WO2013000143A1 - Rapid no-wash disinfectant - Google Patents

Abstract

A rapid no-wash disinfectant composition, which comprises: 50-99wt.% C2-C4 volatile alcohol, 0.01～5wt.% ion which is used for increasing ion strength of the composition system, water rest. The rapid no-wash disinfectant composition can improve the oxidative stress level by increasing the ion strength and get the effect of rapid, no-wash disinfection as a result.

Description

 No-clean rapid anti-toxic preparation

 The invention relates to a brand-new product which can quickly kill germ-inactivated virus and can be used for washing and cleaning skin. Specifically, it is a kind of virus which does not need water washing, rapidly inactivates skin surface by increasing ionic strength and quickly kills A no-clean hand cleaner for germs. Background technique

 The infection of the germ virus causes serious damage to human health. At present, due to the abuse of antibiotics, various antibiotics are produced, and the speed of antibiotic development cannot keep up with the speed of mutation. At the same time, due to the serious pollution of the environment, the bacteria in order to adapt to the environment to survive, the result of constant variability leads to any superbug that cannot be controlled by any antibiotic, and this superbug is a genetic gene that can be transmitted, that is, in theory, any kind of germ It is possible to become a superbug. Once infected, it will be completely dependent on human immunity, thus causing global panic. The virus, because it relies on the body of the infected object to breed, once it enters the human body, the drug removal virus is very harmful to the human body. Therefore, the virus is a big challenge in front of human beings. Prevention of viral infections is further recognized as the most effective and reliable means of combating infectious diseases.

 Many pathogenic viruses can survive on human hand surfaces for up to several hours. (Reference 1 : Mbi thi JN, Springthorpe VS, et al, Survival of hepati ti s A virus on human hands and i ts transfer on contact wi th animate and inanimate surfaces. J Cl in Microbiol 1992 ; 30 : 757-763 (Hepatitis The survival of A virus in human hands and their infection on active and inactive surfaces, Journal of Clinical Microbiology, 1992, No. 30, pp. 757-763. Reference 2: Schurmann W, Eggers HJ. An experimental Study on the epidemiology of enteroviruses: water and soap washing of pol iovirus type

1-Contaminated hands, i ts effectiveness and kinetics. Med Microbiol Immunol 1985 ; 174 : 221-236) (Enterovirus Infectious Experiment: Efficacy and Kinetics of Water and Soap Washing Poliovirus Contamination Hands, Medical Microorganisms Immunology, 1985, No. 174, pp. 221-236)

"Sickness from the mouth" is the most important form of infection for many infectious diseases. The World Health Organization (WHO), the US FDA and the Center for Disease Control (CDC), and the China CDC have clearly pointed out that cleaning hands is cutting off the spread. The most important way of approach. In addition to traditionally susceptible areas such as the hospital environment, as globalization continues to deepen, the number of people on the road is rapidly increasing, and it is difficult to secure clean hand washing water. Simultaneously, Due to environmental pollution, the virulence of viral pathogens has increased, and their pathogenicity and even fatal destructive power have increased rapidly. In recent years, SARS, avian flu, hand, foot and mouth disease, etc. have gradually become apparent.

 So far, there are no products on the market that can quickly inactivate the virus without stimulating the skin. First, traditional aldehydes (such as glutaraldehyde, etc.), halogens (such as bleaching powder, iodine, etc.), and peroxides (such as hydrogen peroxide, etc.) can quickly inactivate deadly viruses, such as Poliovirus, however, these active ingredients are very irritating to the skin and cannot be used in disposable hand products. Secondly, various inactivated viruses synthesized by humans cannot be used for skin-free disposable inactivated viruses because of their high cost, great harm to human cells, and resistance to disease.

 The oxidative stress window theory provides a new way to quickly inactivate the virus without stimulating the skin. The high levels of oxidative stress formed by many substances are fatal to pathogenic viruses, etc. However, the protective effect of the stratum corneum on the surface of human skin makes such an environment with high levels of oxidative stress and has no shadow on human skin. to. 1985 (Reference: Ji l A Zeugin, James L Hartley. Focus, 1985, Vol 7, No 4, 1-2), human studies have found that microbial genetic material RNA or DNA in the presence of sodium acetate, ie At a certain ionic strength (higher oxidative stress level), denaturing precipitation occurs under the action of ethanol. This method has become a classic method for extracting microbial genetic material RNA or DNA in textbooks. Ethanol has a suitable volatility, and because there is a layer of stratum corneum on the skin of the human hand, ethanol does not easily penetrate the stratum corneum of the skin into the active skin cells. The stimulating effect on the skin is in an acceptable range, and it also kills most germs. And the ability to inactivate some viruses, ethanol is generally used as the main ingredient in disposable cleansing products. The virus is generally classified into an enveloped virus and a non-enveloped virus. The outer shell of the enveloped virus is covered by a lipid bilayer membrane of a layer of protein, and the outer membrane is similar to the pathogen and is easily destroyed. The poliovirus and the like are non-enveloped viruses, and the inactivation rate using simple ethanol is very slow, and the use of ethanol alone cannot effectively inactivate some deadly viruses.

 Therefore, development can quickly kill germs and inactivate all viruses (the global requirement for rapidly inactivating viruses is that 99.99% of the viruses are inactivated within 1 minute, often expressed as a logarithmic value of 4). The products are the hardships that human beings urgently need to overcome. Because water-free products must meet two basic requirements, one is to kill germs and inactivate viruses quickly and effectively, and the other is not to cause damage to the skin of the opponent.

In summary, there is a lack of a disposable bactericidal and virus-killing product capable of quickly and effectively killing germs and inactivating viruses without causing damage to the skin of the hand. Therefore, there is an urgent need in the art to develop such a rapid and effective killing. A no-clean bactericidal virus-killing product that kills bacteria and inactivates the virus and does not cause damage to the skin of the opponent. Summary of the invention A first object of the present invention is to obtain a leave-on sterilization composition capable of quickly and effectively killing germs and inactivating viruses without causing damage to the skin of the hand.

 A second object of the present invention is to obtain a leave-on sterilization preparation which is capable of quickly and effectively killing germs and inactivating viruses without causing damage to the skin of the hand.

 A third object of the present invention is to provide a method for preparing a leave-on sterilization preparation which is capable of quickly and effectively killing germs and inactivating viruses without causing damage to the skin of the hand. In a first aspect of the invention, there is provided a leave-free rapid anti-toxic formulation composition, the composition comprising the following weight components:

 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system;

 The remaining components are water. 1〜1重量份。 In a preferred embodiment, the ion parts by weight of 0. 1~1 parts by weight. In a specific embodiment of the present invention, the ion for increasing the ionic strength of the composition system is a monovalent ion, a divalent ion, a trivalent ion or a combination thereof, preferably a divalent ion or a trivalent ion, more preferably a trivalent ion.

In a specific embodiment of the invention, the ion is a monovalent cation, a monovalent anion, a divalent cation, a divalent anion, a trivalent cation, a trivalent anion or a combination thereof. In a specific embodiment of the present invention, the monovalent cation is sodium ion, potassium ion, ammonium ion or a combination thereof;

 The divalent cation is an alkaline earth metal ion, or a transition metal ion;

 The trivalent cation is a cerium ion, a cerium ion, or a cerium ion;

 The monovalent anion is a monovalent halogen anion, a monovalent oxygen-containing anion, or a monovalent organic ion; the divalent anion is a sulfate ion, a carbonate ion, or a diacid ion;

The trivalent anion is a phosphate ion. In a specific embodiment of the invention, the ion is a phosphate ion. In a specific embodiment of the invention, the ionic strength of the composition system is between 16 and 500 mM

In a specific embodiment of the invention, the volatile alcohol is selected from the group consisting of ethanol, propanol, butanol, or a combination thereof. In a specific embodiment of the invention, the ions are present in the form of soluble salts of the ions in water, or in an alcoholic solvent. A second aspect of the invention provides a formulation made from the composition of the invention. A third aspect of the invention provides a method of preparing a formulation of the invention, comprising the steps of:

(a) providing the following 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

 (b) 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system are mixed with the volatile alcohol; the ions are present in the form of soluble salts of the ions in water or an alcohol solvent. . In a preferred embodiment, the ion is present in the form of a soluble salt of the ion in water or an alcohol solvent. Specifically, the acid corresponding to the soluble salt may first be dissolved in water, and then the corresponding base is added to form the soluble salt for further subsequent steps. For example, an aqueous solution of the salt and an alcohol are mixed. detailed description

 The inventors have conducted extensive and intensive research to obtain a disposable sterilized product which can quickly and effectively kill germs and inactivate viruses without causing damage to the skin of the hand, and unexpectedly finds that it is specific. Its performance is particularly excellent at ionic strength. The present invention has been completed on this basis.

 The invention discloses a novel preparation for quickly killing germs and rapidly inactivating viruses, which does not contain small molecules of aldehydes, halogens, peroxides, antibiotics and antiviral drugs, and stimulates human skin. There is essentially no sex, and this preparation can be used to directly clean human skin without washing with water.

 As used herein, "wash-free" means that the formulation is not irritating and toxic to human skin and therefore does not require washing. The "no irritation and toxicity to human skin" can be found in the skin irritation test in the examples.

Herein, the "pathogen" includes an enveloped virus and a non-enveloped virus. Representative ions of the enveloped virus include, but are not limited to, herpes zoster virus, influenza virus, and HIV, etc. Representative examples of non-enveloped viruses include, but are not limited to, poliovirus, hepatitis A virus, hand, foot and mouth virus, and the like. Among them, poliovirus is the most difficult representative of inactivated virus, so the research test for inactivating virus ability is based on inactivation of poliovirus.

 As used herein, the term "rapid anti-virus" means that the inactivation rate reaches 19.99% within 1 minute, that is, the logarithm value 4. Various aspects of the invention are detailed below:

 No-clean rapid anti-toxic preparation composition

 In a first aspect of the invention, there is provided a leave-free rapid anti-toxic formulation composition, the composition comprising the following weight components:

 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system;

 The remaining components are water. 1〜1重量份。 In a preferred embodiment, the ion parts by weight of 0. 1~1 parts by weight. Ethanol is a commonly used disposable hand cleaner, but it does not rapidly inactivate the virus, and is essentially ineffective against many common viruses such as hand, foot and mouth virus, poliovirus, and the like.

 The present inventors have found that a small molecule of alcohol can be used as a carrier to increase the ion concentration in the solution (increasing the ionic strength, that is, to increase the level of oxidative stress), thereby achieving rapid and effective killing of the pathogen and inactivation of the virus while not occupying the part. The effect of skin damage. When the ion concentration is too low, the purpose of increasing the ionic strength cannot be achieved, thereby reducing the rate of killing the germ and inactivating the virus; when the ion concentration is too high, it will cause damage to human skin.

 The present invention does not employ specific reactive ions, but rather increases the ionic strength by using ions to achieve a high level of oxidative stress that is lethal to microorganisms including viruses. The present invention is the first in the world to provide a means and product for rapidly inactivating viruses by increasing the level of oxidative stress. Ions that increase the ionic strength of the composition system

The ions of the present invention which increase the ionic strength of the composition system increase the level of oxidative stress by increasing the ionic strength of the composition system. In a specific embodiment of the present invention, the ion for increasing the ionic strength of the composition system is a monovalent ion, a divalent ion, a trivalent ion or a combination thereof, preferably a divalent ion or a trivalent ion, Trivalent ions are preferred.

 In a specific embodiment of the invention, the ion is a monovalent cation, a monovalent anion, a divalent cation, a divalent anion, a trivalent cation, a trivalent anion or a combination thereof.

 In the products disclosed by the present invention, ions for increasing the level of oxidative stress and killing the virus inactivated virus include all ions which are not irritating and toxic to human skin, including monovalent ions, divalent ions, and trivalent ions. ion. Since the amount of high-valent ion pair required to enhance the equivalent ionic strength is smaller than that of the low-valent ion, a high-valent ion is preferred. The ions used in the present invention may be cationic, including all ions that are stable and do not stimulate human skin. Monovalent cations include, but are not limited to, sodium ions, potassium ions, ammonium ions, and the like.

 Divalent cations include, but are not limited to, alkaline earth metal ions such as calcium ions, magnesium ions, transition metal ions such as zinc ions, iron ions, copper ions, and the like.

 Trivalent cations include, but are not limited to, cerium ions, cerium ions, cerium ions, and the like.

 The monovalent ion is a monovalent halogen anion such as chloride ion, a monovalent oxygen-containing anion such as an inorganic nitrate ion, a monovalent organic ion such as a formate ion, an acetate ion, a propionate ion or the like.

 Divalent anions include, but are not limited to, sulfate ions, carbonate ions, diacids such as succinate ions, and the like. Trivalent anions include, but are not limited to, phosphate ions and the like.

 The ions used in the present invention may be anions including all ions that are stable and do not stimulate human skin. Monovalent ions include, but are not limited to, monovalent halogen anions such as chloride ions, monovalent oxygenated anions such as inorganic nitrate ions, monovalent organic ions such as formate ions, acetate ions, propionate ions, and the like. The divalent anion includes, but is not limited to, a sulfate ion, a carbonate ion, a diacid such as a succinate ion, and the like. Trivalent anions include, but are not limited to, phosphate ions, and the like. In a specific embodiment of the present invention, the monovalent cation is sodium ion, potassium ion, ammonium ion or a combination thereof;

 The divalent cation is an alkaline earth metal ion, or a transition metal ion;

 The trivalent cation is a cerium ion, a cerium ion, or a cerium ion;

 The monovalent anion is a monovalent halogen anion, a monovalent oxygen-containing anion, or a monovalent organic ion; the divalent anion is a sulfate ion, a carbonate ion, or a diacid ion;

 The trivalent anion is a phosphate ion.

It should be noted that the preferred high-valent ions of the present invention are phosphate ions, which are both high-valent ions and It is oxidizing and safe for the skin. High-priced metal ions generally have strong oxidizing properties, so they are not preferred. Thus, in a preferred embodiment of the invention, the ion is a phosphate ion. In a specific embodiment of the invention, the ionic strength of the composition system is between 16 and 500 mM. In one embodiment of the invention, the ions are present in the form of the ions in water, or alcohol. Soluble salts in solvent-like solvents.

 1〜1重量份。 In a preferred embodiment, the ion parts by weight of 0. 1~1 parts by weight.

 For the sake of convenience, it is also possible to carry out the charging with a weight to volume ratio. The weight to volume ratio is the ratio of the weight of the ions to the volume of the composition system. The weight to volume ratio of ions in the product is, for example,

Between 01% and 5%, preferably between 0.1% and 1%. Volatile alcohol

 The carrier of the product disclosed in the present invention is a small molecule alcohol having good volatility, preferably ethanol and isopropanol. The preferably volatile small molecule alcohol may be a C2 to C4 lower alcohol. In a specific embodiment of the invention, the volatile alcohol is selected from the group consisting of ethanol, propanol, butanol, or a combination thereof.

 The amount of the alcohol is between 50 and 99 parts by weight. If calculated as a percentage by weight, it may be between 50% and 99% by weight, based on the total weight of the composition. Preparation and preparation method thereof

 The present invention provides a formulation made from the composition of the present invention. The invention can be made into a fluid dosage form product, and the aerosol product can also be made into a gel type product as long as it does not affect the efficacy of the product. The preparation method of the preparation of the invention comprises the following steps:

 (a) providing the following 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

(b) 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system are mixed with the volatile alcohol; the ions are present in the form of soluble salts of the ions in water or an alcohol solvent. . In a preferred embodiment, the ions are present in the form of soluble salts of the ions in water, or in an alcoholic solvent. Specifically, the acid corresponding to the soluble salt may first be dissolved in water, and then the corresponding base is added to form the soluble salt for further subsequent steps. For example, an aqueous solution of the salt and an alcohol are mixed. The following examples are given to illustrate the invention and are not intended to limit the invention to the following examples. Unless otherwise specified, various starting materials of the present invention can be obtained commercially; or can be prepared according to conventional methods in the art. Unless otherwise defined or indicated, all of the professional and scientific terms used herein have the same meaning as those skilled in the art. Furthermore, any methods and materials similar or equivalent to those described may be employed in the methods of the invention.

 Other aspects of the invention will be apparent to those skilled in the art from this disclosure.

 The invention is further illustrated below in conjunction with specific embodiments. It is to be understood that the examples are merely illustrative of the invention and are not intended to limit the scope of the invention. The experimental methods in the following examples which do not specify the specific conditions are usually carried out according to conventional conditions or according to the conditions recommended by the manufacturer. Unless otherwise stated, all parts are by weight, all percentages are by weight, and the molecular weight of the polymer is number-averaged unless otherwise defined or indicated, all of the technical and scientific terms used herein and the art. Skilled people are familiar with the same meaning. In addition, any methods and materials similar or equivalent to those described can be used in the methods of the present invention.

 The test methods and standards involved in the examples are as follows:

 Ministry of Health of the People's Republic of China "Disinfection Technical Specifications" 2002. 11, Section 2. 1. 1. 5. 5, and Article 2. 1. 1. 7. 4. Example 1~: 10 : Product Formulation

 The poliovirus is the most difficult representative of inactivated viruses, so the study of the ability to inactivate viruses is based on the inactivation of poliovirus.

 The examples are exemplified by three products, which are monovalent salts such as sodium acetate; divalent salts such as copper acetate; and trivalent salts such as sodium phosphate. The preparation method comprises the following steps: first dissolving the used acid in water, then adding an equivalent amount of a base such as sodium hydroxide or ammonia water, controlling the pH to not less than 3, mixing uniformly, cooling to room temperature, and then uniformly mixing with 95% of the alcohol. The final salt content is 0. 6+0. 2%, the formula is as follows:

 Active ingredient Salt amount Alcohol dosage Product appearance

Sample 1 sodium acetate 0. 6% 68% ethanol clear serum Sample 2 Sodium acetate 0. 6% 68% Isopropyl alcohol clear serum sample 3 Ammonium acetate 0. 6% 68% ethanol clear serum sample 4 Ammonium acetate 0. 6% 68% isopropanol clear serum sample 5 Copper acetate 0. 6% 68% ethanol clear serum sample 6 copper acetate 0. 6% 68% isopropanol clear serum sample 7 sodium phosphate 0. 6% 68% ethanol clear serum sample 8 sodium phosphate 0. 6% 68% Isopropyl alcohol clear serum sample 9 sodium phosphate 0. 6% 58% ethanol clear serum sample 10 sodium phosphate 0. 6% 58% isopropanol clear liquid discussion:

 The above samples 1 to 10 correspond to Examples 1 to 10, respectively. The above examples increase the ionic strength by means of increasing the ion concentration, thereby causing a high level of oxidative stress to microorganisms. Samples 1, 2 use monovalent ions, ie acetate ions and sodium ions; samples 3, 4 are still monovalent ions, but cations are replaced with non-metal ions; the cations in samples 5, 6 are divalent ions; In samples 7, 8, 9, 10, trivalent ions were used.

 From the results of the following efficacy tests, the efficacy of rapid sterilization of inactivated virus increases with the price of ions.

13⁄4! 3⁄4. Kill E. coli

 Using E. coli 8099 (Disinfection Testing Center of the Chinese Academy of Military Medical Sciences), the components and concentrations of the neutralizing agent are: 5% sodium thiosulfate, 3. 0% Tween-80, 3 g/L lecithin PBS (phosphate buffer). 3% bovine serum albumin organic interfering substance, TSA (soybean trypsin) medium. The test temperature was 20 ° C ± 1, and was repeated 3 times, and the result was an average value.

 The neutralizer was first tested and it was found that the neutralizer solution and the neutralized product solution did not affect the growth of E. coli. The efficacy test for killing E. coli was tested for 0.5 minutes, 1. 0 minutes, and 1.5 minutes, and the killing values were all greater than 5

 0. 5 minutes 1. 0 minutes 1. 5 minutes

 Sample 1 >5. 00 >5. 00 >5. 00

 Sample 2 >5. 00 >5. 00 >5. 00

Sample 3 >5. 00 >5. 00 >5. 00 Sample 4 >5. 00 >5. 00 >5. 00

 Sample 5 >5. 00 >5. 00 >5. 00

 Sample 6 >5. 00 >5. 00 >5. 00

 Sample 7 >5. 00 >5. 00 >5. 00

 Sample 8 >5. 00 >5. 00 >5. 00

 Sample 9 >5. 00 >5. 00 >5. 00

 Sample 10 >5. 00 >5. 00 >5. 00 Killing Staphylococcus aureus

 Using Staphylococcus aureus ATCC6538, the components and concentrations of the neutralizing agent were: 5% sodium thiosulfate, 3. 0% Tween-80, and 3 g/L lecithin in PBS. 3% bovine serum albumin organic interfering substance, TSA medium. The test temperature was 20 ° C ± 1, and was repeated 3 times, and the results were average values.

 The test found that the neutralizer solution and the neutralized product solution did not affect the growth of S. aureus.

The efficacy test for killing Staphylococcus aureus was tested at 0.5 min, 1. 0 min, and 1.5 min, respectively, and the kill log values were all greater than 5.

0. 5 minutes 1. 0 minutes 1. 5 minutes

 Sample 1 >5. 00 >5. 00 >5. 00

 Sample 2 >5. 00 >5. 00 >5. 00

 Sample 3 >5. 00 >5. 00 >5. 00

 Sample 4 >5. 00 >5. 00 >5. 00

 Sample 5 >5. 00 >5. 00 >5. 00

 Sample 6 >5. 00 >5. 00 >5. 00

 Sample 7 >5. 00 >5. 00 >5. 00

 Sample 8 >5. 00 >5. 00 >5. 00

 Sample 9 >5. 00 >5. 00 >5. 00

 Sample 10 >5. 00 >5. 00 >5. 00 Killing Candida albicans

 Using Candida albicans ATCC10231, the components and concentrations of the neutralizer were: 5% sodium thiosulfate, 3. 0% Tween-80, and 3 g/L lecithin in PBS. 3% bovine serum albumin organic interfering substance, TSA medium. The test temperature was 20 ° C ± 1, and was repeated 3 times, and the results were average values.

 The test found that the neutralizer solution and the neutralized product solution did not affect Staphylococcus aureus

Growth of (Staphyloccocus aureus Rosenbach).

The efficacy test for killing Staphylococcus aureus was tested at 0.5 min, 1. 0 min, 1. 5 min, and the kill log values were all greater than 4

0. 5 minutes 1. 0 minutes 1. 5 minutes

 Sample 1 >4. 00 >4. 00 >4. 00 Sample 2 >4. 00 >4. 00 >4. 00 Sample 3 >4. 00 >4. 00 >4. 00 Sample 4 >4. 00 >4 00 >4. 00 Sample 5 >4. 00 >4. 00 >4. 00 Sample 6 >4. 00 >4. 00 >4. 00 Sample 7 >4. 00 >4. 00 >4. 00 Sample 8 >4. 00 >4. 00 >4. 00 Sample 9 >4. 00 >4. 00 >4. 00 Sample 10 >4. 00 >4. 00 >4. 00 Inactivated poliovirus

 Use poliovirus type 1 (PV-I, vaccine strain, disinfection testing center of the Chinese Academy of Military Medical Sciences), host cell VER0 cells (Disinfection Testing Center of the Chinese Academy of Military Medical Sciences), components and concentrations of neutralizers For: 3. 0% Tween-80, 3g/L lecithin in PBS. 3% of bovine serum albumin organic interfering substances. The test temperature was 20 ° C ± 1, and was repeated 3 times, and the results were average values.

The virus suspension has a titer of 10 ⁷ -10 ⁸ TCID ₅ . The PV-1 virus suspension was diluted with 3% of bovine serum albumin organic interference material, and it was found that the neutralizer solution and the neutralized product solution did not affect the activity of the poliovirus.

The efficacy test for inactivating poliovirus was tested at 0.5 min, 1. 0 min, 1. 5 min, and the kill log values were all greater than 4

0. 5 minutes 1. 0 minutes 1. 5 minutes

 Sample 1 2. 6 3. 1 3. 8

 Sample 2 2. 3 3. 2 3. 7

 Sample 3 2. 5 2. 9 3. 7

 Sample 4 2. 5 3. 1 3. 9

 Sample 5 3. 2 3. 8 4. 1

 Sample 6 3. 1 3. 6 3. 9

 Sample 7 4. 1 5. 5 6. 4

 Sample 8 4. 2 5. 4 6. 3

 Sample 9 3. 9 4. 8 6. 1

 Sample 10 4. 1 4. 9 5. 9 Safety of the invented product

 Safety tests were used separately

1. Acute oral toxicity test in mice: oral LD ₅ . >5000mg/kg body weight, the toxicity rating is actually non-toxic. There are 20 Kunming outbred mice in Switzerland, weighing 18-22 grams, half female, with an animal room temperature of 25 ° C and a relative humidity of 50%. The dose was 6000 mg/kg body weight, and the animals were fasted overnight, and the water was administered freely. The toxic solution was prepared to be 300 mg/ml, and the infected volume was 0. 2 ml/10 g body weight once. The observation period was 14 days, and the animals showed no abnormalities, and no animals died.

 2. Multiple complete skin irritation tests: The average score of the total score is 0, the skin irritation index is <0.5, and the stimuli are non-irritating. There are 3 Japanese white rabbits, all female, weighing 2-2. 5kg, animal room temperature 25 ° C, relative humidity 50%. 24 hours before the test, the hair on both sides of the back of the animal was cut off, and the hair removal range was 3 cm x 3 cm. The next day, 0.5 ml of the test stock solution was directly dropped onto a 2-layer gauze having an area of 2. 5 cm×2. 5 cm, and applied to the skin surface of one side, and then covered with a layer of squeegee-free paper, and then used without flaws. The adhesive tape is fixed. On the other side, a blank control was applied for 4 hours, and then the residue was washed away with warm water once a day for 14 days. The results showed that no erythema and edema were observed in the skin of the three rabbits.

3, mouse bone marrow polychromatic erythrocyte micronucleus test: no micronucleus effect on mouse bone marrow polychromatic erythrocytes. There are 50 Kunming outbred mice in Switzerland, half female, weighing 25-30g, animal room temperature 25 ° C, relative humidity 50%. Cyclophosphamide (CP) was used as a positive control. The test animals were set up in 3 dose groups, 5000, 2000, and 500 mg/kg body weight, and the positive control group was 40 mg/kg cyclophosphamide. Another negative control group was set up. 10 mice per group, half female. The preparation of the drug is 5, 2, 0.5 g, respectively, adding distilled water to 20 ml, cyclophosphamide 20 mg plus physiological saline to 5 ml. Animals were exposed to oral administration for 30 hours, two doses were given 24 hours, and the second dose was taken 6 hours. The volume of the infection was 0. 2ml/10g body weight, and cyclophosphamide was intraperitoneally injected, 0, lml/10g body weight. The cervical vertebrae dislocation method kills the mouse, takes one side of the femur, removes the muscles, wipes the blood stains, and cuts the ends of the femur to expose the marrow cavity. The syringe was aspirated with 0. lml of calf serum, the marrow cavity was rinsed, and the smear was routinely smeared with a rinse solution and allowed to dry naturally. The dried smear was fixed in methanol for 5-10 min, the Giemsa stain was stained for 10-15 min, buffered and dried. Select cells with uniform, complete, and well-colored areas. Count micronucleated polychromatic red blood cells (PCE) under oil microscope, count 1000 PCE per animal, observe the proportion of PCE/NCE (mature red blood cells), micronucleus The cell rate was all less than 0.6 per thousand (same as the negative control), and the positive control micronuclear cell rate was 41 per thousand.

 4. Subacute toxicity test: No harmful dose (NOAEL) was observed at 1000 mg/kg body weight. There were 40 Wi star grade rats, 6-8 weeks old, half female, weighing 180-220 g, animal room temperature 25 ° C, relative humidity 50%. The test group consisted of 3 groups at doses of 1000, 500, 250 mg/kg body weight, and control group. The test solution was 25, 12. 5, and 6.25 g, and distilled water was added to 250 ml. Rats were inoculated with lml/100g body weight, and given the same amount of distilled water, they were exposed once a day for 28 days. Weigh once a week and adjust the dose according to the weight. The indicators were tested 24 h after the last exposure, and then the rats were sacrificed for histopathological examination. The blood analysis items are total red blood cells, total white blood cells, hematocrit, hemoglobin content, and total number of platelets; blood biochemical tests include AST, ALT, B ring, TP, ALB, GLU, CH0; organ weight measurement liver, kidney weight, and calculation Organ weight coefficient; pathology includes all internal organs.

The novel product disclosed by the invention can quickly kill germs, fungi, and rapidly inactivate the virus, and at the same time, the product is not irritating to the skin and has no toxicity to the body.

The above is only the preferred embodiment of the present invention, and is not intended to limit the scope of the technical scope of the present invention. The technical content of the present invention is broadly defined in the scope of the claims of the application, any technical entity completed by others. The method or method, if it is identical to the scope of the claims, or equivalents, is considered to be within the scope of the claims.

 All documents mentioned in the present application are hereby incorporated by reference in their entirety in their entireties in the the the the the the the the the In addition, it should be understood that various modifications and changes may be made by those skilled in the art in the form of the present invention.

Claims

Rights request

A leave-free rapid anti-toxic preparation composition, characterized in that the composition comprises the following weight components: 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system;

 The remaining components are water.

2. The composition according to claim 1, wherein the ion for increasing the ionic strength of the composition system is a monovalent ion, a divalent ion, a trivalent ion or a combination thereof, preferably a divalent ion or a trivalent ion. More preferred are trivalent ions.

3. The composition according to claim 2, wherein the ion is a monovalent cation, a monovalent anion, a divalent cation, a divalent anion, a trivalent cation, a trivalent anion or a combination thereof.

4. The composition of claim 3, wherein

 The monovalent cation is a sodium ion, a potassium ion, an ammonium ion or a combination thereof;

 The divalent cation is an alkaline earth metal ion, or a transition metal ion;

 The trivalent cation is a cerium ion, a cerium ion, or a cerium ion;

 The monovalent anion is a monovalent halogen anion, a monovalent oxygen-containing anion, or a monovalent organic ion; the divalent anion is a sulfate ion, a carbonate ion, or a diacid ion;

 The trivalent anion is a phosphate ion.

5. The composition of claim 3 wherein the ion is a phosphate ion.

6. The composition of claim 1 wherein the composition system has an ionic strength between 16 and 500 mM.

7. The composition of claim 1 wherein the volatile alcohol is selected from the group consisting of ethanol, propanol, butanol, or a combination thereof.

The composition according to claim 1, wherein the ion is present in the form A soluble salt of water in water, or an alcoholic solvent.

9. A formulation made from the composition of claim 1.

10. A method of preparing a formulation according to claim 9, comprising the steps of:

(a) providing the following 50 to 99 parts by weight of a C2 to C4 volatile alcohol;

 (b) 0.1 to 5 parts by weight of ions for increasing the ionic strength of the composition system are mixed with the volatile alcohol; the ions are present in the form of soluble salts of the ions in water or an alcohol solvent. .