Detection composition and method for detecting content of chlorhexidine gluconate in degerming liquid

Abstract

The invention provides a detection composition and a method for detecting the content of chlorhexidine gluconate in a degerming solution. In particular, the detection composition comprises: 0.1 to 20 wt% of boric acid or borate; 5 to 25% by weight of a micellar stabilizer; and 70 to 94.5% by weight of water. The method comprises the following steps: (a) adding a degerming solution into the detection composition, stirring and standing to obtain a mixed solution; and (b) determining the content of chlorhexidine gluconate in the degerming solution by observing the opaqueness of the mixed solution. By adopting the detection composition provided by the invention, the content of chlorhexidine gluconate in the degerming liquid can be quickly and conveniently determined.

Description

Technical Field

[0001] The present invention relates to the field of chemical analysis, and more particularly, to a detection composition and a method for detecting the content of chlorhexidine gluconate in a bactericidal solution. Background Art

[0002] Chlorhexidine gluconate (CHG) is a biguanide chlorobenzene, and more particularly, a disinfectant with a relatively strong broad-spectrum antibacterial and bactericidal effect, which is effective against both Gram-positive bacteria and Gram-negative bacteria. Chlorhexidine gluconate is widely used for skin disinfection, wound irrigation, and is the main active ingredient in bactericidal solution products such as hand sanitizers and disinfectants.

[0003] However, the bactericidal solution containing chlorhexidine gluconate may volatilize, decompose, etc. due to storage environmental conditions during storage, transportation, and use, which results in a decrease in the bactericidal efficacy of chlorhexidine gluconate. At present, regarding the bactericidal efficacy of bactericidal solution products containing chlorhexidine gluconate, the concentration of chlorhexidine gluconate in the product is usually detected by ultraviolet spectroscopy or liquid chromatography. However, the above testing methods have the disadvantages of complex testing procedures, time-consuming and laborious.

[0004] Therefore, it is of great significance to develop a testing method that can quickly and conveniently determine the content of chlorhexidine gluconate in a bactericidal solution. Summary of the Invention

[0005] Based on the technical problems described above, the object of the present invention is to provide a detection composition and a method for detecting the content of chlorhexidine gluconate in a bactericidal solution. By using the detection composition according to the present invention, the content of chlorhexidine gluconate in a bactericidal solution can be quickly and conveniently determined.

[0006] The inventors of the present invention have completed the present invention through in-depth and meticulous research.

[0007] According to one aspect of the present invention, there is provided a detection composition, based on the total weight of the detection composition, the detection composition comprises:

[0008] 0.1 to 20% by weight of boric acid or borate;

[0009] 5 to 25% by weight of a micelle stabilizer; and

[0010] 70 - 94.5% by weight of water.

[0011] According to certain preferred embodiments of the present invention, the detection composition comprises 5 to 10% by weight of boric acid or borate.

[0012] According to certain preferred embodiments of the present invention, the detection composition comprises 5 to 20% by weight of the micelle stabilizer.

[0013] According to certain preferred embodiments of the present invention, the detection composition comprises 70-90% by weight of water.

[0014] According to certain preferred embodiments of the present invention, the borate is sodium borate or potassium borate.

[0015] According to certain preferred embodiments of the present invention, the borate is sodium borate.

[0016] According to certain preferred embodiments of the present invention, the micelle stabilizer is selected from glycerol and ethylene glycol or a mixture thereof.

[0017] According to certain preferred embodiments of the present invention, the micelle stabilizer is glycerol.

[0018] According to another aspect of the present invention, there is provided a method for detecting the content of chlorhexidine gluconate in a disinfectant solution, the method comprising:

[0019] (a) adding the disinfectant solution to the above-mentioned detection composition, stirring and standing to obtain a mixed solution; and

[0020] (b) determining the content of chlorhexidine gluconate in the disinfectant solution by observing the opacity of the mixed solution.

[0021] According to certain preferred embodiments of the present invention, in step (a), the weight ratio of the disinfectant solution to the detection composition is in the range of 10:1 to 100:1.

[0022] According to certain preferred embodiments of the present invention, in step (b), the content of chlorhexidine gluconate in the disinfectant solution is determined by comparing the opacity of the mixed solution with a series of reference substances.

[0023] According to certain preferred embodiments of the present invention, the series of reference substances is a series of reference solutions or a series of photographs.

[0024] According to certain preferred embodiments of the present invention, the series of reference solutions is prepared by a method comprising the following steps:

[0025] (a) weighing a series of different weights of chlorhexidine gluconate and dissolving them separately in water, ethanol or a mixture thereof to obtain a series of chlorhexidine gluconate solutions with different concentrations; and

[0026] (b) mixing the series of chlorhexidine gluconate solutions with different concentrations with the detection composition according to the above and standing.

[0027] According to certain preferred embodiments of the present invention, the series of control solutions respectively contain known amounts of chlorhexidine gluconate.

[0028] According to certain preferred embodiments of the present invention, the series of photos are obtained by taking photos of the series of control solutions respectively.

[0029] According to certain preferred embodiments of the present invention, the bactericidal solution is hand sanitizer or disinfectant water.

[0030] Compared with the prior art in the field, the advantages of the present invention are as follows:

[0031] 1. The method for preparing the detection composition according to the present invention is simple and low-cost; and

[0032] 2. By using the detection composition according to the present invention, the content of chlorhexidine gluconate in the bactericidal solution can be determined quickly and conveniently. Detailed Embodiments

[0033] The present invention will be further described in detail below in conjunction with specific embodiments. It will be understood that other embodiments are contemplated and can be practiced without departing from the scope or spirit of the present invention. Therefore, the following detailed description is non-limiting.

[0034] Unless otherwise specified, all numbers representing characteristic dimensions, quantities, and physical and chemical properties used in this specification and claims should be understood to be modified by the term "about" in all cases. Therefore, unless there is a contrary indication, the numerical parameters listed in the above specification and appended claims are approximate values, and those skilled in the art can appropriately change these approximate values in seeking to obtain the required characteristics using the teachings disclosed herein. The use of numerical ranges expressed with endpoints includes all numbers within that range and any range within that range. For example, 1 to 5 includes 1, 1.1, 1.3, 1.5, 2, 2.75, 3, 3.80, 4, and 5, and so on.

[0035] As mentioned above, there is an urgent need to develop a test method that can quickly and conveniently determine the content of chlorhexidine gluconate in a bactericidal solution. The inventors of the present invention have found through research that chlorhexidine gluconate undergoes a complexation reaction when in contact with specific boric acid compounds, and the complex forms white suspended matter by suspending as micelles in water, thereby causing a change in the opacity (turbidity) of the dispersion. By observing this change in the opacity (turbidity) of the dispersion, the content of chlorhexidine gluconate in the bactericidal solution can be determined. The development idea of the present invention is based on the above discovery.

[0036] Specifically, according to one aspect of the present invention, a detection composition is provided. Based on the total weight of the detection composition, the detection composition comprises:

[0037] 0.1 to 20% by weight of boric acid or borate;

[0038] 5 to 25% by weight of a micelle stabilizer; and

[0039] 70 - 94.5% by weight of water.

[0040] According to the technical solution of the present invention, a combination of boric acid or borate, a specific micelle stabilizer and water in a specific ratio is provided. When a bactericidal solution containing chlorhexidine gluconate is mixed with the detection composition, a suspension with a good observable opacity (turbidity) change gradient can be formed, and the suspension can maintain the stability of opacity (turbidity) for a long time without generating flocculent precipitates, which is beneficial to the later detection application of the chlorhexidine gluconate concentration.

[0041] Preferably, in order to achieve a better observable opacity (turbidity) change gradient and opacity (turbidity) stability for easy observation and comparison, the detection composition comprises 5 to 10% by weight of boric acid or borate.

[0042] Preferably, in order to achieve a better observable opacity (turbidity) change gradient and opacity (turbidity) stability for easy observation and comparison, the detection composition comprises 5 to 20% by weight of the micelle stabilizer.

[0043] Preferably, in order to achieve a better observable opacity (turbidity) change gradient and opacity (turbidity) stability for easy observation and comparison, the detection composition comprises 70 - 90% by weight of water.

[0044] According to the technical solution of the present invention, the borate as an essential component is preferably sodium borate or potassium borate. More preferably, the borate is sodium borate.

[0045] According to the technical solution of the present invention, a micelle stabilizer is used to stabilize the micelles formed by chlorhexidine gluconate and boric acid compounds. Preferably, the micelle stabilizer is glycerol, ethylene glycol or a mixture thereof. More preferably, the micelle stabilizer is glycerol. Preferably, the micelle stabilizer is not disodium ethylenediaminetetraacetate (EDTA-2Na), citric acid or phosphoric acid. The inventors of the present invention have found that chlorhexidine gluconate and boric acid compounds can form micelles. These micelles are mainly water-insoluble solids, which have a hydrophilic outer shell in their microstructure, enabling them to be stably suspended in water for a certain period of time. On the other hand, although disodium ethylenediaminetetraacetate (EDTA-2Na), citric acid and phosphoric acid can also form solids with chlorhexidine gluconate, they cannot form a stable micelle structure. These solids cannot be stably suspended but rather quickly form precipitates in the solution. Therefore, it is impossible to observe and compare the transparency of the solution.

[0046] There is no specific limitation on the method for preparing the detection composition according to the present invention, and it can be prepared by simply mixing and stirring the individual components constituting the detection composition.

[0047] According to another aspect of the present invention, there is provided a method for detecting the content of chlorhexidine gluconate in a disinfectant solution, the method comprising:

[0048] (a) adding the disinfectant solution to the above-mentioned detection composition, stirring and standing to obtain a mixed solution; and

[0049] (b) determining the content of chlorhexidine gluconate in the disinfectant solution by observing the opacity of the mixed solution.

[0050] According to the above technical solution of the present invention, chlorhexidine gluconate in the disinfectant solution will undergo a complexation reaction when contacting with specific boric acid compounds in the detection composition. The complex forms micelles and is suspended in water to form a white suspension, thereby causing a change in the opacity (turbidity) of the dispersion. By observing the change in the opacity (turbidity) of this dispersion, the determination of the content of chlorhexidine gluconate in the disinfectant solution can be achieved.

[0051] Preferably, in the above step (a), the weight ratio of the sterilizing solution to the detection composition is in the range of 10:1 to 100:1, preferably 50:1 to 100:1, more preferably 70:1 to 100:1. When the weight ratio of the sterilizing solution to the detection composition is less than 10:1, since too few complex micelles are produced, the opacity (turbidity) of the dispersion is too low to accurately determine the content of chlorhexidine gluconate in the sterilizing solution. On the other hand, when the weight ratio of the sterilizing solution to the detection composition is greater than 100:1, since the content of the boric acid compound is too small, chlorhexidine gluconate cannot be completely complexed to form micelles, so the determined content of chlorhexidine gluconate in the sterilizing solution is lower than the actual value.

[0052] Preferably, the observation method used in step (b) of the above method is visual observation.

[0053] According to some preferred embodiments of the present invention, in order to more accurately determine the content of chlorhexidine gluconate, in step (b), the content of chlorhexidine gluconate in the sterilizing solution is determined by comparing the opacity of the mixed solution with a series of reference substances.

[0054] Preferably, the series of reference substances are a series of reference solutions (for example, 5, 8, 10, 20 reference solutions) or a series of photos (for example, 5, 8, 10, 20 photos).

[0055] According to some preferred embodiments of the present invention, the series of reference solutions are prepared by a method including the following steps:

[0056] (a) Weigh a series of different weights of chlorhexidine gluconate and dissolve them separately in water, ethanol or a mixture thereof to obtain a series of chlorhexidine gluconate solutions with different concentrations; and

[0057] (b) Mix the series of chlorhexidine gluconate solutions with different concentrations with the above-mentioned detection composition and let them stand.

[0058] The above technical solution utilizes a judgment method similar to that of a "color comparison card" or "pH test paper", in which the content of chlorhexidine gluconate in the sterilizing solution is determined by comparing the opacity (turbidity) of the mixed solution with the opacity (turbidity) of a series of reference solutions or a series of photos.

[0059] Preferably, the series of reference solutions respectively contain chlorhexidine gluconate with known contents. More preferably, the known contents of chlorhexidine gluconate (e.g., "0 wt% CHG", "0.1 wt% CHG", "0.5 wt% CHG", "10 wt% CHG") are marked on the containers (such as beakers, volumetric flasks, etc.) that respectively hold the reference solutions for easy comparison and judgment.

[0060] Preferably, the series of photos are obtained by taking photos of the series of reference solutions respectively. More preferably, the known contents of chlorhexidine gluconate (e.g., "0 wt% CHG", "0.1 wt% CHG", "0.5 wt% CHG", "10 wt% CHG") are marked on each of the series of photos for easy comparison and judgment.

[0061] The detection method according to the present invention is used to detect the content of chlorhexidine gluconate in the germicidal liquid. Preferably, the content of chlorhexidine gluconate in the germicidal liquid is generally in the range of 0.1 - 5 wt%. Preferably, the germicidal liquid is hand sanitizer or disinfectant water.

[0062] The present invention will be described in more detail below in conjunction with the embodiments. It should be noted that these descriptions and embodiments are for the purpose of facilitating the understanding of the present invention rather than limiting the present invention. The protection scope of the present invention is subject to the appended claims.

[0063] Examples

[0064] In the present invention, unless otherwise indicated, the reagents used are all commercially available products and are used directly without further purification treatment. In addition, the "% " mentioned is "wt% ", and the "parts " mentioned are "parts by weight ".

[0065] Table 1 List of raw materials used in Examples and Comparative Examples

[0066]

[0067] Example 1

[0068] 0.1 g of sodium borate pentahydrate, 8 g of glycerol and 91.9 g of water are uniformly stirred and mixed to obtain a detection composition as a clear solution.

[0069] The following turbidity measurement tests are carried out on the above-prepared detection composition:

[0070] Use a pipette to take 0.5 mL of Aihuijia hand sanitizer and add it to 20 g of the prepared detection composition. Shake it evenly to obtain a mixed solution, and then let it stand. After 10 minutes, use a turbidimeter (TL2350; Hach Company) to measure the turbidity of the mixed solution as 50 NTU, and take a photo of the mixed solution. After 1 hour, use a turbidimeter to measure the turbidity of the mixed solution as 44 NTU, and take a photo of the mixed solution. After 2 hours, use a turbidimeter to measure the turbidity of the mixed solution as 47 NTU, and take a photo of the mixed solution. After 3 hours, use a turbidimeter to measure the turbidity of the mixed solution as 45 NTU, and take a photo of the mixed solution.

[0071] In this example, the comparability of the chlorhexidine gluconate concentration in the mixed solution is determined by the measured turbidity value of the mixed solution. If the measured turbidity value is within the range of 40 - 190 NTU, the opacity of the mixed solution is convenient for observation and judgment, and the mixed solution has comparability that meets the basic requirements for chlorhexidine gluconate concentration determination; if the measured turbidity value is within the range of 80 - 150 NTU, the mixed solution performs excellently in terms of meeting the comparability of chlorhexidine gluconate concentration determination.

[0072] In the study of detecting the content of chlorhexidine gluconate in the disinfectant solution, the mixed solution with a turbidity value of 80 - 150 NTU performs excellently in terms of meeting the comparability of chlorhexidine gluconate concentration determination. The reason is mainly based on the human eye's resolution ability for the turbidity of the liquid and the influence of this turbidity range on the accuracy and stability of the detection method. The human eye has the best resolution ability for liquids with turbidity values in the range of 80 - 150 NTU under natural light conditions. When the turbidity of the mixed solution is within this range, the human eye can clearly and accurately distinguish the difference in transparency between different mixed solutions. When comparing mixed solutions containing different chlorhexidine gluconate contents, the level of chlorhexidine gluconate content can be intuitively judged by observing the opacity (turbidity) of the mixed solution, providing a reliable visual basis for concentration determination.

[0073] In addition, it should be noted that when the turbidity value is less than 40 NTU, the turbidity of the solution is lower than the lower limit of the human eye's ability to distinguish and compare the transparency of the solution. For solutions with turbidity values less than 40 NTU, the naked eye looks almost colorless and transparent, and it is impossible to intuitively distinguish and compare the difference in transparency of the solution. On the other hand, when the turbidity value is greater than 190 NTU, the turbidity of the solution is higher than the upper limit of the human eye's easy ability to distinguish and compare its transparency. For solutions with turbidity values greater than 190 NTU, the solution basically loses its transparency, making it impossible to intuitively distinguish and compare the difference in transparency of the solution.

[0074] In addition, the photos taken three times are evaluated. If the opacity can be clearly observed in all three photos, it is determined as "qualified"; if the opacity cannot be clearly observed in any one of the three photos, it is determined as "unqualified".

[0075] The composition ratios and test results in Example 1 are shown in Table 2 below.

[0076] Examples 2-10 and Comparative Examples 1-10

[0077] Examples 2-10 and Comparative Examples 1-10 were carried out in a similar manner to Example 1, and the only difference between them was to change the types and contents of the components used to prepare the detection composition. The composition ratios and test results in Examples 2-10 and Comparative Examples 1-10 are shown in Table 2 below.

[0078] Table 2 Composition ratios and performance test results of Examples 1-10 and Comparative Examples 1-10

[0079]

[0080] From the data of Examples 1-10 shown in Table 2, it can be seen that when the detection composition is prepared within the scope of the present invention, the obtained detection composition has good opacity (turbidity) observability when determining the concentration of chlorhexidine gluconate in the mixed solution, and the obtained suspension can be maintained for a long time, which is beneficial to the subsequent determination of the chlorhexidine gluconate concentration comparison.

[0081] From the data of Comparative Examples 1-10 shown in Table 2, it can be seen that when the composition and content of the detection composition do not meet the conditions of the present invention, the obtained detection composition has poor opacity (turbidity) observability when determining the concentration of chlorhexidine gluconate in the mixed solution, and the system is unstable and prone to quickly produce white flocculent precipitates.

[0082] Application Example 1

[0083] Weigh 8 portions of chlorhexidine gluconate with different weights and dissolve them separately in a mixture of water and ethanol (purchased from Sinopharm Chemical Reagent Co., Ltd.) with a weight ratio of 1:4 to obtain 8 series of chlorhexidine gluconate solutions with different concentrations, and their chlorhexidine gluconate concentrations are 0.1 wt%, 0.5 wt%, 1 wt%, 2 wt%, 4 wt%, 5 wt%, 6 wt% and 8 wt% respectively. The above-prepared series of chlorhexidine gluconate solutions are used as Control Solutions 1-8.

[0084] Then, the Aihuijia hand sanitizer that has been used for a period of time and in which there is an uncertain loss of chlorhexidine gluconate is used as the sample to be tested.

[0085] Nine portions each of 1 mL of the detection composition prepared in Example 1 above were respectively added to 80 mL of the sample to be tested and 80 mL each of the control solutions 1-8 to obtain nine mixtures. Then, the appearance of the mixture of the sample to be tested was compared one by one with each of the mixtures of the control solutions 1-8, and the chlorhexidine gluconate concentration (4% by weight) of the control solution 5 with the closest opacity (turbidity) was counted as the chlorhexidine gluconate concentration in the sample to be tested.

[0086] Obviously, those skilled in the art can make various changes and modifications to the present disclosure without departing from the spirit and scope of the present disclosure. Thus, if these modifications and variations of the present disclosure fall within the scope of the claims of the present invention and its equivalent technologies, the present disclosure is also intended to include these modifications and variations.

Claims

1. A detection composition, based on the total weight of the detection composition, the detection composition comprises: 0.1 to 20% by weight of boric acid or borate; 5 to 25% by weight of a micelle stabilizer; and 70 - 94.5% by weight of water.

2. The detection composition according to claim 1, wherein the detection composition comprises 5 to 10% by weight of boric acid or borate.

3. The detection composition according to claim 1, wherein the detection composition comprises 5 to 20% by weight of the micelle stabilizer.

4. The detection composition according to claim 1, wherein the detection composition comprises 70 - 90% by weight of water.

5. The detection composition according to claim 1, wherein the borate is sodium borate or potassium borate.

6. The detection composition according to claim 1, wherein the borate is sodium borate.

7. The detection composition according to claim 1, wherein the micelle stabilizer is glycerol, ethylene glycol or a mixture thereof.

8. The detection composition according to claim 1, wherein the micelle stabilizer is glycerol.

9. A method for detecting the content of chlorhexidine gluconate in a germicidal liquid, the method comprising: (a) adding the germicidal liquid to the detection composition according to any one of claims 1 to 8, stirring and standing to obtain a mixed liquid; and (b) determining the content of chlorhexidine gluconate in the germicidal liquid by observing the opacity of the mixed liquid.

10. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 9, wherein in step (a), the weight ratio of the germicidal liquid to the detection composition is in the range of 10:1 to 100:

1.

11. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 9, wherein in step (b), the content of chlorhexidine gluconate in the germicidal liquid is determined by comparing the opacity of the mixed liquid with a series of reference substances.

12. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 11, wherein the series of reference substances is a series of reference liquids or a series of photos.

13. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 12, wherein the series of reference liquids is prepared by a method comprising the following steps: (a) weighing a series of different weights of chlorhexidine gluconate and dissolving them separately in water, ethanol or a mixture thereof to obtain a series of chlorhexidine gluconate solutions with different concentrations; and (b) mixing the series of chlorhexidine gluconate solutions with different concentrations with the detection composition according to any one of claims 1 to 8 and standing.

14. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 12, wherein the series of reference liquids respectively contain known contents of chlorhexidine gluconate.

15. The method for detecting the content of chlorhexidine gluconate in a germicidal liquid according to claim 12, wherein the series of photos are obtained by taking photos of the series of reference liquids respectively.

16. The method for detecting the content of chlorhexidine gluconate in the sterilizing solution according to claim 9, wherein the sterilizing solution is a hand sanitizer or a disinfectant solution.

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