Povidone iodine liquid preparation for oral bacteriostasis
Technical Field
The invention belongs to the field of oral disinfectants, and particularly relates to a disinfectant for oral cavityTreatment orAn agent for inhibiting microbial infection of the oral cavityIn particular to a povidone iodine liquid preparation for oral bacteriostatic treatment.
Background
Oral diseases, particularly oral infections, seriously affect people's normal life. The oral cavity, however, is inevitably exposed to the external environment, which results in the oral cavity being inevitably attacked by microorganisms. The breeding of microorganisms in the oral cavity can affect the treatment effect and can lead to the deterioration of the state of an illness in severe cases. In the process of oral treatment, effective removal of bacteria in the oral cavity is crucial to guarantee the treatment effect, and the key point of whether the treatment purpose can be achieved is in most cases. How to control the growth of microorganisms in the oral cavity with high efficiency plays an important role in preventing and treating oral diseases.
Povidone iodine (PVP-I), also known as iodophor, is a complex formed by taking surface active polyvinylpyrrolidone as a carrier and iodine, and is a durable, efficient and non-selective disinfection and sterilization medicine. The document reports that the povidone iodine has strong killing power on various bacteria, viruses and fungi such as hepatitis A virus, hepatitis B virus, black variant spore of bacillus subtilis, staphylococcus aureus, escherichia coli, pseudomonas aeruginosa, influenza virus, gonococcus, treponema pallidum, AIDS and the like, and does not generate drug resistance. The povidone iodine has wide application range, can directly contact wound surfaces and mucous membranes, has no irritation and burning sensation, and has lasting effect. Besides the disinfection of preoperative skin and operation of doctors and nurses in hospitals, the disinfectant also can be used for rinsing pus cavities, treating burn wounds, disinfecting oral cavities, eyes, noses and urogenital mucous membranes and disinfecting medical instruments, tableware and public health environments. Has water solubility, certain cleaning function, no influence of blood plasma, blood, pus, soap, etc. to reduce its curative effect, safe and convenient use and no toxic side effect. The povidone iodine has good curative effect on infection of oral fungi, candida and the like, and has good curative effect on the treatment of the treatment evaluation of the curative effect of the moderate and severe chronic periodontitis. At present, the preparation of povidone iodine for oral cavity is mainly used clinically in gargle and gargle modes. However, in use, the patient reflects the common fishy smell of iodine, discomfort is brought to the patient during use, the patient cannot voluntarily follow the medical advice, the medication compliance is poor, and the curative effect cannot be ensured.
The odor of the iodine of the conventional oral povidone iodine liquid preparation is mainly caused by two reasons, namely taste, and the povidone iodine can stimulate taste cells to cause discomfort. Secondly, the smell of the nose is that the povidone iodine can stimulate the nasal cavity and further cause discomfort. The double stimulation of povidone iodine to taste and smell causes poor taste and patient compliance of povidone iodine liquid preparations, and the clinical treatment effect is difficult to ensure. The povidone iodine liquid preparation which is easily accepted by people is prepared under the prospect of not reducing the sterilization effect of the povidone iodine, and the povidone iodine liquid preparation has very important significance for improving the compliance of patients and improving the curative effect of treating oral diseases.
Disclosure of Invention
The object of the present invention is to overcome at least one of the differences of the prior art and to provide a povidone-iodine liquid preparation for antibacterial treatment of the oral cavity.
The technical scheme adopted by the invention is as follows:
in a first aspect of the present invention, there is provided:
the povidone iodine liquid preparation for oral bacteriostatic treatment comprises povidone iodine, wherein the mass concentration of the povidone iodine is 0.03-0.08%, and saccharin sodium with the mass concentration of 0.01-0.05%, menthol with the mass concentration of 0.01-0.05%, anise oil with the mass concentration of 0.001-0.005%, eucalyptus oil with the mass concentration of 0.001-0.005% and the balance of water are also added.
In some examples of the povidone-iodine liquid preparation, the mass concentration of the saccharin sodium is 0.02 to 0.04%, the mass concentration of the menthol is 0.015 to 0.025%, the mass concentration of the anise oil is 0.002 to 0.004%, and the mass concentration of the eucalyptus oil is 0.002 to 0.004%. Experimental data show that the liquid preparation with the composition has relatively better taste and is more easily accepted.
In some examples of povidone-iodine liquid preparations, the mass concentration of saccharin sodium is 0.02%, the mass concentration of menthol is 0.015 to 0.025%, the mass concentration of anise oil is 0.002 to 0.003%, and the mass concentration of eucalyptus oil is 0.002 to 0.004%.
In some examples of povidone-iodine liquid formulations, the mass concentration of sodium saccharin is 0.02%, the mass concentration of menthol is 0.015%, the mass concentration of anise oil is 0.002%, and the mass concentration of eucalyptus oil is 0.002%.
In some examples of the povidone-iodine liquid preparation, the mass concentration of saccharin sodium is 0.03%, the mass concentration of menthol is 0.015 to 0.025%, the mass concentration of anise oil is 0.002 to 0.004%, and the mass concentration of eucalyptus oil is 0.002 to 0.004%.
In some examples of povidone-iodine liquid preparations, the mass concentration of saccharin sodium is 0.03%, the mass concentration of menthol is 0.015 to 0.020%, the mass concentration of anise oil is 0.002 to 0.003%, and the mass concentration of eucalyptus oil is 0.003 to 0.004%.
In some examples of povidone-iodine liquid formulations, the mass concentration of sodium saccharin is 0.03%, the mass concentration of menthol is 0.020%, the mass concentration of anise oil is 0.002%, and the mass concentration of eucalyptus oil is 0.003%.
In some examples of povidone-iodine liquid formulations, the mass concentration of sodium saccharin is 0.04%, the mass concentration of menthol is 0.015%, the mass concentration of anise oil is 0.004%, and the mass concentration of eucalyptus oil is 0.003%.
With the preferred composition, better mouthfeel can be brought.
The mass concentration of the povidone iodine can ensure effective disinfection and bacteriostasis. In some examples of povidone-iodine liquid formulations, the mass concentration of povidone-iodine is 0.05%.
In a second aspect of the present invention, there is provided:
the preparation method of the povidone iodine liquid preparation comprises the steps of dissolving menthol, anise oil and eucalyptus oil in ethanol, mixing the ethanol solution of the menthol, the anise oil and the eucalyptus oil with povidone iodine, saccharin sodium and water, dissolving, filtering, and subpackaging to obtain the povidone iodine liquid preparation.
In some examples of preparation methods, 95v/v% ethanol is used to dissolve menthol, anise oil, eucalyptus oil.
The invention has the beneficial effects that:
the povidone iodine liquid preparation of some examples of the invention has good taste, weak stimulation to oral cavity and nasal cavity and high medication compliance, and well ensures the curative effect of the product.
According to the povidone iodine liquid preparation provided by some examples of the invention, the mouthfeel regulator is reasonably prepared, so that the povidone iodine liquid preparation has good mouthfeel, and meanwhile, the sterilization and bacteriostasis effects of the povidone iodine liquid preparation are not influenced, and the povidone iodine liquid preparation is particularly suitable for oral sterilization and bacteriostasis.
Detailed Description
The technical scheme of the invention is further explained by combining the examples and experimental data.
In the following examples, the addition amounts of the respective components are mass addition amounts unless otherwise specified.
The povidone iodine liquid preparation is prepared by the following method:
accurately weighing povidone iodine, saccharin sodium, menthol, anise oil and eucalyptus oil, dissolving the menthol, the anise oil and the eucalyptus oil with a proper amount of 95v/v% ethanol, then uniformly mixing the ethanol solution of the menthol, the anise oil and the eucalyptus oil with the povidone iodine, the saccharin sodium and purified water, filtering and subpackaging to obtain the compound.
Taste evaluation method
The reference method selects 6 healthy volunteers, the stomatologist examines the oral cavity condition of the volunteers before gargling, carefully explains the gargling mode, the retention time, the evaluation method and the caution items to the volunteers, and the volunteers are allowed to gargle sequentially after no special problems exist. 20 ml of each mouthwash was placed in the mouth, the lips were closed and the cheeks were massaged 5 times, left for 20 seconds and expectorated. Advising the patient not to swallow the gargle, if the patient has no influence on the body if the patient misswallows the gargle, throwing the gargle into a gargle cup after gargling, and then washing 2-3 times with clear water. The stomatologist evaluated the volunteer's oral status within 5min after gargling, and replaced the next mouthwash after 30 min intervals. The subjective feelings of the volunteers, including the mouth feel of the mouthwash, the mucous membrane irritation and the tongue irritation, were evaluated by the stomatologist within 5min after gargling, and were expressed in 0-10 points. The larger the score is, the better the taste is, and the 0-3 scores indicate that the taste is poor and strong in stimulation and cannot be accepted; 4-6 points show that the tea has common taste, strong stimulation and can be accepted; 7-10 points indicate good taste, weak stimulation and complete acceptability.
The compositions and mouthfeel scores of the examples are shown in table 1:
table 1 composition and mouthfeel scores for different examples
Note: the mass concentration of the povidone iodine is 0.05 percent, the balance is water, and the total amount is 100 mL.
The composition and mouthfeel scores for each scale are shown in table 2:
table 2 composition and mouthfeel scores of different comparative examples
Note: the mass concentration of the povidone iodine is 0.05 percent, the balance is water, and the total amount is 100 mL.
Action of different povidone iodine solutions on staphylococcus aureus, escherichia coli and candida albicans
The inspection basis is as follows: disinfection Specification (2002 edition) 2.1.11.
And (3) testing conditions: the temperature is 20-22 ℃, and the relative humidity is 50-52%.
Sample preparation: a 0.05% povidone-iodine aqueous solution, povidone-iodine liquid formulation of example 10.
0.05% povidone-iodine aqueous solution, povidone-iodine solution of example 10
The data of the bacteriostatic rate of 2min and 5min on staphylococcus aureus, escherichia coli and candida albicans are shown in tables 3-5 respectively.
TABLE 3 bacteriostatic effect of samples on Staphylococcus aureus
As can be seen from the data in Table 3, the inhibitory effect of the different samples on Staphylococcus aureus did not differ.
TABLE 4 bacteriostatic effect of samples on E.coli
As can be seen from the data in Table 4, there was no difference in the inhibitory effect of the different samples on E.coli.
TABLE 5 bacteriostatic effect of samples on Candida albicans
As can be seen from the data in Table 5, there was no difference in the inhibitory effect of different samples on Candida albicans.
And (4) conclusion:
the taste of the povidone iodine liquid preparation is influenced by various factors, and the taste is influenced by the small difference of the composition and the dosage of the taste regulator, which is difficult to predict.
The mouthfeel scores of example 10, example 04, example 12, example 11, example 01, example 07 and example 06 were relatively better, above 8 points; the mouthfeel scores of example 10, example 04 and example 12, even higher than 9 points, are better choices; the subjective sensations after rinsing with the povidone-iodine liquid formulation of example 10, including mouth feel of the rinse, mucosal irritation and tongue irritation, were fed back with good mouth feel, less irritation, and were fully acceptable and best in all examples.
Under test conditions, the povidone iodine liquid preparation in example 10 has average bacteriostasis rates of 99.95% to staphylococcus aureus, escherichia coli and candida albicans after 2min and 5min of action, and has no difference with the average bacteriostasis rates of 0.05% povidone iodine aqueous solution without the taste regulator to staphylococcus aureus, escherichia coli and candida albicans.
The foregoing is a more detailed description of the invention and is not to be taken in a limiting sense. It will be apparent to those skilled in the art that simple deductions or substitutions without departing from the spirit of the invention are within the scope of the invention.