aureus and propionibacterium acnes (P.ace, Propionibacterium vulgaris); further experiments show that the eugenol and the cineole have the synergistic P.ane resistance function; the p.ane oil microscopic observation of the eugenol and the cineole inhibits that the number of bacteria/unit area is obviously reduced compared with that before inhibition, and most of the bacteria are dissolved and dead and lose normal forms. Staphylococcus aureus, corynebacterium acnes (p.acnes), staphylococcus epidermidis are closely related to pathogenesis of pustules and inflammatory papules of acne, and eugenol can reduce the occurrence of acne through inhibiting acne pathogenic bacteria. The study of Zhoujiangxin and the like shows that the bacteriostatic component of clove is enriched in clove oil. The eugenol not only can inhibit bacteria, but also has good inhibiting effect on the synthesis of extracellular water-soluble and water-insoluble glucan of streptococcus mutans, thereby achieving the effects of removing dental plaque, cleaning oral cavity and preventing dental caries. The study of Zhoujiangxin and the like shows that clove oil has different degrees of inhibition effects on the growth of common food molds (aspergillus flavus, aspergillus fumigatus, penicillium chrysogenum, penicillium citrinum and rhodotorula glutinis), is a good natural preservative, and has the effective component of eugenol.

Rhubarb and clove are the two most common Chinese medicines in life, although the researches on the rhubarb and the clove and the active ingredients contained in the rhubarb and the clove are many, the researches on the antibacterial action mainly report monomer compounds, and the extraction, separation and purification of the monomer compounds are difficult and time-consuming and troublesome. The two Chinese medicinal materials can be used together without extraction and separation of monomer compounds, and have antibacterial effect (antiviral effect of decoction without extraction and separation). At present, the two are not combined for research on antibiosis and antiphlogosis.

The broad-spectrum antibacterial, anti-inflammatory and antiviral compound traditional Chinese medicine has a wide antibacterial spectrum, has antibacterial effects on staphylococcus aureus, diplococcus pneumoniae, pseudomonas aeruginosa, staphylococcus epidermidis, escherichia coli and candida albicans, and also has anti-inflammatory and antiviral effects; can be used for treating traumatic infection of various skins by being applied on the skin instead of antibiotics; can be used for preventing influenza by dripping nose; the antibacterial and analgesic effects are achieved when the antibacterial and analgesic paste is applied to the gum; it can be applied to auditory canal for relieving inflammation and pain; can be applied to the urethral orifice to relieve pain and itching. Simple and convenient use, no anaphylactic reaction and no drug resistance after multiple use. Can make the wound quickly heal. Solves the problems that a pure traditional Chinese medicine preparation replaces antibiotics and chemically synthesized antibacterial drugs, removes adverse reactions and harm of the antibiotics to human bodies, simultaneously achieves the purposes of reducing the treatment cost and reducing the serious environmental pollution caused by the antibiotics and the chemically synthesized antibacterial drugs in the production process. The traditional Chinese medicine of the invention, general antibacterial agent (broad-spectrum antibacterial, anti-inflammatory and antiviral compound traditional Chinese medicine), has simple preparation and low cost, the effective period of the effective components is more than two years, and the effective period is longer than that of antibiotics.

The treatment method of the medicine of the invention comprises the following steps:

used for treating burn and scald:

used for treating burn and scald: skin becomes hard to change color but not damaged; skin blisters: coating a layer of absorbent cotton on the burning and scalding part or the blister, dripping the absorbent cotton on the absorbent cotton, keeping the absorbent cotton moist for 1 to several hours until the pain disappears and the skin returns to the normal state. The water bubbles are absorbed naturally.

For toothache: placing the medicated cotton ball with the medicinal liquid on the painful teeth, and biting until the pain disappears.

For skin itch: the liquid medicine is applied to the itching part, and is almost applied to the itching part, but the root of the itching part is not removed.

Prevention and treatment of influenza: during influenza epidemic, as long as a few drops of liquid medicine are dripped in the nasal cavity and the pharynx, the liquid medicine can be put into a throat spray to be sprayed into the oral cavity or directly atomized, and can freely come in and go out in public places without infection, so that the influenza prevention device has good prevention effect; in the early stage of cold (red and swollen throat, nasal cavity pain and eye discomfort), a few drops of medicinal liquid are dripped into nasal cavity and pharyngeal portion, so that the medicinal liquid can directly act on respiratory tract where virus and bacteria propagate, and the propagation of virus and bacteria is killed or inhibited, so that the virus and bacteria cannot be attacked. Cold has already been attacked, the nose runs, and blockage: a few drops of liquid medicine are dripped into the nasal cavity, so that mucus secretion can be reduced, symptoms can be relieved, and smooth respiration can be guaranteed.

As a trauma therapy: construction engineering construction, such as railway repair, bridge building, army daily training, firefighter daily training and fire fighting actual combat, and knife wound and scald of people in daily life, when small wound is continuous, the liquid medicine is particularly suitable for treating carelessness of daily life, four limbs such as fingers, are injured, and are scratched by sharp instruments such as a kitchen knife, and the liquid medicine can be directly smeared on the wound at any time, and the wound can not be inflamed in the next day; if the wound is red, inflamed and suppurative, the pus can be squeezed out, the liquid medicine is coated on the wound for two days, the medicine is applied for several times every day, and the wound can be healed on the third day.

For the treatment of cervical erosion: the liquid medicine is directly applied to the cervical erosion part which is treated after the uterus dilatation, and the affected part can be basically cured once.

For example, the ear is accidentally injured; the liquid preparation can be dripped on a cotton swab which is used for wiping several circles in the auditory canal, so that the pain in the ear is not caused immediately. In a cat that had been treated for a dog bite, the broken left forelimb exposed the bone and the cat could not walk normally. After the liquid preparation coated with the compound is applied for three times, the wound scabs heal, and the cat walks normally.

Can be used for treating urethral orifice pain and itch: the urethral orifice is washed clean, and the liquid medicament is directly smeared on the urethral orifice, so that the pain and itch feel disappears immediately.

Can be used for treating oral cavity, tongue blister and erosion: the liquid medicine is applied or dropped on the bleb or the erosion part for several times a day until healing.

The invention relates to an extraction preparation process (method) of a compound prescription of rhubarb and clove, which comprises two processes, namely a first preparation process, and can be used for preparing liquid medicaments, such as nasal drops, solution agents and the like; the second preparation process can be used for preparing solid preparations, such as suppository, plastics, tablet, ointment, etc. The specific preparation process flow is as follows:

the preparation method comprises the following steps: firstly, extracting volatile oil and volatile components of Chinese medicinal material clove by using distillation method, adding rhubarb into residue, and using ethyl alcohol solution to extract all the components of two Chinese medicinal materials. The weight of each component is as follows: 3-12 g of rhubarb and 1-12 g of clove.

The liquid medicine prepared by the prescription is 100-200 ml.

The liquid preparation can also be added with auxiliary materials consisting of 0.02-0.04 g of broad-spectrum antibacterial preservative ethylparaben and 0.7-1.4 g of isotonic regulator sodium chloride.

The method for preparing the liquid medicament comprises the following steps:

1) weighing 10g of clove, adding 200 ml of purified water, heating, and extracting volatile oil and volatile substances.

2) Adding 30g of rhubarb and ethanol into the decoction dregs and the aqueous solution to ensure that the alcohol content in the mixture reaches 50 percent, and soaking for 24 hours;

3) filtering with six layers of gauze;

4) and (3) recovering the ethanol from the mother liquor, adding the volatile oil, the volatile substances, sodium chloride, ethylparaben and distilled water to 1000 ml, adjusting the pH value to 5.5-6.5 by using 10% NaHCO3, placing the mixture in a refrigerator for more than 48 hours, filtering the mixture by using a 1.2 mm microporous membrane, filling the mixture under the aseptic condition, and sealing the opening for later use.

The preparation method can also multiply the dosage which is put in once according to the actual production scale.

The second preparation method comprises the following steps:

weighing radix et rhizoma Rhei and flos Caryophylli (weight ratio of 3: 1), mixing, pulverizing into small granules, distilling to separate volatile components, extracting the desired parts with 70% ethanol, recovering ethanol extractive solution, making into extract, and measuring content. During production, volatile components are mixed into the extract, and then the materials are fed according to the required amount.

The method for preparing the solid medicament comprises the following steps:

1) weighing 30g of rhubarb, 10g of clove, crushing into small particles, and adding 1000 ml of water to soak for 1 hour;

2) heating and extracting for 4 hr to obtain volatile oil and volatile components.

3) And taking out the residue in the extractor and drying.

4) Weighing dry residues, performing reflux extraction for 3-5 times by using 57% -83% ethanol solution in an amount which is 4-7 times that of the dry residues, wherein each time is 1.5 hours, and filtering.

5) Mixing filtrates, recovering ethanol, and concentrating to obtain extract. Weighing and measuring the content.

The advantages are that: the quality of the Chinese medicinal preparation prepared from the extract prepared by the method can be ensured.

The preparation method can also multiply the dosage which is put in once according to the actual production scale. The traditional Chinese medicine in the prescription of the invention is only two: rhubarb and clove. The Chinese medicinal material feeding weight ratio is characterized in that: 10.2-25.8 g of rhubarb and 3.4-8.6 g of clove. Wherein, the extraction solvent in the preparation method (one) is 33 to 59 percent ethanol solution; the extraction solvent in the second preparation method is 57-83% ethanol solution.

The invention uses the extract after content measurement as the production raw material, and can clearly know how much preparation is produced and how much extract needs to be put in. The produced product reaches the standard, and the product quality is ensured. Overcomes the common diseases that the traditional Chinese medicine preparation has different raw material production areas and different active ingredient contents in medicinal materials, and the quality is not easy to ensure.

Features and effects of the invention

The invention is a pure Chinese medicinal preparation, has no toxic or side effect, has no irritation, is easy to be accepted by patients, and can replace antibiotics to treat and prevent skin trauma infection when being smeared on the skin; can be used for preventing influenza and treating rhinitis by dripping into nose. The use is simple and convenient, the anaphylactic reaction is avoided, and the wound can be quickly healed. Solves the adverse reaction and harm to human body caused by replacing antibiotics with pure traditional Chinese medicine preparation, extracts effective components from medicinal plants by a simple, environment-friendly and convenient production method, and can be prepared into various external preparations: liquid preparation, nose drop, ointment, plastics, liniment, suppository, oral preparation, etc. Meanwhile, the treatment cost is reduced, and the serious environmental pollution caused in the production process of antibiotics is reduced. In addition, the preparation is simple, the artificial cultivation technology of the main raw materials is mature, the production base is determined by the state, the problem of land desertification does not exist in a large amount of cultivation, the price is low, the purchase is easy, and the effective period of the medicine is two years longer than that of the antibiotic.

Drawings

FIG. 1 is a graph of the emodin standard curve of the present invention.

Detailed Description

The invention discloses a compound traditional Chinese medicine formula consisting of rhubarb and clove and having broad-spectrum antibacterial and antiviral effects and a preparation method of a preparation thereof, which are explained in detail by combining with an embodiment as follows:

example 1

The traditional Chinese medicine raw materials and the dosage of the traditional Chinese medicine are 3000-12000 g of rhubarb and 1000-12000 g of clove (1000 times of the dosage of the formula).

The preparation method adopting the raw materials comprises the following steps:

1) adding 12000 g of clove 1000-00 and 200000 ml of water, soaking for more than 6 hours, and extracting volatile oil and volatile components;

2) adding 3000-12000 g of rhubarb and 12000 g of ethanol into the decoction dregs and the water solution to ensure that the alcohol content reaches 50 percent, and soaking for 24 hours;

3) filtering by a plate frame; adding the volatile oil and volatile components, 2800 g of NaCl 700-; heating the filtrate to boil, refrigerating for more than 24 hours, filtering with pulp board, filtering with plate frame, bottling under aseptic condition, and packaging into 1 ten thousand 10ml vials (100000 ml).

Example 2:

the traditional Chinese medicine raw materials and the dosage of the traditional Chinese medicine raw materials in the embodiment are 3000g of rhubarb and 1000g of clove (1000 times of the dosage of the formula). The preparation method adopting the raw materials comprises the following steps:

1) weighing 3000g of rheum officinale and 1000g of clove (the weight ratio of the medicines is 3: 1) crushing into small particles, and soaking in 10000 ml (10 times) of purified water for 1 hour;

2) reflux extraction for 5 h. Obtaining volatile oil and volatile components.

3) The residue was taken out and dried.

4) Weighing dry residue, adding 5 times of 70% ethanol solution, reflux extracting for three times, each for 1.5 hr, filtering

5) Mixing filtrates, and recovering ethanol to obtain extract. Carrying out content measurement;

when the preparation is prepared, the extract with known content is added. Before feeding, the extracted volatile oil and volatile components are uniformly mixed in the extract (care is taken to prevent high temperature).

Content determination:

the content of the Chinese medicinal extract can be determined by ultraviolet spectrophotometry. Emodin is used as a standard substance, and the absorption maximum is at the position of lambda of 515 nm.

1 Standard Curve plotting

Weighing emodin 6mg precisely, placing in 50ml volumetric flask, dissolving with ether and diluting to scale, and shaking up. 0.5, 1.0, 2.0, 3.0, 4.0, 5.0ml of the diluted solution was precisely measured, and the diluted solution was placed in 25ml volumetric flasks, respectively, and diethyl ether was distilled off in a water bath, and a 5% sodium hydroxide-2% ammonium hydroxide mixed alkali solution (hereinafter referred to as mixed alkali) was added to the solution to prepare 2.4, 4.8, 9.6, 14.4, 19.2 and 24.0. mu.g/ml solutions. After 30min, absorbance was measured at a wavelength of 515nm using mixed base as a blank. Taking the absorbance as a vertical coordinate and the concentration as a horizontal coordinate, and making a regression curve, wherein the standard curve is as follows: a is 0.0423-0.009(R is 0.9999, n is 6), which shows that the emodin is good in the concentration range of 2.4-24.0 mug, and the emodin standard curve is shown in figure 1.

2 preparation of test solution

60mg of dry extract of 70% ethanol extract was precisely weighed, and 5ml of 10% sulfuric acid and 10ml of chloroform were added. Heating in water bath, refluxing and hydrolyzing for 2 h. After the chloroform solution was aspirated with a pipette, 10ml of chloroform was added thereto and refluxed for 1 hour. The chloroform solutions were combined and washed with a small amount of purified water. Chloroform was placed in a separatory funnel and extracted with mixed bases in portions. The alkali liquor is combined and washed by a small amount of chloroform. The chloroform solution was discarded and the base solution was adjusted to 25ml volumetric flask scale and heated on boiling water bath for 4min, cooled to room temperature and left to stand for 30 min. As a test solution.

3 determination of the content of the test sample

The absorbance of the test sample is measured on an ultraviolet spectrophotometer, and the content of the test sample is measured in the table.

Content of free anthraquinone

The invention discloses a Chinese medicinal composition, general antibacterial agent, comprising rhubarb horsetails and clove (the weight ratio of rhubarb horsetails to clove is 3: 1, rhubarb horsetails to clove is 2: 2), having broad-spectrum antibacterial action, wherein the antibacterial spectrum is broad, and the detailed description is provided below with reference to the examples:

example 3

Bacteriostatic spectrum of general antibacterial agent

TABLE 1 Effect of general antibacterial on Staphylococcus aureus

TABLE 2 Effect of general antibacterial agents on pneumococci

TABLE 3 Effect of general antibacterial agent on Pseudomonas aeruginosa

And (4) conclusion: the result of an external bacteriostatic experiment of the extract shows that the extract has obvious bacteriostatic action on staphylococcus aureus, pneumococcus and pseudomonas aeruginosa, and the staphylococcus aureus is strongest, which has stronger bacteriostatic action on the three bacteria than a reference medicament furametpus nasal drop.

Anti-infection experiment (test tube dilution)

Medicine general antibacterial agent

[ note ] one: bacterial inhibition without apparent turbidity

Example 4

Anthraquinone derivatives are known as the main active ingredients of rhubarb for antibacterial action, and especially rhein, emodin and aloe-emodin have the best action. The antibacterial effect of the anthraquinone derivative of rhubarb has close relationship with the chemical structure of the anthraquinone derivative of rhubarb. Modern pharmacological tests also prove that the eugenol contained in the aroma emitted by the clove is more than 5 times stronger than carbolic acid in bactericidal capacity, and has excellent air disinfection effect. It has inhibitory effect on pathogenic fungi, coccus, streptococcus, and Bacillus such as pneumonia, dysentery, pyocyania, large intestine, typhoid fever, and influenza virus.

Experimental strains

Staphylococcus aureus ATCC2611, Staphylococcus epidermidis ATCC26069, Escherichia coli ATCC24752 and Candida albicans ATCC10231 are all standard strains purchased from China pharmaceutical and biological product institute.

Batch number of rhein standard: 0756-9505 purchased from China pharmaceutical and biological products institute

In the experiment, the MIC value of the general antibacterial agent to 4 bacteria in the urogenital tract is determined by adopting a test tube double dilution method and an agar plate method, and specific results are shown in Table 1.

MIC result (mg/ml) of general antibacterial agent for in vitro antibacterial action

And (4) conclusion: the results of in vitro bacteriostasis experiments show that the extract has effects on 4 bacteria in the urogenital tract. Wherein the 70% ethanol extract has antibacterial effect (except for Staphylococcus epidermidis) higher than that of control rhein.

Example 5

The general antibacterial agent has little toxicity and is safer and more reliable than antibiotics

LD of general antibacterial agent₅₀Measurement of (2)

In the drug acute toxicity experiment, the LD of general antibacterial agent cannot be found out by using the conventional dosage for mice₅₀Or maximum tolerated dose. We tried to perfuse ICR mice with a pasty general antibacterial agent and the mice were half killed when the volume was as high as about 0.7ml, thus proving that the general antibacterial agent is less toxic.

Example 6

First, curative effect test

1 prevention and/or treatment of colds

In the influenza period, in order to prevent infection, the oral tablet prepared by the formula can be contained in the mouth, or nasal drops are dripped into the nose, or the liquid can be put into a throat spray and sprayed into the oral cavity or directly atomized, so that good prevention effect can be achieved.

1 medicine for preventing and/or treating cold

Note:

the effect is shown: has no common cold after administration

The method has the following advantages: the cold (after) is relieved

2 prevention and/or treatment of traumatic infections

When the skin is lacerated and punctured by a sharp tool; the skin of the cupping glass is soaked and damaged; mosquito bites, itchy skin, skin damage after scratching, and the like. In order to prevent inflammation, suppuration and itching of the damaged part of the skin, the wound can not be infected, suppurated and itchy by applying the liquid preparation of the composition on the damaged part.

If there is wound with wound inflammation and suppuration, squeezing out pus, applying the liquid preparation of the composition on suppuration part, and if the wound is not large, applying the composition for 1-2 times to heal the wound.

2 prevention and/or treatment of traumatic infections

Note:

the effect is shown: wound is not infected after the drug is applied

The method has the following advantages: the wound is not infected continuously after the drug is applied

3 promoting wound healing, for pets:

in a cat that had been treated for a dog bite, the bone had been exposed in the damaged left forelimb and the cat could not walk normally. After the liquid preparation coated with the compound is applied for three times, the wound is healed, and the cat walks normally.

4 treating cervical erosion

The liquid preparation prepared by the composition is used by a gynecologic king doctor of Ningxia Chinese medicine research institute in 2001 to clinically treat more than ten patients with cervical erosion: after expanding uterus, the affected part is cleaned, and the affected part can be cured after being generally applied with the medicine once. The patients with extra serious disease need to be applied twice.

Treating cervical erosion

The effect is shown: disappearance of ulcer surface

The method has the following advantages: reduction of ulcer surface

5 treating effect on burn and scald

When the skin on the hand is burnt or scalded, the wounded part needs to be wrapped by the absorbent cotton, and the liquid medicine of the prescription is continuously dripped on the absorbent cotton to keep the absorbent cotton at proper humidity. The skin on the hand heals and is not painful.

Treating burn and scald

The effect is shown: pain disappears and skin recovers

6 can be used for treating senile pruritus

Can be used for treating senile pruritus

The effect is shown: the itching symptom disappears immediately, and the original damaged skin heals

Note: the symptoms of itching can disappear immediately, but cannot be eradicated.

Second, introduction of three cases after using the product

Case 1: is used for treating diabetic foot, namely a 60-year-old female diabetic patient, and the wound of the diabetic foot can not heal for a long time after infection. The injured feet are swollen and shiny, and no wrinkles are seen. The liquid formulation of the present compound was applied to the skin of her diabetic foot several times (no application to a damaged wound). Half an hour later, the swollen instep begins to subside swelling, no longer shines, and several wrinkles appear, and the diabetic foot symptoms are alleviated.

Case 2: for post-cancer decubitus infection: insomnia due to wound pain. After the medicine is applied, the pain is relieved, and people can sleep at night.

Case 3: the fingers are scalded by the hot pot, and small bubbles are generated at the scalded part, which is very painful. Wrapping the medicated cotton on the bubble, and dripping medicinal liquid to keep the medicated cotton moist. The next day, the cotton wool was removed and the blisters had dried and the pain had disappeared. On the third day, the redness of the scald disappeared and the skin returned to original shape.

Claims

1. A compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects is characterized in that: the adopted raw materials are two traditional Chinese medicines, namely rhubarb and clove, and the weight ratio of the rhubarb to the clove is as follows: the ratio of radix et rhizoma Rhei to flos Caryophylli is 3-2: 1-2.

2. The compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 1: the preferable weight ratio of the rhubarb to the clove is as follows: rhubarb, clove and rhubarb, wherein the ratio of rhubarb to clove is 3: 1; rhubarb, clove and rhubarb are mixed at a ratio of 2: 2.

3. The preparation method of the compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 1 comprises the following steps: the weight of each component is as follows: 3-12 g of rhubarb and 1-12 g of clove, and the mixture is prepared into liquid medicine.

The method for preparing a liquid medicament comprises the steps of:

3) filtering with six layers of gauze;

4. The preparation method of a compound Chinese medicine with broad spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 3, wherein the volatile oil and volatile components of the Chinese medicine clove are extracted by distillation before the step 1), the residue is added with rhubarb, all the components of the two Chinese medicines are extracted by ethanol solution, and the ethanol solution with 33% -59% is used as extraction solvent.

5. The preparation method of the compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 3 comprises the following steps: the liquid medicament is 100-200 ml, and auxiliary materials consisting of 0.02-0.04 g of broad-spectrum antibacterial preservative ethylparaben and 0.7-1.4 g of osmotic adjusting agent sodium chloride are also added into the liquid medicament.

6. The preparation method of the compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 1 comprises the following steps: a method for preparing a solid pharmaceutical dosage form comprising the steps of:

3) And taking out the residue in the extractor and drying.

7. The preparation method of the compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 6 comprises the following steps: weighing rhubarb and clove before the step 1), wherein the weight ratio of the mixture is 3: 1, crushing the raw materials into small particles, separating volatile components by a distillation method, extracting required parts by using 70% ethanol, recovering ethanol extract, preparing extract, performing content measurement, mixing the volatile components into the extract during production, and feeding according to required amount, wherein 57-83% of ethanol solution is an extraction solvent.

8. The preparation method of the compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 7 comprises the following steps: the weight ratio of the traditional Chinese medicinal materials fed into the rhubarb and the clove is as follows: 10.2-25.8 g of rhubarb and 3.4-8.6 g of clove.

9. The compound traditional Chinese medicine with broad-spectrum antibacterial, anti-inflammatory and antiviral effects as claimed in claim 1: the Chinese medicine can be made into liquid preparation, nose drop, ointment, plastics, liniment, suppository, and oral preparation.