CN112315974A - Povidone iodine solution with enhanced stability and preparation method thereof - Google Patents

Povidone iodine solution with enhanced stability and preparation method thereof Download PDF

Info

Publication number
CN112315974A
CN112315974A CN202011280535.0A CN202011280535A CN112315974A CN 112315974 A CN112315974 A CN 112315974A CN 202011280535 A CN202011280535 A CN 202011280535A CN 112315974 A CN112315974 A CN 112315974A
Authority
CN
China
Prior art keywords
solution
iodine
povidone
sodium
sodium hydroxide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN202011280535.0A
Other languages
Chinese (zh)
Other versions
CN112315974B (en
Inventor
郎伟君
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Letai Pharmaceutical Co ltd
Original Assignee
Letai Pharmaceutical Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Letai Pharmaceutical Co ltd filed Critical Letai Pharmaceutical Co ltd
Priority to CN202011280535.0A priority Critical patent/CN112315974B/en
Publication of CN112315974A publication Critical patent/CN112315974A/en
Application granted granted Critical
Publication of CN112315974B publication Critical patent/CN112315974B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/18Iodine; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • A61K31/787Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • A61K31/79Polymers of vinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention discloses a povidone iodine solution with enhanced stability and a preparation method thereof. The povidone iodine solution is composed of povidone iodine, sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, potassium iodate, sodium dodecyl sulfate and purified water, wherein the concentration of each raw material is as follows: 5-20 g/L of povidone iodine, 1-10 g/L of sodium dihydrogen phosphate, 0.5-2 g/L of disodium hydrogen phosphate dodecahydrate, 0.2-1.0 g/L of potassium iodate and 1-10 g/L of sodium dodecyl sulfate, and adjusting the pH value of a sodium hydroxide solution to 5.20-5.30. In the invention, sodium dihydrogen phosphate and disodium hydrogen phosphate dodecahydrate are used as pH value adjusting buffer pairs, so that the acid-base balance of the solution can be maintained, and a buffer effect can be achieved. The potassium iodate and the sodium dodecyl sulfate are used as pH stabilizers, the sodium hydroxide is used as a pH regulator, and the pH value of the povidone iodine solution can be controlled within a specified range, so that the stability of the effective iodine content is ensured, and the sterilization effect of the povidone iodine solution is maintained.

Description

Povidone iodine solution with enhanced stability and preparation method thereof
Technical Field
The invention relates to a povidone iodine solution with enhanced stability and a preparation method thereof, belonging to the technical field of medicines.
Background
Povidone iodine (PVP-I) is amorphous powder with yellow-brown to reddish-brown color, and is an amorphous complex iodine formed by polyvinyl pyrrolidone (PVP) and iodine in a complex form by means of hydrogen bonds and other external forces. PVP forms a micro-cavity carrier, and iodide ions are complexed in the cavity of the microcapsule to form PVP-I. Under the condition of aqueous solution, the PVP has affinity effect on cell membranes, so that iodine can be directly introduced to the surfaces of the bacterial membranes, iodine molecules are slowly released, the cell membranes and proteins of the iodine molecules are damaged, and the effects of disinfection and sterilization are achieved. Povidone iodine has the characteristics of film forming, adhesion, detoxification, slow release, strong water solubility, broad-spectrum sterilization effect and the like, and is more and more widely applied to sterilization and disinfection of skin mucosa, operation, instruments and the like. The povidone iodine is a broad-spectrum strong sterilization disinfectant, has strong killing effect on viruses, bacteria, fungi and mould spores, and has small irritation to skin, low toxicity and lasting effect. Safe and simple use, no irritation to tissues, and is usually used for skin and mucosa disinfection, such as cleaning before operation, and disinfection of operation parts and wounds.
The povidone iodine solution is used as a disinfectant, has broad-spectrum antibacterial action, is used for disinfecting pyogenic dermatitis, dermatophyte infection, small-area mild burns and scalds, and is also used for disinfecting small-area skin and mucous membrane wounds, and is a novel clinical disinfection preservative. Compared with iodine tincture, the povidone iodine solution has the advantages of stable and quick sterilization effect, good water solubility, no irritation and volatility, mild and lasting effect, no toxicity, no harm, no irritation, difficult dyeing and no residue to organisms, is widely applied to clinic,
povidone iodine solid is stable in natural environment, but the stability of the solution is not ideal. Currently, commercially available povidone-iodine solutions are prescribed: povidone iodine (containing effective iodine 9.0-12.0%) 10g, purified water: and preparing a proper amount of povidone iodine solution into 1000 ml. The preparation process comprises the following steps: weighing povidone iodine according to the prescription amount, adding 9 times of purified water, soaking for 24 hours, adding 2/3 of purified water according to the prescription amount, diluting, fixing the volume, stirring, filtering and filling to obtain the povidone iodine. However, the stability of the povidone iodine solution is influenced by various factors such as temperature, pH value, light, concentration, packaging materials and the like, the pH value can be obviously changed, and the povidone iodine solution is easy to decompose and sublimate in the storage process, so that the content of effective iodine is reduced, the effective sterilization concentration cannot be achieved, the product quality is influenced, and a plurality of adverse effects are brought to production, storage and use.
Patent application with publication number CN104906127A discloses a povidone-iodine compound preparation with enhanced stability of effective iodine content and a preparation method thereof. The method proposes that the content of the effective iodine in the preparation can be kept relatively stable by adding the sodium hydroxide, but the method does not investigate the influence of different pH values on the stability of the preparation, and meanwhile, the method only adds the sodium hydroxide as a pH regulator, and has no obvious effect on keeping the stability of the preparation. This application is except adding pH regulator, has still increased pH value and has adjusted the buffering to with the pH stabilizer, more can the effectual stability that keeps povidone iodine solution pH value and content.
Disclosure of Invention
In order to solve the problems occurring in the art, the present invention aims to provide a povidone-iodine solution with enhanced stability and a preparation method thereof.
In order to achieve the purpose, the invention adopts the following technical means:
the povidone iodine solution with enhanced stability comprises povidone iodine, sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, potassium iodate, sodium dodecyl sulfate and purified water, wherein the concentration of each raw material is as follows:
5-20 g/L of povidone iodine, 1-10 g/L of sodium dihydrogen phosphate, 0.5-2 g/L of disodium hydrogen phosphate dodecahydrate, 0.2-1.0 g/L of potassium iodate and 1-10 g/L of sodium dodecyl sulfate, and adjusting the pH value of a sodium hydroxide solution to 5.20-5.30.
Among them, the preferred concentrations of the respective raw materials are as follows:
5g/L of povidone iodine, 2g/L of sodium dihydrogen phosphate, 1.5g/L of disodium hydrogen phosphate dodecahydrate, 0.3g/L of potassium iodate and 2.5g/L of sodium dodecyl sulfate, and the pH value of a sodium hydroxide solution is adjusted to be 5.2.
Wherein, the concentration of the sodium hydroxide solution is preferably 5% w/v.
Further, the invention also provides a method for preparing the povidone iodine solution, which is characterized by comprising the following steps of:
(1) weighing raw materials: weighing the raw materials according to the concentration of the raw materials;
(2) preparation of solution 1: adding the weighed sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate and potassium iodate into purified water to dissolve the sodium dihydrogen phosphate, the disodium hydrogen phosphate dodecahydrate and the potassium iodate to obtain a solution 1;
(2) preparation of solution 2: dissolving the weighed sodium dodecyl sulfate in purified water to obtain a solution 2;
(3) preparation of sodium hydroxide solution: taking sodium hydroxide, and adding purified water to prepare a sodium hydroxide solution;
(4) and adding purified water into the weighed povidone iodine, standing overnight, stirring the weighed povidone iodine by using an electric stirrer until the weighed povidone iodine is completely dissolved, adding the solution 1, continuously and fully stirring the solution, adding the solution 2, fully stirring the solution uniformly, adding purified water to a constant volume, stirring the solution uniformly, and adjusting the pH value to 5.20 to 5.30 by using a sodium hydroxide solution to obtain the povidone iodine solution with enhanced stability.
Wherein, the concentration of the sodium hydroxide solution is preferably 5% w/v.
Furthermore, the invention also provides application of the povidone iodine solution in preparation of a bactericide or a disinfectant.
Compared with the prior art, the invention has the beneficial effects that:
the invention provides a povidone iodine solution with enhanced stability and a preparation method thereof. In the invention, sodium dihydrogen phosphate and disodium hydrogen phosphate dodecahydrate are used as pH value adjusting buffer pairs, so that the acid-base balance of the solution can be maintained, and a buffer effect can be achieved. The pH value of the povidone iodine solution can be controlled within a specified range by adopting the raw material composition of the invention, thereby ensuring the stability of the effective iodine content and maintaining the sterilization efficacy of the povidone iodine solution.
Detailed Description
The invention will be further described with reference to specific embodiments, and the advantages and features of the invention will become apparent as the description proceeds. These examples are illustrative only and do not limit the scope of the present invention in any way. It will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention, and that such changes and modifications may be made without departing from the spirit and scope of the invention.
Example 1: preparation of povidone-iodine solution with enhanced stability
The povidone-iodine solution with enhanced stability in this example is prepared from the following raw materials: povidone iodine 10g, sodium dihydrogen phosphate 4g, disodium hydrogen phosphate dodecahydrate 0.9g, potassium iodate 0.5g, sodium dodecyl sulfate 5g, sodium hydroxide with pH adjusted to 5.3, and purified water added to 1000 mL.
The preparation method comprises the following steps:
(1) weighing the following raw materials in parts by weight:
10g of povidone iodine, 4g of sodium dihydrogen phosphate, 0.9g of disodium hydrogen phosphate dodecahydrate, 0.5g of potassium iodate and 5g of sodium dodecyl sulfate;
(2) preparation of solution 1: adding the weighed sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate and potassium iodate into purified water to dissolve the sodium dihydrogen phosphate, the disodium hydrogen phosphate dodecahydrate and the potassium iodate to obtain a solution 1;
(3) preparation of solution 2: dissolving the weighed sodium dodecyl sulfate in purified water to obtain a solution 2;
(4) preparation of sodium hydroxide solution: taking sodium hydroxide, and adding purified water to prepare 5% w/v sodium hydroxide solution;
(5) and adding purified water into the weighed povidone iodine, standing overnight, stirring by using an electric stirrer until the povidone iodine is completely dissolved, adding the solution 1, continuing to stir fully, adding the solution 2, and stirring fully until the solution is uniform. Adding purified water to reach a constant volume of 1000ml, stirring the mixture until the mixture is uniformly mixed, and adjusting the pH value to 5.30 by using a 5% w/v sodium hydroxide solution to obtain the povidone-iodine solution with enhanced stability.
Example 2: preparation of povidone-iodine solution with enhanced stability
The povidone-iodine solution with enhanced stability in this example is prepared from the following raw materials: 5g of povidone iodine, 2g of sodium dihydrogen phosphate, 1.5g of disodium hydrogen phosphate dodecahydrate, 0.3g of potassium iodate, 2.5g of sodium dodecyl sulfate, pH value adjusted to 5.2 by sodium hydroxide, and purified water added to 1000 mL.
The preparation method comprises the following steps:
(1) weighing the following raw materials in parts by weight:
5g of povidone iodine, 2g of sodium dihydrogen phosphate, 1.5g of disodium hydrogen phosphate dodecahydrate, 0.3g of potassium iodate and 2.5g of sodium dodecyl sulfate;
(2) preparation of solution 1: adding the weighed sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate and potassium iodate into purified water to dissolve the sodium dihydrogen phosphate, the disodium hydrogen phosphate dodecahydrate and the potassium iodate to obtain a solution 1;
(3) preparation of solution 2: dissolving the weighed sodium dodecyl sulfate in purified water to obtain a solution 2;
(4) preparation of sodium hydroxide solution: taking sodium hydroxide, and adding purified water to prepare 5% w/v sodium hydroxide solution;
(5) and adding purified water into the weighed povidone iodine, standing overnight, stirring by using an electric stirrer until the povidone iodine is completely dissolved, adding the solution 1, continuing to stir fully, adding the solution 2, and stirring fully until the solution is uniform. Adding purified water to reach a constant volume of 1000ml, stirring the mixture until the mixture is uniformly mixed, and adjusting the pH value to 5.20 by using a 5% w/v sodium hydroxide solution to obtain the povidone-iodine solution with enhanced stability.
Example 3: preparation of povidone-iodine solution with enhanced stability
The povidone-iodine solution with enhanced stability in this example is prepared from the following raw materials: 15g of povidone iodine, 6g of sodium dihydrogen phosphate, 2.0g of disodium hydrogen phosphate dodecahydrate, 1.0g of potassium iodate, 8.5g of sodium dodecyl sulfate, adjusting the pH value to 5.25 by using sodium hydroxide, and adding purified water to 1000 mL.
The preparation method comprises the following steps:
(1) weighing the following raw materials in parts by weight:
15g of povidone iodine, 6g of sodium dihydrogen phosphate, 2.0g of disodium hydrogen phosphate dodecahydrate, 1.0g of potassium iodate and 8.5g of sodium dodecyl sulfate;
(2) preparation of solution 1: adding the weighed sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate and potassium iodate into purified water to dissolve the sodium dihydrogen phosphate, the disodium hydrogen phosphate dodecahydrate and the potassium iodate to obtain a solution 1;
(3) preparation of solution 2: dissolving the weighed sodium dodecyl sulfate in purified water to obtain a solution 2;
(4) preparation of sodium hydroxide solution: taking sodium hydroxide, and adding purified water to prepare 5% w/v sodium hydroxide solution;
(5) and adding purified water into the weighed povidone iodine, standing overnight, stirring by using an electric stirrer until the povidone iodine is completely dissolved, adding the solution 1, continuing to stir fully, adding the solution 2, and stirring fully until the solution is uniform. Adding purified water to reach a constant volume of 1000ml, stirring the mixture until the mixture is uniformly mixed, and adjusting the pH value to 5.25 by using a 5% w/v sodium hydroxide solution to obtain the povidone-iodine solution with enhanced stability.
Experimental example 1 Effect verification
1. The test method comprises the following steps:
(1) pH value: see the Chinese pharmacopoeia 2015 edition four parts general rule 0631, which should be 3.0-6.5.
(2) Content determination: an appropriate amount of povidone-iodine solution (about equivalent to 1.25g of povidone-iodine) with precise amount is put into a beaker, added with water to 125mL and titrated with sodium thiosulfate titration solution (0.1mol/L) according to potentiometric titration (see 0701 in the four headings of the 2015 version of Chinese pharmacopoeia). Each 1ml of sodium thiosulfate titrant (0.1mol/L) corresponds to 12.69mg of iodine (I). The content of povidone iodine in the product is 8.5-12.0% (g/ml) calculated according to the effective iodine (I).
Measuring the content in 0, 1, 2, 3, 6, 9, and 12 months respectively.
2. And (3) test data statistics:
2.1 stability test with addition of different masses of sodium lauryl sulfate
The povidone-iodine solution was prepared as in example 1 except that the weight of the sodium lauryl sulfate therein was replaced with the weight of the sodium lauryl sulfate listed in table 1, and the results are shown in table 1:
table 1 shows the stability test results (available iodine content% (g/ml)) of sodium dodecyl sulfate added in different amounts
Figure BDA0002780602360000061
2.2 stability test with different quantities of Potassium iodate
The povidone-iodine solution was prepared as in example 1 except that the weight of potassium iodate therein was replaced with the weight of potassium iodate listed in table 2 and the results are shown in table 2:
table 2 stability test results (effective iodine content% (g/ml)) of potassium iodate added in different amounts
Figure BDA0002780602360000062
Figure BDA0002780602360000071
2.3 stability test by adding NaOH to adjust to different pH values
The povidone-iodine solution was prepared as in example 1 except that sodium hydroxide was added to adjust to different pH values, and the results are shown in table 3.
TABLE 3 stability test results (available iodine content% (g/ml)) with sodium hydroxide addition adjusted to different pH values
Figure BDA0002780602360000072
2.4 stability testing of the examples of the invention
The pH and available iodine content% (g/ml) of the povidone-iodine solutions prepared in examples 1 to 3 of the present invention were measured, and the results are shown in table 4.
TABLE 4 stability test results (effective iodine content% (g/ml)) for the examples of the present invention
Figure BDA0002780602360000073
Figure BDA0002780602360000081
2.5 in situ stability test
The original prescription of the povidone iodine solution is as follows: povidone iodine (containing effective iodine 9.0-12.0%) 10g, purified water: and preparing a proper amount of povidone iodine solution into 1000 ml.
The preparation process comprises the following steps: weighing povidone iodine according to the prescription amount, adding 9 times of purified water, soaking for 24 hours, adding 2/3 of purified water according to the prescription amount, diluting, fixing the volume, stirring, filtering and filling to obtain the povidone iodine.
The pH and available iodine content% (g/ml) of povidone-iodine solution prepared according to the original preparation process were measured, and the results are shown in table 5.
TABLE 5 stability test results (effective iodine content% (g/ml))
Time (moon) pH value Effective iodine content
0 3.5 10.52
1 2.61 10.13
2 2.59 10.05
3 2.57 9.84
6 2.55 9.13
9 2.51 8.62
12 2.42 8.41
RSD(%) 13.72 8.51
The result of the detection Fail to be qualified Fail to be qualified
The pH value is unqualified in 1 month of the stability test, and the content is unqualified in 9 months of the stability test.
3. Results
The pH value and the effective iodine content are used as evaluation indexes in the experiment, the pH value and the effective iodine content in the povidone iodine solution are measured by adopting an accelerated stability experiment method, the stability of the pH value and the effective iodine content in the povidone iodine solution is judged by Relative Standard Deviation (RSD), and the smaller the RSD value is, the more stable the product is.
As can be seen from Table 1, the amount of sodium dodecyl sulfate added is out of the range (1-10 g/L) indicated in the invention, and the stability of pH value and effective iodine content is not good enough.
As can be seen from Table 2, the amount of potassium iodate added (0.2-1.0 g/L) is out of the range indicated by the present invention, and the stability of pH value and available iodine content is not good enough.
As can be seen from Table 3, the pH and the available iodine content were not stable enough when the pH was adjusted to a value outside the range of the present invention (5.20 to 5.30) by adding NaOH.
As can be seen from Table 4, the addition of sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, potassium iodate, sodium lauryl sulfate, and sodium hydroxide according to the embodiment of the present invention maintained good stability of available iodine content and pH.
As can be seen from table 5, the povidone-iodine solution prepared according to the original formulation has poor stability of pH and available iodine content.
The test results show that the pH value and the effective iodine content in the povidone-iodine solution can be more stable according to the raw material composition ratio and the preparation method.

Claims (6)

1. The povidone-iodine solution with enhanced stability is characterized by consisting of povidone-iodine, sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, potassium iodate, sodium dodecyl sulfate and purified water, wherein the concentration of each raw material is as follows:
5-20 g/L of povidone iodine, 1-10 g/L of sodium dihydrogen phosphate, 0.5-2 g/L of disodium hydrogen phosphate dodecahydrate, 0.2-1.0 g/L of potassium iodate and 1-10 g/L of sodium dodecyl sulfate, and adjusting the pH value of a sodium hydroxide solution to 5.20-5.30.
2. The povidone-iodine solution of claim 1, wherein the concentrations of the respective raw materials are as follows:
5g/L of povidone iodine, 2g/L of sodium dihydrogen phosphate, 1.5g/L of disodium hydrogen phosphate dodecahydrate, 0.3g/L of potassium iodate and 2.5g/L of sodium dodecyl sulfate, and the pH value of a sodium hydroxide solution is adjusted to be 5.2.
3. The method of claim 1 or 2, wherein the sodium hydroxide solution has a concentration of 5% w/v.
4. A process for preparing the povidone-iodine solution of claim 1 or 2, comprising the steps of:
(1) weighing raw materials: weighing the raw materials according to the concentrations of the raw materials in the claim 1 or 2;
(2) preparation of solution 1: adding the weighed sodium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate and potassium iodate into purified water to dissolve the sodium dihydrogen phosphate, the disodium hydrogen phosphate dodecahydrate and the potassium iodate to obtain a solution 1;
(2) preparation of solution 2: dissolving the weighed sodium dodecyl sulfate in purified water to obtain a solution 2;
(3) preparation of sodium hydroxide solution: taking sodium hydroxide, and adding purified water to prepare a sodium hydroxide solution;
(4) and adding purified water into the weighed povidone iodine, standing overnight, stirring the weighed povidone iodine by using an electric stirrer until the weighed povidone iodine is completely dissolved, adding the solution 1, continuously and fully stirring the solution, adding the solution 2, fully stirring the solution uniformly, adding purified water to a constant volume, stirring the solution uniformly, and adjusting the pH value to 5.20 to 5.30 by using a sodium hydroxide solution to obtain the povidone iodine solution with enhanced stability.
5. The method of claim 4, wherein the sodium hydroxide solution is at a concentration of 5% w/v.
6. Use of a povidone-iodine solution as defined in any one of claims 1 to 3 in the preparation of a bactericide or disinfectant.
CN202011280535.0A 2020-11-16 2020-11-16 Povidone-iodine solution with enhanced stability and preparation method thereof Active CN112315974B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202011280535.0A CN112315974B (en) 2020-11-16 2020-11-16 Povidone-iodine solution with enhanced stability and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202011280535.0A CN112315974B (en) 2020-11-16 2020-11-16 Povidone-iodine solution with enhanced stability and preparation method thereof

Publications (2)

Publication Number Publication Date
CN112315974A true CN112315974A (en) 2021-02-05
CN112315974B CN112315974B (en) 2023-05-16

Family

ID=74317601

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202011280535.0A Active CN112315974B (en) 2020-11-16 2020-11-16 Povidone-iodine solution with enhanced stability and preparation method thereof

Country Status (1)

Country Link
CN (1) CN112315974B (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113396930A (en) * 2021-07-13 2021-09-17 武汉华扬动物药业有限责任公司 Compound iodine disinfectant for aquaculture and preparation method thereof
CN113615708A (en) * 2021-07-19 2021-11-09 西安交通大学 Corneal contact lens nursing composition, preparation method and application
CN113855628A (en) * 2021-11-02 2021-12-31 广东托尔沃登卫生用品有限公司 Production process of povidone iodine disinfectant and product thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102550601A (en) * 2010-12-22 2012-07-11 昆明振华制药厂有限公司 Iodine disinfection liquid and preparation method thereof
CN102919269A (en) * 2012-11-02 2013-02-13 青岛康地恩药业股份有限公司 Povidone-iodine disinfectant and preparation method thereof
CN102949338A (en) * 2012-11-17 2013-03-06 河南省康星药业有限公司 5% povidone-iodine solution for dairy cattle with strong stability and preparation process thereof
US20140255332A1 (en) * 2011-08-25 2014-09-11 Altacor Limited Ophthalmic formulations
CN104906127A (en) * 2015-06-03 2015-09-16 哈尔滨乐泰药业有限公司 Povidone iodine compound preparation with enhanced available iodine content stability and preparation method thereof
CN110037940A (en) * 2019-05-22 2019-07-23 浙江欧洁科技股份有限公司 A kind of sterilizing oral disinfection mouthwash and preparation method thereof and application method
CN110051687A (en) * 2019-04-21 2019-07-26 云南钰普生物科技有限公司 A kind of drip proof type povidone iodine disinfection preserved material and its preparation method and application

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102550601A (en) * 2010-12-22 2012-07-11 昆明振华制药厂有限公司 Iodine disinfection liquid and preparation method thereof
US20140255332A1 (en) * 2011-08-25 2014-09-11 Altacor Limited Ophthalmic formulations
CN102919269A (en) * 2012-11-02 2013-02-13 青岛康地恩药业股份有限公司 Povidone-iodine disinfectant and preparation method thereof
CN102949338A (en) * 2012-11-17 2013-03-06 河南省康星药业有限公司 5% povidone-iodine solution for dairy cattle with strong stability and preparation process thereof
CN104906127A (en) * 2015-06-03 2015-09-16 哈尔滨乐泰药业有限公司 Povidone iodine compound preparation with enhanced available iodine content stability and preparation method thereof
CN110051687A (en) * 2019-04-21 2019-07-26 云南钰普生物科技有限公司 A kind of drip proof type povidone iodine disinfection preserved material and its preparation method and application
CN110037940A (en) * 2019-05-22 2019-07-23 浙江欧洁科技股份有限公司 A kind of sterilizing oral disinfection mouthwash and preparation method thereof and application method

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
SACHIN S THAKUR: "Ex vivo evaluation of the influence of pH on the ophthalmic safety, antibacterial efficacy and storage stability of povidone-iodine", 《CLINICAL AND EXPERIMENTAL OPTOMETRY》 *
周庆民,等: "pH值对聚维酮碘溶液稳定性的影响", 《中国乳业》 *
姜山,等: "提高聚维酮碘溶液稳定性的方法", 《中国医院药学杂志》 *
栗金权,等: "表面活性剂与增稠剂影响聚维酮碘溶液稳定性的研究", 《浙江化工》 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113396930A (en) * 2021-07-13 2021-09-17 武汉华扬动物药业有限责任公司 Compound iodine disinfectant for aquaculture and preparation method thereof
CN113615708A (en) * 2021-07-19 2021-11-09 西安交通大学 Corneal contact lens nursing composition, preparation method and application
CN113855628A (en) * 2021-11-02 2021-12-31 广东托尔沃登卫生用品有限公司 Production process of povidone iodine disinfectant and product thereof
CN113855628B (en) * 2021-11-02 2023-03-14 广东托尔沃登卫生用品有限公司 Production process of povidone iodine disinfectant and product thereof

Also Published As

Publication number Publication date
CN112315974B (en) 2023-05-16

Similar Documents

Publication Publication Date Title
CN112315974B (en) Povidone-iodine solution with enhanced stability and preparation method thereof
JP3531945B2 (en) Stable povidone-iodine ophthalmic solution
EP0487066B1 (en) Disinfectant composition
CN104013573B (en) Available iodine content is the liquid PVP-I of 5-12%
US4954351A (en) Method of producing standardized povidone iodine preparations and such preparations
CN108566954A (en) A kind of disinfectant and its preparation method and application
CN110200989A (en) A kind of stable antiseptic solution for clinic
CN105853397B (en) A kind of povidone iodine concentrate and its preparation method and application
CN112088898B (en) Composition containing oxidation-reduction potential water and preparation method thereof
CN102550601A (en) Iodine disinfection liquid and preparation method thereof
US20210401878A1 (en) Stable Pharmaceutical Articles Containing Dilute Povidone Iodine Formulations
US4427631A (en) Povidone irradiation
CN113318122B (en) Disinfectant composition containing povidone iodine and application thereof
EP0120301B2 (en) Method of producing standardized iodophor preparations and such preparations
KR20200081160A (en) Povidone-Iodine Stable Compositions Containing Sodium Chloride
Benk et al. Economical method for producing nascent iodine products with aprotic solvents (NMP, DMSO) possessing highly effective antimicrobial properties
CN113396930A (en) Compound iodine disinfectant for aquaculture and preparation method thereof
CN105560271A (en) Chitosan povidone-iodine solution and manufacturing technologythereof
WO2023129596A2 (en) Povidone iodine solution and gel, preparation method and application thereof
US6203484B1 (en) Methods for disinfecting wastes
CN109673669A (en) A kind of preparation method and applications of nanometer of micro emulsion iodine
GB2517107A (en) Disinfectant containing a complex of iodine and cyclodextrin
CN108186567B (en) Iodophor cleaning and disinfecting aerosol for personal care and preparation method thereof
CN116407489A (en) Water-soluble povidone-iodine gel, and preparation method and application thereof
CN116407491A (en) Povidone-iodine solution, preparation method and application thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant