Povidone iodine disinfectant and preparation method thereof

Abstract

The invention relates to a disinfection product, in particular to a povidone iodine disinfection product. The povidone-iodine disinfectant is prepared from the following components in percentage by mass: 0.1 to 1 percent of povidone-iodine, 0.001 to 0.01 percent of PHB (Polyhydroxybutyrate) liposome nanoparticles, 0.03 to 0.1 percent of pH (Potential of Hydrogen) regulator, 0.5 to 1.5 percent of humectant and the balance of purified water, the preparation method of the disinfectant comprises the following steps: preparing a solution of the PHB liposome nanoparticles containing povidone iodine; weighing a solution of the povidone-iodine-containing PHB liposome nanoparticles according to a prescription amount, adding the solution into a preparation tank, adding a proper amount of purified water, and uniformly stirring and dissolving; weighing the pH regulator according to the prescription amount, adding the pH regulator into the preparation tank, and uniformly stirring; weighing the moisturizing agent according to the prescription amount, adding the moisturizing agent into the preparation tank, adding the rest purified water, stirring and dissolving uniformly, and filtering to obtain the disinfectant. The disinfectant does not need to be diluted before being used, can be directly used, is convenient to operate, has good stability and adhesiveness and is free of irritation; meanwhile, the preparation process is safe and simple.

Description

Technical Field

[0001] The present invention relates to disinfection products, and particularly to a povidone iodine disinfection product. Background Art

[0002] Povidone iodine is a broad-spectrum and powerful bactericidal disinfectant. Its principle of action is that it can continuously release free iodine in water bodies, disrupt the metabolism of bacteria and viruses, and achieve the purpose of disinfection. Povidone iodine aqueous solution has the advantages of light color, easy elution, low irritation to mucous membranes, low toxicity, etc., and is widely used in medical treatment, hygiene and home care. However, its stability is worthy of attention. In conventional products, the povidone iodine content is 5-10%, and occasionally 4% products, but there is no report on products with a content less than 1%.

[0003] CN 113318122 A relates to a disinfectant composition containing povidone iodine and its uses. The povidone iodine content is 4-6%, two or more alkylaryl polyoxyethylene ether surfactants, one or more pH buffers, one or more pH regulators, and one or more osmotic pressure regulators. It may be considered the influence of packaging on the stability of povidone iodine solution, but the stability of existing povidone iodine solutions for disinfection of human skin and mucous membranes has not been studied, and the povidone iodine content is 4%-6%, and there is no investigation on the stability of low-content povidone iodine.

[0004] CN102919269A relates to a povidone iodine disinfectant and its preparation method. The povidone iodine disinfectant includes 5-10 g of povidone iodine (PVP-I), potassium iodate and potassium iodide. Citric acid and sodium hydroxide are used to adjust the pH of the solution. Similarly, the addition amount of povidone iodine is 5-10 g, there is no investigation on low-content povidone iodine, nor is there an investigation on the stability of povidone iodine solution for disinfection of human skin and mucous membranes.

[0005] In addition, these products with higher concentrations need to be diluted during use, which is inconvenient to operate, and the diluted products will degrade after being placed for a long time, affecting the iodine content and bactericidal effect. Summary of the Invention

[0006] The present invention aims to solve the above-mentioned defects of the prior art and provides a povidone iodine disinfectant and its preparation method. The disinfectant of the present invention does not need to be diluted before use and can be directly used, which is convenient to operate, has good stability and adhesion and no irritation; at the same time, the preparation process is safe and simple. On the other hand, the present invention prepares polyhydroxybutyrate liposome nanoparticles (PHB liposome nanoparticles) by certain means, and solves the problem that liposomes are unstable due to various factors.

[0007] The present invention is implemented as follows. A povidone iodine disinfectant, by mass percentage: povidone iodine 0.1% - 1%, PHB liposome nanoparticles 0.001% - 0.01%, pH regulator 0.03% - 0.1%, humectant 0.5% - 1.5%, and the balance is purified water.

[0008] Further, the ratio of PHB to phospholipid in the PHB liposome nanoparticles is 10% - 15%: 1% - 5%

[0009] Further, the pH regulator is any one of sodium bicarbonate, sodium hydroxide, and triethanolamine;

[0010] Further, the humectant is one or more of aloe vera extract, D-panthenol, sodium acetylated hyaluronate, propylene glycol, and glycerol.

[0011] Preparation method:

[0012] Preparation of a solution of PHB liposome nanoparticles containing povidone iodine:

[0013] Dissolve the PHB and phospholipid in the formula ratio in chloroform and stir evenly to obtain solution A;

[0014] Evaporate solution A in a rotary evaporator to form a uniform thin film.

[0015] Hydrate the thin film with an aqueous povidone iodine solution to form a suspension of PHB liposomes containing povidone iodine;

[0016] Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution.

[0017] Pass the ultrasonic-treated liposome solution through a polycarbonate membrane with a pore size of 100 nm and extrude it repeatedly to obtain a solution of PHB liposome nanoparticles containing povidone iodine with a uniform size.

[0018] A povidone iodine disinfectant and its preparation method:

[0019] Weigh the prescribed amount of the solution of PHB liposome nanoparticles containing povidone iodine and add it to a preparation tank, add an appropriate amount of purified water, and stir until dissolved evenly;

[0020] Weigh the prescribed amount of the pH regulator, add it to the preparation tank, and stir evenly;

[0021] Weigh the prescribed amount of the humectant, add it to the preparation tank, add the remaining purified water, stir until dissolved evenly, and filter to obtain the product.

[0022] The present invention has the following characteristics:

[0023] 1. When the present invention is used, no dilution is required, reducing the large loss of available iodine caused by the too complex preparation process;

[0024] 2. The present invention effectively reduces the decomposition of available iodine and improves the storage stability by adding PHB liposome nanoparticles, thereby accelerating the metabolic process of available iodine destroying cells during use.

[0025] 3. The present invention has high safety and does not contain alcohol, and is non-irritating to human skin and mucous membranes.

[0026] 4. The present invention reduces the irritation and burning sensation of iodine preparations on the skin and mucous membranes by adding a humectant.

[0027] 5. The present invention has a strong bactericidal effect and can reach the disinfection level in a short time.

[0028] Through effective formula proportioning of the present invention, it is obtained from the results of microbial experiments that the bactericidal effect can be achieved in 30 s, and the effective period can reach two years. Detailed implementation mode

[0029] A povidone iodine disinfectant of the present invention, by mass percentage: povidone iodine 0.1%-1%, PHB liposome nanoparticles 0.001%-0.01%, pH regulator 0.03%-0.1%, humectant 0.5%-1.5%, and the balance is purified water.

[0030] Further, the ratio of PHB to phospholipid in the PHB liposome nanoparticles is 10%-15%: 1%-5%

[0031] Further, the pH regulator is any one of sodium bicarbonate, sodium hydroxide, and triethanolamine;

[0032] Further, the humectant is one or more of aloe vera extract, D-panthenol, sodium acetylated hyaluronate, propylene glycol, and glycerol.

[0033] Preparation method:

[0034] Preparation of a solution of PHB liposome nanoparticles containing povidone iodine:

[0035] Dissolve PHB and phospholipid in the formula ratio in chloroform and stir evenly to obtain solution A;

[0036] Evaporate solution A in a rotary evaporator to form a uniform thin film.

[0037] Hydrate the thin film with an aqueous solution of povidone iodine to form a suspension of PHB liposome containing povidone iodine;

[0038] Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution.

[0039] The ultrasonicated liposome solution was extruded repeatedly through a polycarbonate membrane with a pore size of 100 nm to obtain a solution of PHB liposome nanoparticles with uniform size containing povidone iodine.

[0040] A povidone iodine disinfectant and its preparation method:

[0041] Weigh the prescribed amount of the solution of PHB liposome nanoparticles containing povidone iodine and add it to a preparation tank, then add an appropriate amount of purified water and stir until dissolved evenly.

[0042] Weigh the prescribed amount of pH regulator, add it to the preparation tank, and stir evenly.

[0043] Weigh the prescribed amount of humectant, add it to the preparation tank, add the remaining purified water, stir until dissolved evenly, and filter to obtain the product.

[0044] Liposomes have good biocompatibility, can accommodate hydrophobic and hydrophilic molecules, and are widely used in the fields of drug delivery, cosmetics, biotechnology, etc. However, they are not stable during storage and use. Polyhydroxybutyrate (PHB) (hereinafter referred to as PHB) has good chemical stability and excellent active substance carrier ability. In the present invention, polyhydroxybutyrate liposome nanoparticles (PHB liposome nanoparticles) are prepared by certain means, which solves the problem that liposomes are vulnerable to various factors and are unstable. When preparing the povidone iodine disinfectant, PHB liposome nanoparticles are first hydrated in an aqueous povidone iodine solution to form a liposome suspension, and then a small-sized and uniform solution of PHB liposome nanoparticles containing povidone iodine is obtained through ultrasonic treatment and extrusion treatment. During this process, PHB liposome nanoparticles well encapsulate povidone iodine, reduce the degradation of available iodine, and improve the stability of the povidone iodine disinfectant; the povidone iodine disinfectant is weakly acidic. When the PHB liposome nanoparticles containing povidone iodine contact the skin surface, the weakly acidic environment promotes the release of iodine ions from the PHB liposome nanoparticles to play a bactericidal role; PHB liposome nanoparticles can form a thin film on the skin surface to provide a protective barrier, extend the residence time of the povidone iodine disinfectant on the skin, and improve the bactericidal effect.

[0045] The following further illustrates the present invention with reference to examples:

[0046] Example 1

[0047] A povidone iodine disinfectant and its preparation method, by mass percentage, includes the following components: povidone iodine 0.1%, PHB liposome nanoparticles 0.002%, sodium bicarbonate 0.03%, D-panthenol 0.2%, glycerol 0.5%, and the balance is purified water;

[0048] The preparation process is as follows:

[0049] 1. Preparation of PHB liposome nanoparticles:

[0050] ① Dissolve 10 g of PHB and 2 g of phospholipid in chloroform and stir evenly to obtain Solution A;

[0051] ② Weigh 0.1 g of povidone iodine, add it to 50 ml of purified water, and stir to dissolve to obtain Solution B;

[0052] ③ Evaporate Solution A in a rotary evaporator to form a uniform thin film;

[0053] ④ Weigh 0.002 g of the thin film and hydrate it in Solution B to form a PHB liposome suspension containing povidone iodine;

[0054] ⑤ Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution.

[0055] ⑥ Pass the ultrasonic-treated liposome solution through a polycarbonate membrane with a pore size of 100 nm and extrude it repeatedly to obtain a solution of PHB liposome nanoparticles with a uniform size containing povidone iodine.

[0056] Further, the evaporation temperature in step ③ is set at 50 °C and the time is 15 minutes;

[0057] Further, the hydration time in step ④ is 30 minutes;

[0058] Further, the number of extrusion times in step ⑥ is 20 times.

[0059] 2. Preparation of povidone iodine disinfectant

[0060] ① Add the solution of PHB liposome nanoparticles containing povidone iodine prepared above to 20 g of purified water and stir evenly to obtain Solution A;

[0061] ② Weigh 0.03 g of sodium bicarbonate and add it to Solution A and stir evenly;

[0062] ③ Weigh 0.2 g of D-panthenol and 0.5 g of glycerol, add them to the remaining purified water, stir to dissolve evenly, and filter to obtain the product. Further, the stirring time in steps ①, ②, and ③ is 15 minutes and the temperature is at room temperature.

[0063] According to the relevant test standards of the "Disinfection Technical Specification" (2002 edition) of the Ministry of Health, a quantitative bactericidal test was carried out on Example 1.

[0064]

[0065]

[0066] Note: No bacteria grew in each negative control.

[0067] Conclusion: The results of three tests show that when the stock solution of Example 1 acts for 0.5 min, 1 min, and 1.5 min, the logarithmic reduction values of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans in the bacterial suspension are all > 5.00.

[0068] Example 2

[0069] A povidone iodine disinfectant and its preparation method, by mass percentage, include the following components:

[0070] Povidone iodine 0.5%, PHB liposome nanoparticles 0.005%, triethanolamine 0.05%, Aloe vera extract 1%, sodium acetylated hyaluronate 0.2%, and the balance is purified water;

[0071] The preparation process is as follows:

[0072] 1. Preparation of PHB liposome nanoparticles:

[0073] ① Dissolve 13 g of PHB and 3 g of phospholipid in chloroform and stir evenly to obtain Solution A;

[0074] ② Weigh 0.5 g of povidone iodine, add it to 50 ml of purified water, and stir to dissolve to obtain Solution B;

[0075] ③ Evaporate Solution A in a rotary evaporator to form a uniform thin film;

[0076] ④ Weigh 0.005 g of the thin film and hydrate it in Solution B to form a PHB liposome suspension containing povidone iodine;

[0077] ⑤ Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution.

[0078] ⑥ Pass the ultrasonic-treated liposome solution through a polycarbonate membrane with a pore size of 100 nm and extrude it repeatedly to obtain a solution of PHB liposome nanoparticles with a uniform size containing povidone iodine.

[0079] Further, the evaporation temperature in step ③ is set at 50 °C and the time is 15 minutes;

[0080] Further, the hydration time in step ④ is 30 minutes;

[0081] Further, the number of extrusion times in step ⑥ is 20 times.

[0082] 2. Preparation of povidone iodine disinfectant

[0083] ① Add the solution of PHB liposome nanoparticles containing povidone iodine prepared above to 20 g of purified water and stir evenly to obtain Solution A;

[0084] ② Weigh 0.05 g of triethanolamine, add it to Solution A, and stir evenly;

[0085] ③ Weigh 1 g of Aloe vera extract and 0.2 g of acetylated sodium hyaluronate, add the remaining purified water, stir to dissolve evenly, and filter to obtain the product.

[0086] Further, the stirring time in steps ①, ②, and ③ is 15 minutes, and the temperature is at room temperature.

[0087] According to the relevant test standards of the "Disinfection Technical Specification" (2002 edition) of the Ministry of Health, a quantitative bactericidal test was carried out on Example 2.

[0088]

[0089] Note: There was no bacterial growth in each negative control.

[0090] Conclusion: The results of 3 tests showed that the killing logarithm values of the stock solution of Example 2 against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans in the bacterial suspension were > 5.00 after acting for 0.5 min, 1 min, and 1.5 min.

[0091] Example 3

[0092] A povidone iodine disinfectant and its preparation method, by mass percentage, include the following components:

[0093] Povidone iodine 1%, PHB liposome nanoparticles 0.01%, sodium hydroxide 0.08%, propylene glycol 1%, glycerol 0.5%, and the balance is purified water;

[0094] The preparation process is as follows:

[0095] 1. Preparation of PHB liposome nanoparticles:

[0096] ① Dissolve 15 g of PHB and 5 g of phospholipids in chloroform, stir evenly to obtain solution A;

[0097] ② Weigh 1 g of povidone iodine, add it to 50 ml of purified water, stir to dissolve to obtain solution B;

[0098] ③ Evaporate solution A in a rotary evaporator to form a uniform thin film;

[0099] ④ Weigh 0.01 g of the thin film and hydrate it in solution B to form a PHB liposome suspension containing povidone iodine;

[0100] ⑤ Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution.

[0101] ⑥ Pass the ultrasonic-treated liposome solution through a polycarbonate membrane with a pore size of 100 nm and extrude it repeatedly to obtain a solution of PHB liposome nanoparticles with a uniform size containing povidone iodine.

[0102] Further, the evaporation temperature in step ③ is set at 50 °C for 15 minutes;

[0103] Further, the hydration time in step ④ is 30 minutes;

[0104] Further, the extrusion times in step ⑥ is 20 times.

[0105] 2. Preparation of povidone iodine disinfectant

[0106] ① Add the solution of PHB liposome nanoparticles containing povidone iodine prepared above to 20 g of purified water and stir evenly to obtain solution A;

[0107] ② Weigh 0.08 g of sodium hydroxide and add it to solution A, then stir evenly;

[0108] ③ Weigh 1 g of propylene glycol and 0.5 g of glycerol, add them to the remaining purified water, stir and dissolve evenly, then filter to obtain the product. Further, the stirring time in steps ①②③ is 15 minutes and the temperature is at room temperature.

[0109] According to the relevant test standards in the "Disinfection Technical Specification" (2002 Edition) of the Ministry of Health, a quantitative bactericidal test was carried out on Example 3.

[0110]

[0111] Note: There was no bacterial growth in each negative control.

[0112] Conclusion: The results of 3 tests showed that when the stock solution of Example 2 acted for 0.5 min, 1 min, and 1.5 min, the killing log values of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans in the bacterial suspension were all > 5.00. According to Items 2.2.1.2.2 and 2.2.3 of the "Disinfection Technical Specification" (2002 Edition) of the Ministry of Health, the product stability of the povidone iodine disinfectant in Examples 1 - 3 was tested.

[0113]

[0114]

[0115] From the above data, it can be seen that the validity period of the povidone iodine disinfectant of the present invention can reach two years.

[0116] According to Items 2.3.1, 2.3.8, 2.3.3.3.1, 2.3.3.3.3, 2.3.3.3.2, 2.3.5, and 2.3.4 of the "Disinfection Technical Specification" (2002 Edition) of the Ministry of Health, acute oral toxicity tests, micronucleus tests, single full - thickness skin irritation tests, multiple full - thickness skin irritation tests, single damaged skin irritation tests, vaginal mucosa irritation tests, and acute eye irritation tests were carried out on Examples 1 - 3, and the results are as follows:

[0117] 1. Acute oral toxicity test:

[0118] For Examples 1 - 3, the LD50 values of acute oral administration to male and female mice were both greater than 5000 mg / kg, indicating they are practically non-toxic.

[0119] 2. Micronucleus test:

[0120] The results of the micronucleus test on polychromatic erythrocytes in the bone marrow of mice in Examples 1 - 3 were negative.

[0121] 3. Single complete skin irritation test:

[0122] For Examples 1 - 3, the mean (highest) integral of single complete skin irritation to rabbits was 0, indicating no irritation.

[0123] 4. Multiple complete skin irritation test:

[0124] For Examples 1 - 3, the mean integral of skin irritation response per rabbit per day was 0, indicating no irritation.

[0125] 5. Single damaged skin irritation test:

[0126] For Examples 1 - 3, the mean (highest) integral of single complete skin irritation to rabbits was 0, indicating no irritation.

[0127] 6. Vaginal mucosa irritation test:

[0128] For Examples 1 - 3, the vaginal mucosa irritation index to rabbits was 0.5, and the intensity of vaginal mucosa irritation response was no irritation.

[0129] 7. Acute eye irritation test:

[0130] For Examples 1 - 3, the average score of acute eye irritation to three rabbits was 0 for corneal or iris damage and 0 for conjunctival congestion or edema, indicating no irritation.

[0131] From the above test results, it can be seen that a povidone iodine disinfectant and its products provided by this invention application have excellent stability, bactericidal power, and safety.

[0132] The embodiments disclosed in this invention are only preferred embodiments of this invention, and are only used to illustrate the technical solutions of this invention, rather than to limit it. The purpose is to enable those skilled in the art to understand the content of this invention and implement it accordingly, and it cannot be used to limit the protection scope of this invention. Any equivalent changes or modifications made according to the spirit and essence of this invention should be covered within the protection scope of this invention.

Claims

1. A povidone iodine disinfectant, by mass percentage: povidone iodine 0.1% - 1%, PHB liposome nanoparticles 0.001% - 0.01%, pH regulator 0.03% - 0.1%, humectant 0.5% - 1.5%, and the balance is purified water.

2. The povidone iodine disinfectant according to claim 1, wherein, The ratio of PHB to phospholipid in the PHB liposome nanoparticles is 10% - 15%: 1% - 5% 3. A povidone iodine disinfectant according to claim 1, characterized in that, The pH regulator is any one of sodium bicarbonate, sodium hydroxide, and triethanolamine.

4. A povidone iodine disinfectant according to claim 1, characterized in that, The humectant is one or more of aloe vera extract, D-panthenol, sodium acetylated hyaluronate, propylene glycol, and glycerin.

5. A preparation method of the povidone iodine disinfectant as described in claim 1, characterized in that, It includes: S1, Preparation of a solution of PHB liposome nanoparticles containing povidone iodine; S2, Weigh the prescribed amount of the solution of PHB liposome nanoparticles containing povidone iodine and add it to a preparation tank, add an appropriate amount of purified water, and stir until dissolved evenly; S3, Weigh the prescribed amount of the pH regulator, add it to the preparation tank, and stir evenly; S4, Weigh the prescribed amount of the humectant and add it to the preparation tank, add the remaining purified water, stir until dissolved evenly, and filter to obtain the disinfectant.

6. The preparation method of the povidone iodine disinfectant according to claim 5, characterized in that, The S1, Preparation of a solution of PHB liposome nanoparticles containing povidone iodine includes: S11, Dissolve the PHB and phospholipid in the formula ratio in chloroform, and stir evenly to obtain solution A; S12, Evaporate solution A in a rotary evaporator to form a uniform thin film; S13, Hydrate the thin film in an aqueous povidone iodine solution to form a suspension of PHB liposome nanoparticles containing povidone iodine; S14, Use ultrasonic treatment for 10 min to obtain a monolayer liposome solution; S15, Pass the ultrasonic-treated liposome solution through a polycarbonate membrane with a pore size of 100 nm, Extrude repeatedly to obtain a solution of PHB liposome nanoparticles with a uniform size containing povidone iodine.

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